FDA Assails Wrinkle Treatment as Illegal : Health: Injections of silicone may pose dangers for consumers, agency chief says. Misuse of collagen and Retin-A also are being probed.

WASHINGTON —  David A. Kessler, commissioner of the Food and Drug Administration, warned Tuesday that his agency will not tolerate the illegal use of drugs and medical devices that he said may pose “significant dangers” to consumers, including injections of liquid silicone to remove wrinkles.

“This is an illegal product and its use must stop,” he said in testimony before a House Government Operations subcommittee. “Consumers should know (that) the safety and effectiveness of this product have never been fully evaluated and, therefore, consumers are exposing themselves to unknown risks.”

The testimony was a signal that Kessler--who already has begun to move his once-sluggish agency toward aggressively enforcing claims made on food labels--intends to similarly increase pressure in the area of drugs, cosmetics and medical devices, which also are regulated by the FDA.

“Be assured that the full force of the statute will be mustered to deal with such practices . . . “ he said.

The FDA began investigating the illegal use of liquid silicone injections after receiving reports from plastic surgeons angry about “having to undo the damage” done by dermatologists who were using the product illegally, Jeff Nesbit, an agency spokesman, said.

Nesbit said that the agency does not have figures on the extent of the illegal use of liquid silicone for this purpose, “but advertising and conferences promoting silicone injections in the face seem to be most prevalent in California, Las Vegas, New York and Florida.”

Liquid silicone can be found easily because it is sold for use as a lubricant on needles, medical catheters and valves, Nesbit said.

Kessler said that some of the “risky results” of injecting liquid silicone include swelling, reddening of the skin, lumpiness of the face and development of tumors.

“We cannot even assure consumers about the composition of the material being injected,” he said. “There is no standard product.”

Further, the product has not been approved for cosmetic research purposes, he said.

“In the case of liquid silicone for injection, the sale, shipment, distribution, manufacture, use and promotion are illegal,” he added.

Kessler said that the agency is also looking into unapproved uses of collagen for lip augmentation, Retin-A to prevent wrinkles and the use of calcium channel blocker drugs to prolong the survival of patients who are recovering from heart attacks.

Collagen, a liquid protein extracted from cowhide, has been approved to treat acne scars but not to enlarge lips, Kessler said. “FDA has not reviewed the safety and effectiveness of the data for this use,” he said. “Consumers should not undergo lip augmentation procedures with collagen.”

Retin-A, a compound that contains tretinion, a chemical derivative of Vitamin A, is approved for treating severe acne, but “its use to prevent wrinkles is an unapproved use,” Kessler said.

“One of our concerns, for example, is that Retin-A is a photosensitizer, which, if used chronically, could potentially increase the risk of skin cancer,” he said.

Kessler said drugs known as calcium channel blockers, which are approved for treating angina--or chest pain--and high blood pressure, have been promoted for the unapproved use of enhancing post-heart attack survival.

“The manufacturers of these products have, in effect, encouraged physicians to substitute calcium channel blockers for beta blockers, a class of drugs that has been shown to improve survival in certain patients who have suffered a heart attack,” he said.

Kessler noted that some research has shown a decrease in the survival rate of patients given calcium blockers after heart attacks compared to patients given a a medically worthless pill.

Kessler said that longstanding FDA policy allows physicians some flexibility in deciding to use an approved drug for purposes that go “beyond the labeling.” However, he said, the agency would not permit physicians to promote such uses.