Better late than never, FDA to hold long overdue safety hearing on Essure ... - HealthNewsReview.org
On Thursday, September 24, an FDA panel of 19 experts will re-hash the risks and benefits of the Essure metal coil permanent sterilization device. Representatives of Bayer are also obligated to defend the device, touted as the only non-surgical alternative to tubal ligation. Both the FDA and Bayer have released new information on the device prior to the meeting. The public can listen and watch online Thursday as the hearing is live-streamed from 8 a.m. to 7:30 p.m. Eastern.
On top of the agenda are the safety and side effect risks not documented in the initial clinical trials the FDA used as the basis for its approval. The FDA said in its latest review that some of the side effects “are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.â€
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