Bayer to Stop Selling Essure in U.S.

Bayer's birth control implant Essure

Bayer's birth control implant Essure

Essure has also been the subject of a social media movement, most notably on Facebook, where more than 36,000 women have joined a private group called Essure Problems - a forum in which they share stories about their medical ordeals. The company said it was expecting additional lawsuits. The Company states that the decision to discontinue Essure was based on declining U.S. sales and not on any changes to the benefit-risk profile of the product. Those problems include chronic pain and perforations of the uterus and fallopian tubes.

Courtney Mallon, a spokeswoman for Bayer, said the "voluntary discontinuation" is not indicative of safety issues and that the company is "working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported". This is the last place in the world where Essure was still sold.

Bayer said the safety of its Essure implant has not changed, but it will stop selling the device at the end of the year due to weak sales.

In recent years, thousands of women have claimed Essure caused serious health issues. "This is what we've been fighting for for seven years".

When we first became aware of an increase in adverse events submitted to our database concerning this device, we launched an ongoing effort to review these reports to better understand concerns. Rusmisell said she got the device in 2008 and developed severe pain and bleeding.

The agency is monitoring Essure in several clinical studies to gather more information on the device's safety. The agency announced that it meant to require labeling changes to help patients better understand the potential risks of the device. About 750,000 women have been implanted with the device since its approval.

The agency said it received almost 12,000 reports in 2017 related to Essure. A self-described "data advocate", she analyzed public data on Essure and presented her findings to hospitals, patients and attorneys to help argue against the product. Each study participant will be followed for a total of three years and the company will continue to submit reports to the FDA on the study's progress and results.

The Essure System for Permanent Birth Control will no longer be available in the USA after December 31, 2018, according to a press release issued by Bayer. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take. Not one more woman will be harmed by this device. We'll share what we learn to help doctors and patients make informed decisions.

Essure, approved by the Food and Drug Administration (FDA) in 2002, is a permanently implanted contraceptive device that does not require a surgical incision.

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