Urgent Market Withdrawal of GYNECARE INTERGEL Solution
FDA Patient Safety News: Show #16, June 2003

Now for an alert about a product that's been voluntarily withdrawn from the market. The product is the GYNECARE INTERGEL Adhesion Prevention Solution, and it's used to reduce post-surgical adhesions in patients undergoing open, conservative gynecologic surgery.

Adverse event reports associated with this solution have included late-onset post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence. In some patients, a residual material was observed during the repeat surgery.

GYNECARE Worldwide, a division of Ethicon, Inc. is urging customers to immediately stop using the INTERGEL Adhesion Barrier Solution, and return all remaining product and samples to the company.

GYNECARE is taking this action while it completes an assessment of the experience with the device. Part of the assessment will include adverse events associated with off-label use, for example in laparoscopy and non-conservative surgical procedures such as hysterectomy.

Additional Information:

FDA MedWatch Safety Alert: 2003 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements (INTERGEL Adhesion Prevention Solution).
http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#interg