Tuesday, May 01, 2018 by Isabelle Z.
The U.S. FDA has finally followed the lead of other countries and restricted the sale of the birth control implant Essure. This comes after they gave the device the strongest possible safety warning in 2016 and asked its manufacturer, Bayer, to carry out a post-market study. The device is already banned in every other country besides the U.S.
This non-hormonal and non-surgical permanent birth control procedure entails inserting a coil directly into the fallopian tubes. The scar tissue build-up that the procedure causes prevents any eggs from making their way into the womb.
Since its introduction in 2002, more than 34,000 women have lodged complaints about its side effects, with 26,000 women in the U.S. reporting complications like allergic reactions, irregular bleeding, pain, fatigue, device migration and headaches to the FDA. Eight adult deaths related to Essure have also been reported to the FDA. Angry patients and other concerned parties have protested outside of medical conferences about the device’s use and approval. It earned a temporary suspension last year in the EU, while UK hospitals have been urged to avoid them. It was then pulled from the market entirely everywhere but the U.S.
The device contains polyester and nickel, which are believed to be behind the allergic reactions. For some women, the pain caused by the device is serious enough to make them suicidal. Some women have also experienced abnormal uterine bleeding and ectopic pregnancies.
Since the FDA required it to carry a black box warning two years ago outlining its side effects and warning that it can travel into the pelvic cavity and abdomen and require surgical removal, sales of Essure in the country have dropped by around 70 percent.
Under the new restriction, Bayer can only sell the device to health care facilities and providers who can guarantee that their patients have been completely informed of its possible side effects, like perforation of the fallopian tubes and uterus. Doctors will be required to review a checklist with patients, which must then be signed by both the doctor and the patient.
It’s hard to believe that something like that could be enough or that Bayer would even believe that anyone would want to go forward with the procedure after being honestly informed of its effects, so it seems likely the system could be abused somehow by profit-minded doctors; it’s an easy insertion process that takes just 15 minutes and it’s the only permanent contraception device available that does not require a surgical incision.
One woman told the Daily Mail about her nightmarish Essure ordeal. She experienced serious damage from it, so she had it removed, followed by a hysterectomy, yet broken fragments of it remain in her body. She has to use a motorized wheelchair to get around, and the pain is so bad that she can’t get out of her bed some days. Frustrated by a lack of experts who can get the 1-2-millimeter fragments out of her body, the English woman may have to visit a Dutch specialist to deal with the problem.
There are also questions about its efficacy. Although manufacturer Bayer says that Essure has an efficacy rate of 99.3 percent in preventing pregnancy, the French National Agency for Medicines and Health Products reports that it failed for 4.8 percent of women.
It’s nice to see the FDA actually stepping in and doing something about Essure, but it’s hard to believe that they aren’t giving this dangerous product an outright ban like we’ve seen happen elsewhere in the world.
Sources for this article include: