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

Pearl Mccarthy
July 23, 2018

Get breaking news alerts and special reports. The U.S.is the last country in which Essure is being sold, meaning the device will no longer be available anywhere after Bayer halts sales at the end of this year.

Essure, the only non-surgical permanent form of birth control for women marketed in the United States, is inserted into the fallopian tubes, where scar tissue forms and builds a barrier to block sperm from reaching - and fertilizing - a woman's eggs.

While the agency has said that Essure's benefits outweigh its risk, it did slap a "black box" warning on the implant in 2016, and ordered more safety studies.

Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes. Then, scar tissue slowly forms around the implant, blocking passage of the egg from the ovaries to the uterus via the fallopian tubes.

In recent years, thousands of women have claimed Essure caused serious health issues. "No more women are going to be harmed by this device".

The Food and Drug Administration said earlier this year that over a 15-year period - November 2, 2002, when Essure was approved, through December 2017 - the agency received more than 26,000 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue.

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European governments tend to want to exert more control than the US. "We will continue to do it, no matter the political context". Google has rejected the EU's accusations, arguing that its approach encourages competition.

The FDA's April action was a "unique type of restriction" in which it imposed additional requirements "to provide a reasonable assurance of the device's safety and effectiveness", Gottlieb said. The agency is still investigating and has not indicated the device is unsafe, previously stopping short of outright banning it. In a statement released by the Agency, FDA Commissioner Scott Gottlieb, MD, said "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 maker of a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators said Friday that it will stop selling the device in the US, the only country where it remains available. In addition, the Company will continue to enroll patients in the Essure postmarket surveillance study, as requested by the FDA.

More than 16,000 Essure users have filed lawsuits against Bayer.

The group was created by Angie Firmalino, 45, of Tannersville, New York, who received the Essure implant nine years ago and later the device had become dislodged and migrated to her uterus. Protesters at Moscone Center demand Essure be taken off the market This has been an ongoing issue for years.

Firmalino told CNN that Friday's announcement about Essure "has brought us all to our knees in gratitude, relief and celebration". Our Medical Device Safety Action Plan, issued in April, captures numerous efforts that we're undertaking. "We have won, we have finally won".

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