FDA Recommends Contraception Device for Sterilization

In a 10-3 vote, FDA recommended the approval under certain conditions, including long-term follow up of current pivotal trial patients, more specific labeling, and a new postapproval study of new patients and doctors. The procedure, which takes about 15 minutes, uses radio signals to make a lesion inside the fallopian tube. Once a catheter introduces a soft material (smaller than a grain of rice) into the tube, tissue grows on and around the material to create a permanent blockage. Women can resume their normal activities in one day, versus conventional bilateral tubal ligation, which is performed under general anesthesia and requires a four- to five-day recovery period. The device's pregnancy prevention efficacy rate is 98.9% after one year.