FDA Reverses Itself, OKs Surgery Gel

WASHINGTON —  The Food and Drug Administration made an unprecedented about-face Monday, approving a gel that promises less internal scarring for women undergoing certain surgeries--even though regulators originally deemed the product too risky.

The FDA initially had rejected Lifecore Biomedical Inc.’s Intergel, which promises to reduce internal scarring from some gynecologic operations. The reason: In studies, women given the gel during open pelvic surgery had only one fewer internal scar but almost twice the risk of infection as women given standard treatment.

Lifecore argued that Intergel was better than that, citing study results that suggested even if women did have internal scars, they were smaller and less severe when their surgeons used the lubricating gel.

So Lifecore became the first company to test a new law ordering the FDA to allow appeals without making manufacturers go to court. Mediators ruled in September that the FDA erred and should approve Intergel; Monday, the agency did.

Still, the FDA’s approval announcement was lukewarm at best. The agency called use of Intergel “reasonably safe,” and provided surgeons with a list of restrictions about how it should be used.

The gel, named Gynecare Intergel Adhesion Prevention Solution, is intended to reduce adhesions, internal scar tissue that can cause chronic pain or intestinal obstruction. Various adhesion-preventing treatments already are on the market, but Intergel is the first in liquid form.

Also, the FDA warned, a study of 281 women found that 5.6% of Intergel recipients suffered an infection at the surgical site, versus 2.9% of women who received standard surgical treatment.

But one veteran FDA-watcher, Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, noted that the agency rejects few medical products and “needs to be strong enough to stick with its guns” when it does.

Intergel should be available in February and will cost about $200, Minnesota-based Lifecore said.