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FDA Posts Interim Results from Required Essure Postmarket Surveillance Study

FDA Posts Interim Results from Required Essure Postmarket Surveillance Study

“Although Essure is no longer available for implantation in the U.S., the FDA remains committed to evaluating long-term safety information in women who have received the device, including data from an FDA-required postmarket surveillance study.”

“Today we’re providing important early overall results—from patients at varying points of follow up—from that prospective study to help patients and health care providers better understand complications women with Essure may experience. ”

 

 

“Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control. Also, patients with Essure had higher rates of gynecologic surgical procedures—including surgery to remove Essure—than patients who had tubal ligation. Lastly, pregnancy rates are similar for patients with Essure and tubal ligation.”

 

 

“The FDA is working with Bayer, Essure’s manufacturer, to modify its study to include an additional interim analysis at one year of follow up after patients’ permanent birth control procedure—this is earlier than the previously planned analysis at three years. We believe this change is important to continue to closely monitor patient outcomes and communicate about the results in a more meaningful way.”

 

 

FDA Posts Interim Results from Required Essure Postmarket Surveillance Study

Darshana

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More news about: global pharma | Published by Darshana | July - 10 - 2020 | 182

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