An advisory panel to the Food and Drug Administration recommended on Thursday the approval of a new method for sterilizing women that would give them another option to tubal ligation.
The alternative procedure recommended takes about 15 minutes to complete and involves using radio signals to create a lesion inside the fallopian tube. A catheter delivers a soft material smaller than a grain of rice into the tube. Healthy tissue then grows on and around the material to create a permanent blockage. Patients are typically able to return to work within a day.
The device, called Adiana, is made by Hologic Inc. of Bedford, Mass. The company markets the product as a low-risk procedure that can be performed in the doctor’s office. Overall, about 700,000 women in the U.S. elect to have their tubes tied each year, which typically occurs in a hospital operating room.
FDA documents showed that the procedure was not foolproof. During a clinical trial, 570 women were told they could rely on Adiana for contraception. That assurance came after they had the procedure and made follow-up visits to the doctor. During the 15 months following the procedure, pregnancies occurred in 11 cases. Five of the pregnancies happened while the women were told to rely also on alternative birth control. Six pregnancies occurred after they were told they could rely exclusively on Adiana.
The FDA said the one-year efficacy rate for Adiana was 98.9 percent.
The recommendation for Adiana’s approval came from the FDA’s Obstetrics and Gynecology Devices Panel. The vote was 10-3, and the approval came with six conditions. They include long-term follow-up of current patients, the conducting of studies tracking patients yet to be treated and a requirement that the company will have to make adjustments to the product’s suggested labeling with emphasis on the uncertainty of “long-term effectiveness and risk.”
Company officials said they had not yet set a price for the procedure. It will be up to the FDA to determine when Adiana will be made available to the public.