In major reversal, FDA approves controversial surgical gel
Tuesday, November 20th 2001, 12:00 am
By: News On 6
WASHINGTON (AP) _ 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 had initially rejected Lifecore Biomedical Inc.'s Intergel, which promises to reduce internal scarring from certain 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. The government picked a panel of independent scientists to review the Intergel decision. These mediators ruled in September that the FDA had erred and should approve Intergel _ and on Monday, the agency did.
Still, the FDA's approval announcement Monday was lukewarm at best. The agency called use of Intergel ``reasonably safe,'' and provided surgeons with a list of warnings restricting how it should be used.
The gel, formally 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 sold, but Intergel is the first liquid one.
It is only for use during open gynecologic operations _ not the increasingly common ``keyhole'' surgeries where doctors operate through a small incision, the FDA warned. Nor is it for women with abdominal or pelvic infection, or who have cancer or are pregnant.
Also, the FDA warned, a study of 281 women found 5.6 percent of Intergel recipients suffered an infection at the surgical site, versus just 2.9 percent of women who received standard surgical treatment.
``We don't care how it got approved, we just care that it got approved,'' responded Lifecore President Jim Bracke. ``They'll be watching us carefully for safety and that's fine. It'll prove out.''
The FDA's mediators ruled that agency scientists used too harsh a statistical interpretation in judging Lifecore's U.S. studies, and wouldn't consider better data from Europe, where the product has been sold for several years.
The case shows the government established ``a fair and impartial appeals mechanism'' and ``that industry could get a fair shake,'' said FDA ombudsman Les Weinstein, who arranged the potentially precedent-setting appeal. He said he was surprised that no other companies have sought similar mediation.
But one veteran FDA watcher called the Intergel saga ``a very dangerous precedent,'' questioning why outside scientists who reviewed the product for one day were trusted more than FDA's own scientists who had pored over Lifecore data for months.
FDA rejects few medical products, and ``needs to be strong enough to stick with its guns'' when it does, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.
Intergel should begin selling in February and cost about $200, said Minnesota-based Lifecore.