24 weeks: clips and snips

FDA panel supports new sterilization method for women
Fri, Dec 14, 2007 (HealthDay) — A new method for sterilizing women — which would provide an alternative to tubal ligation — should be approved by the U.S. Food and Drug Administration, an advisory panel to the agency recommended Thursday.

This new approach, which takes about 15 minutes to accomplish, involves the use of radio signals to create a lesion inside the fallopian tube, the Associated Press reported. Doctors use a catheter to place a soft material — smaller than a grain of rice — into the fallopian tube. Healthy tissue grows on and around the material and blocks the tube.

The product, called Adiana, is made by Hologic Inc. of Bedford, Mass, which promotes it as a low-risk procedure that can be performed in a doctor's office. According to study data in FDA documents, the efficacy rate for Adiana is 98.9 percent, the AP reported.

By a 10-3 vote, the FDA's Obstetrics and Gynecology Devices Panel recommended that Adiana be approved for use in the United States. But the panel attached certain conditions, including follow-up of patients treated with Adiana. The FDA isn't required to follow the advice of its advisory panels, but usually does.