Silicone Injections for Cosmetic Use
New York , NY ( August 12, 2008 )
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 safety of the use of liquid injectable silicone for cosmetic purposes is controversial, and that 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 protocols. For many of these deformities, liquid silicone represented the only hope for treatment at that 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 the 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 grade: A silicone product has recently been approved by the FDA specifically for ophthalmic use in the treatment of retinal detachment. Although this product which generated most of the problems seen through the years, any cosmetic use would be “off label,” and the same potential risks noted above would still be of concern.
The safety of the injection of liquid silicone for cosmetic purposes remains highly controversial. Many other effective 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 from any source should never be injected into the breasts.
This document was updated from October, 2001.
The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS) is the only plastic surgery organization devoted entirely to the advancement of cosmetic surgery. ASAPS is recognized throughout the world as the authoritative source for cosmetic surgery education. U.S. members are certified by the American Board of Plastic Surgery. Canadian members are certified in plastic surgery by the Royal College of Physicians and Surgeons of Canada.
Toll-free referral line: 888.ASAPS.11 (272.7711). Web site: www.surgery.org
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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