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FDA to Publish Essure Safety Review by February 2016

FDA to Publish Essure Safety Review by February 2016

December 3, 2015 — The FDA plans to release its findings on Bayer’s Essure sterilization device by February 2016, the Associated Press reports.

The FDA is currently reviewing information from a panel meeting in September, newly published medical literature, and adverse event reports. According to a statement posted online:

“Patient health and well-being is our first priority regarding this device and all medical devices. … This is a high priority issue for the Agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps.”

Since Essure was approved in 2002, the FDA has received over 5,000 adverse event reports involving extreme fatigue, depression, weight gain, chronic pain, uterine perforation, fallopian tube perforation, migration of Essure into the abdomen, heavy bleeding, hypersensitivity reactions, and surgery to remove the device.

A summary of the meeting indicates that the panelists wanted more safety data, especially for nickel allergies and hypersensitivity.

The panelists also evaluated the risk-benefit profile of Essure. They agreed that Essure is an important option for women who cannot undergo surgical sterilization, but the device might pose serious risks for women with known metal allergies, autoimmune diseases, pelvic inflammatory disease, or abnormal uterine bleeding.

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