FDA Panel Recommends More Research for Essure
Yesterday, an FDA advisory panel met to discuss the safety of Bayer’s Essure female sterilization device. In the end, the panel recommended that the agency limit the use of the device until more is know about the safety of the product. The panel decided to meet on the issue after thousands of women reported serious health issues.
About the Essure Problem
Essure is the only approved permanent birth control device in the U.S. The small metal coil is placed in the fallopian tubes via catheter.
In the 13 years since the FDA approved Essure in 2002, the health regulator said that it has received 5,093 complaints. The reports include cases of the device breaking, five fetal deaths in women who became pregnant after using the device, and four adult deaths caused by infections and uterine perforation.
Bayer’s director of global pharmacovigilance risk management, Dr. Andrea Machlitt, told the panel that is has received 17,000 adverse event reports, 15,000 of which included U.S. patients. These numbers include a nearly 1,400% spike in the last three years
FDA Panel Recommends Stricter Label for Essure
The panel came to the conclusion that the device should not be used in women with metal allergies, chronic pelvic inflammation, prior uterine procedures, and autoimmune diseases.
They also recommended that the products label should be strengthened to include more information about potential adverse events. A second recommendation was that a patient registry be created to track adverse reactions and more training for doctors on removing the coils and intervening when patients complains about pain.
Many panelists pointed out discrepancies in the clinical study used to back Essure’s pre-market approval application. They pointed out that the study was not randomized, had no control group, and failed to provide adequate data on nickel-related side effects.
These discrepancies lead many panelists to believe that a new trial is needed to compare Essure with tubal litigation to determine if Essure is really the cause of the adverse effects. Dr. Milner also asked, “how can we register an opinion on this if we’re not satisfied with the method [the data] was captured?”
During the hearing, the panel heard testimony from several women who attribute their health issues to the Essure device. One such woman was Gabriella Avina, who was found to have celiac disease, a thyroid disorder and myasthenia gravis, illnesses that required multiple hospitalizations, chemotherapy and transfusions after having participated in the clinical trials for the device.