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Bayer pulls controversial birth control off market after years of complaints

Bayer pulls controversial birth control off market after years of complaints
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Bayer announced Friday it would stop selling a controversial birth control implant after years of lawsuits from thousands of women alleging it caused injury and health issues.

Bayer attributed the Essure decision to declining sales, saying it still stands by its safety and efficacy. 

The decision follows action the Food & Drug Administration (FDA) this year restricting Essure's sale and distribution to health-care facilities that provide full information about the device's risks.

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The permanently implanted birth control device was approved in 2002 and given the FDA's strongest safety warning label in 2016, following thousands of complaints from women who said it caused pelvic pain, hair loss, muscle weakness, perforation of the uterus and other issues. 

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

The FDA said the product saw a 70 percent decline of sales in the U.S. after it added a boxed warning and patient decision checklist to the labeling. 

FDA Commissioner Scott Gottlieb said Friday that ensuring the safety of Essure will continue to be a priority for the agency for women who still use the product. 

"I also want to reassure women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so," Gottlieb said.

"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. Device removal has its own risks. Patients should discuss the benefits and risks of any operation or procedure with their health care providers before deciding on the best option for them."