WASHINGTON -- Bayer will end U.S. sales of Essure, the controversial permanent sterilization device already pulled from foreign markets, at the end of this year, .
"The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018," said FDA Commissioner Scott Gottlieb, MD, in a .
"The decision today to halt Essure sales also follows a series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use," he continued.
Gottlieb noted that sales of the device declined by about 70% following these actions, which included requirements for a boxed warning, a post-market study, and more recently, an informational brochure for patients that included a consent form.
Bayer said its decision was driven purely by the sales decline. "The benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research," the company said.
Gottlieb said the post-market safety studies will continue and are a top priority for the FDA.
He also noted that women using Essure successfully to prevent pregnancy do not need to have the devices explanted.
Essure, a sterilization device, was marketed to women who have decided not to have any, or any more, pregnancies.
Once inserted in a women's fallopian tubes, the device, made of an expandable nickel-titanium coil with a stainless steel coil inside it, triggers tissue growth, ultimately blocking these tubes and preventing sperm from entering the duct. At least, that is how the device was supposed to work.
Tensions between the FDA and thousands of women who believe the sterilization device is dangerous have been mounting for years.
In September 2015, during the public portion of an FDA advisory committee meeting, dozens of women described a laundry list of symptoms they experienced after receiving the implantable device, including severe abdominal pain, bleeding irregularities, migraines, painful sex, auto-immune disorders, extreme fatigue, psoriasis, perforation of the uterus, and even narcolepsy and cataplexy. Some also said they became pregnant, in spite of the device.
At that time, roughly 5,000 medical device reports -- indicating adverse effects in women who had the device implanted -- had been filed with the FDA.
Bayer removed Essure from all foreign markets in September 2017, also citing commercial reasons.
(See this article for a timeline of major events in Essure's product life.)
Rep. Rosa DeLauro (D-Conn.), who had complained to the FDA repeatedly about the device, celebrated Friday's announcement.
"Until today, the United States was the only country in the world where you could purchase Essure -- a distinction for which no one should be proud," said DeLauro in a press release.
"I am glad that women in America have joined the ranks of those whose safety will no longer be threatened by this dangerous product."
To date, DeLauro noted, there have been 20,000 documented adverse events.
Women who say they have been harmed by Essure also applauded the news on Friday.
"Seven long years of fighting to get Essure off the market has finally paid off," wrote Angie Firmalino, founder of the Facebook group "Essure Problems" and president of Advocating Safety in Healthcare E-Sisters (ASHES), in a message to 鶹ý.
"Today's announcement that Bayer will be pulling Essure from the market here in the U.S. has brought us all to our knees in thanks, relief, and celebration. Not one more woman will be harmed by this device. We have won, we have finally won," Firmalino said.
Nearly a decade has passed since Firmalino was implanted with Essure. She said she experienced fevers, achy joints, and constant bleeding and ultimately had the device removed, but pieces remained.
The FDA approved Essure, marketed by Conceptus, which was later acquired by Bayer, in November 2002. According to the agency, Essure is estimated to have been used by more than 750,000 patients worldwide.