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Obstetrics and Gynecology Devices Advisory Panel

FDA panel recommends limited use of Bayer’s Essure until more is known about safety

September 25, 2015 By Brad Perriello

An FDA advisory panel yesterday recommended that the agency limit the use of Bayer‘s (ETR:BAYN) Essure female sterilization device until more is known about its safety, after thousands of women reported serious health issues they attribute to the nickel-titanium implant. Essure, the only approved permanent birth control device in the U.S., is a small metal coil that […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Women's Health Tagged With: Bayer, Obstetrics and Gynecology Devices Advisory Panel

UPDATE: FDA panel inconclusive on power morcellators

July 14, 2014 By Ingrid Mezo Leave a Comment

UPDATE: FDA panel inconclusive on power morcellators

An FDA panel convened last week to consider the use of a controversial procedure to remove uterine fibroids failed to come to a clear decision on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees.

Filed Under: Food & Drug Administration (FDA), Gynecological, News Well, Regulatory/Compliance Tagged With: Johnson and Johnson, Obstetrics and Gynecology Devices Advisory Panel

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May 20, 2022
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