The Bleeding Edge, a 2018 Netflix documentary by Kirby Dick and Amy Ziering, covers the medical device industry, a multi-billion-dollar outfit that constantly pushes innovation regardless of whether or not the innovation is needed. Much of the new technology discussed in the documentary is on the market, to the detriment of the health of many of the users. The devices discussed in the nerve-racking documentary cover a variety of medical treatments, from birth control to joint replacement, and how each of the products meant to alleviate these health issues is instead causing life-wrecking side effects.
Aside from discussing the specific products harming medical patients, the documentary also discusses exactly how device manufacturers are able to push these damaging accessories through FDA approval and into unsuspecting patients. The Bleeding Edge is a distressing look at the modern medical field, and its findings might make you rethink any future trips to the hospital.
One Woman Has Mesh Permanently Stuck In Her Body
While the narrative of the FDA's broken system is captivating, the personal stories told in The Bleeding Truth are even more gut-wrenching. One woman, Tammy Jackson, explains how she underwent surgery to have pelvic mesh put in her body to treat stress urinary incontinence.
However, rather than help Jackson, the mesh became brittle and even 21 surgeries failed to remove the entirety of it. In the documentary, Jackson explains that the mesh is so brittle that while having intercourse with her husband, he cut himself.
One Woman Lost Her Job Because Of Constant Hospital Visits
While some of the stories in The Bleeding Edge have happy endings, many of them don't - including that of Ana Fuentes, a woman who suffered excessive bleeding because of her Essure implant. Doctors told her the bleeding was because of her ethnic background, but because she was going to the doctor and the hospital so frequently for her symptoms, her job fired her.
Throughout the documentary, Fuentes's life spirals more and more out of control. However, she tries to stay positive. The film ends with her giving up her four children to church foster families while she attempts to regain her health and get her life back on track.
According to the film's producers, after the film wrapped, Fuentes was able to find a place to live thanks to a homeless assistance program. She also eventually regained custody of her children.
More Than 16,000 Women Are Suing Bayer For Medical Complications
According to the documentary, more than 16,000 women in the US are suing Bayer, the manufacturer of Essure, after suffering countless complications. Many of the women were forced to get hysterectomies after using the device, and Bayer's never admitted to any wrongdoing and maintains the device is safe. According to Insurance Journal:
Essure consists of two thin-as-spaghetti nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman's eggs. Because of the reported complaints, the FDA added its most serious warning to the device in 2016 and ordered the company to conduct a 2,000-patient study.
Many of the women in the lawsuit met through Facebook groups where they discussed their similar complications. In The Bleeding Edge, one woman claims she's had a nonstop headache since she received an Essure implant, while other women have had unwanted pregnancies or life-threatening illnesses.
A Loophole Helps Many Devices Get On The Market
According to The Bleeding Edge, many of these harmful devices are able to get on the market thanks to a lack of clinical testing. While medication is under a set of strict guidelines by the FDA, medical devices don't have to deal with stringent examinations due to the fact that many of them are merely "updates" to older, already approved devices.
A loophole many manufacturers use is an approval based on whether or not a device is equivalent to a device already on the market, regardless of whether or not it's been recalled. This is how many harmful medical devices make their way into the world. In fact, according to the film: "98% of medical devices go through the 510 (k) FDA approval process, while just 2% go through premarket approval."