FDA orders further testing, label changes for Essure birth control device
Available for 14 years, Essure is a permanent form of birth control. Using flexible coils implanted through the cervix, vagina and fallopian tubes, Essure causes scar tissue to form around inserts over an approximately three-month period, which blocks sperm from reaching eggs.
FDA officials are requiring a new clinical study for Essure in an attempt to determine whether or not certain women are at a higher risk of complications related to its use.
Additionally, the FDA has mandated changes to Essure's labeling to include a boxed warning and patient decision checklist.
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, said. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
Serious complications may result from the use of the Essure device, including chronic pain, perforation of the uterus or fallopian tubes, abnormal bleeding, and allergy or hypersensitivity reactions.
In addition, Bayer has been mandated by the FDA to perform a new post-market surveillance study to evaluate risks associated with Essure use and to compare the risks to those associated with laparoscopic tubal ligation.
Public comment will be accepted for 60 days at www.fda.gov.
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