BEDFORD, Mass., Dec. 13 (UPI) -- A U.S. Food and Drug Advisory Panel has given pre-market approval to a female sterilization system that would provide permanent non-surgical birth control.
Hologic Inc. said the Adiana Transcervical Sterilization System provides women with a safe and effective permanent transcervical alternative to tubal ligation.
The FDA Obstetrics and Gynecology Devices Advisory Panel recommended approval of the device contingent upon several conditions, including long-term follow-up of current pivotal trial patients, a post-approval study of new patients and physicians, and more specific labeling recommendations, Hologic said Thursday in a release.
The FDA is not required to accept, but traditionally follows the recommendations of, its advisory panels.
The device -- which was tested on 645 women in the United States, Australia and Mexico -- was 98.9 percent effective at preventing pregnancy during the 12 month testing period, the company said.
