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Nonsurgical Approach to Permanent Contraception Investigated.

ORLANDO, FLA. -- Permanent contraception may one day be available without surgery.

A new technique known as the selective tubal occlusion procedure (STOP) involves the use of an experimental device that is implanted within the fallopian tubes during hysteroscopy. The office-based procedure was found to be safe and effective in phase II trials, and a phase III trial is now underway, Dr. Jay M. Cooper said at the annual meeting of the American Association of Gynecologic Laparoscopists.

It is expected that the trial will be completed and the data sent to the Food and Drug Administration for review early next year, said Dr. Cooper, a paid consultant to Conceptus Inc., the device manufacturer.

To date, more than 200 women have received STOP devices. In the phase II trial, 70 women were followed for at least 12 months. All of these women rated their experience with the device as excellent or very good, and in more than 1,600 women-months of use, no pregnancies have been reported, said Dr. Cooper, who is founder and medical director of Women's Health Research in Phoenix, Ariz. "There have been no complaints of pain or bleeding necessitating removal of the device," he added.

The STOP device is placed inside a tiny protective catheter and is inserted into the fallopian tube during a hysteroscopic examination. The catheter is then removed, allowing the device to expand as necessary to fit securely inside the fallopian tube.

In the weeks following the procedure the biocompatible mesh core of the device initiates a tissue response, and the fallopian tube permanently incorporates the device, thereby occluding the tube, Dr. Cooper explained in an interview.

While there are theoretical concerns that pathology in the uterine cavity, such as fibroid tumors, could reduce visibility and thereby make it more difficult to insert the device, this has not proved to be an issue in practice.

Most women who are candidates for surgical tubal ligation--and some who are not candidates due to obesity or prior abdominal surgery--are candidates for STOP.

The procedure takes less than 20 minutes to perform in an office setting under local sedation.

Based on the available data, it appears this permanent contraceptive method will be a safe, effective, and cost-effective alternative to traditional laparoscopic tubal ligation, he said.
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Publication:OB GYN News
Date:Jan 15, 2001
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