Bayer recently announced that it will be pulling the Essure birth control device from the US market at the end of 2018.
As for why there is this arguable “Essure recall”, we will start with Bayer’s spin on the situation. From this July 20, 2018 Washington Post news report, “Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device”:
The company said Essure’s removal from the market was “business decision” prompted by precipitous declines in sales in recent years. It said in a statement that it stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to “confidently” rely on it.
The United States is the last country where Essure is being sold. Last September, citing “commercial reasons,” Bayer announced it was ending sales outside the United States….
For some background and so as to put this Bayer action regarding Essure in perspective, we get this timeline from another item issued July 20, 2018, “Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed”:
February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.
March 2018: The FDA reported on a rise in new medical device reports submitted to the agency’s public database in 2017 with more than 90 percent of the reports involving potential device removal.
April 2018: In order to address concerns that not every patient was receiving adequate risk information, the FDA restricted the sale and distribution of the Essure device.
One last observation and nothing more: Thousands of Essure products liability lawsuits have been filed against Bayer in U.S. courts during the past few years.
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