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

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 is placed in the fallopian tubes via catheter. The FDA approved the device in November 2002. In the near 13 years since then, the health regulator said it had received 5,093 complaints, including those of pain or menstrual irregularities after using the device, as well as complaints of the device breaking. Those adverse event reports include 5 fetal deaths in women who became pregnant after using Essure and 4 adult deaths for reasons such as infection and uterine perforation, the FDA said. In a report issued before yesterday’s meeting of the FDA’s Obstetrics and Gynecology Devices advisory panel, the agency said it logged a nearly 1,400% spike in complaints filed over Essure in the last 3 years. Yesterday a Bayer’s director of global pharmacovigilance risk management, Dr. Andrea Machlitt, told the panel that it’s received 17,000 adverse event reports, 15,000 of which involved U.S. patients. Yesterday the 16-member panel agreed that the device shouldn’t be used in women with metal allergies, autoimmune disease,...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Bayer HealthCare Obstetrics and Gynecology Devices Advisory Panel Source Type: news

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