April 20, 2003
INTERGEL Adhesion Prevention Solution
Health Care Person,
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.