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 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.
The panel agreed that the device shouldn’t be used in women with metal allergies, autoimmune disease, chronic pelvic inflammation or prior uterine procedures. Panelists recommended strengthening the product label to provide more information about potential adverse events and the creation of a patient registry to track adverse events. They also recommended more training for doctors, including how to remove the coils and suggested a protocol be developed to intervene earlier when patients complain about persistent pain.
Although the panel did not take a formal vote and the FDA isn’t bound to follow its advice, the agency often follows the lead of its advisory committees.