Bayer has revealed plans to voluntarily stop selling its birth control product Essure in the US after 31 December this year.
In April this year, the FDA ordered a restriction on the marketing of the device, and asked Bayer to provide adequate risk information as well as imposed other requirements to ensure the device’s safety and effectiveness.
However, Bayer noted that the decision to discontinue sales and distribution of the non-surgical implant is not due to its benefit-risk profile.
The move to withdraw Essure has been attributed to a fall in sales in the country in recent years.
The minimised interest in the device is said to be due to a decrease in the overall use of permanent contraception and improved reliance on other options such as long-acting reversible contraceptives (LARCs).
Bayer further added that inaccurate and misleading publicity about the system has also contributed to the declining interest among the US women.
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A statement from Bayer read: “Most importantly, we want to let the many women who have chosen Essure for their reproductive health know that our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure.
“Women who currently have Essure in place may continue to confidently rely on the device, and Bayer will continue to support women with Essure and their healthcare providers.”
Bayer has informed the US Food and Drug Administration (FDA) about the discontinuation of the device.
Commenting on Bayer’s decision FDA said: “The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use.”
The regulatory authority has further asked Bayer to perform a new post-market surveillance study in order to better assess Essure’s safety profile in the real world.