Bayer to Stop Selling Essure in U.S.

Bayer to Stop Selling Essure in U.S.

Bayer to Stop Selling Essure in U.S.

Dr. Yesmean Wahdan, an OB-GYN at Bayer US Medical Affairs, Women's Healthcare, said in a video statement to the press posted online Friday that the company "made a business decision to discontinue sales and distribution because of a decline in sales".

Bayer has said it doesn't know how many women have the implants, just that about a million Essure "kits" have been sold worldwide, most in the U.S. 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". Once implanted, the coils trigger an immune response that causes scar tissue to form, blocking the tubes so that eggs can't make their way into the uterus for fertilization.

The U.S. 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. This April, the FDA significantly restricted sales and distribution of Essure. "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 Company states that the decision to discontinue Essure was based on declining U.S. sales and not on any changes to the benefit-risk profile of the product.

Based on that investigation, the FDA issued a black-box warning-the agency's most serious kind of warning-and ordered Bayer to conduct a post-market study to evaluate the safety of Essure.

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.

Mesut Ozil retires from Germany after political tensions over Turkish roots
Ozil also went with Germany to the 2010 and 2018 World Cups and was named national team player of the year five times. He also played a key role in their 2014 World Cup triumph.

"Thousands of women have reported serious complications from Essure, and there has been no unbiased long-term research to refute or confirm those reports", Diana Zuckerman, president of the National Center for Health Research, told the New York Times. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take.

February 2016: The FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. "Device removal has its own risks".

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

Bayer is facing numerous lawsuits over the device.

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