Silicone Injections for Cosmetic Use
New York, NY:
In 1991, the Food and Drug Administration (FDA) issued guidelines prohibiting the marketing of injectable liquid silicone for any cosmetic purpose. The FDA has since approved monitored clinical studies investigating the safety and efficacy of injectable silicone, but none has been completed as yet. Long-term follow-up will be key to evaluating any studies. In the meantime, some practitioners continue to purchase liquid silicone intended for the treatment of retinal detachment and inject it for aesthetic improvements. It is the position of the American Society for Aesthetic Plastic Surgery (ASAPS) that the use of liquid injectable silicone for cosmetic purposes is controversial, and it should not be used outside legitimately approved clinical trials.
Clinical investigation of liquid silicone injection for the correction of facial deformities took place from 1978 to 1988 under FDA-approved and monitored protocol. For many of these deformities, liquid silicone represented the only hope for treatment at the time. According to investigators, liquid silicone injections resulted in substantial improvements of the deformities with some complications. Good results have also been reported with the use of liquid injectable silicone for cosmetic purposes, such as correction of wrinkles, creases and scars. Unlike collagen or fat, liquid silicone does not need to be repeatedly injected to achieve the desired effect.
Once injected, liquid silicone cannot be altered or removed. Many reports of complications have been published, including severe complications from liquid silicone used for breast enlargement as long ago as the 1950s. Almost all of the problems noted were never seen by the injecting physician and tended to occur years after injection. Among complications cited were:
- Movement of silicone to other parts of the body
- Inflammation and discoloration of surrounding tissue
- Formation of masses of chronically inflamed tissue
In addition, liquid silicone comes in different grades:
- Industrial: developed only for non-medical uses
- Medical: removed from the market
- Ophthalmic: FDA-approved for treatment of retinal detachment and used by some physicians for cosmetic purposes
Alternative treatments for wrinkles or acne scars are available and may be discussed with an aesthetic plastic surgeon certified by the American Board of Plastic Surgery. Liquid silicone should never be injected into the breasts.
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 non-surgical 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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