Face: Liquid Silicone Injections ASAPS — Position
The American Society for Aesthetic Plastic Surgery (ASAPS) warns against the use of liquid injectable silicone until such time as it may be approved by the Food and Drug Administration for cosmetic purposes or clinical investigation. However, in considering the results of previous FDA-approved clinical investigations of liquid silicone, it should be noted that their primary aim was to assist patients with severe facial deformities for whom proven alternative treatments were not available.
Clinical investigation of liquid silicone injection for the correction of facial deformities took place from 1978 to 1988 under FDA-approved and monitored protocol. Some of the patients participating in these clinical trials suffered from hemifacial microsomia or hemifacial atrophy, conditions in which half of the face is abnormally small due either to arrested development or other disorders that have decreased its size. Other patients suffered from lipodystrophy, a disorder of the fat metabolism that can result in a severe "skin and bones" appearance of the face.
For many of these deformities, liquid silicone represented the only hope for treatment at the time in which these clinical studies were undertaken. According to investigators, the liquid silicone injections resulted in substantial improvement of the deformities without complications in the majority of patients participating in the clinical trials. In some cases, however, complications did occur. These resulted primarily when patients had poor quality tissues, when a large volume of silicone was necessary to correct the deformity, or a combination of the two.
The FDA has stated that it considers liquid silicone injections to be in violation of Federal law because the product does not have an approved application for marketing or currently approved investigational exemption to permit scientific study. Liquid injectable silicone has been regulated as a device by FDA since 1976. It was previously regulated as a drug.
According to FDA, actions to prevent physicians and their clinics from using liquid injectable silicone were undertaken in February 1992 after it was brought to the agency's attention that three New York physicians and a California physician were performing silicone injections, primarily for the treatment of facial wrinkles and creases. None of the physicians named in the action are board-certified plastic surgeons.
Good results have been reported with the use of liquid injectable silicone for cosmetic purposes, such as the correction of wrinkles, creases and scars. However, if too great a volume of liquid silicone is injected, or if it is placed too superficially in the skin, this may result in inflammation and discoloration of surrounding tissue and the formation of granulomas (nodules of firm, inflamed tissue). Alternative treatments for wrinkles or acne scars are available and may be discussed with an aesthetic plastic surgeon who is certified by the American Board of Plastic Surgery.
ASAPS members have voiced strong opposition to the use of liquid injectable silicone in the breast, as well as the use of other injectable substances including autologous fat for breast augmentation. They have reported seeing patients with severe complications from having their breasts injected with liquid silicone. Most of these cases involve procedures that were done in the 1950s. In some cases, removal of the breast was necessary.
The silicone gel contained in gel-filled silicone breast implants, including the microscopic "bleed" of silicone particles across the implant membrane, is not associated with the complications caused by the free injection of liquid silicone into the breast.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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