On Friday, pharmaceutical giant Bayer announced that by the end of the year, it would stop selling its controversial Essure birth control implant. This decision by Bayer is welcomed news for the more than 16,000 women who have filed lawsuits alleging that the Essure device has caused them life-altering injuries.
This news comes after the FDA has significantly restricted Essure sales and marketing on numerous occasions following patient reports of injuries including bleeding, autoimmune reactions, migration of the device, pain, and allergic reactions to name a few. Most recently, in April 2018, after meeting with advocates for women who were injured by Essure, the FDA restricted sales of the Essure device to only doctors and healthcare facilities who use the FDA approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”.
The sale and distribution of Essure, therefore, became limited to healthcare providers who agreed to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation. At that time, the FDA reported that from the time Essure was approved in 2002, through the end of 2017, the FDA had received nearly 27,000 reports of adverse events. The FDA did note, however, that some might have been duplicates.
Though consumers of Essure have been asserting for years that the device is unsafe, Bayer continues to stand by the safety and effectiveness of the device. In fact, in a statement, Bayer said, “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.” Bayer additionally blamed “inaccurate and misleading publicity” as a major factor for its decision. The company also said that that American women were simply becoming less interested in permanent contraception.
The United States was the last country to continue selling the device after Bayer ended sales outside of the United States last September, citing “commercial reasons.”
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