Bayer to stop selling Essure birth control device in US

This image provided by Bayer Healthcare Pharmaceuticals shows the birth control implant Essure

This image provided by Bayer Healthcare Pharmaceuticals shows the birth control implant Essure. Bayer Healthcare Pharmaceuticals via AP

In recent years, thousands of women have claimed Essure caused serious health issues.

The Food and Drug Administration has placed multiple restrictions on the device following patient reports of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place.

The news was welcomed by women who have advocated against the device. In 2016, it ordered Bayer to conduct a post-market safety study and to add warning labels and a patient risk checklist to the device's packaging.

Bayer will no longer distribute or sell the Essure permanent birth control device in the United States after December 31, the company said Friday.

Pharmaceutical giant Bayer announced this week that it will cease USA sales of the controversial birth-control implant Essure, which has been linked to a smattering of serious health problems.

Courtney Mallon, a spokeswoman for Bayer, said the "voluntary discontinuation" is not indicative of safety issues and that the company is "working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported".

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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".

Marcus Susen, a Florida-based lawyer representing a number of women who have sued the company, called its decision long overdue, and said it would be up to a jury to decide if Bayer stopped the sale of Essure for commercial or safety reasons.

"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", Bayer said in a statement. At the time, Essure was manufactured and marketed by Conceptus Inc., which Bayer acquired in June 2013. The Company states that the decision to discontinue Essure was based on declining USA sales and not on any changes to the benefit-risk profile of the product. And we'll communicate publicly on any new findings or concerns. The film includes the stories of some women who claim they suffered permanent, serious complications from Essure. We'll share what we learn to help doctors and patients make informed decisions.

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

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.

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