House bill would ban Bayer’s Essure

A bill introduced by Rep. Mike Fitzpatrick (R-Pa.) would ban U.S. sales of the Essure female sterilization implant made by Bayer (ETR:BAYN). The “E-Free Act” or H.R. 3920 was introduced Nov. 4 and has 3 co-sponsors: Reps. Marsha Blackburn (R-Tenn.), Gregorio Sablan (I-N. Mariana Islands) and Christoper Smith (R-N.J.). It would direct the FDA commissioner to withdraw approval for the Essure device, the only approved permanent birth control device in the U.S. Essure 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 a September meeting of the FDA’s Obstetrics & 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. The panel voted to recommend limited use of Essure unt...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Legal News Women's Health Bayer HealthCare Source Type: news