Showing Articles for

Medical Devices

Photo of knee and hip implants which were discussed at an FDA Panel addressing metal-containing medical devices and dental amalgam implants.

FDA Panel Reveals: Not All Medical Devices Created Equal

Crystal Duan · December 6, 2019

This November, the FDA hosted a public advisory committee meeting, referred to as the Immunology Devices Panel of the Medical Devices Advisory Committee. Patients, medical professionals and researchers discussed the short-term and long-term health impacts of adverse biological responses to metal-containing implants.

News
A photo of money and a stethoscope, representing ProPublica's Dollars for Docs database.

Is Your Doctor Under the Influence of Industry Money?

Nicole Knight · December 4, 2019

Dollars for Docs, a free ProPublica database, allows patients to find out whether their healthcare provider has taken payments from drugmakers or device makers — including money for meals, gifts, travel, consulting, research activities and speaking fees.

Health Features
A close-up photo of a dark-skinned man with hazel eyes, representing the current focus on LASIK risk and safety.

Former FDA Adviser Draws Attention to Complications With LASIK

Emma Schkloven · November 22, 2019

Dr. Morris Waxler, a retired Food and Drug Administration advisor who voted to approve LASIK in the 1990s, is now calling for the medical device to be removed from the market.

News
A photo of an FDA-recommended disposable duodenoscope, prior to recommendations to use disposable duodenoscopes.

FDA Encourages Use of Disposable Duodenoscopes

Tess Francke · November 18, 2019

Traditional duodenoscopes may cause infection. The FDA recommends hospitals transition to disposable duodenoscopes and warns against illegal ATP test strips used to determine cleanliness.

FDA Regulation
A photo of a woman on her computer perusing FDA website after issuing Black Box Warnings on Breast Implants. 

FDA Recommends Black Box Warnings on Breast Implants 

Carah Wertheimer · October 24, 2019

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.

News
A photo of the Supreme Court to represent Riegel v. Medtronic case which set the precedent for lawsuits filed by patients harmed by Class III medical device.

Riegel v. Medtronic: How the Landmark Case Limits Patient Rights

Carah Wertheimer · October 17, 2019

In 2008, a complex case set a legal precedent that dictates how Class III medical devices are approached. It's the landmark Supreme Court ruling, known as Riegel v. Medtronic, that changed everything. Now, those harmed by Class III medical devices struggle to seek legal recourse.

Legal Developments
A photo of a mesh fence to resemble the latest transvaginal mesh trial where testimony stated that J&J Mesh Misleads Consumers with Marketing Tactics.

Marketing Tactics Mislead Consumers, Says Latest Testimony Against J&J Mesh

James Parker · July 31, 2019

In the latest transvaginal mesh trial, led by California Attorney General Xavier Becerra, expert testimony speaks to the way Johnson & Johnson's advertisements mislead consumers. Surgeon Margolis believes their mesh causes "substantial, significant, irreversible damage," despite consumer-friendly ads.

Legal Developments
Photo of Frances Scott, who suffered cobalt toxicity after hip implants, and other advocates of Medical Device Problems group while they lobbied at the Capitol for the Medical Device Safety Act.

Cobalt Toxicity: The Poison in Her Hip Replacement

S. Nicole Lane · June 28, 2019

Frances was 39 when she had cobalt alloy hips implanted. Within weeks, her skin broke out in boils. Within months, she faced effects ranging from memory loss and visual disturbances to severe tinnitus and PTSD-like rage/anxiety attacks. The effects of cobalt toxicity on the brain are evident.

Patient Stories
A photo of Billie Copley next to a photo of Jennifer Snowden, two women injured by transvaginal mesh.

Stories Not Statistics: Faces of Transvaginal Mesh

Carah Wertheimer · May 31, 2019

For Pelvic Pain Awareness Month, MedTruth is sharing patient stories. We're recognizing two transvaginal mesh survivors living with chronic pain. For Billie Copley, 44, and Jennifer Snowden, 34, transvaginal mesh implants have changed their lives forever.

Patient Stories
A photo of a woman with transvaginal mesh after news of Transvaginal Mesh Sales Halted by FDA.

FDA Stops Sales of Transvaginal Mesh

Carah Wertheimer · April 19, 2019

The FDA gave transvaginal mesh companies Boston Scientific and Coloplast 10 days to submit plans to withdraw their products from the market - officially ending transvaginal mesh sales. Unfortunately for many, the damage has been done.

FDA Regulation
A photo of a rally protest where people take a stand for the Medical Device Safety Act.

Why You Should Care About the Medical Device Safety Act

Carah Wertheimer · April 17, 2019

Advocates and individuals harmed by Essure, mesh, breast implants and hip replacements are lobbying representatives to support the Medical Device Safety Act, a bill that would allow consumers to get justice from manufacturers for medical device injuries.

Health Features
A photo of a finger pointing to a breast implant as woman asks what is breast implant illness.

What is Breast Implant Illness?

Lauren Styx · April 9, 2019

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.

Patient Stories
A photo of a pregnant woman holding her baby bump to demonstrate the way Essure Birth Control may lead to Unplanned Pregnancy.

Essure Birth Control May Result in Unplanned Pregnancy, Birth Injuries

Nicole Knight · October 5, 2018

An unknown number of women who had the permanent birth control implant Essure still became pregnant—in some cases, resulting in miscarriage or birth injuries.

Women's Health
Photo of doctor talking to female patient about birth control while Essure sill sold in US despite risks.

Essure Still Sold to U.S. Women Through 2018, Despite Risks

S. Nicole Lane · September 13, 2018

Even though the device is no longer selling in other countries, Bayer, its manufacturer, will continue to offer Essure to women in the U.S.

Health Features
Toilet with plunger representing bowel problems after hernia mesh surgery

5 Signs You Have Hernia Mesh Complications

Ashley Lombardo · April 25, 2018

More than one million hernia repairs are performed each year. After a hernia mesh surgery, a non-healing wound may develop and the following surgeries could require longer recovery times. Here's how to identify the most common hernia mesh complications.

Health Features
A photo of a woman holding her hip in pain, considering undergoing hip subchondroplasty as a hip replacement alternative.

New Procedure May Become A Hip Replacement Alternative

Ashley Lombardo · January 22, 2018

A necessary advancement in hip surgery is being performed in an Ohio hospital, with hopes it will ease the burden of hip implant risks by offering a hip replacement alternative.

News
A photo of a woman in a doctor's office, refusing power morcellator treatment for uterine fibrioids after the FDA warning.

Morcellator Use Declines Following FDA Warning

Ashley Lombardo · January 17, 2018

The FDA has affirmed a four-year-old warning over the risk of developing uterine sarcoma after undergoing surgery with morcellation.

FDA Regulation
Young woman lying in fetal position

New Zealand Fully Bans Transvaginal Mesh

Ashley Lombardo · January 10, 2018

New Zealand's staunch health advocacy has led to a full vaginal mesh ban and continued efforts to improve medical device safety for women.

News
A photo of a young woman suffering from hip pain from a metal-on-metal hip implant.

Newly Discovered Gene May Help Metal-on-Metal Hip Patients

Ashley Lombardo · January 10, 2018

An incredible discovery in Australia could change the way we approach metal-on-metal hip replacement procedures to better protect patients from metal poisoning.

Research + Findings
A photo of a fence to resemble mesh to reflect how reported complications reveal unforeseen hernia mesh risks.

The Truth About Hernia Mesh

Ashley Lombardo · October 18, 2017

More than one million hernias occur each year. Hernia mesh, a common treatment device, may cause serious complications.

Health Features
A group of chairs representing Congress' work on Ariel Grace's Law and the Medical Device Guardians Act to improve medical device safety.

Could These New Bills Improve Medical Device Safety?

Ashley Lombardo · May 28, 2016

Congressman Mike Fitzpatrick proposes two bills, Ariel Grace's Law and the Medical Device Guardians Act, to improve regulations for medical device safety based on injuries related to Essure and power morcellators.

Laws + Congress