Bayer to stop sales of birth control device tied to injuries


The Food and Drug Administration has placed multiple restrictions on the device following patient reports of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place.

Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we'll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure. This decision follows the FDA's patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device's safety and effectiveness. The flexible coils are inserted through the vagina and cervix and into the fallopian tubes. At the time, Essure was manufactured and marketed by Conceptus Inc., which Bayer acquired in June 2013.

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Pharmaceutical powerhouse Bayer on Friday announced that it will voluntarily end sales of its controversial Essure sterilization coils in the United States at the end of the year, giving a huge victory to women who blame the device for chronic pain, uterine perforations, miscarriages, hysterectomies, and other problems.

In a Facebook message to NBC News on Friday, Firmalino hailed Bayer's decision and said all the years of "fighting to get Essure off the market has finally paid off". "No more women are going to be harmed by this device". "Instead, tens of thousands of women reported deeply troubling complications from using Essure, but the USA was the last country where Essure continued to be sold". "The safety and efficacy of Essure have not changed". The Company states that the decision to discontinue Essure was based on declining USA sales and not on any changes to the benefit-risk profile of the product.

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FDA Commissioner Scott Gottlieb said in a statement that the agency would continue to monitor Essure's safety, and added, "We expect Bayer to meet its postmarket obligations concerning this device".

The FDA said the product saw a 70 percent decline of sales in the US after it added a boxed warning and patient decision checklist to the labeling.

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On Tuesday, Firmalino and other Essure activists held a daylong protest outside Bayer's USA headquarters in Whippany, N.J. As part of it, they broadcast a clip from the forthcoming Netflix documentary about medical device failures called The Bleeding Edge.