Bayer Throws in the Towel on Essure Birth Control Implant

Bayer said Friday it will stop selling its Essure birth control system in the United States at the end of the year, citing a decline in U.S. sales of the device and the conclusion that the Essure business is no longer sustainable. Although the controversial product is the subject of nearly 30,000 adverse event reports to FDA and thousands of patient lawsuits, Bayer insisted in a statement Friday that its decision to discontinue sales of the product is for business reasons only, "not for any safety or efficacy concerns about Essure." The company added that the benefit-risk profile of Essure has not changed and that Bayer continues to stand behind the product's safety and efficacy.   Regardless of the reasons behind Bayer's decision to stop selling Essure in the United States, the patient advocacy group known as the E-Sisters is certainly considering the move a victory. "So proud of my wife and the work the Essure Problems teams has done over the many years to stop Bayer from selling this harmful product. Mission accomplished," Tweeted Jeremy Schulman, the husband of one patient advocate.  FDA turned up the heat on Bayer in April to make sure women considering the implantable contraceptive device are adequately informed of its risks. Now, patients must be given the opportunity to sign an acceptance of risk and informed decision acknowledgment, and the same "patient-doctor discussion checklist" must be signed by the physician implanting the device. The agency said Bayer wil...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Implants Source Type: news