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A new report indicates that a group of women who suffered severe and often debilitating complications from the Essure birth control implant recently met with the head of the U.S. Food and Drug Administration (FDA), as part of an effort to urge the agency to remove the product from the market, as it has been throughout much of the rest of the world.
On February 10, BuzzFeed reported that a group of patients, lawyers and women’s health advocates met with FDA Commissioner Scott Gottlieb, calling for an Essure recall. The group included women representing a popular Facebook group known as “Essure Problems“, which has included vocal critics of the device and played a critical role in raising awareness about numerous health issues experienced by women after receiving the sterilization device.
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.
The group presented Gottlieb with data and photos of broken coils, stillbirths, injuries and other problems linked to the Essure coils. They also noted that a survey of women on the Facebook group found that out of 476 women who inquired about the implant since the FDA added a black box warning in 2016, only eight were made aware of the warning by their doctors.
Gottlieb reportedly told the women that he was waiting for Bayer to finish a safety study, which involves 2,800 women and is designed to examine the side effects of Essure coils. That study is not expected to be completed until 2023.
The meeting comes several months after Bayer announced it was halting sales of the Essure implant all over the world, except in the United States. The company claimed that the decision to stop selling Essure was a marketing decision and not related to the numerous complaints of adverse events.
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.
The agency also required that women be provided with a checklist to make sure they are aware of the risks before undergoing an Essure coils procedure, and many medical experts suggest that no woman should elect to undergo the sterilization.
Bayer now faces a hundreds of Essure injury lawsuits filed by women nationwide, each raising similar allegations that the manufacturer has known about the serious risks and failed to adequately warn women and the medical community.
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.