Bayer HealthCare announced today that a study published online this week in The Journal of Minimally Invasive Gynecology reinforces findings from previous clinical studies that support the effectiveness and safety of the Essure inserts and procedure for hysteroscopic sterilization, or permanent birth control. The prospective five-year follow-up study followed the initial cohort of women in the Phase III clinical trial that led to the approval of Essure® by the U.S. Food and Drug Administration in 2002.The study enrolled previously fertile women 21 to 40 years of age who were seeking permanent contraception, were engaged in a monogamous relationship, and were willing to use a temporary contraceptive method for the first three months following Essure insert placement. Among the 364 women relying on Essure inserts who completed the full five years of follow-up, no pregnancies were reported. In addition, the Essure inserts were generally well tolerated.
“Female sterilization is the second most common form of contraception in the United States and Essure, as the only available hysteroscopic approach, does not require incisions and represents an important contraceptive option for women who have completed their families,” said John E. Nichols, Jr., MD, FACOG, Medical/Laboratory Director, Piedmont Reproductive Endocrinology Group, Greenville, SC, and study investigator. “The results of this study, which are consistent with other published literature on Essure, document the extended five-year effectiveness, safety, and tolerability of Essure inserts.”
The Phase III study was designed to include five years of follow-up, one year of which was to be completed prior to a pre-marketing approval filing. The remaining four years of follow-up was completed as part of a post-approval study. For the full five years of follow-up (five years in total of relying on the Essure inserts for contraception) the end points of interest were safety and satisfaction, reliance on Essure for contraception and prevention of pregnancy. The five-year study evaluating long-term effectiveness was required by the FDA as part of the evaluation and approval of the Essure inserts.
The following severe events were reported as being possibly related to the Essure inserts or procedure: one woman with irregular menstrual bleeding, another woman with lower abdominal pain and very heavy periods, and a third woman with continuous bleeding. The latter two resulted in hysterectomy.
Throughout the five-year study, pelvic pain was reported in no more than 7% of study participants at any visit. Women with pre-existing chronic pain were excluded from participation and no study participants reported persistent pelvic pain of any kind at the 3-, 4-, and 5-year follow-up visits.
“Essure is supported by more than a decade of science and real world clinical experience,” said Edio Zampaglione, MD, Vice President, U.S. Medical Affairs, Women’s Healthcare and Neurology. “Bayer is strongly committed to providing access to a wide range of safe and effective contraceptive options for women, and we look forward to continued research on Essure.”
Essure is a safe and effective permanent birth control option for women when health care providers and patients follow the Instructions for Use. Most of the side effects that have been reported about Essure are known and included in the Instructions for Use.
Source: Bayer
Filed Under: Drug Discovery
