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Birth control implant linked to dangerous side effects

It is the only permanent, nonsurgical form of birth control available on the American market, but a new order from the U.S. Food and Drug Administration warns users about the dangers of the contraceptive Essure. Launched in 2002, Bayer’s Essure has been plagued by reports of ineffectiveness and side effects over the years, with users submitting more than 12,000 “adverse event” reports relating to the birth control device in 2017 alone.

Users logged another 5,000 complaints about Essure between 2002 and May of 2015, leading the FDA to require that the product manufacturer, Bayer, add a black-box warning to the product, which is the strictest safety warning the agency can issue.

Reported Essure side effects

Essure users reported a variety of side effects and complaints relating to the device, with thousands of women reporting that they experienced severe bleeding, stillbirths, miscarriages, severe pain and unintended pregnancy, among related issues and complications. The FDA also reported that, in some cases, Essure users had the birth control insert migrate within their bodies, ultimately taking up residence in their pelvic or abdominal cavities. Other users, yet, reported that they had to have hysterectomies when removing the devices from their bodies, while some users reported experiencing depression and weight gain after product use.

A failure to adequately warn patients

While the overall safety of the Essure birth control device is a serious concern, so, too, is the fact that many product users are unaware of the dangers associated with the product. To help raise awareness about potential product dangers, the FDA has limited the sale and distribution of the birth control device to doctors and medical facilities that agree to have every patient review and sign a brochure containing information about product risks.

While the FDA’s efforts may help more patients recognize the dangers associated with Essure, some safety advocates feel the product should undergo removal from the market entirely to protect more women from suffering dangerous, debilitating side effects.

 

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