New Permanent Birth Control Option
Quick, Nonsurgical Technique Awaits FDA Approval
Although there have not been any pregnancies reported among the 600 women involved in the two clinical trials, the women have only been followed for about two years. Allina says failure rates with permanent birth control methods typically don't begin to appear until several years after the procedure.
Allina says it is also not known whether the device would affect ablation therapies that use electricity to treat endometriosis, fibroids, or uterine bleeding.
The device's manufacturer, Conceptus Inc., says it plans to continue to follow the study participants for five years to monitor the safety and effectiveness of Essure.
Essure is already approved and in use in Australia, Europe, Singapore, and Canada. A final decision about U.S. FDA approval is expected in early 2003.