The Bleeding Edge: Which Medical Devices Are Dangerous?

Essure Birth Control

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

Filmmakers Kirby Dick and Amy Ziering 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, Firmalino began to research Essure. 

Firmalino learned that other women who had an Essure implant experienced bleeding, weight gain, sharp pains and other ongoing 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. 

For a number of women, Essure coils had fractured, migrated and became untraceable or irremovable. Doctors even implanted additional coils into women when the implantation procedure misfired, with some women having five coils in them, according to Firmalino.

Through the community, Firmalino learned Essure could spark other health problems, like autoimmune diseases. Firmalino herself developed a debilitating connective tissue disorder, which she said keeps her from hiking with her family and carrying out other day-to-day activities.

Even more heartbreaking, women who had the permanent birth control device were still getting pregnant, leaving their newborns to suffer from severe health problems. There were 800 failed births with Essure, according to Device Events.

Through her outreach work, Firmalino cultivated the Essure Problems community where thousands of women were able to connect, share their experiences and find trusted physicians able to remove the device. There are currently 11 subgroups for Essure Problems worldwide, with patient advocacy meetups for women who are fighting to get the media to hear their stories. 

Also depicted in the film is the story of Ana Fuentes, a 35-year-old Latina mother who had a full hysterectomy at 31 because of her Essure-related side effects. Fuentes experienced heavy bleeding, and when she complained to her doctor, her symptoms were dismissed as normal for a latina woman Fuentes, no longer able to work, left her children with a foster family.

Though the Essure birth control device was only studied for a one and a half years before entering the market, the device is intended 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, according to the interviews in the documentary. 

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 interview Stephen Tower, an orthopedic surgeon, who suffered serious issues from a metal-on-metal hip replacement.

From his own experience and subsequent research, Tower discovered that cobalt poisoning from hip replacements may cause symptoms that are similar to degenerative neurological diseases. Tower describes his difficult journey of discovery throughout the film, where he learned his failed hip implant was leaking excessive cobalt into his bloodstream.

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, and a revision or removal surgery may be necessary.

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, which could become a debilitating issue for any of the 10 million people with hip replacement implants that use cobalt. 

Vaginal Mesh  

Another medical device featured in the film is vaginal mesh, which is used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Vaginal mesh was also marketed as superior to traditional methods for treating SUI and POP. It was presented as easily placed, with few complaints.

Filmmakers show the dangers of vaginal mesh through the story of Tammy Jackson, a Kentucky woman who has had 18 revision surgeries since her vaginal mesh was first 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. She co-founded the Mesh Awareness Movement (MAM) to inform women of the risks. 

◆

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

Though The Bleeding Edge focuses primarily on a few dangerous medical devices, it also briefly mentions other devices. The film introduces IVC filters, which can cause various complications, including floating to 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.