Sept. 20, 2002 -- After being banned for a decade, liquid silicone is making a comeback.
The practice of injecting silicone into the skin to fill wrinkles and other depressions dates back decades. But in 1992, concerns about leaks from silicone in breast implants put a serious crimp in all cosmetic uses of the substance. The Food and Drug Administration prohibited its use.
But some dermatologists are now once again offering this wrinkle smoother to patients. They are using Silikon 1000, a silicone preparation approved in 1997 to treat detached retinas.
Dr. Rhoda Narins, clinical professor of dermatology at New York University Medical Center and director of the Dermatology Surgery and Laser Center, injects her patients with Silikon 1000, although the FDA has not specifically approved it for this use.
"It's an 'off-label' use in the skin, but many products are used off label by physicians," Narins tells Good Morning America's medical correspondent Dr. Nancy Snyderman.
Silicone makes an attractive line filler because of its longevity. Unlike other line-eraser treatments available in the United States, such as collagen, fat and Botox, liquid silicone is permanent.
An Unfortunate Past
Silicone's permanence makes it attractive to those weary of facial lines and returning for repeated injections, but that permanence is also the source of its potential for problems. Once injected, the material cannot be removed.
For some, the problems that plagued silicone in the past can be attributed to improper technique or using an adulterated or impure formulation.
"Many of the problems that were caused in the past were caused because if silicone is used in too great a volume, you can get migration," says Narins. "Adulterated forms can give you granulomas, which are bumps in the skin. They can give you ulcers, redness, intermittent or permanent swelling … there are a lot of side effects that you can get from it if it is used incorrectly."
But Dr. Marvin Rapaport, a Beverly Hills-based plastic surgeon, isn't convinced that technique is the culprit. He's wary of silicone itself. "It's still a foreign body. It's a very innocuous foreign body — that's why it's taking so long to get a reaction."
Rapaport would prefer that dermatologists err on the side of caution and conduct long-term studies into silicone's safety and efficacy. "It does do a better job on lines as best we know, but I've never heard a lecture, I have never seen a paper of five, 10, 15 years of follow-up about how great the line looks. No one has ever done that."
Leaving the Past Behind?
Silikon 1000 isn't the only FDA-approved liquid silicone preparation. A product known as SilSkin has been approved for study for the cosmetic improvement of wrinkles and depressions as well as facial wasting in AIDS patients.
Diane Richard, the vice president of Richard James Inc., the Peabody, Mass.-based manufacturers of SilSkin, hopes that people will be able to separate newly manufactured silicone products from the troubled products of the past.
"I just hope that someone will stop and realize that this is a totally new product that we're dealing with," says Richard. "It's a product the FDA approved for clinical study. … The only thing we're asking the critics to do is follow the study and see what the results are. Unfortunately, we started with a product that had a history."
If silicone's shady past can fade into the background, men and women who worry about halting time's march across their faces may have a better alternative to fillers that fade.
"I think that you're talking about a very large market if you can show that this is safe and make the public comfortable with it after all of the things they've heard in the past," says Narins. "It's permanent … it really can be a wonderful filling agent."
ABCNEWS' Sarah Adler contributed to this report.