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SafetyAlerts
April 20,  2003

INTERGEL Adhesion Prevention Solution Alert

(SafetyAlerts) - Dear 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.

More Information Click Here


Source: FDA

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.