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After receiving thousands of reports involving women who experienced painful and debilitating complications from Essure sterilization, federal health regulators are placing new restrictions on the sale of the birth control implant, but will continue to allow it to remain on the market in the U.S.
On April 9, the FDA made changes to the Premarket Approval (PMA) of Bayer’s Essure sterilization procedure, 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.
The agency says it considers the move a “unique” way to restrict sales and distribution of the device, whose sales have declined 70% in the U.S. According to an FDA press release announcing the move, the agency decided to add the new requirement after becoming aware that some women were not being adequately informed about potential Essure complications, even after the agency added a black label warning and a patient checklist.
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.
Under the new requirements, it will be illegal for doctors to implant patients with the Essure without both parties signing off that they have discussed the potential health risks. Only doctors and healthcare facilities have agreed to do so will be allowed to sell the implant. Bayer has been charged with ensuring the checklists have been read and signed, or it could face criminal and civil penalties, the FDA warns.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable,” Gottlieb said in the press release. “Every single woman receiving this device should fully understand the associated risks.”
In addition to the patient-doctor checklist requirement, the FDA is adding the following statement to the device’s label:
“The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.”
No Essure Recall In The U.S.
The move is not quite what many critics of the implant wanted. Bayer has withdrawn the Essure from every market in the world except the United States, and many women who say they were injured by the device, some of whom have filed Essure injury lawsuits, had urged the FDA to issue an Essure recall here as well.
Gottlieb previously 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.