Holly Kelly Ennis
The Bleeding Edge Documentary Exposes Truth About Essure and Medical Devices
This past weekend a vitally important documentary, The Bleeding Edge, premiered at the Tribeca Film Festival in New York City. The film, directed and produced by Hollywood documetary heavyweights, Kirby Dick, Amy Ziering and Amy Herdy, exposes the dirty secrets of the $400 billion medical device industry and the quest for profits from 'innovative products' at the expense of patient safety. The film is intensely relevant as all Americans will either have a medical device implanted in their lifetime or have a close relative who will undergo such a procedure.
Prominently featured in the film is Essure Problems Group founder, Angie Firmalino, who exquisitely details not only her own painful journey with the Essure device, but illustrates how the Essure Problems' grassroots movement is creating change to hold device manufacturers, physicians and the FDA accountable for poorly tested and unsafe medical devices. A particularly disturbing portion of the film shows a clip from the FDA meeting approving the Essure device, wherein several doctors' concerned questions regarding Essure go unanswered, yet the approval panel is laughing and joking about the lack of rigour in the process. Gaby Avina, a former paid spokeswoman for Essure also implanted with the device, provides a compelling story. After suffering a variety of health issues, Ms. Avina underwent a hysterectomy to remove the Essure devices and joined the Essure Problems Group in the fight against Bayer.
Honest and frank comments by former FDA commissioners reveal that the medical device approval process is broken and far too many untested and unsafe devices make it to market. This, coupled with the FDA's inability to provide post market surveillance after a device is put into unsuspecting patients, creates hundreds of thousands of device-related injuries and deaths. Unfortunately, the FDA does little to address or alleviate these problems and as film critic, Eric Kohn noted, "Scott Gottlieb, the Trump-appointed FDA head...seems to care as much about patient safety as Scott Pruitt cares about the environment."
The Bleeding Edge also portrays the gripping story of Tammy Jackson, implanted with transvaginal mesh, whose life has been unforgivably ruined, undergoing nearly 20 surgeries to remove the mesh. Another fascinating story concerns an orthopedic surgeon who underwent a DePuy ASR metal-on-metal hip implant surgery, who was left with serious neurological and orthopedic deficients caused by the cobalt and chromium in the implant. The most graphic stories involved women who underwent hysterectomies by poorly trained physicians using the Da Vinci Robot, whose internal organs literally prolapsed completely out of their vaginas, much to their sheer terror and absolute horror.
The disturbing issues portrayed in the film all boil down to lax oversight and insufficient regulatory practices coupled with overt greed masked as 'innovation'. The film makes one determined to prove that we can do better for our own healthcare and those of our loved ones as well as stressing the importance of grassroot movements such as the Essure Problems Group to force the necessary changes within the industry, physicians and the FDA.