New Documentary Film Is Scathing Indictment Of FDA’s Regulation Of Medical Devices

A new Netflix documentary – The Bleeding Edge  – highlights a wide range of systemic flaws in the FDA’s regulation of medical devices. As always, the patient stories are truly heartbreaking (and often clinically gruesome), but what makes this documentary different is the sheer volume of clinical and legal testimony aimed so directly and forcefully at the FDA – the one organization purpose-built to protect patients from a wide range of clinical risks – including those from medical device manufacturers.

According to the documentary (Netflix subscription required), the medical device industry is about $300 billion per year and nearly 70 million Americans have been implanted with a device over the last 10 years. While patient horror stories are always tragic – and there are many horrific ones in The Bleeding Edge – they rarely include practicing doctors as victims. One of the lead stories is of Dr. Stephen Tower – an orthopedic surgeon – who suffered severe metallic poisoning from a hip replacement that used a metal-on-metal device. The primary metal alloy for these joint replacements is cobalt, and according to the documentary, there are now more than 10 million people worldwide who have hips, knees or shoulders made with cobalt parts.

Another compelling storyline was that of Gaby Avina. At different times in her profile, she was a nurse who assisted in the placement of Bayer’s Essure sterilization device, a product spokesperson for Bayer’s device, and then finally a victim herself. Marketed as a device with a 99% (or higher) efficacy rate, it turns out that aside from the many adverse events, “women with the Essure device experienced sterilization failure rates that were seven times higher than women who had their tubes tied.”

Video of the FDA Pre-Market Approval hearing (obtained by an Essure patient advocacy group) is particularly damning. Filmed in 2002 during the actual hearing process, members of the panel are seen laughing about the personal consequences if the device ever failed in the future. After thousands of adverse cases, and under enormous patient pressure, Bayer has finally agreed to stop selling the Essure device this year.

Photo: Forbes