Nonsurgical procedure developed for permanent contraception in women

Last Updated: 2000-11-17 17:32:05 EDT (Reuters Health)By Anthony J. Brown, MD

WESTPORT, CT (Reuters Health) - A new nonoperative procedure for permanent contraception in women was described Thursday at the American Association of Gynecologic Laparoscopists' 29th Annual Meeting in Orlando, Florida.

The technique, known as the selective tubal occlusion procedure (STOP), takes about 18 minutes and can be performed in an office setting without the need for general anesthesia, according to a press release from Conceptus, Inc., the company that developed STOP. 

Under hysteroscopic guidance, the physician places a small microcoil in each fallopian tube. Fibrosis occurs around the coil, eventually occluding the tube. Patients are instructed to use an alternate contraceptive device for 3 months after the procedure before relying solely on the STOP device.

During phase II clinical trials of STOP, patients were asked to rate their experience at 3-month (n = 177), 6-month (n = 138), and 12-month (n = 70) check-ups after the procedure. Overall, 99% of women reported their experience as "good," "very good," or "excellent." 

According to the press release, "more than 1600 woman-months of effectiveness...have been accumulated in the phase II trial with no reported pregnancies." Adverse events occurred in 6.2% of women and typically involved improper placement, technical difficulties, or events associated with hysteroscopy.

Dr. Jay Cooper, an Ob/Gyn physician who performed many of the phase II procedures, told Reuters Health that a salpingogram is taken at 3 months to ensure blockage of the fallopian tubes.

Regarding patient charges, Dr. Cooper stated that "HMOs almost universally pay for sterilization procedures." He predicted that "HMOs will be pleased to pay for the STOP procedure" because it eliminates the costs associated with anesthesia and ambulatory care."

STOP is currently being sold in Australia and approval is pending in Europe. In the United States, patients are being enrolled in a pivotal clinical trial as part of the process of seeking marketing approval from the US Food and Drug Administration.

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