Surgical Gel Sales HaltedApr 17, 2003 | www.drkoop.com
Sales of a surgical gel used during gynecological operations have been halted due to reports of pain, internal scarring, repeat surgeries and three deaths possibly linked to the gel.
The manufacturer, Johnson & Johnson division Gynecare Worldwide, suspended international sales of Intergel on March 28, the Associated Press reports.
That followed 103 complaints about problems with the gel. U.S. Food and Drug Administration officials say there were 72 reports in the United States, including three possible deaths.
FDA officials are still evaluating the reports, which they say don't establish any cause-and-effect for the problems, but do indicate the need for further investigation.
Intergel is meant to limit formation of a certain kind of scar tissue following some pelvic surgeries in women. The FDA approved it in November 2001 for use in the United States, despite initially saying it was too risky.