U.S. Files Suit to Halt Silicone Use by Doctor
Federal authorities filed suit Friday to stop a Newport Beach dermatologist from injecting patients with industrial grade liquid silicone to correct skin conditions such as wrinkles and acne scars and to enlarge lips.
The complaint was filed against Dr. James E. Fulton, a co-developer of Retin-A, the Vitamin A derivative that has been touted as effective in preventing wrinkles.
Fulton has developed other cosmetic products that purport to soften and smooth wrinkles and scars. The suit names three clinics he operates in Newport Beach, as well as Vivant Inc. and Acne Research Institute Inc., a nonprofit research organization.
The lawsuit, filed in U.S. District Court in Los Angeles, charged that Fulton and the clinics are violating the Food, Drug and Cosmetic Act by promoting and using liquid silicone, which is not approved for medical treatment.
The Justice Department told Fulton last Sept. 23 that use of liquid silicone violated the law, the complaint said.
Fulton was unavailable for comment. In a letter to federal prosecutors in October, he argued that his use of silicone is not illegal.
The complaint charges that Fulton has administered the liquid silicone despite warnings from its manufacturer, Dow Corning Corp., and the U.S. Food and Drug Administration.
Fulton allegedly obtained industrial grade silicone from sources outside of California and from the manufacturer under false pretenses.
“He did not disclose to them when he ordered it that (use on humans) would be the purpose,” said Assistant U.S. Atty. Suzanne H. Segal.
“Consumers should know that liquid silicone injections have never been scientifically evaluated for safety and effectiveness,” FDA Commissioner David A. Kessler said in a statement. “People who undergo these injections are exposing themselves to unknown, potentially dangerous risks.”
Last month, Kessler called for a voluntary moratorium on the sale and use of silcone-gel breast implants, which are made by Dow Corning and other companies, until an FDA study determines whether they should remain on the market.
