Bayer announced Friday that it will discontinue sales and distribution of its Essure permanent birth control device at the end of the year after a warning from the Food and Drug Administration.
The agency back in April restricted sales and distribution of Essure after a series of safety issues surrounding the device, which is an implant that provides permanent birth control.
The decision by device maker Bayer, which goes into effect on Dec. 31, is the culmination of a series of moves by the agency to respond to reports of safety issues. Serious risks associated with the device included persistent pain and tears of the uterus and fallopian tubes.
In 2017, the FDA got 11,854 safety reports linked to Essure, a major increase from the 5,019 reports in 2016, according to agency data.
At first the FDA required Bayer, which got FDA approval for the device in 2002, to add more warnings about the safety issues of Essure and conduct safety surveillance studies.
But in April the agency became aware that many patients weren’t being properly counseled and required restrictions on the sales and distribution of the device to only healthcare providers that provide information on the benefits and risks of the device. A patient also had to sign a waiver that they understood the risk about the implanted birth control implant.
Since the FDA ordered Bayer to conduct the study and add a boxed warning sales in the U.S. of Essure have declined by 70 percent.
“The company stated its decision to halt sales and distribution of the device was due to commercial reasons,” FDA Commissioner Scott Gottlieb said in a statement.
Bayer said that it continues to believe the product is safe and effective. It said the decision to stop sales was due to declining sales.
“Women who continue to have Essure in place can continue to confidently rely on the device,” the company said in a statement.
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