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).
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.
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).
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.
Studies + Science
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.
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.
Breast Implant Illness
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.
"(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.
“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.’”
However, studies have shown that there may be symptoms of breast implant poisoning, these symptoms may include:
- Chronic fatigue
- Joint and muscle pain
- Brain fog and confusion
- Food and chemical sensitivities
- Hair loss
- Dry eyes
- Persistent flu-like symptoms
BIA-ALCL: Breast Implant Cancer
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.
So far, BIA-ALCL has only been associated with textured implants. Researchers in Australia and New Zealand confirmed “increased risk” between BIA-ALCL and textured implants after analyzing brands connected to the greatest health risks, Allergan and Silimed.
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.
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.
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.
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.
A Brief History of Breast Implant Regulation
The silicone breast implant is invented and first augmentation procedure is performed.
The FDA issues controls and performance standards for silicone breast implants.
Breast implants are placed in the class III category, the highest-risk class for medical devices.
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.
January: The FDA calls for a voluntary moratorium on silicone gel breast implants until further review.
April: The FDA advises silicone breast implants only be used for reconstructive surgery or to correct deformities.
The FDA lifts restrictions on silicone breast implants.
The FDA publishes a safety announcement identifying a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL).
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.
As of September, the FDA claims to have received 414 medical device reports and reports of nine deaths from ALCL linked to implants.
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.
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.”
December: Textured breast implants manufactured by Allergan are suspended from European and Brazilian markets.
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.
March: The FDA holds a two-day public advisory committee meeting on breast implant safety and potential links to life-threatening health problems.
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 over 8,500 followers, has organized to get the attention of regulatory bodies.
“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.”
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.
“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.”
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.
Connect with a community of consumer advocates and make moves toward a better future.Contact Us
Get our reporting in your inbox
Read more about Breast Implants
Lauren Styx · June 4, 2020
Breast implant manufacturer Allergan announced the launch of a digital campaign to reach patients currently or formerly implanted with recalled Biocell breast implants.News
Lauren Styx · June 4, 2020
As part of its ongoing efforts to protect patients, the FDA issued warning letters to two breast implant manufacturers citing violations of quality system and medical device reporting regulations.FDA Regulation