Device Used for Permanent Female Birth Control Carries Heightened Risk for Post-Procedure Operation

Dr. Art Sedrakyan

A common, nonsurgical form of birth control carries a heightened health risk for patients, finds a new comparative study by a team of Weill Cornell Medicine researchers.

The study is the first to compare the efficacy of laparoscopic sterilization, a procedure that obstructs the fallopian tubes, with a nonsurgical method that uses the implant Essure contraceptive device, a metal spring made from a nickel-titanium alloy, to block the tubes. The Weill Cornell Medicine team found the risk of post-procedure operation for women who opt for hysteroscopic sterilization was 10 times higher than for women who underwent laparoscopic sterilization.

Using New York State patient information, the authors extrapolate that nearly one-fourth of the estimated 600,000 women nationwide who underwent a permanent birth control procedure chose hysteroscopic sterilization.

"We found tenfold higher risk of repeat surgery after Essure when compared to laparoscopic surgery. This means that nationally more than 10,000 women likely underwent additional surgery in the past five years," said Dr. Art Sedrakyan, a professor of healthcare policy and research at Weill Cornell Medicine, who led the study published Oct. 13 in the BMJ.

In hysteroscopic sterilization, the metal Essure device is inserted into the patient's fallopian tubes. In time, scar tissue grows around the device, forming a barrier that prevents eggs from becoming fertilized. Essure says the procedure takes about 10 minutes, and it doesn't require general anesthesia.

But patients have recently filed lawsuits against the device's manufacturer, Bayer, claiming the implant has led to allergic reactions to nickel, severe pelvic pain and post-procedure operations, including attempts to stabilize the Essure device after it has inappropriately shifted, and hysterectomies.

The U.S. Food and Drug Administration is reviewing complaints about the safety of the device, but the Weill Cornell Medicine study represents the first analysis of 30-day, and one-, two- and three-year outcomes of 50,000 patients in New York undergoing permanent birth control procedures.

The Weill Cornell Medicine researchers recommend deeper communication between physician and patient regarding the risks associated with the device, plus the creation of national and state registries to track specific safety issues related to the Essure device.

"Establishing registries can help us elucidate specific complications that lead to repeat surgeries and better understand if it is possible to overcome technological limitations that cause these device failures," Dr. Sedrakyan said.

"We hope this publication and dissemination will lead to appropriate action by decision makers," he added.

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