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Bayer to Stop Selling Controversial Birth Control Device That Sparked Thousands of Lawsuits

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Updated: | Originally published: ;

Bayer announced Friday that it will no longer sell a controversial, permanent form of birth control that thousands of women say led to serious complications.

Essure, a non-surgical sterilization device that is inserted into the fallopian tubes and prevents pregnancy by producing scar tissue that blocks sperm from fertilizing eggs, will no longer be available in the U.S. after December 31, 2018, Bayer announced in a statement. “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable,” the statement reads.

While Bayer maintains that “the safety and efficacy of Essure have not changed,” many women have different stories. More than 16,000 lawsuits have been filed against Bayer in relation to Essure, citing complications ranging from migraines and hair loss to organ perforation and unintended or dangerous pregnancies, according to ConsumerSafety.org. Many of these women have chronicled their ordeals in Essure Problems, a nearly 37,000-member Facebook group for women who are “suffering or have suffered from side effects which may be attributed to Essure.”

The Food and Drug Administration (FDA), which approved Essure in 2002, has also taken steps to warn women of the risks associated with the device. In 2016, it ordered Bayer to conduct a post-market safety study and to add warning labels and a patient risk checklist to the device’s packaging. This April, the FDA significantly restricted sales and distribution of Essure.

“Since the FDA ordered Bayer to conduct the post-market study and then to add a boxed warning and a Patient Decision Checklist to the labeling, there has been an approximate 70 percent decline in sales of Essure in the U.S,” FDA Commissioner Scott Gottlieb said in an April statement. About 750,000 women have been implanted with the device since its approval.

Bayer, however, maintains that other factors are behind the product’s drop in popularity. “Several factors have contributed to declining interest in Essure among women in the U.S., including decreased use of permanent contraception overall, increased reliance on other birth control options, such as long-acting reversible contraceptives (LARCs), and inaccurate and misleading publicity about the device,” the company said in its statement.

Bayer halted sales of Essure in every country besides the U.S. last fall.

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Write to Jamie Ducharme at jamie.ducharme@time.com