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Following thousands of complaints involving women who suffered painful and debilitating complications from Essure implants, Bayer has finally decided to remove the controversial permanent birth control device from the market in the United States.
In a press release issued on July 20, Bayer said it made a business decision to voluntarily discontinue the Essure sterilization coils due to declining sales. The company indicated that sales in the U.S. will end on December 31, 2018, and the move comes months after the company recalled Essure from the market in a number of other countries.
Essure is designed to provide permanent protection against pregnancy, involving an outpatient procedure where coils are placed in the uterus, which develop scar tissue that prevent pregnancy. However, thousands of women have experienced painful and debilitating injuries when the coils migrated, perforated the uterus or Fallopian tubes, caused allergic reactions, infections or other complications.
According to FDA Commissioner Scott Gottlieb, the FDA received about 12,000 adverse event reports related to the Essure birth control implant last year.
“The decision 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,” Gottlieb said in an FDA press release, also issued on July 20. “For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device.”
Although Essure is being removed from the market, Bayer claims it stands by the safety of the device and maintains that the market removal decision was a result of falling sales from competition and the implant’s declining reputation.
“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, undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades,” the Bayer press release states. “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.”
Bayer currently faces several thousand Essure lawsuits brought on behalf of women who have been left with devastating injuries, each raising similar allegations that the company manufactured and sold an unreasonably dangerous and defective sterilization product, withholding information about the risks associated with the procedure.
Last year, Essure was withdrawn from every other market in the world, except the United States. However, in May, after Gottlieb met with a number of women who claimed they were injured by the device, the FDA added new restrictions to Essure procedures, indicating that both the doctor and the patient must sign off on a checklist of potential problems, to ensure that the patient is fully informed about the risks.
In November 2016, following controversial hearings in the U.S., where testimony was heard from large numbers of women and medical experts, the FDA decided not to recall Essure in the United States. However, the agency did require Essure black box warnings, which are the strongest that the FDA can require a medical device carry.
Approximately 750,000 women worldwide have been implanted with the device, and Bayer has previously estimated that 70% of those have been implanted in women in the U.S.
The manufacturer has reportedly spent about $413 million defending the Essure litigation over the last year, and may face substantially greater liability at trial if Essure settlements or another resolution for the cases is not reached.