Bayer, the pharmaceutical company, will discontinue the marketing and sales of the controversial birth control device Essure in all countries outside of the United States, the company announced Monday.
Multiple reports have linked the Essure implants to health problems, including chronic pain and bleeding, but Bayer said it’s pulling the device from non-U.S. markets for commercial reasons.
The sale of the implants in the European Union was temporarily suspended last month.
Essure is a permanent birth control procedure that involves two nickel-titanium coils placed inside the fallopian tubes to spur the growth of scar tissue that eventually blocks the tubes to prevent pregnancy.
The controversial implant has left some women in chronic pain, and some have even needed hysterectomies to remove it. Other women reported the implant had fallen out of position and embedded itself elsewhere in the body.
Last year, the U.S. Food and Drug Administration ordered Bayer to carry out long-term testing on Essure and put a warning on its packaging.
“The FDA has taken several steps to ensure the ongoing evaluation of Essure’s safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device,” she said.
The U.S. is the biggest market for the product. More than 15,000 women have reported problems to the US Food and Drug Administration, which include “pain”, “allergic reactions” and the coil moving to other parts of the body.
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