Patients and medical professionals are encouraged to report adverse events directly to the FDA Web site MedWatch. This program was created in 1993 to encourage voluntary reporting by doctors, patients and health care professionals.
Vanity has a price, they say. That couldn't be truer for some unhappy women and men who have used liquid, injected silicone to enhance their beauty, only to experience health problems or deformities years later.
In New York, dermatologist Amy Newberger has treated a number of older women who, 20 or 30 years ago, had small amounts of silicone injected under the skin in order to plump out facial wrinkles. For most patients, silicone didn't present problems. But for some, the silicone hardened over time and became more pronounced.
Newberger describes one patient who had injections when she was in her 40s. As the patient reached her 60s, her skin started to thin, a normal process of aging. "But the silicone didn't thin," says Newberger, "so the patient was left with ridges where she had wrinkles." The permanent raised ridges of silicone became discolored and now, Newberger says, the patient looks like a "klingon."
Once silicone hardens, it can also migrate to other parts of the body. Newberger has a number of patients who have lumps and bumps on their cheeks and other parts of their face as a result of the silicone moving away from the initial site of injection.
Newberger says problems like these just can't be predicted. Many patients are fine for years; no one knows why certain patients eventually have problems.
Regulation And Controversy
Silicone is a synthetic rubberlike substance that is not metabolized by the body. Silicone gel implants are approved by the Food and Drug Administration for use in breast reconstruction or augmentation. Medical grade silicone is also approved to treat complicated retinal detachments. It literally holds the retina in place until it reattaches to the inner surface of the eye. The silicone, says FDA spokesperson Siobhan DeLancey, is not intended to remain in the eye permanently. She says that in most cases, it should be removed within a year after surgery.
Silicone injections for cosmetic treatments are not approved by the FDA, but physicians may still provide the treatments. Silicone is considered a medical device by the agency and, since it is approved to treat retinal detachment, DeLancey says, health care professionals may use it for other purposes.
Dermatologist David Orentreich practices in New York City. He says that when silicone is used in extremely tiny quantities, called microdroplets, the substance isn't dangerous and is highly effective in removing the appearance of wrinkles. Orentreich says that practitioners must be skilled at injecting the silicone, and it must be pure. He says problems can occur when the silicone is not pure or when it is injected improperly.
But the procedure is controversial, and dermatologists like Newberger argue that silicone is potentially dangerous and should not be used at all as an anti-wrinkle treatment.
An Underground Business
Some doctors say they have heard from patients that silicone injections are given at so-called pumping parties. They say injections typically are given by people who call themselves cosmetologists, or they are self-administered by individuals attending the party.
According to these physicians and some media accounts, the practice is most common among young transgender individuals who are born male but who feel deeply female and are receiving medical treatment to change gender.
Dr. Marvin Belzer heads the transgender center at the adolescent medicine division of the Los Angeles Childrens Hospital. He sees dozens of adolescents who are "transitioning" to the opposite gender. If the individual is under 18, there is a year of counseling and discussions with parents, after which patients can begin a regimen of hormones to decrease or increase certain male or female hormones.
Such hormone treatment can take years, and many patients just don't want to wait that long, Belzer says. They are young and impatient, he says, and silicone offers immediate results, especially for those who want to live as women, plumping out buttocks, thighs and breasts to give a more curvaceous female appearance.
Dr. Nick Gorton, an emergency room doctor who treats transgender patients at the Lyon-Martin Health Services clinic in San Francisco, says he often tries to tell his patients that hormone treatment is a long-term process. He tells them, "We're trying to give you a lifetime of the body that feels right to you and feels normal to you, so slow and steady wins the race." Many patients, however, just don't listen.
Party Injections Cause Health Problems
When people get injected with silicone at pumping parties, Gorton says "there is no way to verify if they're using medical-grade silicone. You can go to hardware stores and buy a big tub of it," he says. "The element is the same, but it's just not the same safety or purity or quality."
And Belzer says silicone is often mixed with other chemicals. "Who knows what they're really putting in there as filler," he says. "As long as it's partially thick, not real watery, it will fill up the skin and make it the shape they want it."
Belzer says he has sometimes seen patients hospitalized with severe infection or burns, some with their skin literally sloughing off as a result of mixing silicone with some unknown, toxic substance. "It can be really miserable," he says.
In the worst case, a piece of silicone can break off and enter the bloodstream or the lung, causing a deadly embolism. There have been a number of silicone-related deaths, including a 43-year-old woman who died this past March due to a silicone embolism in her lungs. A study from the University of Texas Health Science Center in San Antonio, reported at the 2006 annual meeting of the Radiological Society of North America, found that dozens of patients who received liquid silicone injections died from pulmonary silicone embolism.