Originally Published MDDI January 2002

NEWS & ANALYSIS

Approval for "Disputed" Device

James G. Dickinson

As if to subconsciously underscore some of the points made in the Science at Work in CDRH report, CDRH in November issued an approval for Lifecore Biomedical's Gynecare Intergel solution—the first device review submitted to the Center's new Dispute Resolution Panel.

The product is "reasonably safe," said FDA—in an uncharacteristically ambivalent November 19 talk paper about its approval, which had been recommended unanimously by the Dispute Resolution Panel in September. A creature of the 1997 FDA Modernization Act, the panel had criticized faulty CDRH staff work in the Lifecore device's review.

In its Intergel talk paper, FDA said the product produced only one less adhesion overall than it did in patients who received the standard solution. FDA's paper said the solution was approved for open gynecologic surgery only, and was not approved for laparoscopic surgery.

FDA claimed its approval was based on only one Lifecore Biomedical clinical study of 281 women in which "approximately" one less adhesion was observed than in the control group. But the agency pointed out that the surgical site infection rate was twice as high in the women who received the gel than it was with the standard solution.

The paper said there was a reduction in the number of women with moderate and severe adhesions of the pelvic reproductive organs, but stressed that two studies of the substance's role in laparoscopic surgery showed no evidence of effectiveness and an increased incidence of infection rates than in those who did not receive the product. FDA said the product has not been studied in patients with cancer and is not recommended for cancer patients or in patients with pelvic or abdominal infections.

Lifecore Biomedical refused to comment on the talk paper, which may be reviewed at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01117.html.

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