Monday, 22 October, 2018

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

ANGIE MARIE FIRMALINO	
 
		Angie Marie Firmalino 44 a cofounder of the Essure Problem group on Facebook ANGIE MARIE FIRMALINO Angie Marie Firmalino 44 a cofounder of the Essure Problem group on Facebook
Ben Pena | 24 July, 2018, 13:18

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.

Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we'll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure.

Essure activists held a daylong protest outside Bayer's USA headquarters in Whippany, N.J.

In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits. "The safety and efficacy of Essure have not changed".

Ensuring the safety and effectiveness of medical products is a core part of our consumer protection role, and I want to outline some of the steps we've taken in recent years with respect to Essure. About 750,000 women have been implanted with the device since its approval.

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".

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The device was developed by Conceptus Inc. and acquired by Bayer in 2013.

FDA Commissioner Scott Gottlieb said in a statement that the agency would continue to monitor Essure's safety, and added, "We expect Bayer to meet its postmarket obligations concerning this device".

The majority of those sales were in the United States, he said, where the company has seen an average 40 percent annual sales decline in the device since its introduction.

In recent years, the ranks of women who claim harm from the device have ballooned, and more than 15,000 have filed "adverse event" reports with the FDA.

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. It was not immediately clear what impact Bayer's decision would have on the studies.

Bayer, however, maintains that other factors are behind the product's drop in popularity. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression.

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