Bayer to stop sales of birth control device tied to injuries

Ben Davidson
July 23, 2018

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.

This image provided by Bayer Healthcare Pharmaceuticals shows the birth control implant Essure. Last year, Bayer stopped selling the device in Europe.

The FDA received almost 12,000 reports in 2017 related to Essure, the only permanent, nonsurgical birth control on the market in the U.S.

Women who say they were harmed by Essure "have advocated for one another and on Capitol Hill to educate others about the safety of medical devices", said Madris Tomes, founder and CEO of Device Events.

On Tuesday, Firmalino and other Essure activists held a daylong protest outside Bayer's USA headquarters in Whippany, N.J. As part of it, they broadcast a clip from the forthcoming Netflix documentary about medical device failures called The Bleeding Edge. "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. Over the course of three months following implantation, scar tissue - or a "natural barrier", as Bayer puts it - builds up around the coils, blocking the fallopian tubes and thus the ability of sperm to fertilize a woman's eggs.

Dr. Christopher M. Zahn, vice president of the American College of Obstetricians and Gynecologists, said in a statement Friday that the safety data on hysteroscopic sterilization, the fallopian tube procedure by which Essure works, "has not changed".

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.

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The agency is monitoring Essure in several clinical studies to gather more information on the device's safety.

Bayer denies that Essure is unsafe or ineffective, and in Friday's statement said that women now using the product can "confidently" rely on it.

They also claimed that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression. Those who think it's causing problems, such as persistent pain, should consult with their doctors, Gottlieb added.

The announcement comes after years of claims by thousands of American women who used the implant that Essure caused serious problems.

And earlier this year, the agency restricted sales of the device to healthcare providers who agreed to have patients sign paperwork acknowledging the device's risks and benefits.

"I would hope Bayer would use this opportunity to think about future research and product development", Brandi said.

Bayer spokeswoman Courtney Mallon said the company had no plans to re-design the device.

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