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Bayer announced on Friday that it might discontinue sales of
its Essure contraception implant by the top of the year, bowing to a lengthy campaign
by health advocates and thousands of girls to urge the device off the market.
The implant has had a troubled history.
it's been the topic of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and therefore the fallopian tubes.
Several deaths, including a couple of infants, have also been attributed to the device or to complications from it.
Bayer said its decision to halt sales of the device wasn't associated with the litigation or safety issues, but with a decline in use as women chose other options.
Bayer has repeatedly denied that the implant is dangerous or caused injuries.
Women who had filed injury claims and advocacy groups, including one called Essure Problems that had 36,000 members on Facebook, had repeatedly demanded that the Food and Drug Administration ban the device. But the agency declined.
In April, after meeting with advocates for the ladies, the F.D.A. required Bayer to limit sales to doctors’ offices and medical practices that agreed to completely inform women about the product’s risks.
At that point, the agency said that from 2002, when Essure was approved, through the top of 2017, it had received nearly 27,000 reports of adverse events — although the F.D.A. noted that some may need to be duplicate.
Madris Tomes, a former F.D.A. medical device official who runs a corporation that analyzes adverse event data, puts the figure closer to 30,000.
“With side effects starting from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages, and even death, the benefit-risk profile touted by Bayer simply didn’t jibe with the info that was pouring into the F.D.A. from both patients and physicians,” said Ms. Tomes, who has done unpaid work for an Essure patient advocacy group.
The Essure implant consists of two small coils made from a nickel-base alloy and a polyester-like fiber.
it's placed through the vagina into the fallopian tubes and is meant to make an inflammatory response that causes connective tissue to make, blocking the tubes.
The United States was the sole country where the device, considered a nonsurgical sterilization implant was still being sold. Bayer had stopped selling it in England, Brazil, Canada, France, and a number of other countries.
In 2016, the F.D.A. ordered placement of a “black box warning” on the merchandise package that warned of the injury risk, including that the implant could travel into the abdomen and cavity, possibly requiring surgical removal.
Dr. Scott Gottlieb, the F.D.A. commissioner, said Friday those sales of the device within The United States had declined by about 70 percent since the agency ordered Bayer to conduct a post-market study on women using the device and to put the boxed warning and patient decision checklist on the labeling.
Dr. Gottlieb also said the F.D.A. would still evaluate reports filed about injuries related to Essure, also as reports of surgeries required to get rid of it.
Bayer blamed “inaccurate and misleading publicity” as a key thinks about sales loss.
The company also said that American women were becoming less curious about permanent contraception, and instead were relying more on other contraception options, like long-acting reversible contraceptives.
“The benefit-risk profile of Essure has not changed,” the corporate said, “and we continue to stand behind the product’s safety and efficacy, which are demonstrated by the extensive body of research.
” Public health advocates have long been troubled by what they see as a scarcity of solid data on Essure’s safety and effectiveness.
“Thousands of girls have reported serious complications from Essure, and there has been no unbiased long-term research to refute or confirm those reports,” said Diana Zuckerman, president of the National Center for Health Research, who has been a paid expert witness in one among the cases involving Essure plaintiffs against Bayer.
“Both the F.D.A. and therefore the company is liable for a situation where women couldn't make informed decisions.”
The company said it might still enroll patients during a postmarket surveillance study and will work with the F.D.A. to make sure appropriate follow up.
Steven Immergut, a Bayer spokesman, said that as of mid-April, there have been about 16,800 plaintiffs who have filed claims regarding Essure.
Many of the lawsuits are consolidated or merged from states across the country.
“We believe we've meritorious defenses and shall still vigorously defend Essure,” he said.
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