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Federal health regulators have essentially rejected a citizen petition calling for a recall of the Essure birth control implant, despite numerous complaints from women about damaging complications and side effects.
The FDA issued a letter (PDF) on March 26, responding to a petition signed by more than 2,100 women and indicating that the agency will not force an Essure recall and that it is closing the petition.
The original petition was reportedly filed incorrectly, according to the FDA, which indicated that since it was a trade complaint, the petition will be forwarded to the Office of Compliance within the Center for Devices and Radiological Health (CDRH). The agency then stated that the petition was considered closed.
Essure is a birth control implant offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.
In January, a citizen petition was filed with the FDA regarding reports of severe and debilitating problems from Essure implants, including extreme abdominal pain, excessive bleeding and internal organ injuries.
The transfer to the office of compliance means that the FDA is rejecting and closing the petition. However, the agency could still determine that regulatory action is needed against Bayer over the Essure complaints.
According to the letter, the petition, which called for an Essure recall, claimed that Bayer and the Essure’s original creators had committed fraud in respect to the clinical trials over the device and that they had violated the terms of Essure premarket approval.
“The Office of Compliance will enter the information into the Allegation of Regulatory Misconduct system, send you an acknowledgement, review the information and investigate the complaint,” the response letter indicates. “The Office of Compliance will pursue actions as deemed necessary.”
Although the procedure has become increasingly popular, the FDA has received hundreds of adverse event reports over the past year involving side effects of Essure birth control, including instances where women had to undergo a hysterectomy due to complications that may have been experienced.
Concerns over the birth control implant gained substantial media attention over the summer, following Congressional testimony involving an Essure injury during a briefing by the National Center for Health Research that called for legislation to improve the FDA approval process.
Bayer, which bought the original company that designed the Essure implant and now markets the device worldwide, has downplayed the complaints, maintaining that there are relatively few cases out of the Essure implants used worldwide.