![]() ![]() Stephen Tower, an orthopedic surgeon featured in the documentary, started suffering neurological issues after having a hip replacement. market, effective December 31, 2018.Įssure is just one of the medical devices featured in The Bleeding Edge, which takes a sharp look at the profit-driven mind-set that rushes implanted devices into the marketplace with proper clinical trials. The company also stood by its product's 'safety and efficacy' in it's latest statement announcing that it is being pulled from the U.S. last year, once again insisting that the decision was made for 'commercial reasons and that it is not related to a safety or product quality issue.' There have even been reports of deaths, including a few infants, that have been attributed to Essure or complications from it.Īs a result of rising complaints about the device, the FDA made the decision in 2016 to have a 'black box' added to Essure to to call attention to serious or life-threatening risks.īayer halted sales of Essure outside of the U.S. Others alleged the coils dislodged and migrated to other parts of the body. Some women claimed their bleeding and pelvic pain was so severe they needed to have the device removed, which at times required a hysterectomy. ![]() There have been roughly 16,000 lawsuits or claims filed against Bayer by women who reported bleeding, pain, and other alleged medical issues, including damage to the uterus and fallopian tubes. The sterilization implant was initially marketed as the only permanent birth control method that did not require a surgical incision, but the product has been steeped in controversy over the years. Once permanently implanted inside the fallopian tubes by a doctor, scar tissue forms around the device over a three-month period and creates a barrier that keeps sperm from reaching the eggs, preventing pregnancy. ![]() 'This is exactly why we do this work: This film has already changed policies and changed history,' Dick said.Įssure, which was first approved by the FDA in 2002, is a metal coil device used by women as an alternative to tubal litigation (also known as having one's 'tubes tied'). In a statement released by Nexflix, Dick and Ziering applauded the decision, calling Bayer's action 'a gratifying affirmation of the power of documentary.'
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