Counting down to the end of 2018, we wanted to highlight some wins and accomplishments the medical device safety movement achieved this year.
Essure’s removal from the market
Medical device companies like Bayer, the manufacturer of the sterilization device Essure, have been increasingly under fire since the film premiere of The Bleeding Edge. In early April, the FDA restricted the sale of Essure by requiring providers to first review a brochure with patients that lists Essure’s risks along with requiring the physician implanting the device and patient to sign it. Then a week before the release of The Bleeding Edge, Bayer announced it would stop selling Essure at the end of 2018, a huge victory not only for the film but for the E-Sisters, a group of 40,000+ women who have been fighting Bayer and the FDA for years to get Essure pulled from the market.
Countries around the world stop the use of vaginal mesh
Starting in January of 2018, countries around the world started changing their policies to ban the use of vaginal mesh, which causes complications such as severe pain, nerve damage, tissue erosion, and organ perforation. In January, New Zealand banned the device, in July, England and Northern Ireland restricted its use unless absolutely necessary. In September, Scotland halted its use of vaginal mesh, and in October, Australia issued an apology for its use of vaginal mesh.
FDA announced plans to reform the medical device approval process
In November, the FDA announced plans to reform medical device approval processes to rely on more modern predicate devices or “objective performance criteria” for device approval. While the FDA acknowledges some of the flaws that exist in approving medical devices, it is only a small step in the right direction. These updates still keep in place a dangerous loophole: the 510(k) process, which allows high-risk devices to be implanted in people without undergoing sufficient human clinical trials putting thousands at risk.
Patients organizing, telling their stories of medical device harm
Since the release of The Bleeding Edge, there has been a groundswell of support for survivors of medical device harm. Patients who experienced the medical device industry’s injustices have come forward and told their stories. Through the digital campaign #IWasntWarned, patients from around the globe told their personal stories about how doctors did not inform them of the possible risks or side effects of medical devices like Essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants. You can follow the stories and tell your own using the hashtag.
Press around the world reported more on device problems in 2018 than in any other year
National and international media added more voices to the accounts of patient harm through stories such as
“Medical Devices Harm Patients Worldwide as Governments Fail on Safety,” a project by the International Consortium of Investigative Journalists.
An important new website was created that focuses on all medical device problems
Patients, advocates and experts now have a common community they can join, the Medical Device Problems website where concerned consumers can come together for education and support.
Although personal stories are powerful and create change, we need to hold medical device companies and the FDA accountable together. We need to place people’s lives over profit.
To learn more about how to protect people from medical device malpractices, check out the current laws activists are lobbying Congress members to pass the Medical Device Safety Act, that will restore a patient’s right to litigation if harmed by a medical device.
Continue spreading the word about the medical device industry by encouraging friends and family to stream the film on Netflix, call on the FDA to enforce strict guidelines for medical device approvals, and uplift the stories of survivors using #IWasntWarned.