Risks assessed by FDA
Essure is undergoing a new, mandatory FDA clinical trial to evaluate the possible risks associated with implantable birth control. The FDA Approved Essure in 2002.
Essure is a permanent form of birth control. In short, flexible coils insert through the cervix and vagina into the fallopian tubes. Scar tissue forms around the coils and creates a barrier that stops sperm from reaching the eggs.
“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… They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.” – William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health
The FDA also plans to add a warning on the product box to help consumers choose appropriate birth control. The FDA ordered Bayer to conduct a surveillance study of current Essure users to provide more information about potential risks.
Rep. Mike Fitzpatrick, a Republican from Pennsylvania and Madris Tomes, owns Device Events which analyzes FDA public data. Fitzpatrick provided the FDA with data showing 303 fetal deaths among women who used the device.
“I actually think the 303 number is conservative,” Tomes said, “because some of these women have had multiple miscarriages, they’ve had multiple pregnancies, after confirmation, but I only counted them once.”
If you or anyone you know have been injured or suffered side effects after using Essure, file an adverse event report with the FDA here.
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