Register for FDA Approves New Antiadhesion Treatment For Gynecologic Surgery
Surgical ScarsDecember 16, 2001
2001 DEC 16 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has approved a solution that surgeons can use to help reduce postoperative surgical adhesions in women undergoing open gynecologic surgery. Adhesions (scars) are an undesirable clinical consequence of gynecologic surgery.
The product is Gynecare Intergel Adhesion Prevention Solution, manufactured by Lifecore Biomedical, Inc., of Chaska, Minnesota. FDA approved the solution based on a review of clinical studies of safety and effectiveness conducted by Lifecore.
A randomized trial inolving 281 women undergoing certain types of open gynecologic procedures at 16 medical centers in the United States and Europe compared the Intergel solution with standard irrigating solution.
The results showed that use of the Intergel solution was reasonably safe and was associated with a lower rate of adhesions than the standard treatment. Patients who received Intergel had approximately one less adhesion overall than those who received the standard solution, and there was a reduction in the number of women with moderate and severe adhesions of the pelvic reproductive organs. The surgical site infection rate reported in this study was higher (5.6%) with Intergel than with the standard solution (2.9%).
Although the product is approved for open gynecologic surgery, it is not approved for laporoscopic surgery, a minimally invasive surgery performed through a flexible fiberoptic instrument passed through a small incision in the abdominal wall.
Lifecore conducted two additional randomized studies in which the Intergel solution was applied during gynecologic surgery performed through a laparoscope. The studies failed to demonstrate effectiveness and also showed higher infection rates in those patients treated with the Intergel solution than in those who did not receive the product.
The product has not been studied and is not recommended for use in patients with cancer. The product should also not be used in patients with pelvic or abdominal infections or during pregnancy. This article was prepared by Medical Devices & Surgical Technology Week editors from staff and other reports.
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