Bayer says it will stop U.S. sales of birth control device Essure

In recent years, thousands of women have said Essure caused serious health issues.
by Daniel Arkin /  / Updated 
Image: Bayer's birth control implant Essure
Bayer's birth control implant Essure.Bayer / via AP file

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The pharmaceutical giant Bayer announced Friday it would stop selling the Essure birth control device in the United States by the end of the year, handing a symbolic victory to thousands of women who say the implant caused serious health issues and excruciating pain.

In a statement, Bayer attributed the decision to a "decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable." The company said it continues to "stand behind the product's safety and efficacy."

Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes. The coils are designed to cause inflammation, building up scar tissue that blocks the tubes and stops eggs from being carried from the ovaries to the uterus.

In recent years, thousands of women have claimed Essure caused serious health issues. Many women reported that the device had become dislodged or broken, migrating to other organs in their body.

The Food and Drug Administration said earlier this year that over a 15-year period — Nov. 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.

In a notice in April, the FDA said it was "unknown whether these symptoms are related to Essure." The agency is still investigating and has not indicated the device is dangerous.

But earlier this year, the FDA announced it would put restrictions on the sale and distribution of Essure, saying that Bayer could sell the device only to health care providers and facilities that guarantee women have been fully informed about its potential side effects.

In its statement on Friday, Bayer said the "declining interest" in the device was attributable to the decreased use of permanent contraception overall, increased use of other birth control methods, and supposedly "inaccurate and misleading publicity about the device."

Bayer is facing numerous lawsuits over the device.

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.

The group was created by Angie Firmalino, 45, of Tannersville, New York, who received the Essure implant nine years ago; later the device became dislodged and migrated to her uterus. (The device was later removed, but that procedure left behind metal fragments that ravaged her reproductive system.)

In a Facebook message to NBC News on Friday, Firmalino hailed Bayer's decision and said all the years of "fighting to get Essure off the market has finally paid off."

The announcement "has brought us all to our knees in thanks, relief and celebration. Not one more woman will be harmed by this device. We have won, we have finally won."

CLARIFICATION (July 20, 2018, 5:40 p.m. ET): An earlier version of this article implied that the FDA had considered banning Essure but decided not to do so. Although many patients have requested that the device be banned, the agency has consistently said that the benefits of Essure outweigh its risks.

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