UPDATE: FDA mandates new study, ‘black box’ label for Bayer’s Essure

Updated with comment from Bayer The FDA today said it would put a pair of measures in place for the controversial Essure permanent contraception device made by Bayer (ETR:BAYN), mandating a new clinical study and new guidance on using the device. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, including for pain or menstrual irregularities after using the device, and complaints of the device breaking. In addition to 5 fetal deaths, there were 4 reports of adult deaths for reasons such as infection and uterine perforation, the FDA said. Earlier this month an analyst who examined the FDA’s adverse events website for cases involving the Essure device said the federal safety watchdog likely underestimated the number of fetal deaths linked to the implant. Today the FDA said it would require Bayer to run a new trial designed to “determine heightened risks for particular women” and draft guidance including a boxed warning label explaining the potential for adverse events connected with Essure. Bayer must design and conduct the post-market surveillance study comparing Essure with laparoscopic tubal ligation, the FDA said, using measures such as rates of complications including unplanned pregnancy, pelvic pain and other symptoms, explantation surgery and an evaluation of the complications’ impact on quality o...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Women's Health Bayer HealthCare Source Type: news