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FDA Warns Against Cosmetic Silicone Injections

February 3, 1992

WASHINGTON (AP) _ The Food and Drug Administration warned two doctors to quit giving patients liquid silicone injections, because it hasn’t approved the procedure to smooth wrinkles or puff up lips.

The letters to Dr. Norman Orentreich of New York City and Dr. Ricardo Samitier-Cardet of Miami were the result of an FDA investigation between July and September of last year, agency spokeswoman Suzan Cruzan said Monday.

The letters, dated Nov. 12, 1991, warned the doctors that the agency could take legal action against them if they did not stop giving the injections.

David Kessler, the FDA commissioner, has testified before Congress that medical literature alleges the liquid silicone causes swelling or lumpiness in the skin and has been associated with soft-tissue tumors.

The FDA currently is investigating whether breast implants filled with silicone gel pose a health risk. At the FDA’s request, sales of the implants have been suspended in the United States while the agency examines new information on their safety.

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