FDA to Evaluate Safety of EssureNov 30, 2015
The U.S. Food and Drug Administration (FDA) has issued an update on the status of its evaluation of Essure, Bayer's permanent birth control device for women. Essure has been enshrouded in safety concerns due to a growing number of injury reports. In September, the FDA held a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the device. The meeting heard scientific and clinical perspectives along with patient experiences to discuss the risks and benefits. Public comments were also accepted on the issued from July 22 to October 24, 2015; the FDA is reviewing more than 2,800 comments submitted during this time.
Essure is a permanent form of birth control, or female sterilization. The procedure involves two springs that are inserted through the vagina and cervix and into each fallopian tube. As scar tissue grows around the spring, it prevents sperm from being able to fertilize the eggs. Essure has been marketed as a non-surgical approach because it does not involve a surgical incision.
The FDA has been reviewing an increasing number of injury reports associated with Essure in the past several years. According to the FDA announcement, adverse events include "persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions." In some cases, women have undergone surgery to remove Essure. The device is designed to be permanent, and is not intended for removal. There have also been reports of Essure failure and sometimes incomplete patient follow-up, leading to unwanted pregnancies.
The FDA says it is reviewing information from the panel meeting, public comments, medical literature and adverse event reports. "This is a high priority issue for the Agency, and we are working expeditiously to conduct an evidence-based review of the available information and identify appropriate next steps. We anticipate communicating our actions publically at the end of February 2016." the agency stated.