FDA plans Essure action for February

The FDA said today it will issue an evidence-based review of information on Bayer‘s (ETR:BAYN) controversial Essure permanent birth control for women in February next year. The agency said patient health and well-being was its 1st priority regarding the device, and named the issues with Essure specifically as a high-priority issue for it. The federal watchdog said it is reviewing information from the panel meeting it held in September, the public docket and additional medical literature and adverse event reports published since the panel meeting. The review will focus on concerns identified by speakers at the panel as well as recommendations provided by the panel, the FDA said. In September, the panel recommended that the agency limit the use of  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 ut...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Bayer HealthCare Source Type: news