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[text] => Breast implant maker Allergan issued a recall of breast implants today following a request from the FDA. The agency placed this request upon discovering a link between the Allergan implants and a rare form of immune system cancer, BIA-ALCL (breast implant-associated anaplastic large cell lymphoma).
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[meta_description] => Breast implant maker Allergan issued a recall of breast implants today following a request from the FDA. The agency placed this request upon discovering a link between the Allergan implants and a rare form of immune system cancer, BIA-ALCL (breast implant-associated anaplastic large cell lymphoma).
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[text] => Irvine, California-based Allergan issued today a global recall of its Biocell textured breast implants, going above and beyond an FDA request that the pharmaceutical company voluntarily withdraw specific models of its textured breast implants from the U.S. market.
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[text] => The FDA request was based on an agency analysis indicating that the incidence of a rare form of immune system cancer, BIA-ALCL (breast implant-associated anaplastic large cell lymphoma), was six times more frequent in Allergan implants compared with other brands available in the U.S.
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[text] => Internationally, textured breast implants have been linked to 573 cancer cases and the deaths of 33 women.
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[text] => According to NBC News, 481 of those 573 cancer cases overall involved Allergan implants.
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[text] => As reported by the New York Times, the implant manufacturer was known in 13 cases of death and in 12 out of the 13, the manufacturer was Allergan.
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[text] => The FDA first became aware in 2011 of a possible link between breast implants and cancer. Its voluntary recall request lags behind the 38 other countries which have already recalled the Allergan implants.
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[text] => According to an FDA press release, the recall is intended to ensure the removal of unused products from medical device suppliers and doctors’ offices.
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[text] => The agency issued a safety communication specifying the known risks of these textured breast implants for health care providers, patients with implants and patients considering implants.
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[text] => The FDA advises asymptomatic women to be on the lookout for changes around the breast implant area but does not advise implant removal.
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[text] => Symptoms of BIA-ALCL, which develops not in the breast itself but in surrounding tissues, include swelling, pain and fluid accumulation in the implant area. For a complete list of possible symptoms along with information and resources about the condition, please visit www.biaalcl.com.
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[text] => “Symptomatic women can reach out to us through the website and we can direct them to physicians familiar with the disease,” Michelle Forney, one of three advocates who created the BIA-ALCL website, said.
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[text] => Forney, a human resources manager from Sacramento, California, had her textured Biocell implants removed in January 2018, after being diagnosed with BIA-ALCL.
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[text] => Typically this cancer is cured by removing the implant and surrounding scar tissue, but if not detected and treated early it can be fatal.
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[text] => Textured breast implants, which can be silicone or saline, have a suede-like coating which causes the development of scar tissue in order to reduce the likelihood of movement within the breast.
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[text] => It’s estimated that 10 percent of the 400,000 women undergoing breast implant surgery in the U.S. each year have textured breast implants.
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[text] => “I’m happy to see (this recall). However, what we know today I would say is much different than what we knew yesterday. I think now we know that the magnitude and the seriousness of this disease is changing rapidly, and it’s increasing at an alarming rate. We have now recorded 33+ deaths and that’s growing. From the announcement, I think now we’re at the starting line. I felt before like we were behind the starting line. At least today we can move forward and hopefully the doctors and the pathologists will see the seriousness of this disease and how rapidly it’s increasing and start supporting the women who are symptomatic,” Forney said. “It’s a step in the right direction for sure.”
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[text] => “The next thing is that the FDA will look at the other manufacturers as well as following through with Allergan and strategizing to make sure that all their implant patients are notified of what the symptoms are. That’s what they say, let’s hope they do it,” she said.
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[text] => Some thirty years after the first breast implant procedures, HBO set out to produce the film, "Breast Men." Though the piece does reflect the legal conflicts and health battles that breast implants would go on to create, its crude telling of such a sensitive topic struggles to withstand the test of time.
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[text] => In 1997, Breast Men aired on HBO. Written by John Stockwell and directed by Lawrence O'Neil, the semi-biographical dark comedy film depicts the lives of the two men who invented breast implants.
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[text] => By the title alone, viewers may have expected visuals that would not be broadcasted on regular cable. A film that focuses on plastic surgery and the human body toddles along a fine line. It's clear that the filmmakers had no problem exploring both sides of that line - incorporating the heavy legal onslaught that silicone implants eventually faced along with "breastimonials" in which bare-chested women were filmed from the waist to the shoulders only, while they described their reasoning for getting implants.
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[text] => Though perhaps these clips were an attempt at conveying the female perspective in a film that was largely created by men, they seemed a bit flat in representing the lives of the women. Meanwhile, the hedonistic aftermath of success for the two male stars in the film was quite fleshed out. (No pun intended.)
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[text] => So, who are the two male leads?
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[text] => David Schwimmer and Chris Cooper star as Dr. Kevin Saunders and Dr. William Larson. As the two modern pioneers of aesthetic procedures gain financial success, they go on to lead different lives. Dr. Saunders, played by Schwimmer, quickly falls into the rising fixation with bigger implants - willing to adhere to the high demand for large breasts that was often requested by exotic dancers and women in the sex industry. Alternatively, Dr. Larson pursues a more functional approach to implants - helping cancer survivors with reconstructive surgery after mastectomies.
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[text] => The film is meant to be absurd and comedic, but it does raise a serious question about the ethics of breast implants. The unnaturally large implants that Schwimmer's character willingly placed in those who wanted them represent a corrosion of a procedure that was initially meant to be a confidence-booster and even a form of emotional healing for those whose breasts had been affected by cancer treatment. The humanistic intentions turned to a wild pursuit among women for bigger and better breasts. To this day, the issue remains complex as a result of this dichotomy in function.
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[text] => As far as the test of time goes, it’s hard to take this film seriously when David Schwimmer's character comes across as a darker version Ross from F.R.I.E.N.D.S.. The way his character sexualizes breasts in the film is cringe-worthy, outdated, and frankly offensive in the way it makes light of women coping with serious insecurities as well as breast implant illness. Making light of something that has caused serious complications for patients isn’t Oscar-award-winning. Despite the dark humor, both the acting and long-winded narrative are lackluster and tiresome.
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[text] => Where breast implants were meant to enhance someone’s body, the film objectifies breasts by continuously bombarding the viewer with sexualized images and full frontal shots.
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[text] => It’s relevant to note that the narrative is largely dramatized and the two characters in the film are entirely fictional. Indeed, Texas plastic surgeons Thomas Cronin and Frank Gerow are credited with inventing the first prosthetic breast implant in 1961, but their descent into the world of implants wasn't the kitschy, sexual fever dream story that Hollywood depicted.
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[text] => Breast implants have since been revised following the first implant in 1961, including the incorporation of silicone which has been associated with complications and illness. Still, the obsession with the cosmetic procedure remains. More than 400,000 women and teenagers undergo breast implant augmentation surgeries every year, with 75% for augmentation of healthy breasts and 25% for reconstruction after mastectomy, according to the National Center for Health Research. The popularity of breast implants has risen dramatically in the last 20 years and has more than tripled since 1997.
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[text] => By 2018, there were more than 50,000 women reporting a range of symptoms they refer to as “breast implant illness.”
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[text] => Only time will tell the true implications of the global frenzy that the real breast men incited. The Breast Menfilm, however, is a sensationalized reduction at best.
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[text] => Since 2011, researchers have investigated breast implant cancer. Despite hundreds of cases, women are still unaware of the risks.
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[meta_title] => Investigating Anaplastic Lymphoma, a Breast Implant Cancer Risk
[meta_description] => Since 2011, researchers have investigated breast implant cancer. Despite hundreds of cases, women are still unaware of the risks.
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[text] => Breast implants have been inserted in more than 10 million women worldwide and touted as a safe cosmetic surgery. Whether a procedure is pursued for reconstruction or enhancement, women are often unaware of a potential, life-altering breast implant cancer risk.
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[text] => Since 2011, regulatory authorities, scientific experts and manufacturers have researched the association between breast implants and a rare form of cancer known as anaplastic large-cell lymphoma. Recently, nine deaths and 359 reports of breast implant cancer have raised concerns about the knowledge and treatment of the disease.
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[text] => Some doctors may not inform women of the risk of anaplastic lymphoma, making breast implant cancer awareness an essential women's health issue. Women who developed cancer after having a breast implant procedure are beginning to speak out, informing others about the risk in news coverage and online communities.
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[text] => About ALCL: Research On Breast Implant Cancer
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[text] => Anaplastic large-cell lymphoma (ALCL) is a rare kind of non-Hodgkin’s lymphoma. ALCL is a T-cell lymphoma affecting the immune system, which differs from B-cell breast lymphomas that develop in women without implants. On average, ALCL develops eight years after the implant has been inserted into the breast. However, it may develop within two to 28 years.
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[text] => The National Cancer Institute estimates 1 in 500,000 U.S. women are diagnosed with ALCL each year. Breast ALCL affects an estimated 3 in 100 million U.S. women per year.
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[text] => Though researchers have yet to determine the exact cause, possible factors contributing to ALCL include bacterial inflammation, chronic infection, immune response or genetic predispositions. Textured or roughened implants, rather than smooth-surface implants, may lead to cancer-causing inflammation. Though research about the kind of carcinogenic implant or exact is inconclusive, studies conclude the possibility of developing ALCL is greater in women with breast implants.
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[text] => In 2011, regulatory agencies had identified 60 cases of ALCL in women with breast implants worldwide, which led them to analyze studies from PubMed, Embase, Web of Science and more. Researchers released three key findings:
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[text] => 1. Possible association.
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[text] => Studies show that the incidence of ALCL is low. However, available data illustrates a consistent pattern linking breast implants to the possible development of cancer.
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[text] => The cancer cells form around the breast implant, suggesting an association. If the cancer were unrelated to the implant, researchers believe it would be located throughout the breast. The type of cancer, T-cell lymphoma, is different from the majority of B-cell breast lymphomas, which develop in women without implants.
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[text] => 2. Texture matters.
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[text] => Researchers have yet to determine if saline or silicone implant has a greater risk. Additionally, studies do not show if women undergoing breast reconstruction are more likely to develop cancer than women choosing aesthetic augmentation.
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[text] => Studies show that women with textured implants are more frequently diagnosed with ALCL. Because many ALCL cases are self-reported, it’s difficult to determine how much the texture raises the risk.
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[text] => 3. Statistical uncertainty.
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[text] => Though a possible link has been demonstrated, researchers cannot say with statistical certainty that breast implants cause ALCL. Large-scale studies including thousands of women over a decade are necessary to confirm the risk.
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[text] => The FDA and the American Society of Plastic Surgeons and others are registering reports of ALCL to better understand the potential carcinogenic effects of breast implants. The agency is still reviewing medical device reports to better understand the risk.
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[text] => FDA On Breast Implant Cancer Risk
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[text] => Though some researchers have targeted textured implants as a risk-increasing factor, the Food and Drug Administration (FDA) does not have enough information to initiate recalls. In 2011, the agency released safety announcement summarizing research and providing recommendations to healthcare providers, along with a questions and answers update for women considering breast implants.
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[text] => In March, the agency released an additional announcement encouraging women to "educate yourself about breast implants before agreeing to surgery." For those who have breast implants already, the FDA does not recommend having the implant removed if no symptoms are present.
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[text] => ✚
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[text] => Implants may be reconstructive after a mastectomy, making it particularly difficult for women who have survived another type of cancer to deal with ALCL. Women who experience pain, swelling, lumps and the buildup of fluid should seek medical assistance. Knowing the risks, and getting an examination if you experience symptoms, can lead to early diagnosis and treatment of ALCL. The good news is ALCL is not often fatal.
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[text] => Only about 30 percent of plastic surgeons were routinely discussing the cancer risk patients in 2015, according to Dr. Mark W. Clemens II, a plastic surgeon interviewed by The New York Times.
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[text] => The bad news, however, is that some doctors may not know how to diagnose and treat ALCL. Experts recommend removing the implant and surrounding scar tissue, which is often curative. Some women told the New York Times they underwent numerous rounds of chemotherapy and radiation before the implants were removed.
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[text] => Women have a right to be informed of the risks and, if diagnosed with ALCL, to be treated properly. Please feel free to contact MedTruth advocates for more information.
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[title] => Breast Implants
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[text] => Breast implants can cause life-altering symptoms and are linked to serious illness.
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[text] => Studies have linked breast implants to BIA-ALCL, a type of cancer.
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[text] => Advocates are pressing the FDA to better regulate breast implants and hold manufacturers accountable.
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[meta_description] => Breast implants have been sold in the U.S. since the 1960s. In the past 20 years, studies and patient stories have uncovered serious complications, including breast implant illness and even cancer.
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[text] => Breast implants have been sold in the U.S. since the 1960s. In the past 20 years, studies and patient stories have uncovered serious complications, including breast implant illness and even cancer.
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[text] => A breast implant is a Class III medical device. Implanted under the breast tissue or chest muscle, breast implants are used to increase breast size (augmentation) or rebuild breast tissue after a mastectomy or other damage (reconstruction).
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[text] => Breast implants can be made of silicone gel or saline, with a textured or smooth surface. Manufacturers of approved U.S. breast implants include Allergan, Ideal Implant Incorporated, Mentor World Wide and Sientra.
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[text] => Since the 1980s, breast augmentation has become increasingly popular despite FDA warnings. Associated risks include pain, capsular contracture, additional surgeries, rupture, infection and most recently, a rare type of cancer known as breast implant-associated large cell anaplastic lymphoma (BIA-ALCL).
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[text] => Now, more women are choosing to undergo explant surgery to remove their implants due to discomfort or severe illness. Symptoms reported include skin rash, joint aches, insomnia, memory loss, fatigue, brain fog, vertigo, light and sound sensitivity and excruciating pain.
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[text] => Studies + Science
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[text] => In 2018, more than 310,000 women and teenagers underwent breast augmentation surgery, according to the American Society of Plastic Surgeons. More than 100,000 breast cancer patients underwent reconstructive surgery.
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[text] => While breast implants can vary in size, thickness, surface texture and shape, they all have a silicone outer shell and are filled with either saline or silicone gel.
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[text] => Breast Implant Illness
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[text] => Women report experiencing adverse side effects in the weeks, months or years after undergoing breast implant surgery, but it’s often a struggle for patients to find doctors who can help them — or even believe them.
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[text] => "(The doctors) didn't believe that anything was associated with the breast implants when it came to my health," says Meredith Kilmer, who began experiencing symptoms almost immediately after her implant surgery. Kilmer suffered for 11 years before she was able to remove them.
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[text] => “Every time I would visit a doctor," Kilmer said, "I would mention, ‘Do you think it could be my breast implants?’ and every doctor either would say ‘I’ve never heard of that,’ or emphatically, ‘No.’”
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[text] => However, studies have shown that there may be symptoms of breast implant poisoning, these symptoms may include:
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[text] => Chronic fatigue
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[text] => Joint and muscle pain
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[text] => Brain fog and confusion
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[text] => Vertigo
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[text] => Food and chemical sensitivities
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[text] => Hair loss
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[text] => Dry eyes
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[text] => Persistent flu-like symptoms
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[text] => BIA-ALCL: Breast Implant Cancer
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[text] => Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a type of non-Hodgkin’s lymphoma that forms around a breast implant and causes a build-up of fluid. This cancer of the immune system develops in the capsule surrounding a saline or silicone gel-filled implant.
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[text] => So far, ALCL has only been associated with textured implants. Researchers in Australia and New Zealand confirmed “increased risk” between ALCL and textured implants after analyzing brands connected to the greatest health risks, Allergan and Silimed.
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[text] => Regulation Recap
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[text] => Breast implants, approved by the FDA in 1962, have had a tumultuous regulatory history. In the early '90s, the FDA began to regulate breast implants due to the potential for rupture. The agency advised that physicians should only use breast implants for reconstruction.
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[text] => However, in 2006, the agency lifted the ban on breast implants. An unknown number of women underwent the procedure, later suffering a slew of health issues potentially related to the implant. Data on breast implant illness and ALCL has been largely ignored.
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[text] => A data-based investigation conducted by the Madris Tomes, CEO of Device Events, uncovered more than 350,000 FDA incident reports involving breast implants since 2009. Tomes, who previously worked for the FDA, has built a program that makes it easier to sort and draw conclusions from FDA's existing repository of adverse events.
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[text] => In April 2018, Tomes presented the data to the International Consortium of Investigative Journalists (ICIJ), who continued the work and later launched an in-depth investigation known as The Implant Files. Now, advocates who have suffered from breast implant illness or BIA-ALCL have called for FDA hearings and other regulatory actions to protect the public.
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[text] => A Brief History of Breast Implant Regulation
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[text] => 1962
The silicone breast implant is invented and first augmentation procedure is performed.
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The FDA issues controls and performance standards for silicone breast implants.
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Breast implants are placed in the class III category, the highest-risk class for medical devices.
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[text] => 1991
A jury in San Francisco awards $7.3 million to Mariann Hopkins, who suffered severe illness after her implant ruptured. This was the beginning of thousands of similar lawsuits being filed against breast implant manufacturers by women across the country.
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[text] => 1992
January: The FDA calls for a voluntary moratorium on silicone gel breast implants until further review.
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[text] => April: The FDA advises silicone breast implants only be used for reconstructive surgery or to correct deformities.
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The FDA lifts restrictions on silicone breast implants.
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The World Health Organization designates breast implant-associated ALCL as a T-cell lymphoma that can develop from breast implants with textured surfaces rather than smooth surfaces.
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As of September, the FDA claims to have received 414 medical device reports and reports of nine deaths from ALCL linked to implants.
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As of September, the FDA claims to have received 660 medical device reports of BIA-ALCL, of which 457 were unique and confirmed by a physician or testing. This is a 246 increase from the previous year.
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[text] => However, the International Consortium of Investigative Journalism reports the FDA has received more than 350,000 incident reports involving breast implants since 2009. ICIJ reports the agency has allowed manufacturers to “bury so-called adverse event reports.”
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[text] => December: Textured breast implants manufactured by Allergan are suspended from European and Brazilian markets.
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February: The FDA issues a letter to health care providers to increase awareness of the association between BIA-ALCL and all breast implants. The French government recommends Allergan Biocell implants be permanently banned.
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[text] => March: The FDA holds a two-day public advisory committee meeting on breast implant safety and potential links to life-threatening health problems.
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[text] => The lack of information and resources has moved advocates to create their own. Jamee Cook, founder of the Breast Implant Victim Advocacy group on Facebook, wanted to create a community for advocates to better understand the disease. The group, which now has 6,000 followers, has organized to get the attention of regulatory bodies.
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[text] => “If I had known these things, I wouldn’t have gotten implants,” Cook says. “They’re not lifetime devices. And while the FDA and manufacturers might say that, we still see doctors in that gray area, which is misleading to women. This is just as scary to a physician who should have access to this data.”
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[text] => Michelle Forney, founder of biaalcl.com, created the website in hopes of saving lives. Forney has been present at meetings with the FDA concerning the regulation of breast implants.
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[text] => “Recently there’s been more pressure on the FDA,” Forney says. “They’re listening, and we appreciate that. We need their support, we need them to listen because we’re the ones bringing solutions. We’re doing some of the legwork for them.”
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[text] => Advocates are speaking out about their experiences with breast implants to raise awareness, provide support and get the attention of the FDA, who has reported at least nine deaths linked to BIA-ALCL. Read up on important safety information or report a problem on the FDA’s site.
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[text] => In the past 20 years, more women have been coming forward suffering from symptoms related to their breast implants. While doctors insist these ailments are caused by other health issues, victims of breast implant illness take a stand to share their truth.
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[text] => More than 400,000 women undergo breast augmentation surgery every year for either reconstructive or cosmetic purposes. In the past 20 years, though, more and more women with implants are experiencing similar symptoms: skin rashes, joint aches, brain fog, insomnia, vertigo, light and sound sensitivity, and at times, excruciating pain.
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[text] => In most instances, their doctors have no answers.
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[text] => These mystery ailments are common symptoms of breast implant poisoning. Whether it's the fault of the manufacturers, doctors, or regulatory bodies, the dangerous truth here is that vital information about this condition is kept from patients and endangers life. When it comes to implants, patients are rarely made aware that these devices might contain toxic chemicals and metals. Even in small quantities, these toxins can prove life-altering, and due to the invasive nature of breast implant procedures, it's fairly easy for them to leak into the body. What's more? These toxins which often evade FDA-approval processes can also be linked to autoimmune illness and cancer.
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[text] => So, how can women protect themselves when their health and safety isn’t being prioritized? Efforts to raise awareness of breast implant illness are only beginning, and social media is playing a major role in the widespread effectiveness. More than 170 pages and groups on Facebook are related to breast implant illness — some with more than 70,000 members.
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[text] => “Ladies have been fighting this since the 90s,” says Jamee Cook, founder of the Breast Implant Victim Advocacy group on Facebook.
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[text] => “I wish that they had had the social media outlets that we have now because maybe we wouldn’t be rehashing the same situations. You have women all over the world that are telling you the same stories, suffering the same symptoms, all fighting regulatory bodies.”
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[text] => Cook spoke at the FDA advisory panel hearing in March and has high hopes that regulations will improve. Here, she and two others affected by breast implant illness shared their stories in hopes that, if major legislative powers won’t take action, at least a seed would be planted in the minds of women who would consequently raise their own questions.
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[text] => As Cook stepped out of the shower one morning, she looked down to find her left breast almost completely flat. She knew what had happened: After 14 years, her textured saline implant had ruptured.
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[text] => “I just cried,” Cook says. “I knew there wasn’t anything I could do.”
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[text] => At the time, she couldn’t afford replacement surgery, and three years passed before she had them removed. Now, Cook sees that waiting period as a blessing in disguise. Had she been able to replace the implant right away, she wouldn’t have done the research to find that the ruptured implant had not been approved by the FDA and was linked to complications her doctor hadn’t mentioned.
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[text] => The rupture wasn’t the first cause for concern. About three years after implant, Cook developed an autoimmune disease, chronic fatigue and brain fog. The rupture then led to arm and hand numbness and recurrent migraines. But once the implant was removed, most of these symptoms disappeared immediately.
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[text] => In 2012, there were days Carla Perkins couldn’t raise her hands over her head. Her body felt like it was burning, her joints ached, she was chronically fatigued — and she didn’t know why. When she looks back now, she notices these symptoms appeared within two years of getting smooth saline breast implants.
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[text] => Physical symptoms aren't the end of it, however. Breast implants may also impact cognition. In fact, the cognitive effects of breast implant illness can be even worse than the physical - affecting relationships, jobs, and the ability to lead a normal life.
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[text] => When Perkins first started experiencing brain fog, her surroundings felt completely foreign. She was barely able to move and didn’t want to interact with anyone, which can be especially difficult when you have a son with an intellectual disability. The illness from the breast implants had seeped into every area of her life, but doctors never made the connection and continued to tell her these symptoms were autoimmune-related.
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[text] => In 2018, seven years after undergoing breast augmentation surgery, some unusual test results from her gynecologist alerted Perkins that it was time to explant. She felt a difference the moment she woke up from the surgery. The brain fog had lifted, and she was able to stop taking some of the medication she had relied on for years.
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[text] => Then, within seven months of her explant surgery, Perkins was diagnosed with breast cancer.
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[text] => Weeks later, her fatigue is apparent even through the phone. At the time of this interview, Perkins was to undergo a lumpectomy the following week and possibly need radiation after that. While none of her doctors have explicitly linked the breast cancer to having had breast implants, Perkins has read about cases eerily similar to hers through postings in advocacy groups.
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[text] => For 11 years, Meredith Kilmer was certain her breast implants were the cause of her inability to sleep, shortness of breath, night sweats, weight loss then weight gain, muscle tenderness, and extreme fatigue. She even started to notice some of these same symptoms in her two children that were born after she’d been implanted — both pregnancies had also been almost unbearable, the opposite of her two pregnancies pre-implant.
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[text] => Her doctors denied any correlation and blamed the symptoms on slow C-section healing and being a mom. They recommended therapists and asked about the health of her marriage, but they wouldn’t remove the implants.
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[text] => Finally, a cardiologist she was seeing to treat her newly occurring seizure spells asked if she thought her ailments could be linked to her breast implants.
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[text] => “The second he said that I literally had the energy to sit up and say, ‘Yes, I do. What can you tell me?’” Kilmer says.
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[text] => Within a month she had her implants removed. Almost immediately, she felt the energy return to her body, the stiffness melted away — she could breathe again. Then 28 days later, Kilmer was diagnosed with a rare form of leukemia and given a 20% chance to live.
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[text] => Because she had immersed herself in research regarding her breast implants, she used this knowledge to maintain a strict diet and rest regimen while undergoing full-body chemo and radiation. Now five years out, she is cured. She fully believes the acquired knowledge and explant surgery are what saved her.
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[text] => “The information is out there, we’re just not made privy to it,” Kilmer says. “If I hadn’t removed the implants, I wouldn’t be alive today.”
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[text] => When asked if they would’ve gotten implanted had they known the risks involved, all three women respond with the same: Absolutely not.
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[text] => The majority of women affected by this illness would probably have a similar answer. Every patient deserves the right to make an informed decision. Until further action is taken, women will continue to push the FDA for better regulation, urge doctors to pay closer attention, and demand that manufacturers tell the truth.
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[text] => For more information, visit www.breastimplantillness.com.
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[text] => The FDA has just released a 21-page document articulating the risks and benefits associated with breast implants to ensure that all consumers have access to "complete information" on the medical devices. This is the agency’s first update to breast implant consumer information practices since 2006. All members of the public and professionals of the medical world are invited to comment within the next 60 days for any revisions to the draft before the document is finalized.
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[text] => Today, the FDA released a 21-page document, “Breast Implants – Certain Labeling to Improve Patient Communication,” directed toward breast implant manufacturers and the general public. This draft version allows 60 days for all to comment before the statement is finalized.
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[text] => According to an FDA statement, the intention behind the guidance is to protect women’s health by ensuring women have access to “complete information” regarding the risks and benefits of breast implants. This is the agency’s first update to breast implant consumer information practices since 2006.
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[text] => The guidance includes a product label black box warning, the FDA’s strongest form of warning for consumers, and was developed in response to a two-day public advisory panel hearing held by the agency in March at which dozens of affected women testified about the potential dangers of breast implants.
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[text] => The agency wants the black box to clearly communicate the following information:
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[text] => breast implants cannot be expected to last for a lifetime
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[text] => the chance of complications arising increases the longer a patient has an implant
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[text] => additional surgery may be required to address implant-related complications
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[text] => breast implants may be associated with systemic symptoms like fatigue or joint pain
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[text] => breast implants have been associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
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[text] => The black box warning is perhaps the most dramatic but certainly not the only agency recommendation. The FDA likewise suggested inclusion of a patient decision checklist at the end of a patient information booklet or brochure to encourage patient-doctor consultation, more user-friendly access to ingredient information including chemicals and heavy metals found in or released by breast implants, and the addition of more comprehensive information on the “device cards” given to patients post-surgically.
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[text] => For healthcare providers, the agency proposed revisions to existing rupture screening imaging protocols for patients with silicone gel-filled implants to reflect the most current data on the timing of implant ruptures.
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[text] => The agency has come under increasing pressure in recent years alongside mounting evidence of breast implant dangers, including a March report by the International Consortium of Investigative Journalists (ICIJ) that the FDA had withheld hundreds of thousands of breast implant incidents from the public eye.
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[text] => In March, the FDA issued warning letters to two implant manufacturers regarding their failure to comply with post-approval safety research requirements.
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[text] => In July, the FDA called on manufacturer Allergan to recall its Biocell textured breast implant after it was linked to BIA-ALCL. Textured implants are much more common in Europe where they’ve already been recalled by many countries and represent only 5 percent of implants used in the United States as of a July New York Times report.
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[text] => Public comments on the draft guidance can be submitted through December 23 at www.regulations.gov under docket number FDA-2019-D-4467.
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[text] => Breast implant surgery is the leading type of cosmetic surgery in the United States, with about 100,000 post-mastectomy reconstructive surgeries and an additional 300,000 breast augmentation procedures performed annually. The agency’s recommendations apply to both with saline (salt water) and silicone gel-filled implants.
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[text] => Six women are suing Allergan Inc., claiming the Irish pharmaceutical giant “buried” reports that its now-recalled textured silicone breast implants were linked to a rare form of cancer to hide possible safety risks from the public.
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[text] => In a potential national class-action suit filed in federal court last month, the women allege that Allergan failed to properly file safety reports in the Food and Drug Administration's public database, as reported by Law360. Instead, Allergan registered the reports as "alternative summary reports,” delaying their discovery with an “intent to deceive,” according to a press statement from consumer-rights law firm Fegan Scott, which represents the women.
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[text] => The reports — and the knowledge of the serious injuries they contained — only came to light in 2017 when the FDA tightened its reporting requirements, according to Law360.
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[text] => In September, the FDA asked Allergan to issue a sweeping recall of its Biocell Natrelle textured breast implants, warning of an increased “risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system.”
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[text] => But the six plaintiffs claim that Allergan knew as far back as 2006 that the Biocell implants posed a significant risk of BIA-ALCL, according to the Fegan Scott statement.
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[text] => “For decades, Allergan knew that its recalled implants were six times more likely to cause BIA-ALCL, but it continued to market these products, seemingly with little regard for the well-being of its users,” plaintiffs’ attorney Beth Fegan said.
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[text] => The women are asking Allergan to fund a medical monitoring program to detect BIA-ALCL and other diseases.
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[text] => As it stands today, women with the recalled implants can use a manufacturer's warranty to replace their implants with other, supposedly safer Allergan implants. But Allergan has so far “refused to help the women who simply wanted to take the implants out or make medical monitoring possible to guard against developing cancer later,” Fegan said.
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[text] => The potential class-action suit is the latest since the recall, as Law360 reported. A similar suit filed in September also alleges Allergan suppressed problems with its implants rather than reporting possible safety concerns to the FDA in a public, searchable database called Manufacturer and User Facility Device Experience (MAUDE).
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[text] => In 2017, after the FDA enacted more rigorous reporting requirements, the number of breast implant-related adverse events soared from 200 to 4,567 in 2017 and reached 8,242 in the first six months of 2018, as Law360 reported.
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[text] => While more information on breast implant illness (BII) is sought by the FDA, some patients suffering from BII symptoms crowdfund explant surgery through platforms like GoFundMe. Miami-based healer Daniela Sage was among them, utilizing the power of social media to remove toxic implants.
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[meta_title] => Healer Crowdfunds Explant Surgery for Breast Implant Illness
[meta_description] => While more information on breast implant illness (BII) is sought by the FDA, some patients suffering from BII symptoms crowdfund explant surgery through platforms like GoFundMe. Miami-based healer Daniela Sage was among them, utilizing the power of social media to remove toxic implants.
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[text] => An unknown number of patients will reportedly develop breast implant illness (BII), a constellation of chronic symptoms with a mysterious root cause associated with a negative response to breast implants.
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[text] => However, breast implant illness isn't the issue that prompted the U.S. Food and Drug Administration (FDA) to request a voluntary recall of manufacturer Allergan's textured breast implants. The action was intended to protect patients from a different condition—breast implant-associated anaplastic lymphoma (BIA-ALCL).
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[text] => Now, patients have become increasingly desperate to be free of their implants, but the current healthcare system doesn’t cover the exorbitant cost of implant-removal surgery. Many breast implant patients consequently take matters into their own hands through crowdfunding sites like GoFundMe.
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[text] => ‘I feel like I’m slowly dying’
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[text] => Late last year, Daniela Sage started experiencing paralyzing pain in her breasts.
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[text] => The 28-year-old has had silicone implants since 2011, and in recent years, she noticed changes in her body. Her joints ached, she felt chronically tired, and she suffered migraines, hair loss and blurred eyesight.
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[text] => Sage believes she has breast implant illness.
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[text] => Though the symptoms mirror those reported by other women, BII is understudied and little understood.
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[text] => Researchers in the Journal of American Society of Plastic Surgeons called breast implant illness a “challenging issue,” requiring more research and scientific evaluation to better understand how the condition affects people with implants.
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[text] => Sage, holistic wellness coach based in Miami, Florida, said she no longer felt like the vibrant, energetic individual she once was because of her implant-related illness.
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[text] => “There have been days when I’ve said it out loud: I feel like I’m slowly dying,” she acknowledged.
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[text] => When two good friends saw how sick Sage had become, they urged her to start a GoFundMe campaign to pay for immediate implant removal. She wrote on her page about the devastating symptoms of breast implant illness, and the contributions began pouring in.
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[text] => "In order for me to regain a normal and healthy life, I have no choice but to undergo this surgery or else my health will continue to decline even more, and just the thought alone has me absolutely scared," Sage wrote on the GoFundMe fundraiser.
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[text] => Daniela Sage, a holistic wellness expert, reflects on her experience with breast implant illness. Photo by Andrea Sarcos.
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[text] => Rising Reports of Implant-Related Cancer
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[text] => In the last year alone, women have filed hundreds of reports to the FDA saying their textured implants led to anaplastic lymphoma, a type of non-Hodgkin’s lymphoma that can be fatal.
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[text] => The number of reports of implant-related anaplastic lymphoma, or BIA-ALCL, jumped 46 percent between 2017 and 2018 and included 457 doctor-confirmed cases and nine patient deaths attributed to BIA-ALCL, per the FDA’s latest figures.
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[text] => The possible extent of the problem of BIA-ALCL remains unknown because no one tracks the number of Americans with breast implants. We do know more than a half-million breast implants are used every year, and of those 70,000 are textured, according to estimates from the American Society of Plastic Surgeons(ASPS).
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[text] => It’s worth noting ASPS appears to undercount the problem of implant-related lymphoma compared to the FDA’s accounting of adverse events. ASPS recognizes only 282 BIA-ALCL cases in the U.S., according to estimates as of May 14, 2019. The FDA updated its estimates after the March 2019 meeting on breast implants, where Madris Tomes, CEO of Device Events, presented an organized data set.
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[text] => Implants in general, not just the textured form, are also linked to breast implant illness — and have been since the '90s.
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[text] => The journey to diagnosis, treatment, and removal in those affected, however, will remain difficult and expensive until the medical industry recognizes BII as a real illness, according to advocates.
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[text] => How did we get here?
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[text] => Crowdfunding medical expenses
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[text] => The average American household spends one-fifth of their income on health care. So it’s no surprise 28 million Americans go without, either because their employer doesn’t provide it or they can’t afford it on their own, the Financial Times reported.
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[text] => Crowdfunding to shoulder the burden of health-care bills has become a widespread practice, and it's particularly common for people with breast implants, who face extensive and costly removal surgery.
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[text] => Sage said her doctor will remove both implants and the surrounding scar tissue in a procedure called an en-bloc total capsulectomy. The procedure aims to rid her body of all of the unhealthy tissue that’s formed around the implants. It amounts to $9,350 in medical costs.
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[text] => "I simply do not have the funds at the moment and neither does my family," Sage wrote on the GoFundMe fundraiser page. "These overwhelming emotions are what led me to create this GoFundMe page, in hopes of helping me manifest my surgery in June with your help and donations."
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[text] => Campaigns to cover medical expenses account for about a third of all money raised on GoFundMe, although it’s unclear how many fundraisers are for explant surgery like Sage’s, or related to breast implant illness. Sage’s campaign has raised $7,526.95 in contributions both on the platform and off since she launched the fundraiser. Although she has health insurance, she’s paying for the surgery out-of-pocket.
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[text] => While breast implant illness isn't currently recognized as a diagnosable medical condition that health insurance will cover, this may change soon.
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[text] => The FDA is now researching breast implant illness, which is a significant milestone for women with the condition, said Maria Gmitro, an advocate who spoke at an FDA hearing in March on breast implants. The agency is also asking for people to report BII, including the brand name of their implant, implant maker and details of the adverse event.
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[text] => The GoFundMe for Daniela Sage's explant surgery, which raised more than $4,000 for her breast implant removal on June 14, 2019.
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[text] => Drawing inspiration from shared experiences
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[alt] => A photo of Daniela Sage's breast implants. Photo by Andrea Sarcos.
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[text] => Sage's textured breast implants sit on a marble table in Miami, Florida, after her removal surgery on June 14, 2019. Photo by Andrea Sarcos.
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[text] => Upwards of 4,500 women have had their breast implants removed to treat breast implant illness since 2015, as MedTruth reported. One study found that 75 percent of patients had their silicone breast implants removed enjoyed significant changes in their health.
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[text] => As Sage waited for her surgery date, she took vitamins and supplements to improve her health. She also avoided foods containing trace amounts of copper after learning she now has copper toxicity.
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[text] => Throughout her ordeal, Sage said she’s found solace in knowing she’s not alone. She’s drawn inspiration from hearing about other women's experiences with breast implants, including a woman who shared how her health had rebounded after explant surgery.
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[text] => “There are thousands of women going through this," she said. "If you’re open about it and you talk about it, and you share it on your social media, you could be saving another woman’s life. That’s the most important thing — that human connection.”
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[text] => Post-Explant Surgery
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[text] => Sage underwent surgery on June 14, 2019. During the nearly four-hour procedure, her surgeon removed two intact capsules and excess scar tissue that had formed around her lymph nodes.
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[text] => If she’d delayed her surgery any longer, Sage believes her condition could have potentially progressed to lymphoma.
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[text] => She’s already noticed an improvement in her health, although she’s still recovering. The daily migraines? Gone. Plus, her energy is gradually returning.
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[text] => “Overall, I just feel a lot more clarity,” she said. “People close to me told me right away I look so much lighter and happier.”
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[text] => Sage hopes to encourage and inspire women who feel daunted by either the cost of explant surgery, or the fear they’ll look like less of a woman without breast implants.
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[text] => “So many women have reached out to me saying they’ve experienced the same symptoms and they're inspired now to get them out to,” she noted. She urges them to not be afraid and to explore their options.
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[text] => In fact, three of her friends followed her example in recent weeks and had their implants removed. For them, and for Sage, the explant surgery has been about health empowerment.
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[text] => “We’re putting our health first," Sage said.
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[text] => A portrait of Daniela Sage, who posted on social media that she felt grateful after her en-bloc total capsulectomy explant surgery on June 14, 2019. Photo by Andrea Sarcos.
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[text] => FDA officials are asking for patients with symptoms of breast implant illness to report adverse events here.
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[text] => In this week's news, Johnson & Johnson is officially denied transfer into federal court and Allergen announces breast implant recall from the market worldwide. Meanwhile, the opioid crisis wages on, California's latest mesh trial proceeds, and solutions for HIV are sought around the globe.
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[meta_title] => MT Weekly: Historic Breast Implant Recall, Talc Trials Kept in State Courts
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[text] => MedTruth Weekly delivers the latest developments in medical research, regulation, legislation and legal actions. The best way to be an advocate for yourself is to know the facts. Staying informed starts here.
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[text] => Legal Developments
Johnson & Johnson Attempts to Eliminate Plaintiff Experts In Talcum Lawsuits
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[text] => In May, Johnson & Johnson struck out a bid to transfer state talcum suits to federal court. This month, their request to transfer some 2,400 lawsuits over talc-based baby powder was officially denied. Judge Maryellen Noreika, who delivered the ruling, explained: "the judges in the states who are already handling these cases are better suited to hear the claims before them than is this Court, which would have to hear thousands of cases and apply different state laws to each."
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[text] => This leaves J&J at the mercy of dozens of different state courts and judges. Despite the setback, Johnson & Johnson is currently attempting to dismiss 22 expert witness testimonies from their opposition so they can argue that the plaintiffs do not have sufficient logical and scientific backing to pursue lawsuits against them. If they are successful, as many as 12,000 could face dismissal.
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[text] => In Kentucky Johnson & Johnson and Colgate-Palmolive are also facing litigation after asbestos and talc that matched the chemical makeup of cosmetic talcum powder were found in the lungs of Donna Hayes, who passed away from mesothelioma.
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[text] => Breast Implants
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[text] => Regulation
FDA Breast Implant Recall Marks Victory For Women’s Health
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[text] => On Wednesday, breast implant manufacturer Allergan moved forward with a worldwide recall of their BIOCELL textured breast implant products following a request from the U.S. Food and Drug Administration (FDA). The company publicly acknowledged findings revealing the link between their implants and breast implant-associated large-cell lymphoma (BIA-ALCL).
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[text] => Though the FDA claimed to have been monitoring this link since 2011, the agency only just acted on it after the link between Allergan's implants and BIA-ALCL was confirmed. FDA Principal Deputy Commissioner Amy Abernathy M.D., Ph.D. stated, "once the evidence indicated that a specific manufacturer's product appeared to be directly linked to significant patient harm, including death, the FDA took action." The agency also issued a safety communication for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL.
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[text] => Legal Developments
First Transvaginal Mesh Trial Involving State Attorney General Begins
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[text] => California's 33rd Attorney General, Xavier Becerra, is filing a lawsuit against Johnson & Johnson pelvic mesh product, Prolift, made by their subsidiary, Ethicon. Becerra believes the product poses significant health risks for women and charges Johnson & Johnson with unfair competition, false advertising, and cases of injury. Though the pharmaceutical giant continues to claim innocence, Johnson & Johnson settled in a recent lawsuit filed by Washington State earlier this year in which $9.9 million was awarded to the plaintiff.
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[text] => Public Health
Opioid Crisis Muddles On With Both Victories and Defeats
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[text] => Despite the arrests of Miami-Luken executives and pharmacists for providing hydrocodone and oxycodone pills to more than 200 pharmacies in Ohio, West Virginia, Indiana and Tennessee, news breaks that another company, Mallinckrodt Pharmaceuticals, may transfer liability onto a subsidiary company for their involvement with oxycodone and hydrocodone distribution.
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[text] => The opioid crisis also wreaks havoc in New York where prosecutors and law-enforcement officials are calling for a ban on unregulated synthetic opioids, at fault for 900 overdose deaths in New York City since 2017. One of the most common culprits? Legal prescription fentanyl.
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[text] => Device News
United Fronts Continue to Hunt Down The HIV Epidemic
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[text] => Across the globe, steps are being taken to stop the spread of HIV. In LA county, the Center for Disease Control has paired with county health officials to diagnose and suppress the disease in “hot zones” to potentially minimize the disease’s effects in the next generation.
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[text] => In the tech sector, a new HIV-prevention drug could be heading to the U.S. market soon. A matchstick-sized implant, the device would distribute regular doses of prevention drugs. Meanwhile, in China, volunteers are testing a long-term HIV vaccine using DNA segments from the HIV virus.
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[text] => In this week's MT Weekly, recently published opioid statistics reveal that prescriptions for opioids are actually down by a notable percentage. Additionally, successful treatment methods for HIV are underway, and Zofran litigation is stalled by the pharmaceutical company's request for an FDA statement.
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[meta_description] => In this week's MT Weekly, recently published opioid statistics reveal that prescriptions for opioids are actually down by a notable percentage. Additionally, successful treatment methods for HIV are underway, and Zofran litigation is stalled by the pharmaceutical company's request for an FDA statement.
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[text] => MedTruth Weekly delivers the latest developments in medical research, regulation, legislation and legal actions. The best way to be an advocate for yourself is to know the facts. Staying informed starts here.
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[text] => Legal Developments
Johnson & Johnson's Talc Litigation Continues
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[text] => Johnson & Johnson (J&J) has received a new trial in the case of a $417 million verdict with a woman who claimed that their baby powder gave her ovarian cancer.
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[text] => The California appeals court sustains the lawsuit’s first assertion that Johnson&Johnson failed to properly warn Eva Echeverria about the health risks of talc-based powder. Unfortunately for Ms. Echeverria, who died approximately a month after the jury delivered its August 2017 decision, the judge did not agree with the lawsuit’s second assertion that talcum powder may cause ovarian cancer. Johnson&Johnson spokesman Ernie Knewitz has stated that he is looking forward to retrying the second assertion. Johnson&Johnson has already paid out over $330 million in June for claims blaming talcum powder for giving consumers cancer, and they hope to turn around their recent losing streak in this retrial. Echevveria's daughter, Elisha, awaits the retrial as as trustee and, now, named plaintiff.
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[text] => Studies
Seven-Year Grant to Fund Innovations in HIV Treatment
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[text] => The National Institute of Health has announced earlier this month that they are committing $129 million to HIV research led by Scripps Research.
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[text] => The seven-year grant intends to continue the work that has been conducted with the previous seven-year grant and begin human trials for HIV treatment. Other companies, including British multinational company GlaxoSmithKline, have also been striving to find successful treatment methods for HIV. Their product, Dovato, was able to suppress the disease for 48 weeks in a recent trial that ended last Wednesday. Australia has made similar strides by instructing citizens in the use of the PrEP drug regimen which has been shown to drastically reduce the contraction rate of HIV.
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[text] => GSK argues they cannot be held liable for birth defects caused after pregnant women were prescribed the drug because the FDA rejected any scientific correlation between the medication and health risks. GSK representation contends that the FDA twice considered whether or not to add pregnancy warnings to the Zofran label and declined both times.
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[text] => Adamant that this information will sway the court in their favor, GSK has submitted a motion for U.S. District Judge F. Dennis Saylor to delay the first Zofran trial until the FDA releases a formal statement on the Zofran lawsuits. This statement would address whether the FDA believes GSK failed to warn consumers of Zofran's risks, whether the studies cited in the litigation would warrant a labeling change, and whether the FDA believes federal law preempts the state laws plaintiffs are using to file the lawsuits. As of this time, the FDA has not commented.
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[text] => While the numbers seem to be decreasing, the University of Michigan discovered on Thursday that the number of opioids being prescribed for minor injuries, such as a sprained ankle, is becoming uncommonly high. These conflicting statements go to the heart of the issue’s complexity, as explored by the New York Times.
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[text] => For many, the opioid crisis’ first wave of ignorance and overprescription has ended. Now, the crisis has entered a stage of institutionalized addiction and needless use that must be treated.
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[text] => Held in Silver Spring, Maryland, the panel follows warning letters issued by the FDA on March 19th to two breast implant manufacturers for noncompliance with premarket approval requirements.
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[text] => As noted in their press announcement, “every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants.”
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[text] => These letters of warning, however, are only beginning for action combatting the discovered health problems that women with breast implant complications have been reporting for decades.
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[text] => In fact, the International Consortium of Investigative Journalists reported that the federal agency has received more than 350,000 incident reports involving breast implants since 2009, according to a chart shared by the agency.
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[text] => “That’s more than 20 times as many reports as the agency had posted on its public-facing database as of late last year," according to the ICIJ.
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[text] => Finally, the FDA has opened dialogue to plastic surgeons, women’s and cancer advocacy groups, and the general public concerning a wide range of breast-implant-related concerns.
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[text] => The agenda stated that their panel of federal medical advisors would address the following topics:
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[text] => Some panel members called for a ban on certain implants while others, like committee chair Frank R. Lewis Jr., MD who emphasized that linking breast implants to their seemingly vast multitude of consequent symptoms would be challenging without a standardized measure of the common BII symptoms.
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[text] => As quoted in the MDedge summary of the meeting, Lewis added, “that may be exceedingly difficult, with as many as a hundred reported symptoms.”
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[text] => Diana Zuckerman, PhD, president of the National Center for Health Research, pushed for regulatory measures despite these obstacles. She went on to report 449 women who had approached the Center in 2018 and 2019 for help obtaining health insurance coverage for medically-necessary removal of their breast implants.
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[text] => While no consensus for affirmative action was reached, panel members, plastic surgeons, advocacy groups, and attendees who endured the negative health effects of FDA-approved breast implants all recognized the importance of expanding required, routine surveillance on breast implants and increasing transparent labeling of the risks.
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[text] => Biopharmaceutical giant Allergan has stopped selling a type of textured breast implant in Europe, according to a report in the New York Times. Updated reports from the U.S. Food and Drug Administration (FDA), along with new research from Australia and New Zealand, have associated textured breast implants with a higher risk of cancer.
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[text] => The National Agency for the Safety of Medicines and Health Products, the equivalent of the FDA in France, has pulled Allergan’s marketing approval. It will no longer allow sales of the implants throughout the European Union.
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[text] => The European ban brings health implications for women on this side of the Atlantic as well.
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[text] => For years, textured breast implants have been associated with anaplastic large-cell lymphoma, or ALCL, around the globe. MedTruth has been investigating the link between textured breast implants and cancer, specifically a rare form of non-Hodgkin’s lymphoma known as ALCL.
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[text] => ALCL typically causes a build-up of fluid in the breasts and swelling. ALCL develops an average of 8 years after an implant is inserted, but some women have reported ALCL in as few as two years after implant surgery.
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[text] => Health regulators have long known about the link between textured breast implants and anaplastic large-cell lymphoma. In 2011, regulatory agencies pinpointed a few cases, about 60 worldwide.
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[text] => Data at the time was fragmented and hard to come by but suggested cancer formed more consistently with textured, rather than smooth, breast implants. A lack of large-scale studies meant the link wasn’t statistically proven.
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[text] => Now, more sweeping studies and a renewed focus on ALCL is bringing the cancer risks into greater relief in the United States.
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[text] => Here’s what the U.S. Food and Drug Administration has reported most recently:
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[text] => The FDA received a total of 414 medical device reports and reports of nine deaths from ALCL linked to implants, as of September 30, 2017.
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[text] => Recent research suggests the risk of contracting ALCL ranges from 1 in 3,817 women to 1 in 30,000 women with textured breast implants.
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[text] => ALCL was found more often in women undergoing implant revision surgery for late-onset, persistent seroma, which occurs when fluid collects around the implant.
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[text] => The FDA’s recent report reinforced the link between textured implants and cancer, showing that more women with textured implants are developing ALCL compared to women with smooth implants.
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[text] => Of the 414 complaints the FDA received as of September 30, 2017, 272 included information on the surface material of the implant. Out of those 272 reports, the majority — 242 implants — had textured surfaces.
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[text] => Last year, research in Australia and New Zealand confirmed an “increased risk” between ALCL and leading brands of textured implants. After analyzing years of sales data from implant manufacturers Allergan, Mentor and Silimed, scientists found 55 cases of breast implant-associated ALCL, in addition to four deaths between 2007 and 2016.
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[text] => The team identified the brand names of textured implants carrying the greatest health risks. They found the risk of contracting ALCL was 14.11 times higher with Allergan’s Biocell textured implants and 10.84 higher with Silimed’s polyurethane textured implants, compared with Mentor’s Siltex textured implants.
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[text] => Allergan continues to stand behind its product. In an Allergan statement, the global biomedical manufacturer said it “disagrees” with the European recall of its textured implants. It intends to appeal the decision to France’s National Agency for the Safety of Medicines and Health Products.
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[text] => Allergan added that the agency’s decision “is not based on any new scientific evidence regarding these products. Furthermore, ANSM has not identified any immediate risk to the health of women with textured breast implants.”
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[text] => Many patients with breast implant illness suffer from autoimmune symptoms, fatigue, fever, numbness and joint pain.
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[text] => Since 1964, researchers have been examining the connection between breast implants and autoimmune diseases. However, women continue to suffer from breast implant illness, also known as breast implant disease (BII), with no warnings to protect them from the disease and no treatments for the debilitating ailments.
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[text] => In the Journal of American Society of Plastic Surgeons, researchers discuss how BII is a “challenging issue.” Ongoing studies and scientific evaluation are still necessary to better understand the illness.
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[text] => According to researchers, there is a “variability and a broad range of symptoms, the lack of clear diagnostic criteria, the absence of long-term safety and efficacy data, and the need for better understanding of the interaction between host and implant cloud the picture.”
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[text] => Recognizing Breast Implant Illness
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[text] => Knowledge of breast implant illness begins on a grassroots level, with Facebook groups paving the way in helping patients recognize and understand the disease.
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[text] => Sia Cooper, like many others, was not familiar with the side effects of silicone implants. Cooper, a nurse and personal trainer certified by the National Academy of Sports Medicine, didn't realize that breast implants were causing her illness until she connected with other women who shared her symptoms.
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[text] => Cooper discovered Healing Breast Implant Illness, a Facebook group with over 70,000 women. Finding the online support group helped her to realize she wasn’t alone.
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[text] => “It wasn't until I started doing research and finding other women with silicone implants who were dealing with the exact same symptoms that the dots started connecting," Cooper said.
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[text] => Symptoms of Breast Implant Illness
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[text] => In the initial stages of breast implant illness, problems under the muscle occur first. The breast will harden due to the immune system fighting internal wounds, which created scar tissue. Pain spreads to the chest, upper back and neck. Exercise, which can cause silicone debris to spread throughout the body, can worsen the symptoms.
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[text] => “At 7 years post-op, I was nearly bedridden sleeping for up to 14 hours a day, requiring daily naps, due to debilitating fatigue," Cooper said. "Fatigue was the first sign and possibly the worst one I had to deal with.”
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[text] => “Other symptoms included chest pains, joint swelling, muscle weakness, hair loss, dry skin, rashes, and worsening anxiety/depression," Cooper said.
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[text] => Many patients with breast implant illness suffer from autoimmune symptoms, fatigue, fever, numbness and joint pain. For women who have a family history of autoimmune disease, BII may be more common. Additionally, the urge to empty the bladder is a more severe form of BII.
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[text] => Breast Implant Removal and Treatment
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[text] => Since 2015, more than 4,500 women have had their breast implants removed to treat breast implant illness. According to a study, 75 percent of patients had their silicone breast implants removed and found significant changes.
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[text] => “Within the first two weeks after my explant, most of my symptoms were either improved or gone,” Cooper said. "It’s seemingly good news that patients can remove the implant and symptoms disappear."
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[text] => In order to prevent BII, closely monitoring breasts is advised. Notifying your surgeon right away is imperative if there are any changes in health or breasts.
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[text] => Previously, the World Health Organization found a link between breast implants and a type of cancer called breast implant-associated anaplastic large cell lymphoma, particularly linked to textured breast implants. However, the FDA concluded there is no obvious association that breast implants and chronic diseases are linked.
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[text] => Diana Zuckerman, president of the National Center for Health Research, said, “The studies at that time were not very good and did not have the statistical power to determine rare diseases.”
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[text] => On March 25th, FDA began a committee meeting where safety concerns of breast implants were discussed over two days. The press announcement concluded that manufacturers will be required to conduct “post-approval studies to further evaluate the safety and effectiveness of the products.”
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[text] => An estimated 100,000 women implants after a mastectomy, and approximately 400,000 women having breast implant surgery every year. Breast implant illness is a huge concern not only because it puts women at risk of lymphatic cancer, but it also could trigger cancer a second time.
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[text] => Cooper said she feels failed as a “patient and as a woman,” requesting that the agency better regulate breast implants.
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[text] => “A major weakness of most breast implant studies funded by implant manufacturers and plastic surgeons is that they only evaluated diagnosed diseases rather than symptoms," according to the National Center for Health Research. "Therefore, it’s important for patients to speak out, and for doctors to listen, in order for any change to occur on a larger level."
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[text] => Contact the FDA directly by listing symptoms at 1-800-FDA-1088 or online at MedWatch in order to inform regulation and public knowledge of BII.
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[text] => Advocates for BIA-ALCL awareness call on women and medical professionals to get serious about textured breast implant risks. The FDA will hold an advisory committee panel meeting on breast implant safety in March.
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[text] => After receiving hundreds of reports linking breast implants to cancer, the U.S. Food and Drug Administration (FDA) has made a public statement acknowledging the potential risk. Also referred to as anaplastic lymphoma, the reports focus on a type of non-Hodgkin’s lymphoma that forms around a breast implant.
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[text] => Not to be confused with breast cancer, BIA-ALCL is a cancer of the immune system that develops in the fibrous scar known as the “capsule” surrounding a saline- or silicone gel-filled implant used in breast reconstruction surgery or cosmetic breast augmentation. Thus far, BIA-ALCL has only been verified in women with textured implants.
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[text] => FDA Reports on Breast Implants and Anaplastic Lymphoma
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[text] => As of the most recent medical device reports update, the FDA received 660 MDRs of BIA-ALCL, of which 457 were unique and confirmed by a physician or testing. This number is an increase of 246 from the previous year and includes the death of nine patients that could be attributed to BIA-ALCL.
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[text] => To relay this information, the FDA issued a statement from Binita Ashar, MD, of the FDA’s Center for Devices and Radiological Health, as well as a letter to health care providers urging them to be aware of BIA-ALCL, educate patients on the risk, and report all confirmed cases.
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[text] => “We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” Ashar said in the statement. “At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue.”
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[text] => According to the American Society of Plastic Surgeons (ASPS), an estimated 550,000 breast implants are used in the U.S. each year, and of these, 70,000 are textured. The FDA first identified a possible association between breast implants and ALCL in 2011. They've since been met with criticism from health advocates on the grounds of poor regulation and failure to raise awareness of the risks associated with breast implants.
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[text] => In response, the FDA will hold an advisory committee panel meeting on breast implant safety in March. Members of breast implant victim advocacy groups fighting for public awareness of this issue will be in attendance.
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[text] => Advocates Fight to Inform Women of Breast Implant Risks
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[text] => One particular advocacy leader on this issue, Michelle Forney, was diagnosed with BIA-ALCL in January 2018. She, along with three other advocates, launched biaalcl.com later that year as a resource for women seeking answers regarding potential risks, signs, symptoms, and resources for support.
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[text] => Forney and eight others diagnosed with BIA-ALCL will attend the FDA public hearing in hopes of the chance to speak and provide more context for the issue.“When you look at a connection between a medical device and a cancer, and you know that (breast implants are) one of the number one medical devices sold on the market, then it should’ve been a no-brainer that this is going to be emerging and that we’re going to need to get this out in front of everybody quickly,” Forney says.
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[text] => “Everyone was hung up on the fact that it’s rare — it’s only rare because it’s unknown.”
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[text] => Dr. Eric Swanson, a Kansas-based plastic surgeon, will also be attending the FDA hearing and has written extensively on the topic. He points to manufacturers and their profitability margin for surgeons as reasoning for why textured implants are still available on the market. Swanson hopes the FDA will consider banning, if not all textured implants, at least the types of implants associated with the highest cancer risk.
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[text] => “Really the answer should be obvious, which is if you’ve got a defective product, not only do you not implant it, you remove it from the marketplace so that women’s health is protected,” Swanson says.
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[text] => At the hearing, advocates hope to discuss plans to increase awareness of BIA-ALCL and effective methods for testing and treatment. It’s important health care providers of various disciplines know how to diagnose BIA-ALCL, as symptomatic women will most likely visit their gynecologist or primary care physician first, rather than their plastic surgeon.
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[text] => The concern, however, expands beyond physicians and labs. Forney urges women who have undergone both cosmetic and reconstructive surgery to take their health and safety seriously.
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[text] => From Sept. 20-23, plastic surgeons and allied health professionals gathered in San Diego, California to learn about the latest research and industry practices to improve patient care.
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[meta_description] => From Sept. 20-23, plastic surgeons and allied health professionals gathered in San Diego, California to learn about the latest research and industry practices to improve patient care.
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[text] => From Sept. 20-23, plastic surgeons and allied health professionals gathered in San Diego, California to learn about the latest research and industry practices to improve patient care. Plastic Surgery: The Meeting is an annual conference uniting an international community of surgeons to discuss plastic and reconstructive surgery.
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[text] => But this September, the 88th event of its kind saw a significant addition. For the first time, organizers welcomed the patient presence and perspective.
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[text] => Current knowledge and emerging studies on breast implant illness (BII) and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) were a major focus. Advocates from the Breast Implant Safety Alliance (BISA) and Breast Implant Victim Advocacy (BIVA) exhibited in the main hall, spoke on panels and participated in private discussions that will shape the future of breast implant safety.
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[text] => Defining Breast Implant Illness: Patient-Reported Outcomes after Breast Explantation
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[text] => Defining Breast Implant Illness: Patient-Reported Outcomes after Breast Explantation
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[text] => Presented by Corinne Wee, MD
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[text] => On Friday, Sept. 20, Corinne Wee, MD, started her presentation by referring to known complications of breast implants. Dr. Wee, a third-year plastic surgery resident at University Hospitals Cleveland Medical Center, outlined the standard preoperative counseling, which includes informing patients of complications like bleeding, poor scarring and wrinkling of skin over the implant.
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[text] => She also referenced the largest research study of breast implant outcomes, conducted by MD Anderson, which found silicone implants are associated with higher rates of Sjögren's syndrome, scleroderma, rheumatoid arthritis and more.
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[text] => Standard Preoperative Complication Counseling
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[text] => The research presented by Dr. Wee, which is spearheaded by senior author Dr. Feng at the Lu-Jean Feng Clinic in Cleveland, Ohio, focuses on the complications that aren’t as frequently discussed.
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[text] => Breast implant illness, described as a constellation of symptoms, is a controversial topic, Dr. Wee said. Dr. Wee, who became involved with data collection in 2018, was part of the independent team of collaborators at University Hospitals. The purpose of the study was to evaluate the prevalence of symptoms for women seeking explant, identify how the symptoms changed before and after total capsulectomy, and better understand which patients would benefit most from explant.
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[text] => During a retrospective study beginning in 2017, the researchers gathered data from 741 patients and examined 11 common symptoms of breast implant illness using a patient assessment. Participants rated each symptom from zero (absent) to five (severe) before and after total capsulectomy performed by Dr. Feng at The Lu-Jean Feng Clinic.
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[text] => Patient Symptoms and Severity
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[text] => The study revealed improvement in certain combinations of symptoms upon complete removal of breast implants and scar capsules surrounding the implants, according to an email from Dr. Feng.
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[text] => “In other words, simply removing the implants and not the capsules did not produce the same significant improvement in health,” Dr. Feng wrote.
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[text] => Patient symptom severity saw a statistically significant improvement: on a scale of 0 (all symptoms absent) to 55 (all symptoms severe), the severity score dropped from an average of 26.4 to an average of 9.0. Patients were followed for 200 days, and the results indicated a dramatic improvement maintained over time, Dr. Feng wrote. Patient factors, such as body mass index, could affect the level of improvement.
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[text] => The patient population came from every state in the U.S. and more than 39 countries around the world. However, the study does not represent the population of all implant recipients. The frequency of breast implant illness cannot be estimated in any unbiased population, Dr. Feng wrote.
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[text] => When the floor was opened for questions, there were doubts about the research. A surgeon in the audience asked about population controls, sham symptoms and the cause and effect placebo. In response, Dr. Wee acknowledged the study has not yet been validated.
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[text] => The researchers will follow patients for a longer term. Additionally, researchers will be pinpointing specific symptoms and working on an additional study focusing on difficulty breathing.
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[text] => Moderated by Jeffery Janis, MD
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[text] => Hundreds of plastic surgeons filled the ballroom on Saturday, Sept. 21 for a long-awaited panel on BIA-ALCL. The panel, moderated by Jeffrey Janis, MD, included eight speakers from different backgrounds.
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[text] => The BIA-ALCL panel began with video clips recorded at the U.S. FDA Advisory Committee Hearing on Breast Implants, which took place in March 2019. The video featured testimony from Terri McGregor, a breast implant safety advocate, who was present at the conference. She spoke of her agonizing experience with BIA-ALCL, referred to other harmed patients and asked the FDA to withdraw all textured implants from the market.
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[text] => Dr. Binita Ashar, director of the F.D.A.’s Office of Surgical and Infection Control Devices, spoke after the video, presenting on the history of breast implant regulation. She described a long and complicated regulatory record,acknowledging difficulties with post-approval studies and an uptick in adverse events from 2011 to 2019.
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[text] => In her statement, Dr. Ashar said the FDA’s goal is to work collaboratively with surgeons, patients and manufacturers to better understand breast implant complications. She said the agency is currently learning how to test for BIA-ALCL.
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[text] => The Plastic Surgery Foundation (PSF)
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[text] => Andrea Pusic, MD, president of the Plastic Surgery Foundation (PSF), presented on the importance of submitting information to the registry on breast implant illness. The American Society of Plastic Surgeons (ASPS) has created a task force on Women’s Health and Breast Devices, asking surgeons to contribute to the National Breast Implant Registry (NBIR) to improve post-market surveillance in tracking all operations and reoperations in the U.S.
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[text] => “This work is moving forward very rapidly,” Pusic said.
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[text] => In 2020, the goal is to devise additional research grants to fund breast implant safety studies. Pusic is working on coverage and care for adverse effects, and she requested for NBIR membership to double following the event.
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[text] => Jamee Cook, a former paramedic and a patient advocate who founded BIVA, spoke of her experience with an undefined illness. After removing her breast implants, she went from suffering and symptomatic to finding relief that made her certain the implants were the culprit. She founded BIVA on Facebook in 2016 to create a community of women who could share similar experiences.
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[text] => As a Facebook page for patient support, BIVA grew to 8,000 members. Cook has a direct line to thousands of patients, and she’s calling for a rational discussion focused on finding common ground and moving forward.
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[text] => “There is crucial data that is missing from study information,” Cook said.
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[text] => The moderator opened the floor for questions, and plastic surgeons, implant manufacturers and advocates took to the microphones. The audience response was mixed, but concerns for patient safety were present. Potential conflicts of interest may have also played a role.
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[text] => “What should we tell our patients?” An anonymous surgeon asked the panel.
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[text] => “Exposure to any textured implant is a risk,” Dr. Scot Glasbeg, former president of ASPS, said. “I can’t say that it’s zero.”
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[text] => “What about smooth implants?” Another surgeon asked.
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[text] => “It’s ill-advised to inform patients that they are risk-free with smooth implants, as we just don’t know,” Dr. Ashar said.
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[text] => A mention of patient hysteria turned the conversation, exploring the concept that patients may seek unnecessary explant. On the topic of not informing smooth implant patients of a potential risk, a woman raised her hand and objected.
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[text] => “To withhold that information is irresponsible and unethical,” said Karuna Jagger, executive director of Breast Cancer Action, a grassroots education and activism organization for getting real about breast cancer. “I would urge you to disclose all possible risks to patients.”
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[text] => “These patients are real,” Cook said.
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[text] => “The only way we can learn more is to get data,” Dr. Glasberg said. The call to action stands.
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[text] => Breast implants are not lifetime devices. Breast implants, regardless of texture grading and saline or silicone gel, age over time. Aging affects the implant and increases the risk of a gel bleed, which occurs when microscopic gel from inside the implant leaks into the body.
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[text] => Breast implant illness and BIA-ALCL are two separate diseases. There are potentially tens of thousands of cases of undiagnosed breast implant illness, an unofficial condition made up of various symptoms. Currently, there are 573 confirmed cases of BIA-ALCL, which is a man-made lymphatic cancer.
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[text] => Complications for patients with aesthetic and reconstructive breast implants differ. Textured implants may be more common in reconstruction patients who have injured tissue from a mastectomy. Additionally, patients who received breast implants for reconstruction may be more likely to have surgical mesh.
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[text] => Textured breast implants and smooth breast implants come with distinct challenges. The texturing on breast implants can flake off and create a thicker capsule or a double capsule around the implant. There have been no cases of BIA-ALCL linked to smooth implants.
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[text] => ‘US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.’ January 2019. Department of Plastic Surgery, MD Anderson Cancer Center, Houston, TX
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[text] => This October, in honor of Breast Cancer Awareness Month, MedTruth recognizes the AiRS Foundation, which supports cancer survivors by providing information and financial aid to those considering reconstruction. It's important to note that reconstruction isn't the only option. Some women are taking social media by storm, advising women to "choose flat."
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[text] => With roughly 1.38 million new cases of breast cancer reported annually, there has never been a more vital time to educate, inform, and promote research on the life-threatening disease that has claimed 458,000 lives in the past year alone.
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[text] => During Breast Cancer Awareness Month 2019, thousands of organizations and foundations do just that — bringing visibility to a topic that means so much more than pink shirts and 5Ks.
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[text] => Among these advocacy groups is AiRS Foundation, a non-profit that works in partnership with U.S. physicians to provide access to education, health resources, and financial assistance for breast cancer patients seeking reconstruction.
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[text] => It's federally mandated for insurance companies to provide patients who have undergone mastectomy with breast reconstruction, but not everyone has insurance. For such patients, full coverage opportunities on reconstruction of any kind are slim.
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[text] => The AiRS Foundation Breast Construction Program allows applicants to apply for a grant to cover medical expenses relating to breast reconstructive surgery. The grants awarded range from “co-pay to the full cost of surgery, hospitalization, and other related medical expenses.”
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[text] => The financial aid has helped many, but perhaps most integral to AiRS Foundation advocacy work is the emphasis they place on informing patients. Whether assisted by insurance or not, lack of guidance before and after mastectomy can be detrimental. As noted by breastcancer.org, studies from the American Society of Plastic Surgeons have found that more than 70% of women aren’t fully informed about their reconstructive options before mastectomy.
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[text] => When a patient isn’t fully informed on the risks of implants and the emotional or physical changes they may experience after reconstruction, decision-making becomes a gamble. Founded by Janet Denlinger and Morgan Hare, AiRS aims to address this concern and fill the gap in patient education and care options.
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[text] => So, what exactly are the options for a patient following mastectomy?
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[text] => On Going Flat
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[text] => The two most common techniques for reconstructive breast surgery are implant reconstruction and autologous or “flap” reconstruction, which incorporates tissue from another area of the body. This October 7th, however, patient advocates stood together in support of a third option: going flat.
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[text] => Christy Avila, teacher at San Jose City College and founder of the advocacy group Fierce, Flat, Forward, says she was aware of the “flat option” from the get-go as she had an aunt who chose not to reconstruct following mastectomy. Avila, however, wasn’t properly informed about the risks of breast implants and elected for reconstruction following her own surgery. As a result, she never asked her doctor about the flat option and was never provided information on it.
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[text] => In general, Avila says, “it is extremely difficult for women to get support for “going flat.” Most women are not presented with it as an option at all.” She added, “women are openly dissuaded from going flat and are often even sent for psychiatric evaluations when they make the request to go flat before the doctor will agree to their surgery."
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[text] => Defense from the medical professionals has included warnings of “low self-esteem,” “bad posture” and being “too young to not have breasts.” Since plastic surgeons are never required to cover the flat option in their consultations, however, most patients of mastectomy never have the chance to engage in a dialogue on it.
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[text] => “Many women believe they have to go through reconstruction and that is why advocates are working to “put flat on the menu" (a flat-community phrase)" says Avila. And that’s exactly what they’re doing.
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[text] => They’re the women in the blue shirts, stomping out the stigmas associated with going flat.
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[text] => The flat advocates, self-termed “The Flatties,” bring more to the breast cancer community than information. They also provide representation. Standing proud as flat women, they de-stigmatize views in both the plastic surgery community and society at large about being flat-chested.
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[text] => Allyn Rose, a 31-year-old spokesperson for AiRS, has found that failure of representation in media creates a false image of what it means to be beautiful. As the first model with a mastectomy to be in Sports Illustrated, Rose was never before able to “envision flipping through the pages [of a magazine] and see a woman with a mastectomy as a standard of beauty.” She noted, “that’s a problem that all types of women are facing every day.”
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[text] => After being included in the magazine issue, Rose realized, “I didn’t have to choose between my health and my femininity or the opportunity for someone like me to be seen as powerful, resilient and beautiful.” As a patient-first organization, AiRS offers those affected a path to finding the right reconstructive choice for their body and lifestyle — whether that means going flat, autologous reconstruction, or implants.
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[text] => “Being a spokeswoman means more than being a mouthpiece for an organization, it means being an educated and compassionate resource,” said Rose, who was so moved by the issue that she decided to create The Previvor. With this educational platform, which launched this month, women can learn about their options before, during, and after mastectomy. “The more we encourage patients to be their own best advocates,” she says, “the better their opportunities for success.”
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[text] => Tamara Sieger, a breast cancer survivor and the Director of the AiRS Advocacy Program, finds that people become advocates as a way to give back. Volunteers have flexibility since they can work from home and “offer support primarily via phone, email, and text.” Sieger believes having an advocate is one of the best forms of assistance during what can be a confusing and isolating time.
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[text] => Those interested in becoming an advocate for the AiRS Foundation can fill out an application, begin training, and connect with patients. People who have experienced breast cancer or breast reconstructive surgeries are preferred but anyone with a compassionate attitude is welcome to apply and volunteer.
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[text] => Groundbreaking new research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) reveals complete removal of tumor growth during explant procedures may be safest. Meanwhile, limits on nicotine levels in e-cigarettes are proposed to protect the youth and Australia takes action against Monsanto.
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[text] => A recent study published in Histopathology provided an unprecedented, in-depth analysis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). According to the researchers, “a comparison of the bacterial biofilm on breast implant capsules associated with ALCL when compared to that on implant capsules with contracture has revealed a distinct microbiome in BIA-ALCL.” This revelation may inform treatment options for physicians treating the man-made cancer.
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[text] => The study also describes “the chronic inflammatory reaction induced by capsule contents or surface” which further supports the prevailing theory that textured breast implants are a primary cause of BIA-ALCL. While the study acknowledges that there are no standardized treatments, the research team strongly recommends complete removal of capsules during explant procedures.
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[text] => Opioid Crisis: Seeking Alternatives and Solutions
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[text] => Last week, Rutgers Dental School was awarded $11.7 million to research alternatives to opioids for pain management, alongside four other universities. Dean of Rutgers, Cecile Feldman, believes despite the drop in opioid prescriptions by dentists in recent years, there is “still way too much prescribing of opioids.” It is hoped that the study will provide solutions for the nationwide epidemic. As reported by Psychiatric Times, cannabinoids and ketamine may be two potential options.
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[text] => On Thursday, the U.S. Department of Health and Human Services (HHS) also released new guidelines for opioid prescriptions. To manage the prevalence of opioid overprescription, the guidelines now advise doctors be slow in changing dosages and pay increased attention to the needs of each individual patient to ensure there is minimal abuse potential.
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[text] => Johnson & Johnson emerged victorious last week in the retrial of California spouses Carolyn Weirick and Elvira Escudero who claimed that the pharmaceutical company’s talcum powder contained asbestos and caused their mesothelioma.
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[text] => Following five weeks of testimony, the jury’s verdict rejected allegations that Johnson & Johnson had produced a defective product, failed to perform safely as expected, and had known potential risks at the time of manufacture or sale of the products.
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[text] => Across the country, Georgia’s first Talcum Powder case against Johnson & Johnson ends in mistrial. In 2016, at the age of 65, Brower died of ovarian cancer, following years using J&J’s baby powder. The jury was deadlocked despite the judge’s admonition that they reach a consensus if possible. Unable to reach a unanimous verdict, the case was declared a mistrial. Brower’s legal representation, Ted Meadows, now forges onward on behalf of ovarian cancer victims across the nation.
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[text] => The last RoundUp trial of 2019, scheduled for October 15 on behalf of Walter Winston, has been postponed indefinitely after requests from both parties. Presiding judge of St. Louis Circuit Court, Michael Mullen, set a case check-in for February 2020. Currently in the midst of appealing three lawsuits, Monsanto has expressed positive sentiments on the postponement.
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[text] => But while Monsanto’s trial is put on pause in the U.S., Australia is taking action. Australia native, Ross Wild, filed a lawsuit with the Victoria Superme Court alleging that his exposure to Monsanto’s Roundup caused his non-Hodgkins lymphoma. Melbourne-born lawyer Tony Carbone expects more Australians to come forward with claims against Monsanto’s agro-chemical.
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[text] => Last Monday, Representative Raja Krishnamoorthi of Illinois proposed the Ending Nicotine Dependence from Electronic Nicotine Delivery Systems Act. Under this act, the ratio of nicotine to fluid would be capped at 20 milligrams per milliliter in an effort to make e-cigarettes less addictive to youths. Representative Krishnamoorthi told reporters that this bill is part of an ongoing struggle to prevent a new generation of nicotine addicts.
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Government Efforts Continue to Combat the Opioid Epidemic in America
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[text] => This past week has seen a number of initiatives aimed at utilizing public resources to address the opioid crisis. In Arkansas, a $200,000 grant was awarded to Legal Aid as a Response to the Opioid Crisis in Arkansas (LAROCA) to promote prevention, treatment and recovery options to help those suffering with opioid addiction.
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[text] => Dr. Jonas Shaende, the chief economist with the Fiscal Policy Institute, raised awareness of the costs of the opioid crisis at the THRIVE Recovery Community and Outreach Center in Hauppauge, NY. Dr. Shaende told attendees that the opioid crisis costs the Long Island region $22 million a day in lost wages, medical costs and other economic factors related to opioid addiction.
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[text] => Last week also saw the release of a statement by the United States Government Accountability Office that sought to outline safe disposal methods for excess opioids once treatment concludes.
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[text] => Talcum Powder
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[text] => Legal Developments
Johnson & Johnson Lawyers Have Closing Arguments Removed From Records
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[text] => Last week, the heated New Jersey talcum powder trial between four mesothelioma victims and pharmaceutical titan Johnson & Johnson entered the deliberation phase. The trial has notably featured a number of judicial sidebars as both plaintiff and defense attorneys have raised repeated objections over the qualifications and assertions of their respective medical experts.
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[text] => These objections came to a head last Wednesday when J&J lawyer Diane Sullivan’s closing argument was struck from the record for repeatedly implying to the jury that the plaintiffs had manufactured evidence that J&J’s talc contained asbestos. Judge Anna C. Viscomi admonished Sullivan, telling her, “What could have been a good closing statement commenting on the evidence was replete with conduct this court has already warned you about.” While Sullivan protested the striking as “draconian and unfair,” Judge Viscomi stated that “to leave in only the appropriate comments on the record would be impossible” and warned Sullivan about her outbursts.
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[text] => Breast Implants
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[text] => Legal Developments
Allergan Comes Under Litigatory Fire, Robotic Device May Prevent Breast Implant Rejection
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[text] => Multiple class action lawsuits have been filed against the breast implant manufacturing company Allergan for their textured breast implant products, which were recalled in July by the Food and Drug Administration (FDA) due to its connection to Breast Implant-Associated Anaplastic Large-Call Lymphoma (BIA-ALCL).
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[text] => Future recipients of breast implants may also be receiving good news, as researchers at the Science Foundation Ireland research center AMBER, NUI Galway and MIT have unveiled a new soft robotic product designed to protect implant recipients from rejection. This soft robotic device is designed to prevent rejection by the body by breaking up the fibrous shell that the body attempts to place around the implants during a process called fibrosis. When completed, this device could reportedly be lifesaving to the 30% of women whose bodies reject breast implants.
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[text] => JUUL
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[text] => Public Health
Communities and States Come Together to Educate About and Protest JUUL
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[text] => The past week has seen an enormous outpouring of civic advocacy from the local to national levels in response to JUUL Labs’ products. In Indiana, the $21 million “What’s Beyond the Haze” campaign is using social media and schools to educate youths about the dangers of JUUL e-cigarettes and encourage them to stop using the products.
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[text] => On Tuesday, the nonprofit Common Sense Media announced the beginning of its own educational campaign across the nation to inform people about the dangers of e-cigarettes and to “counter Big Tobacco's dangerous and deceptive tactics and encourage policymakers to take action to protect children.” Other advocacy movements include Milwaukee’s public health notice calling for residents to cease e-cigarette usage and San Francisco Lt. Gov. Eleni Kounalakis and Common Sense Media CEO Jim Steyer speaking out against JUUL and e-cigarettes at a rally outside of San Francisco city hall.
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[text] => HIV
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[text] => Medical Breakthrough
Global Advances in Research Continue to Further HIV Understanding
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