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Published: December 14, 2007
WASHINGTON - An advisory panel to the Food and Drug Administration recommended Thursday the approval of a new method for sterilizing women that would give them another option to tubal ligation.
The alternative procedure takes about 15 minutes to complete and uses 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 of Bedford, Mass. The company markets the product as a low-risk procedure that can be performed in a doctor's office. Overall, about 700,000 women in the United States 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. The FDA said the one-year efficacy rate for Adiana was 98.9 percent.
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