An advisory panel to the U.S. Food and Drug Administration is recommending approval of a new method of sterilization for women.
The Adiana Transcervical Sterilization System, made by Hologic Inc., a medical technologies company, would act as an alternative to the procedure known as tubal ligation, or "getting your tubes tied." It was recommended by the FDA's obstetrics and gynecology devices advisory panel.
Tubal ligation involves a surgeon making incisions in a woman's abdomen and "tying," cutting or burning her fallopian tubes to prevent the egg from meeting sperm at ovulation. The egg then dissolves and is absorbed by the body. The failure rate is two to 10 pregnancies per 1,000 women, according to the Society of Obstetricians and Gynaecologists of Canada.
The new, non-surgical method takes about 15 minutes to complete and involves placing a catheter at the entrance of each fallopian tube, which emits radio signals to remove a layer of cells.
Soft polymer material smaller than a single grain of rice is then inserted in the area. It generates the growth of healthy tissue, which creates a permanent blockage in each tube. Patients do not have to receive general anesthesia during the procedure — local freezing is administered.
Patients can typically go back to work within a day, versus the four- to five-day recovery period from a tubal ligation. However, the procedure is not 100 per cent effective. During a clinical trial, 570 women were told they could rely on it, but within 15 months, 11 of them got pregnant.
The FDA is not required to accept the panel's recommendation.
With files from the Associated PressRelated
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