Gynecare surgical gel removed from market
Gynecare Worldwide, a division of Ethicon of Somerville, NJ, has voluntarily withdrawn Gynecare Intergel Adhesion Prevention Solution from the market and is urging customers to immediately stop using this product. Pain and repeat operations have been reported among women who received it during gynecological operations, according to the Food and Drug Administration (FDA). Three deaths have been reported; however, "the deaths cannot be conclusively tied to the Intergel," according to an FDA spokesperson.
This product is intended to be used in open, conservative gynecological surgery to reduce post-surgical adhesions. But Gynecare has received about 103 complaints worldwide of pain, internal scarring, and repeat surgeries, FDA officials said. They said there were 72 reports from the United States, which the FDA still is evaluating.
Intergel products and samples should be returned to Gynecare. Questions about returning these products can be answered by Gynecare sales representatives or the customer hotline at (800) 551-7683. Further information can be found at www.fda.gov/medwatch/safety/2003/Intergel.pdf. The FDA also is investigating and will update this web page as information becomes available.