The U.S. Food and Drug Administration on Monday instructed the maker of Essure to conduct further studies on the controversial birth control device, and recommended that a warning be added to the product label.
“While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications,” the agency said in a statement. “These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.”
Essure, approved by the FDA in 2002 for women ages 21 to 45, is a flexible coil that is inserted by doctors into the fallopian tubes. An estimated 750,000 women have received the product, manufactured by Bayer.
Essure has been the target of thousands of complaints from women across the country, including in Connecticut. A majority of complaints cite abdominal pain, irregularities in menstrual cycles, fatigue and possible nickel allergy. Some women have reported perforation of the uterus and/or fallopian tubes or intra-abdominal or pelvic device migration.
U.S. Rep. Rosa DeLauro, who was among the first members of Congress to speak out against Essure, said Monday that the device should be pulled off the market until the requested post-market studies are completed.
“Women and their doctors have filed more than 5,000 adverse events reports to the FDA regarding the negative side effects of Essure, yet the device is still on the market,” DeLauro said in a statement. “While conducting a post-market study and issuing labeling recommendations are positive developments, these actions mean nothing unless the FDA is able to take action. . . “The FDA cannot continue to drag its feet on medical device safety when women are suffering.”
The FDA instructed Bayer to conduct a clinical study to look at the “heightened risks for particular women,” and announced plans to require changes to product labeling, including a boxed warning and a “Patient Decision Checklist” to help to ensure women receive information regarding the benefits and risks of using the device.