Essure Study Raises Safety Concerns

A study published in the British Medical Journal lends support to claims some women have made about the safety of Essure, Bayer’s permanent birth control device. The study, which was led by Dr. Art Sedrakyan of Weill Cornell Medicine in New York, found that women were ten times as likely to undergo surgery to correct complications if they had Essure compared to those who had surgery instead.

Essure consists of two metal springs that are inserted into the fallopian tubes to permanently prevent pregnancy. It is marketed as a surgery-free alternative to laparoscopic surgery. Following thousands of complaints from women, the U.S. Food and Drug Administration (FDA) is reviewing the safety of the device. Reported injuries range from allergic reactions to the metal to severe abdominal pain, NBC News reports.

Researchers compared 8,048 women who had Essure to 44,278 women who had their “tubes tied” by undergoing a standard surgery to block the fallopian tubes between 2005 and 2013. “A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern,” the authors wrote.

“Essure helped them avoid surgery in some instances, but they are still facing a 10-fold high risk of getting that surgery done,” said Sedrakyan to NBC. “And that translates to one in 49 or 50 women getting this surgery again…And that surgery is likely to be much more complicated than the laproscopic approach that they should be considering.”

The authors noted that Essure users were more likely to be over 40 and have other complications such as pelvic inflammatory disease. “There are over 750,000 procedures done, so far most of them in United States,” Sedrakyan said, according to NBC. “So we believe this is commonly done procedure, and even small risk matters on a population level.”