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Sale and distribution of Essure device to be discontinued in US by Bayer

Pharmaceutical company Bayer has decided to stop selling its birth control product Essure in the US after 31st Dec 2018. US FDA imposed restriction on the marketing of the device on Bayer in April this year due to inadequate risk information and other requirements to ensure the device’s safety and effectiveness. However according to Bayer,” The decision to discontinue the product is not due to the benefit- risk profile rather it is due to a fall in sales of the device in the country in recent years.” The reason for fall in sales 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).According to Bayer inaccurate and misleading publicity about the system has also contributed to the declining interest among the US women.

Bayer has informed the US Food and Drug Administration about the discontinuation of the device on which FDA has given the comment that the company's decision to stop the sale and distribution of "Essure" follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use."
USFDA has asked the company to perform a new post market surveillance study in order to assess the safety and efficacy of Essure in the real-world.