U.S. Files Suit to Halt Silicone Use by Doctor

WASHINGTON —  The Justice Department filed suit Friday to stop a California doctor from using liquid silicone to treat wrinkles and acne scars or to puff up lips.

The lawsuit, filed in federal court in Los Angeles, follows Food and Drug Administration warnings to doctors that liquid silicone injections are not approved for medical treatment.

The civil complaint charges that James E. Fulton Jr.’s clinics are illegally promoting and using liquid silicone to enlarge lips or to treat scars and wrinkles.

The lawsuit charged that Fulton and the clinics he operates in the Los Angeles area were violating the Food, Drug and Cosmetic Act.

FDA Commissioner David Kessler said in a statement that “consumers should know that liquid silicone injections have never been scientifically evaluated for safety and effectiveness.”

“People who undergo these injections are exposing themselves to unknown, potentially dangerous risks,” said Kessler.

In congressional testimony, Kessler has cited medical literature stating that liquid silicone causes swelling or lumpiness in skin that has been associated with soft-tissue tumors.

The complaint noted that Dow Corning Corp. advised Fulton in a 1990 letter that injecting liquid silicone into patients was a misuse of its product.

The Justice Department told Fulton last Sept. 23 that use of liquid silicone violated the law, the complaint said.

The suit seeks an injunction barring Fulton and his clinics from injecting liquid silicone into patients until the FDA approves the treatment.

Also named in the case were Fulton’s Vivant Inc., and Acne Research Institute Inc., a nonprofit research organization he operates.

The lawsuit was filed as the Justice Department reached a consent decree with three New York City doctors who agreed not to use liquid silicone or to promote it as a treatment.

The consent decree was signed late Thursday by Norman Orentreich, David S. Orentreich and Michael A. Kalman.

The FDA is studying the safety of silicone-gel breast implants, which are made by Dow Corning and other companies.