Sterility devices lead to ten times more reoperations

A study run by Art Sedrakyan of Weill Cornell Medicine found that women implanted with Bayer AG’s Essure sterility device were ten times more likely to need new operations as women who got standard sterility surgery

Essure implants are inserted through the vagina into a woman's fallopian tubes and designed to cause inflammation and fibrous tissue growth that will block the pathway between sperm and egg.

However, women at a Food and Drug Administration workshop complained of extreme pain and allergic reactions to the device.

The study by Weill Cornell researchers appeared online in the publication BMJ and included the records of 8,048 women who underwent the Essure procedure and 44,278 others who got traditional tubal ligation surgery.

The researchers evaluated the cases of patients with such procedures in New York state between 2005 and 2013. Reoperations one year afterward were the main outcome measured.

Researchers from Weill Cornell Medicine wrote: "A more than 10-fold high occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern."

However, Bayer said in a statement: "Essure is a highly effective birth-control option with a positive benefit-risk profile for women who have completed their families and want permanent contraception with a nonsurgical procedure."