The US Food and Drug Administration just announced that they will be holding a public meeting of the Obstetrics and Gynecology Devices Panel on September 24th in order to discuss “the safety and effectiveness” of Essure, a permanent birth control device manufactured by Bayer.
“Some women have reported to the FDA that they have experienced pain or other health problems after Essure placement,” the FDA states on their website. “Problems have also been reported in clinical studies, and they are addressed in the Essure product information (labeling for physicians and patients). Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.”
According to the FDA’s site, the most frequently reported issues include (in order of most complaints) abdominal pain, heavier periods, headache, fatigue and weight fluctuations, with most of the reports listing multiple side effects. Eleven deaths have been reported, yet confirming whether or not the device was the sole reason for these fatalities is difficult.
So what exactly is Essure? The product’s official website promotes this device as being “99 percent effective,” as well as “the only permanent birth control you can get with a non-surgical procedure.”
“Essure is a small spiral device that is placed in a manner similar to an internal tubal ligation,” Sara Gottfried, a gynecologist and author of The Hormone Reset Diet, tells Yahoo Health. “It’s inserted via the cervix and through the uterus into the fallopian tubes to block fertilization.”
She adds that Essure was approved by the FDA back in 2002, “but adverse events, including multiple deaths, have ballooned in the past few years.”
Back in 2013, famous environmental activist Erin Brockovich (yes, from the movie) launched Essure Procedure, an online forum for women to share their personal stories about Essure. “I believe that collectively we are strong voices that can create change and not only help ourselves but educate and share our stories so that we can help others find the help and comfort they need,” she writes on the site’s homepage. “It is a woman’s right to decide for herself if she wants a certain form of birth control but when they are NOT told of the devastating side effects, well that isn’t right.”
Gottfried concurs. “I have not been a fan of Essure because it doesn’t have a long-enough track record of safety and efficacy,” she states. “I feel like women, in general, don’t get the full informed consent they need and deserve to make decisions about contraception, and Essure is the latest example of that failure.”
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