After its premiere on Netflix, the documentary, The Bleeding Edge,immediately received attention for its critical look inside the billion-dollar medical device industry in the United States. In the documentary, men and women across the country openly discussed how their lives were affected after they used FDA approved medical devices. Most of the critics in the film focused on Bayer’s Essure sterilization device and Johnson & Johnson’s vaginal mesh, while also shedding light on artificial metal hip replacements and Intuitive’s Surgical da Vinci robotic arm. The documentary’s investigation into the FDA’s regulatory process of medical devices shows that more often than not medical devices get on the market without proper testing.
The FDA conducts its regulation pursuant to the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act, which established three regulatory classes for medical devices. Several of the devices the documentary discussed are Class III devices, which “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.” Class III devices are subject to a pre-market approval process where companies must produce research that proves that the new device is safe and effective. Bayer’s Essure, Johnson & Johnson’s vaginal mesh, and artificial metal hips are considered implants, under the Class III definition, but most of these were not subject to this process.
Bayer’s and Johnson & Johnson’s devices made their way through the 510(k) certification, which was created for Class II devices that are less risky to patients. This certification process allows the FDA to certify a company’s new medical device based on evidence that it is “substantially equivalent” to another device already on the market. To be clear, this is not an approval process, instead, this is a clearance process that allows new medical devices to enter the market without requiring device testing. This process is, in essence, a “loophole” and allows devices to hit the market at a faster rate. Most medical devices are now regulated under this loophole instead of the pre-market approval process.
A serious question still remains: Can we trust that devices are safe and effective when they are cleared but not approved through this certification process? The patients in The Bleeding Edgesay no, yet Bayer and many other companies say yes. Days after the documentary premiered on Netflix, Bayer hit the media calling the allegations in the documentary “inaccurate and [a] misleading picture of Essure” and described the documentary as an “anecdote” created to fit an agenda.
Patients continue to seek better regulation even if the medical device industry and the FDA seem to be unbothered by the film and defend their regulation. However, even before the film aired, Johnson & Johnson and Bayer faced several class action suits due to their products. Specifically, about 16,000 women have sued Bayer in a class action suit. This prompted the FDA to issue a warning to Bayer and ordered the company to conduct risk assessment studies, which in hindsight should have been required. Bayer will now take Essure off the market by the end of this year. This is good news for those affected by this device, but it is not the only one out there causing life-threatening problems.
The FDA has yet to try to bridge the gap in their current regulation of medical devices, but many supporters of the film hope it will encourage movement toward more thorough regulation and safety of medical devices. As technology and innovation continue to advance, regulating medical devices will only get worse unless the FDA closes the holes in its regulatory process and puts patient safety first.