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The head of the U.S. Food and Drug Administration (FDA) indicates that the agency received nearly 12,000 adverse event reports involving problems with Essure procedures last year, highlighting continuing concerns about the safety of the birth control device, which has been linked to issues with migration, organ perforation, allergic reactions and other complications among women nationwide.
In a press release issued on March 7, FDA Commissioner Scott Gottlieb provided an update on the ongoing investigation into the safety of Essure birth control coils, which carries a “black box” warning in the U.S., but has been removed from the market in many 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 Gottlieb, the FDA received nearly 12,000 adverse event reports related to the Essure birth control implant last year, with the majority being submitted in the last quarter of the year.
Gottlieb indicates that most of the reports were linked to the growing number of Essure injury lawsuits being pursued in federal and state courts nationwide, and the FDA is uncertain at this point whether they represent new safety concerns. The agency is reviewing whether many of the reports were previously submitted.
More than 90% of the reports mentioned problems with Essure removal, according to Gottlieb. The FDA is now investigating potential risks associated with removal of the coils.
The update comes after a meeting between Gottlieb and a number of women last month, who called for an Essure recall to be issued in the United States, arguing that stronger warnings added in late 2016 are insufficient. Bayer has previously decided to remove Essure from the market in other countries worldwide, but still markets the product in the U.S.
“Some of the women I spoke to went on to develop significant medical problems that they ascribe to their use of the product. As a physician, I know that patients are uniquely positioned to provide feedback to the FDA about their experiences with currently available medical products, and I appreciated the thoughtful discussion,” Gottlieb wrote. “Ensuring the safety and effectiveness of medical products is paramount to the FDA and a core part of our consumer protection role. The FDA takes concerns about Essure very seriously.”
Gottlieb indicated that the FDA 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.
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.
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.