Essure Injuries Continue As Bayer “Drag its Feet” on Study: Congressional Letter
A group of U.S. lawmakers are asking FDA officials why Bayer has not completed a required study on complications linked to its Essure birth control implant, indicating that women are continuing to suffer serious injuries while the manufacturer is being allowed to “drag its feet”.
U.S. House representatives Rosa L. DeLauro, Jim Schakowsky, and Louise M. Slaughter, all Democrats, sent a letter (PDF) this week to Dr. Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), inquiring about the status of post-marketing an Essure study, which was required due to widespread safety concerns, rather than recalling the birth control device.
Although it has been a year and a half since the study was initiated, the lawmakers indicate that it is unclear whether Bayer has taken sufficient steps to enroll participants, raising questions about whether the results will be delayed. The representatives have requested a meeting with Gottlieb to discuss the situation.
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In March 2016, the FDA decided not to remove the device from the market, instead requiring stronger warnings about Essure risks and requiring Bayer to conduct studies to better understand the safety of the procedure, which involves implanting coils that permanently sterilize women.
A year and a half later, Bayer has only enrolled one patient, according to the FDA, and only 100 according to Bayer’s own statements, the letter notes. That’s despite a plan released in March 2016, in which Bayer claimed it would be enrolling 78 patients per month once the study’s sites were activated. The FDA has approved 60 such sites for the study.
Essure procedures are designed to provide permanent birth control, as scar tissue forms around the coils to prevent pregnancy. However, thousands of women have suffered painful injuries when the coils migrated, perforated the uterus or fallopian tubes, caused allergic reactions, infections or other complications.
“Despite widespread safety concerns, the FDA has allowed Essure to remain on the market even while mandating that the manufacturer, Bayer, conduct an additional post-market safety study,” the letter notes. “However, a year and a half after the study was initiated, it is unclear whether Bayer has acted with urgency to enroll patients, or if the study results will be delayed. The FDA cannot continue to allow Bayer to drag its feet on this post-market study while women are continuing to suffer.”
The letter indicates that the problem goes beyond Essure, calling the situation a “prime example” of medical device oversight and enforcement problems in the FDA. The lawmakers cited a 2015 report by the Government Accounting Office which warned that companies lacked incentive to actually follow through on FDA-mandated post-marketing studies due to a lack of enforcement.
The letter comes about a month 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 currently faces Essure lawsuits brought on behalf of about 3,700 women in the United States, alleging 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.
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