Apparently, once a medical device gets approved by the FDA to go on the market, it is almost impossible to take it back off, even if the device has proven to be dangerous or even deadly, according to Michael Carome from the public watchdog group Public Citizen. In fact, the FDA has only withdrawn a total of two products from the market, ever.
This incomprehensible situation is proving injurious and even fatal for some women. One group of these women, known as E-Sisters, are women who have been implanted with the permanent contraceptive device called Essure. In 2017 alone, the FDA received 12,000 reports of adverse effects from women with Essure, ranging from bleeding, bloating, and pelvic pain to rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction. Madris Tomes, a former FDA analyst, tracked more than 26,000 total adverse reports about Essure, including eight deaths. In addition, there may be as many as 32,000 more complaints made to the manufacturer of Essure that were never officially reported to the FDA.
Shortly after Essure went on the market, independent research began challenging the safety and efficacy of the device. One study found that women who had Essure needed follow-up surgery ten times as often as women who had their tubes tied. And the surgery to fix the problem is not a simple one. In fact most surgeons recommend a hysterectomy as the best way to remove Essure.