FDA: New Tubal Sterilization Method Safe, Effective
FDA Obstetrics and Gynecology Devices Advisory Panel votes system is approvable
FRIDAY, Dec. 14 (HealthDay News) -- The Adiana System of tubal sterilization, which involves application of radio frequency energy to the fallopian tubes via a hysteroscopically-placed catheter, followed by placement of a biomaterial matrix to occlude the tubes, appears to be a safe and effective method of permanent contraception, according to a U.S. Food and Drug Administration (FDA) advisory panel.
The FDA Obstetrics and Gynecology Devices Advisory Panel voted Thursday (10 to 3) that Adiana's pre-market application for female sterilization is approvable. Approval was recommended but contingent on several conditions, including long-term follow-up and more specific labeling. The FDA will take these recommendations into consideration when making its final decision.
In formulating the recommendation, the panel reviewed data from the EASE trial. Of the 604 women with bilaterally placed matrix evaluated by hysterosalpinogram for tubal occlusion, 570 (94 percent) were deemed able to rely on the system for contraception. During the ongoing follow-up period, the one-year, two-year and three-year method failure rates for the Adiana System were 0.54 percent, 1.29 percent and 1.29 percent, respectively, rates that are comparable to other methods of tubal sterilization at the same time points.
"Women are looking for choices for their long-term contraceptive needs," said Ted Anderson, M.D., Ph.D., of Vanderbilt University Medical Center, and clinical investigator of the study. "Adiana provides a novel, safe and effective permanent transcervical alternative to tubal ligation."
The EASE trial was sponsored by Hologic Inc. of Bedford, MA, the manufacturers of Adiana.