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U.S. Department of Health and Human Services

Safety

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INTERGEL Adhesion Prevention Solution

Audience: Gynecological healthcare professionals

GYNECARE Worldwide (a Johnson & Johnson Company) and FDA Center for Devices and Radiological Health (CDRH) announced the voluntary market withdrawal of “GYNECARE INTERGEL Adhesion Prevention Solution” from the global market and are urging customers to immediately stop using this device. Post-market reports include 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.

This product has been distributed in the following countries; Austria, Canada, Egypt, England, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Republic of Singapore, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and the United States.

[April 16, 2003 - Statement - FDA / CDRH]