Essure, a common, nonsurgical form of birth control, carries a heightened health risk for patients, a new study finds.
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.
“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,” says Art Sedrakyan, a professor of health care policy and research at Weill Cornell Medicine, who led the study published 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 recently have 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 US Food and Drug Administration is reviewing complaints about the safety of the device, but the new 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 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 Essure.
“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,” Sedrakyan says.
“We hope this publication and dissemination will lead to appropriate action by decision-makers,” he adds.
Source: Timothy Malcolm for Cornell University