Update on FDA Evaluation of the Safety of Essure Birth Control System

FDA Evaluation of the Safety of Essure Birth Control System

FDA Evaluation of the Safety of Essure Birth Control System


The Food and Drug Administration (FDA)’s Office of Women’s Health has issued an update on the agency’s evaluation of the safety of the Essure birth control system.

Essure—a form of permanent birth control (female sterilization)—is under FDA review in response to thousands of adverse event reports. The agency is reviewing information from a September panel meeting, the public docket, and medical literature and adverse event reports that have been published or received since the panel meeting. The FDA anticipates communicating its recommendations at the end of February 2016.

Essure is a permanent birth control method for women. Implantation of the Essure System does not require a surgical incision and the insertion can be done in a doctor’s office. A health care provider inserts flexible metal coils through the vagina and cervix and into the fallopian tubes, which carry the eggs from the ovaries to the uterus. Over a period of about three months, scar tissue forms around the coils. The tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception, the FDA explains. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

The FDA has been examining a growing number of reports of harm with Essure. The adverse events reported include persistent pain, perforation of the uterus and/or fallopian tubes, migration of the device, abnormal or irregular bleeding, and allergy or hypersensitivity reactions to the metal in the coils. Some women have needed surgical procedures to remove the device. Essure failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies. Some women have experienced ectopic pregnancy, where the embryo implants outside the uterus; ectopic pregnancy can be life-threatening.

The FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear expert scientific and clinical opinions as well as patients’ experiences about the benefits and risks of the Essure System. In addition, a public docket soliciting comments on the device remained open from July 22, 2015 until October 24, 2015. The FDA said it received more than 2,800 comments in this docket and is reviewing each comment.

Among the new material is research study published in the online edition of the British Medical Journal. The study found that women with the Essure device had 10 times as many surgeries to correct problems as women who had surgical sterilization, according to NBC News. Dr. Art Sedrakyan of Weill Cornell Medical College in New York and colleagues analyzed data from 8,048 women in New York State who had Essure implants between 2005 and 2013. They compared these women to 44,278 women who had standard surgery to block or “tie” their fallopian tubes. “A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern,” Sedrakyan said. Sedrakyan does not say Essure should be pulled from the market, he said women need to understand the implantation is “not a low-risk procedure,” according to NBC News. He recommends that women be tested for nickel allergies, which is not routinely done now, and could be important to the outcome of the procedure.

 

 

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