Long-Term Essure Safety Risks To Be Evaluated by FDA Long After Market Withdrawal
Although Bayer decided earlier this year to stop selling Essure birth control, federal regulators are providing reassurances to women who already have the birth control device implanted in their body that they will continue to monitor and review the long-term safety of Essure devices.
Following years of reports involving painful and debilitating Essure complications experienced by women who had the device implanted as a form of permanent birth control, Bayer previously announced a market withdraw for the product, indicating that all sales will be stopped by December 31.
Last week, FDA Commissioner Scott Gottlieb issued a statement (PDF) that indicates the agency is extending a post-marketing surveillance study and taking other measures to ensure long-term Essure oversight, even after the product is no longer sold.
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Gottlieb announced that the FDA is revising the protocols of an Essure postmarket surveillance study, extending the follow-up period for women in the study from three to five years. In addition, the FDA is requiring additional blood testing of patients, looking for potential immune reactions, and is requiring Bayer to submit more frequent reports on the study’s progress.
The announcement notes that some of the changes are due to Bayer having trouble reaching the required sample size of the study, which Gottlieb says is due to restrictions the FDA placed on the sale of Essure devices earlier this year, as well as declining sales.
The extension is also due to reports of injuries occurring during the removal of Essure devices, which can reportedly fracture, leaving behind fragments and shards, or pierce internal organs. According to the FDA, removal issues made up the majority of more than 15,000 medical device reports submitted from 2017 through June 2018.
The agency issued a review of Essure removal medical device reports on December 20, noting that device removal reports made up 85% of adverse event reports in 2017 and the first half of 2018.
“Based on this information, the FDA instructed Bayer to extend the postmarket surveillance study from three years to five years to capture longer term information about device removals,” Gottlieb said in his statement. “We believe it’s important to continue closely monitoring device removals in the postmarket surveillance study to gain greater knowledge of this issue.”
Bayer also issued a statement in response to the FDA’s new requirements.
“The safe and effective use of our medicines and devices is our highest priority, and we are committed to the postmarket study for Essure,” said Dr. Edio Zampaglione, vice president of Bayer U.S. Medical Affairs, Women’s Healthcare and Neurology. “Bayer has worked cooperatively with the FDA throughout the implementation of the study and on these study amendments, which provide a measure of flexibility for patient enrollment and allow us to collect additional and valuable long-term data.”
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.
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