July 8, 2020 / 6:14 PM / a month ago

BRIEF-U.S. FDA Posts Interim Results For Postmarket Surveillance Study On Essure, A Permanently Implanted Birth Control Device For Women

July 8 (Reuters) - U.S. FDA:

* U.S. FDA - POSTED INTERIM RESULTS FOR POSTMARKET SURVEILLANCE STUDY ON ESSURE, A PERMANENTLY IMPLANTED BIRTH CONTROL DEVICE FOR WOMEN

* FDA - EARLY RESULTS SHOW ESSURE TENDS TO HAVE HIGHER RATES OF CHRONIC LOWER ABDOMINAL, PELVIC PAIN & ABNORMAL UTERINE BLEEDING VERSUS LAPAROSCOPIC TUBAL LIGATION

* FDA - PATIENTS WITH ESSURE HAD HIGHER RATES OF GYNECOLOGIC SURGICAL PROCEDURES, INCLUDING SURGERY TO REMOVE ESSURE VERSUS PATIENTS WHO HAD TUBAL LIGATION

* FDA - PREGNANCY RATES ARE SIMILAR FOR PATIENTS WITH ESSURE & TUBAL LIGATION

* FDA - WORKING WITH BAYER TO MODIFY STUDY TO INCLUDE ADDITIONAL INTERIM ANALYSIS AT 1 YEAR OF FOLLOW UP AFTER PATIENTS’ PERMANENT BIRTH CONTROL PROCEDURE Source text: (bit.ly/3iITzin) Further company coverage:

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