Bayer to stop selling Essure birth control implant in US

Bayer's birth control implant Essure

Bayer said in a statement that the decline in sales was due to an overall decrease of permanent contraception in the United States, a growing reliance on other birth control methods and "inaccurate and misleading publicity about the device".

Bayer will no longer distribute or sell the Essure permanent birth control device in the United States after December 31, 2018, the company said Friday. About 750,000 women have been implanted with the device since its approval.

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.

Essure, the only non-surgical permanent form of birth control for women marketed in the U.S., is inserted into the fallopian tubes, where scar tissue will form and build a barrier to block sperm from reaching - and fertilizing - a woman's eggs. And in February, the FDA ordered that Essure only be sold through doctors who guaranteed that women were being fully informed about risks connected to the device. That includes monitoring "adverse event" reports and holding Bayer to its promise to conduct further safety studies.

September 2015: The FDA convened a panel of experts to get their input on how we should investigate patient complaints that included abdominal pain, abnormal uterine bleeding and device migration. She took part in patient-organized rallies accusing Bayer for not disclosing potential risks and said, choking back tears, "Our very grassroots effort has worked".

Essure is made of two inch-long flexible metal coils.

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

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.

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The majority of those sales were in the U.S. Since then, the company has seen an average 40 percent annual decline in U.S. sales, Immergut said.

While the agency has said that Essure's benefits outweigh its risk, it did slap a "black box" warning on the implant in 2016, and ordered more safety studies.

"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", Gottlieb continued. Its current labeling lists hives, rash, swelling and itching as possible reactions. It also says removal may require complicated surgery, including a hysterectomy, that might not be covered by insurance.

In recent years, thousands of women have claimed Essure caused serious health issues. "If patients had been listened to when the first clinical trials were conducted on Essure, better research would have been conducted to determine exactly how safe and effective Essure is".

While the pharmaceutical giant is standing by the safety of its product, many others are not.

Kate Nicholson, of Dallas, got an Essure implant a year ago after she and her husband decided not to have children.

"Pulling it from the market is yet another way to limit our choices about our own bodies", Nicholson said.

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