Injecting Silicone, and Risk
All of these problems had been caused by injections of liquid silicone, one of the most controversial substances in cosmetic medicine. Long used without official sanction and then banned by the Food and Drug Administration, liquid silicone was finally approved for medical use in 1997: to hold detached retinas in place. And it has been gradually regaining popularity, as doctors use it off-label to fill wrinkles, furrows and acne scars or add volume to lips and cheeks.
These doctors say they like silicone because it is less expensive than fillers like collagen and Restylane (a gel made of hyaluronic acid), it is easy to work with, and side effects occur in less than 1 percent of patients. But most of all they like silicone because it is permanent. Collagen and Restylane last up to six months, so patients must be injected over and over again. With silicone, once a wrinkle or furrow is flattened, it stays that way.
But that means that the side effects, though rare, are permanent too. The lumps and ridges can be surgically removed, but doing so can leave scars that look worse than the original protrusions, Dr. Kane said. "The small percentage of people who have reactions look so bad that it makes using silicone not worth the risk," he said. "If, God forbid, silicone becomes widespread and every doctor starts injecting it, it will become a disaster."
Critics of silicone say that because clinical trials have not demonstrated its safety as a permanent cosmetic filler, it is too risky to use for that purpose.
"Silicone is a time bomb," said Dr. Marvin J. Rapaport, a dermatologist in Beverly Hills, Calif., who has collected case reports on 80 patients who have had side effects from silicone shots since 1974. One of these patients had 50 inflamed nodules at injection sites on her face, and she needed injections of steroids several times a year to reduce the swelling, he said. "Delayed reactions to silicone can happen 1 to 25 years after treatment," he said. "You can't predict who is going to react or when."
Silicone has been used in the body since just after World War II, when doctors in Japan and Las Vegas began injecting it to enlarge women's breasts. Initially they used the industrial kind of silicone that goes into making furniture polish and transformer fluid. Complications like cysts, sores and painful hardening of the breasts were in some cases so severe that women needed mastectomies. Three women died when silicone obstructed their blood vessels and lungs. In the 1960's the breast injections fell out of favor.
In the 1950's Dr. Norman Orentreich, a dermatologist in New York City, pioneered the use of tiny amounts of silicone to fill facial wrinkles. These injections became popular with celebrities like Helen Gurley Brown, the editor of Cosmopolitan. In 1992, however, the F.D.A. ordered a number of prominent doctors to stop using liquid silicone in the face. At the time the agency's commissioner, Dr. David A. Kessler, warned that "people who undergo these injections are exposing themselves to unknown, potentially dangerous risks."
Then in 1997 the agency approved a purified form of liquid silicone called Silikon 1000 for correcting detached retinas. Because a material that is approved for one medical purpose can legally be used off-label for another, some dermatologists picked up the silicone syringe again.
Liquid silicone, also known as silicone oil, has the consistency of motor oil. When injected into the skin, it causes the body to surround the foreign material with collagen. The new collagen, in turn, bulks up the skin.
Doctors use the so-called "microdroplet technique," which calls for only one- to two-tenths of a teaspoon of silicone per treatment. It is injected droplet by droplet into lips, acne scars, hollow cheeks, sunken chins or furrows like the nasolabial folds that descend from the nostrils to the outer corners of the lips. Each treatment costs $500 to $800. And several treatments may be needed before the collagen builds up enough for effects to show, dermatologists say.
Temporary wrinkle fillers like collagen and Restylane are made of organic materials that eventually break down. But silicone is inorganic; once put in the skin, it stays there. And that makes it more convenient.
Arlene Louis, 61, of Fort Lee, N.J., tried both fat and Restylane injections in the two deep folds called marionette lines that ran from the corners of her mouth down to her chin. But the injections did not fully erase her lines, and she didn't like the prospect of repeating them. So five years ago she went to Dr. Rhoda S. Narins, a dermatologist in New York City, for a series of eight monthly silicone treatments.
"My puppet lines are gone. I look 10 years younger," Ms. Louis said earlier this month when she returned to Dr. Narins's office for silicone injections in her cheeks.
Before Dr. Narins gives silicone shots, she has patients sign a consent form that describes the possible side effects. Permanent lumps or inflamed nodules in the skin, intermittent swelling at the injection sites, and permanent red or brown patches can occur years after treatment. But Dr. Narins said that among the several hundred patients she has treated with silicone since 1998, she has never seen a problem.
"Most of the side effects you hear about are caused by nonphysicians injecting an impure substance in nonmedical settings," like spas and hotel rooms, Dr. Narins said. When it is administered correctly, she said, "silicone is a superior product that gives you fabulous results."
But Dr. David M. Duffy, a dermatologist in Torrance, Calif., has found that liquid silicone can cause problems even when administered by a master injector. He said he has treated about 4,000 patients with silicone in the last 22 years, and he has seen one serious complication (a patient's face became extremely swollen and purple from inflammation) as well as some "lumps and bumps that are a nuisance."
"In good hands the ballpark complication rate could be 4 in 1,000" patients, Dr. Duffy said. "In bad hands there are horror stories."
Lindsay Taylor, a country-western singer in Toronto, said she has a line of bumps from silicone injections that look "like tiny rice grains" running along her forehead. She also has a walnut-size bump between her eyebrows and a raised line along her top lip, she said.
"I paid money to a professional to improve my looks," Ms. Taylor said. "But instead I got disfigured as if I'd been in a car accident."
Ms. Taylor is one of 450 patients participating in a class action suit against Dr. Sheldon V. Pollack, a Toronto dermatologist who injected them with silicone. The complaint alleges that Dr. Pollack failed to inform them that Canada's health department prohibits the cosmetic use of injectable silicone, according to J. Adam Dewar, a lawyer for the plaintiffs. About 75 of the patients have cosmetic problems including lumps and raised lines on their faces, Mr. Dewar said.
Lawrence E. Thacker, a lawyer representing Dr. Pollack, did not return calls seeking comment.
Even if no direct side effects occur, the silicone can migrate inside the face. "Gravity changes your face over time, and the filler does not end up in the place you started," said Dr. Arnold W. Klein, a dermatologist in Beverly Hills.
But other doctors are learning to like silicone. Dr. Jeffrey S. Dover, a dermatologist in Chestnut Hill, Mass., first tried the injections as part of a clinical trial. From 2002 to 2004 his practice treated eight volunteers with a new kind of liquid silicone called SilSkin. Each patient had silicone injections in one nasolabial fold and collagen injections in the other. Eighteen months later all the volunteers preferred the silicone, he said.
Dr. Dover found it so "spectacular" for both deep furrows and acne scars that he has started injecting liquid silicone occasionally in his own patients. Still he worries that injectable silicone may prove to be the Russian roulette of cosmetic dermatology. "You do wonder," he said, "whether this is the patient who is going to come back in 10 or 15 years asking you, 'What are these bumps in my face where you injected the silicone?' "
These doctors say they like silicone because it is less expensive than fillers like collagen and Restylane (a gel made of hyaluronic acid), it is easy to work with, and side effects occur in less than 1 percent of patients. But most of all they like silicone because it is permanent. Collagen and Restylane last up to six months, so patients must be injected over and over again. With silicone, once a wrinkle or furrow is flattened, it stays that way.
But that means that the side effects, though rare, are permanent too. The lumps and ridges can be surgically removed, but doing so can leave scars that look worse than the original protrusions, Dr. Kane said. "The small percentage of people who have reactions look so bad that it makes using silicone not worth the risk," he said. "If, God forbid, silicone becomes widespread and every doctor starts injecting it, it will become a disaster."
Critics of silicone say that because clinical trials have not demonstrated its safety as a permanent cosmetic filler, it is too risky to use for that purpose.
"Silicone is a time bomb," said Dr. Marvin J. Rapaport, a dermatologist in Beverly Hills, Calif., who has collected case reports on 80 patients who have had side effects from silicone shots since 1974. One of these patients had 50 inflamed nodules at injection sites on her face, and she needed injections of steroids several times a year to reduce the swelling, he said. "Delayed reactions to silicone can happen 1 to 25 years after treatment," he said. "You can't predict who is going to react or when."
Silicone has been used in the body since just after World War II, when doctors in Japan and Las Vegas began injecting it to enlarge women's breasts. Initially they used the industrial kind of silicone that goes into making furniture polish and transformer fluid. Complications like cysts, sores and painful hardening of the breasts were in some cases so severe that women needed mastectomies. Three women died when silicone obstructed their blood vessels and lungs. In the 1960's the breast injections fell out of favor.
In the 1950's Dr. Norman Orentreich, a dermatologist in New York City, pioneered the use of tiny amounts of silicone to fill facial wrinkles. These injections became popular with celebrities like Helen Gurley Brown, the editor of Cosmopolitan. In 1992, however, the F.D.A. ordered a number of prominent doctors to stop using liquid silicone in the face. At the time the agency's commissioner, Dr. David A. Kessler, warned that "people who undergo these injections are exposing themselves to unknown, potentially dangerous risks."
Then in 1997 the agency approved a purified form of liquid silicone called Silikon 1000 for correcting detached retinas. Because a material that is approved for one medical purpose can legally be used off-label for another, some dermatologists picked up the silicone syringe again.
Liquid silicone, also known as silicone oil, has the consistency of motor oil. When injected into the skin, it causes the body to surround the foreign material with collagen. The new collagen, in turn, bulks up the skin.
Doctors use the so-called "microdroplet technique," which calls for only one- to two-tenths of a teaspoon of silicone per treatment. It is injected droplet by droplet into lips, acne scars, hollow cheeks, sunken chins or furrows like the nasolabial folds that descend from the nostrils to the outer corners of the lips. Each treatment costs $500 to $800. And several treatments may be needed before the collagen builds up enough for effects to show, dermatologists say.
Temporary wrinkle fillers like collagen and Restylane are made of organic materials that eventually break down. But silicone is inorganic; once put in the skin, it stays there. And that makes it more convenient.
Arlene Louis, 61, of Fort Lee, N.J., tried both fat and Restylane injections in the two deep folds called marionette lines that ran from the corners of her mouth down to her chin. But the injections did not fully erase her lines, and she didn't like the prospect of repeating them. So five years ago she went to Dr. Rhoda S. Narins, a dermatologist in New York City, for a series of eight monthly silicone treatments.
"My puppet lines are gone. I look 10 years younger," Ms. Louis said earlier this month when she returned to Dr. Narins's office for silicone injections in her cheeks.
Before Dr. Narins gives silicone shots, she has patients sign a consent form that describes the possible side effects. Permanent lumps or inflamed nodules in the skin, intermittent swelling at the injection sites, and permanent red or brown patches can occur years after treatment. But Dr. Narins said that among the several hundred patients she has treated with silicone since 1998, she has never seen a problem.
"Most of the side effects you hear about are caused by nonphysicians injecting an impure substance in nonmedical settings," like spas and hotel rooms, Dr. Narins said. When it is administered correctly, she said, "silicone is a superior product that gives you fabulous results."
But Dr. David M. Duffy, a dermatologist in Torrance, Calif., has found that liquid silicone can cause problems even when administered by a master injector. He said he has treated about 4,000 patients with silicone in the last 22 years, and he has seen one serious complication (a patient's face became extremely swollen and purple from inflammation) as well as some "lumps and bumps that are a nuisance."
"In good hands the ballpark complication rate could be 4 in 1,000" patients, Dr. Duffy said. "In bad hands there are horror stories."
Lindsay Taylor, a country-western singer in Toronto, said she has a line of bumps from silicone injections that look "like tiny rice grains" running along her forehead. She also has a walnut-size bump between her eyebrows and a raised line along her top lip, she said.
"I paid money to a professional to improve my looks," Ms. Taylor said. "But instead I got disfigured as if I'd been in a car accident."
Ms. Taylor is one of 450 patients participating in a class action suit against Dr. Sheldon V. Pollack, a Toronto dermatologist who injected them with silicone. The complaint alleges that Dr. Pollack failed to inform them that Canada's health department prohibits the cosmetic use of injectable silicone, according to J. Adam Dewar, a lawyer for the plaintiffs. About 75 of the patients have cosmetic problems including lumps and raised lines on their faces, Mr. Dewar said.
Lawrence E. Thacker, a lawyer representing Dr. Pollack, did not return calls seeking comment.
Even if no direct side effects occur, the silicone can migrate inside the face. "Gravity changes your face over time, and the filler does not end up in the place you started," said Dr. Arnold W. Klein, a dermatologist in Beverly Hills.
But other doctors are learning to like silicone. Dr. Jeffrey S. Dover, a dermatologist in Chestnut Hill, Mass., first tried the injections as part of a clinical trial. From 2002 to 2004 his practice treated eight volunteers with a new kind of liquid silicone called SilSkin. Each patient had silicone injections in one nasolabial fold and collagen injections in the other. Eighteen months later all the volunteers preferred the silicone, he said.
Dr. Dover found it so "spectacular" for both deep furrows and acne scars that he has started injecting liquid silicone occasionally in his own patients. Still he worries that injectable silicone may prove to be the Russian roulette of cosmetic dermatology. "You do wonder," he said, "whether this is the patient who is going to come back in 10 or 15 years asking you, 'What are these bumps in my face where you injected the silicone?' "
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