Published: Mon, July 23, 2018
Medicine | By Tracy Klein

Bayer to phase out Essure birth control device in U.S.

Bayer to phase out Essure birth control device in U.S.

Bayer said in a statement that the decline in sales was due to an overall decrease of permanent contraception in the United States, a growing reliance on other birth control methods and "inaccurate and misleading publicity about the device".

Steven Immergut, a Bayer spokesman, said the company had sold roughly one million Essure devices worldwide since the product came on the market in 2002. Doctors will be able to perform Essure procedures throughout 2019, until they are asked to return unused devices by the end of next year.

Introduced in 2002, the Essure implant consists of two coils made of polyester and a nickel alloy that are placed in the fallopian tubes and cause scar tissue that effectively blocks them.

Essure, the only non-surgical permanent form of birth control for women marketed in the U.S., is inserted into the fallopian tubes, where scar tissue will form and build a barrier to block sperm from reaching - and fertilizing - a woman's eggs. In April, when the FDA became aware that many patients were not being adequately counseled, we required a restriction which limits the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and gives patients the opportunity to sign an acknowledgement that they fully understood these potential risks before having the device implanted. "This decision is based on a decline in USA sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable", the statement reads.

Gottlieb said the FDA will continue to monitor adverse events reported to its database after Essure is removed from the market. About 750,000 women have been implanted with the device since its approval.

I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who've already had this device implanted.

The majority of those sales were in the United States, he said, where the company has seen an average 40 percent annual sales decline in the device since its introduction.

Essure has also been the subject of a social media movement, most notably on Facebook, where more than 36,000 women have joined a private group called Essure Problems - a forum in which they share stories about their medical ordeals. Those who think it's causing problems, such as persistent pain, should consult with their doctors, Gottlieb added.

February 2016: The FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world.

"As a result, when thousands of women reported serious complications from Essure, there was no unbiased long-term research to refute or confirm those reports", Zuckerman said.

Gottlieb noted that device removal "has its own risks".

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