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Bayer Stops US Sale of Essure Birth Control Implant

24 July 2018

Bayer took the action after the Food and Drug Administration in April restricted the sale and distribution of the device because of the agency's concerns over the product's track record of unsafe side effects.

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. This April, the FDA significantly restricted sales and distribution of Essure.

The device was developed by Conceptus Inc. and acquired by Bayer in 2013.

In their press statement, Bayer notes that the "increased reliance on other birth control options, such as long-acting reversible contraceptives, and inaccurate and misleading publicity about the device" is what contributed to the decline in interest for Essure.

Bayer in a statement said the decision was not related to safety concerns.

Essure was touted as a breakthrough alternative to surgical sterilization when it was approved by the U.S. Food and Drug Administration 16 years ago. Using a scope device that enters the uterus through the vagina, a doctor implants one coil in each of the openings of a woman's fallopian tubes (see the diagram at the bottom of this post). The United States was the last country in which Bayer marketed Essure, the Washington Post noted. "This decision is based on a decline in US sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable", the statement reads.

"The benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research", the company said.

The FDA said the product saw a 70 percent decline of sales in the USA after it added a boxed warning and patient decision checklist to the labeling. Doctors will be able to perform Essure procedures until the end of next year when they will be asked to return unused devices.

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.

In recent years, the ranks of women who claim harm from the device have ballooned, and more than 15,000 have filed "adverse event" reports with the FDA. It was not immediately clear what impact Bayer's decision would have on the studies.

"The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen", according to Gottlieb.

Bayer, however, maintains that other factors are behind the product's drop in popularity.

Bayer Stops US Sale of Essure Birth Control Implant