Bayer AG said Friday they would voluntarily discontinue sales of their Essure birth control system in the U.S., saying their 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 also said "our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure."
They added "the benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy."
According to Bayer, several factors "contributed to declining interest in Essure among women in the U.S.," including a decrease in the use of permanent contraceptive options, increased use of other birth control methods, and "inaccurate and misleading publicity about the device."
The company said it "would continue to enroll patients in the Essure postmarket surveillance study" and will work closely with the FDA to ensure appropriate follow up.
In April, the U.S. Food and Drug Administration tightened restrictions on the sale and distribution of the device, requiring both patients and health-care providers to sign an acceptance-of-risk form. That followed an FDA decision earlier in the year that required Bayer to add a boxed warning following studies that linked the device to pain and other health issues among women.
Company website: https://www.bayer.com/
Write to Stephen Nakrosis at [email protected]
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