Netflix’s The Bleeding Edge Exposes Essure, Mesh and Other Dangerous Devices

Medical devices have become a way of life in our current society. Whether it’s a permanent implant or a piece of equipment, medical devices are embedded in and used on millions of Americans each year.

The hard-hitting Netflix documentary The Bleeding Edge, which premiered last week, delves into the risks of the multibillion-dollar medical device industry. It chronicles the lives of various patients who have been victims of poor regulation, misleading marketing and a failure to properly educate physicians.

In The Bleeding Edge, filmmakers Kirby Dick and Amy Ziering deliver a thought-provoking commentary on the American healthcare system. The pair, who also produced who also documentaries The Hunting Ground and The Invisible War, takes a fearless approach to exposing the truth about the various industry players putting profits over people.

The film captures real human stories of complications with Essure birth control, vaginal mesh, metal hip implants and other commonly used devices. Thanks to The Bleeding Edge, the public has an authentic picture of just how dangerous a failed medical device can be.

Medical Devices

Essure Birth Control

The film focuses primarily on Essure, a permanent birth control device marketed as an easier, non-surgical option for female sterilization. When Essure was introduced in 2002, it was heralded as the birth control implant with no incisions and no anesthesia. A major selling point for Essure was that it could take longer to get your nails done than to get sterilized.

Filmmakers follow Angie Firmalino, a 45-year-old woman who had an Essure implant and developed life-changing complications. After experiencing ongoing pain and finding little information about Essure side effects, she began to research the medical device.

Firmalino learned that other women who had an Essure implant experienced heavy bleeding, sharp pains and other issues. Unwittingly, she became the leader of the Essure Problems awareness campaign that connected more than 35,000 women who had been affected by the birth control device.

The film also shares the story of Ana Fuentes, a 35-year-old Latina mother who was no longer able to work because of her Essure-related side effects. Fuentes experienced heavy bleeding, and when she complained to her doctor, her symptoms were dismissed as normal. She had a full hysterectomy at 31.

For many women, the Essure coils fractured, migrated and became untraceable or irremovable. When the devices misfired into the uterus, doctors implanted additional devices. Some women had five coils in them, according to Firmalino.

Some women who had the permanent birth control device were still getting pregnant, and their babies were born with severe health problems. There were 800 failed births with Essure, according to Device Events.

Through her outreach work, Firmalino cultivated the Essure Problems Facebook community where women were able to connect, share their experiences and find physicians able to remove the device. It was there she learned about how Essure could spark other health problems, such as autoimmune disease. Firmalino herself developed a debilitating connective tissue disorder, which keeps her from hiking with her family and carrying out other day-to-day activities.

Though the Essure birth control device was only studied for a one and a half years before entering the market, the device is meant to be permanent. The lack of extensive clinical trials sets the stage for a much larger conversation on testing medical devices. Manufacturers, who are in charge of the studies, also reportedly encouraged the trial participants to alter their responses to make the device seem safer.

There are currently 11 subgroups for Essure worldwide, with patient advocacy meetups for women who are fighting to get the media to hear their stories.

Cobalt Hip Replacements

Hip replacements, another common medical device, are often marketed to active individuals as a way to increase mobility. In The Bleeding Edge, filmmakers tell the story of Stephen Tower, an orthopedic surgeon, who himself suffered serious issues from a metal-on-metal hip replacement.

Tower describes his difficult journey of discovery, where he learned his failed hip replacement was leaking excessive cobalt into his bloodstream. In the film, he says the implants can actually become “liquefied” in the body.

From his own experience and his subsequent research, Tower discovered that cobalt poisoning may cause symptoms that are similar to degenerative neurological diseases.

According to Tower, many physicians don’t yet believe that an orthopedic implant can cause neurological issues. He’s working to inform other physicians that patients with failed hip replacements are being misdiagnosed with dementia.

The most frightening thing about Tower’s story is that many patients are being diagnosed with a permanent form of cognitive decline that may actually be reversible. He compares cobalt poisoning to the mercury poisoning. There are 10 million people with hip replacement implants that use cobalt, according to the film.

Vaginal Mesh

Another medical device featured in the film is vaginal mesh, which is used to treat stress urinary incontinence and pelvic organ prolapse. Vaginal mesh is yet another medical device that was marketed as superior to traditional methods. It was presented as easily placed with few complaints.

Filmmakers show the dangers of vaginal mesh through the story of Tammy Jackson, who has since had 18 revision surgeries since her vaginal mesh was implanted. Jackson describes how the mesh has migrated and fused to her body, which has affected her family and destroyed her intimate life with her husband.

Though The Bleeding Edge focuses primarily on three dangerous medical devices, it also briefly mentions other devices. The film introduces IVC filters, which can float to the atrium in the heart. It also discusses the da Vinci robotic surgery device, power morcellation procedures and mold found in breast implants.

Many of these devices are part of a slick machine of promotion, and patients aren’t getting the information they need. The Bleeding Edge brings these issues to the forefront, calling on the industry to make changes and empowering patients to ask better questions.