Study finds higher surgery risk with Bayer’s Essure

(Reuters) — Women implanted with Bayer‘s (ETR:BAYN) Essure female sterilization device were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization, according to a study published today in the British Medical Journal. The findings could cast additional doubt on the safety of the Bayer device, which was approved in 2002 as an alternative to surgical sterilization and acquired by Bayer in 2013. It has faced recent scrutiny from U.S. health regulators following numerous patient complaints and calls for its withdrawal from the market. By 1 year after the initial procedure, 2.4% of Essure patients had required follow-up surgery, compared with 0.2% of those who underwent a minimally-invasive tube-tying procedure called laparoscopic sterilization, the researchers found. That translates to about 21 additional surgeries per 1,000 patients receiving Essure, they said. “Small risk in large numbers of patients translates into large numbers,” said study leader Dr. Art Sedrakyan, professor of healthcare policy and research at Weill Cornell Medicine in New York. “In some instances, these re-operations are quite major surgeries,” including hysterectomies, Sedrakyan added. The study analyzed coding data on medical records of some 52,000 women from outpatient ambulatory surgical centers in New York state between 2005 and 2013. If the New York data were to be extrapolated to Essure use throughout the ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Gynecological Regulatory/Compliance Women's Health Bayer HealthCare Source Type: news