Worldwide sales of a surgical gel have been suspended pending investigation of reports of pain, repeat operations and even three deaths among women who received it during gynecological operations, the Food and Drug Administration said Wednesday.
The FDA publicized the Gynecare Intergel withdrawal by posting on its Web site letters from the manufacturer urging that physicians stop using the surgical gel.
Intergel’s maker, Johnson & Johnson division Gynecare Worldwide, had suspended sales on March 28.
Intergel is supposed to reduce a type of internal scar tissue that forms after some pelvic operations. But Gynecare has received about 103 complaints worldwide of pain, internal scarring and repeat surgeries, FDA officials said. They said there were 72 reports from the United States, including three deaths, which the FDA is still evaluating. FDA spokeswoman Sharon Snider said that the reports alone did not establish any cause and effect for the problems, but merely suggested further inquiry.
In some patients, when doctors reoperated they found an unexpected amber-colored residue left inside the woman.
The FDA initially deemed Intergel too risky to sell here, citing studies that found women given the gel had only one fewer internal scar but almost twice the risk of infection as women given standard treatment.
But Intergel’s maker appealed, and in November 2001, the FDA made an unprecedented about-face and approved Intergel after all, terming it “reasonably safe” if used only in select patients.
With “many marketed products, you really don’t get the true story, the full story, on a product until it’s out there and it’s widely used,” said Tim Ulatowski, the FDA official monitoring Intergel, when asked if that decision was now proving wrong.
It’s too early to predict if Intergel will resume sales, he said.
The gel also was sold in 22 other countries, and Gynecare called complaints low considering 80,000 doses were sold.