Netflix’s newest documentary, “The Bleeding Edge,” brings a different perspective to the medical device industry as filmmakers recount patients’ experiences with poorly researched and regulated medical devices.
According to Forbes, most devices face little to no regulation and are favored over similar products because manufacturers persuade doctors to use their products instead. The complications could result in long-term health effects for patients, or possibly death.
Since the documentary released in late July, Bayer AG, a multinational pharmaceutical company, has criticized the film, describing as misleading and inaccurate. The filmmakers have defended the accuracy of their work.
Why does Bayer care?
The statements released by Bayer followed “The Bleeding Edge” and its examination of Bayer’s Essure birth-control device. According to the documentary, the device has devastating effects on women who receive the implant. Bayer is now pulling the device from the U.S. market at the end of 2018 due to the publicity surrounding the film’s accusations.
According to a statement from Bayer, “‘the producers’ comment that Essure trials ‘weren’t randomized or non-blinded’ and ‘lacked comparator groups’ only further expose their ignorance of the underlying science and the ethics involved in studying a medical device.”
Bayer also clarified that a randomized clinical trial requires neither the patient nor the doctor knowing which treatment the patient is receiving, which is not impossible with the permanent placement of Essure.
The company wants to assure women that the safety of the device is unchanged and positive, and they currently have a safety-information warning about the device on their website.
Should I be concerned about my medical device?
Despite the public argument between the filmmakers and Bayer AG, the film is not against the medical field. The filmmakers said they wanted to emphasize the calamities caused when profits are prioritized over health. Having a medical device does not necessarily mean there are symptoms.
If you feel that you or a loved one is suffering due to a medical device, seek medical attention immediately and consult with your physician about the next steps in the treatment process. It may prevent long-term damages.