Ilegal silicone injections on the rise across the US

[Guest guest]

THE SILICONE — which was injected into her lips and the tiny lines that were beginning to radiate around her mouth — created a hard ball on her upper lip. Within a few months, the entire lip area had ballooned to five times its normal size, so that it protruded past the end of her nose. “I looked like a duck from the side — people thought I had been severely punched,” she said. The quest for beauty has turned ugly for many in South Florida. Thousands of women and men are buying into promises of fuller lips, smoother skin and made-to-order measurements by untrained, unlicensed practitioners wielding syringes of liquid silicone, state health officials report. And the practice — which has been linked to severe disfigurement and even death — appears to be spreading to other areas of the country, from South Carolina to Southern California. For fees ranging from $100 to $500, cosmetologists, travelling South American pseudo-doctors and even house cleaners illegally inject liquid silicone — an oily fluid similar to the gel used inside silicone breast implants — into customers’ wrinkles, lips, breasts, buttocks, legs and hips. The immediate effects can be pleasing — smoother thighs, tauter cheeks, sexier pouts — but the long-term results can be far from beautiful.

“Imagine the biblical description of leprosy,” said Dr. Rosenberg, a plastic surgeon in Delray Beach, Fla., who has seen about 20 silicone-injected patients in the last two years. “Their faces look like they are melting. They have boils and abscesses.” In at least one case, the consequences of the practice have gone beyond disfigurement. In March, Vera Lawrence, a 53-year-old Miami secretary and mother of two, died after she received injections of silicone into her buttocks and hips, allegedly from a house cleaner. The medical examiner recorded the cause of death as silicone embolism, caused when the thick fluid traveled to one of her lungs. This was the first such case recorded in Florida but doctors say silicone injections have likely resulted in other deaths by blocking blood vessels or leading to other damage. Dr. no Busso, a dermatologist in Coconut Grove, Fla., and clinical instructor of dermatology at the University of Miami, also blames the injections for severe bruising, recurring infections, nerve damage, chronic inflammation and painful tumor-like lumps. “It is crazy to do this, it’s an extremely unsafe procedure,” he said. ‘OPERATION HOT LIPS’ A year and a half ago, the Florida Health Department’s Office of Unlicensed Activity created a task force dubbed “Operation Hot Lips” to take on the underground cosmetic injection industry. The investigation has yielded 14 arrests, according to chief investigator Enrique . “We’ve just begun to scratch the surface,” he said. “It’s an epidemic in Florida.” Most recently, Ruiz, who police suspect of injecting silicone into customers from her home near Miami for years, was arrested last month for practicing medicine without a license after a WTVJ/NBC 6 undercover investigative report tipped off the authorities. The case is currently awaiting trial. Calls to her lawyer were not returned.

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A woman who asked that she not be identified said she was left with lumps under her eyes and distorted lips after she received a series of injections from Ruiz. “She said it was the latest thing from Europe, that not a lot of people knew about it and it was being tested in the United States,” the woman recalled of Ruiz’s sales pitch. The woman, a former model, says she feels so self-conscious about her “disfigurement” that she seldom leaves her house. She receives regular cortisone injections to reduce the swelling but doctors refuse to remove the silicone for fear of causing further damage. “I just want my face back,” she said. says the practice is so widespread in South Florida because it’s the gateway to South America, where silicone injections are widely used. The practice first gained a foothold in Florida among the foreign-born population, but it quickly crossed social, economic and racial lines. “I’ve seen it in the poorest neighborhoods and in affluent Palm Beach,” said. The practice has gained a following among AIDS patients who use it to plump up faces that have grown gaunt from anti-retroviral drugs — a side effect of the drug regimen is redistribution of body fat that can result in sunken cheeks. Transsexuals are also major consumers, using large volumes of it to create feminine curves. FROM FLORIDA TO CALIFORNIA The practice is not restricted to Florida. The house cleaner arrested in the death of Lawrence is suspected of running a silicone injection service for transsexuals in Greenville, S.C. Dr. Wolf, a Miami plastic surgeon, says he has treated patients who say they were injected in California, New York and New Jersey. “Florida is where this has been exposed because it’s so rampant,” he said. “This is just the tip of the iceberg — within a year we’re gonna find it all over the country.” THE LURE OF A QUICK FIX says clients are seduced by cut-rate prices and the promise of permanency. The effects of approved cosmetic injectables like collagen are short-lived because they are natural substances that the body absorbs after a few months. Koebel, who was injected by a Brazilian cosmetologist at the woman’s apartment, said for $300 it sounded like a good deal: “That’s less than collagen and you have to do that every three months,” she recalled thinking. But Dr. Malcolm , president of the American Society for Aesthetic Plastic Surgery and clinical assistant professor of plastic surgery at the University of California, Irvine, warns women: “You just might get what you wish for. It’ll be permanent but then when there are problems you won’t be able to get rid of it.” “People want a cheap, quick fix and don’t even think about the consequences,” Wolf said.

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The trouble, Busso says, is that no one can predict who will have a bad reaction. He estimates the complication rate at somewhere around 10 percent — “outrageous” for a cosmetic procedure. Unpredictable effects may take years to appear, or can arise almost immediately. The area of the body where the silicone is injected can swell to grotesque proportions. “I’ve seen lips that look like hot dogs sitting on a face,” Busso said. In other cases, the silicone can migrate, causing reactions in other parts of the body. Just before talking with MSNBC, for example, Busso consulted with a patient whose silicone had migrated from her cheeks down to her jaw, where it formed an unsightly lump. But the result most dreaded by plastic surgeons is the chronic inflammatory reaction, in which the body’s immune system recognizes the silicone as a foreign body and mounts an all-out war against it. Large pockets of scar tissue can form around the silicone, creating tumor-like bulges that can continue to grow larger and larger, Busso said. The reaction is similar to that experienced by some women whose silicone gel-filled breast implants leaked or ruptured — migration of the gel with lumps of scar tissue forming around it, according to the Food and Drug Administration. With liquid silicone, the body’s craze to get rid of the substance can trigger sudden swelling, pain, redness and fever, Busso said. “Not long ago, I had a patient who had to be admitted to a hospital eight years after being injected. Her face suddenly blew up like a balloon, turned red like a tomato and she had a fever of 103. She had to get [intravenous] antibiotics and be put on steroids,” he recalled. SILICONE SOIREES The underground silicone network operates on word of mouth, said. Both Koebel and the unnamed woman were referred for silicone injections by aestheticians at beauty salons. Clients go to back-room clinics, private homes and hotel rooms for the procedure. Some practitioners even host “silicone parties.” “Some are real high class, offering Cristal [champagne],” said. The champagne may be expensive, but the hygiene is Third World. said the seizure of one practitioner’s bag revealed dog hair, candy remnants and used needles. He suspects some of the practitioners are even reusing needles — adding AIDS and hepatitis to the list of possible complications of silicone injections.

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The silicone’s purity is doubtful. Often called “biopolymer” in the underground industry, patients often don’t even know what substance they are having injected, noted. He says some of it is medical silicone brought in from outside of the country, illegally; but often it’s industrial-grade silicone — the type used in paints and lacquers or to coat automobile parts. It may not even be silicone at all — Wolf says he has seen a patient with injected paraffin that left her face “hard as a rock.” Doctors say contaminants in non-medical silicone can cause potentially deadly reactions and horrific recurring infections. Rosenberg notes the industrial silicone may also contain carcinogenic materials. “People are playing Russian Roulette,” said. HISTORY OF CONTROVERSY Cosmetic silicone injections have a controversial past. After World War II, the shots became popular among Japanese women who would use liquid silicone to augment their breasts. In the 1960s, the practice became popular among strippers in the United States. The results were disastrous: hardened, lumpy painful breasts, with some women requiring mastectomies. Liquid silicone was never actually approved for any medical use during that time, but the FDA overlooked the practice until the early 1990s when it issued a ban on injecting the substance. Silicone gel breast implants also were banned for cosmetic use in 1992, when their makers could not prove their safety to the FDA’s satisfaction. However, silicone implants remain an option in some medical cases — for breast reconstruction after a mastectomy, for example — and for women enrolled in clinical trials.

But in 1994 a liquid silicone product was approved by the FDA for treating detached retinas. That opened an avenue for doctors to begin using liquid silicone for cosmetic injections again: Once a drug or device is approved by the FDA, doctors can use it as they see fit. Currently, there are two such products on the market for eye surgery. Dr. Orentreich, a dermatologist at the Orentreich Medical Group in New York City — and son of Dr. Norman Orentreich, who helped pioneer cosmetic injections of silicone — currently uses the approved ophthalmologic silicone as a wrinkle, scar and lip filler. However, the American Society for Aesthetic Plastic Surgery opposes cosmetic silicone injections because they are not FDA-approved, according to , the society’s president. Wayne , president of , the developer of Silikon 1000, one of the silicone products approved for eye surgery, said his company does not want physicians using their product for off-label purposes. But the company will begin FDA-approved clinical trials at the end of this month on a new formulation designed specifically for cosmetic injections into facial wrinkles. expressed concern that the illegal activities in Florida may spark unfounded fears about legitimate medical uses of silicone. “Silicone is a very misunderstood substance — you can’t just fill a syringe and inject it. The results can be quite disastrous if it’s not done properly, but labeling silicone as poison is ridiculous.” He points out that silicone has been used successfully for years in many medical devices, from the coating on needles that allows them to slide through the skin, to artificial joints, catheters, shunts and heart valves made of solid silicone rubber. PICKING UP THE PIECES After the charlatans skip town, Florida’s plastic surgeons and dermatologists are often left to pick up the pieces. “Someone who is doing this in the back of a beauty parlor or in a hotel room is not likely to be there for you when you have a problem,” said Wolf, adding that he sees several victims of the fad every week. Removing the silicone is nearly impossible and often involves carving out huge areas of skin and tissue. “You have to treat it like a cancer — excise and reconstruct,” Rosenberg said. Wolf recently performed Koebel’s eighth reconstructive surgery. He is unable to remove the silicone entirely because it has grown into tissues, but Koebel says she’s grateful she can at least come out of hiding now. She returns for steroid injections every several months to keep down the swelling — something she will have to do for the rest of her life. Ironically, she notes, the procedure she opted for to save money has ended up costing her tens of thousands of dollars in reconstructive surgery and lost earnings. But she says the worst part of the ordeal is that she doesn’t really have sympathy of her family and friends. “People say, ‘Well, she was vain, she got what she deserved,’” she said. “But I don’t think anyone deserves this.” Return next Monday for Skin Deep Part 2: Why some cosmetic surgeons are seeking the return of silicone breast implants.

A return to silicone valley?

2 of 4

1. Back-alley beauty injections

2. A return to silicone valley?

3. Sprouting new breast tissue

4. Novel wrinkle fillers in the pipeline

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Voice your views on the news

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THE SILICONE — which was injected into her lips and the tiny lines that were beginning to radiate around her mouth — created a hard ball on her upper lip. Within a few months, the entire lip area had ballooned to five times its normal size, so that it protruded past the end of her nose. “I looked like a duck from the side — people thought I had been severely punched,” she said. The quest for beauty has turned ugly for many in South Florida. Thousands of women and men are buying into promises of fuller lips, smoother skin and made-to-order measurements by untrained, unlicensed practitioners wielding syringes of liquid silicone, state health officials report. And the practice — which has been linked to severe disfigurement and even death — appears to be spreading to other areas of the country, from South Carolina to Southern California. For fees ranging from $100 to $500, cosmetologists, travelling South American pseudo-doctors and even house cleaners illegally inject liquid silicone — an oily fluid similar to the gel used inside silicone breast implants — into customers’ wrinkles, lips, breasts, buttocks, legs and hips. The immediate effects can be pleasing — smoother thighs, tauter cheeks, sexier pouts — but the long-term results can be far from beautiful.

“Imagine the biblical description of leprosy,” said Dr. Rosenberg, a plastic surgeon in Delray Beach, Fla., who has seen about 20 silicone-injected patients in the last two years. “Their faces look like they are melting. They have boils and abscesses.” In at least one case, the consequences of the practice have gone beyond disfigurement. In March, Vera Lawrence, a 53-year-old Miami secretary and mother of two, died after she received injections of silicone into her buttocks and hips, allegedly from a house cleaner. The medical examiner recorded the cause of death as silicone embolism, caused when the thick fluid traveled to one of her lungs. This was the first such case recorded in Florida but doctors say silicone injections have likely resulted in other deaths by blocking blood vessels or leading to other damage. Dr. no Busso, a dermatologist in Coconut Grove, Fla., and clinical instructor of dermatology at the University of Miami, also blames the injections for severe bruising, recurring infections, nerve damage, chronic inflammation and painful tumor-like lumps. “It is crazy to do this, it’s an extremely unsafe procedure,” he said. ‘OPERATION HOT LIPS’ A year and a half ago, the Florida Health Department’s Office of Unlicensed Activity created a task force dubbed “Operation Hot Lips” to take on the underground cosmetic injection industry. The investigation has yielded 14 arrests, according to chief investigator Enrique . “We’ve just begun to scratch the surface,” he said. “It’s an epidemic in Florida.” Most recently, Ruiz, who police suspect of injecting silicone into customers from her home near Miami for years, was arrested last month for practicing medicine without a license after a WTVJ/NBC 6 undercover investigative report tipped off the authorities. The case is currently awaiting trial. Calls to her lawyer were not returned.

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A woman who asked that she not be identified said she was left with lumps under her eyes and distorted lips after she received a series of injections from Ruiz. “She said it was the latest thing from Europe, that not a lot of people knew about it and it was being tested in the United States,” the woman recalled of Ruiz’s sales pitch. The woman, a former model, says she feels so self-conscious about her “disfigurement” that she seldom leaves her house. She receives regular cortisone injections to reduce the swelling but doctors refuse to remove the silicone for fear of causing further damage. “I just want my face back,” she said. says the practice is so widespread in South Florida because it’s the gateway to South America, where silicone injections are widely used. The practice first gained a foothold in Florida among the foreign-born population, but it quickly crossed social, economic and racial lines. “I’ve seen it in the poorest neighborhoods and in affluent Palm Beach,” said. The practice has gained a following among AIDS patients who use it to plump up faces that have grown gaunt from anti-retroviral drugs — a side effect of the drug regimen is redistribution of body fat that can result in sunken cheeks. Transsexuals are also major consumers, using large volumes of it to create feminine curves. FROM FLORIDA TO CALIFORNIA The practice is not restricted to Florida. The house cleaner arrested in the death of Lawrence is suspected of running a silicone injection service for transsexuals in Greenville, S.C. Dr. Wolf, a Miami plastic surgeon, says he has treated patients who say they were injected in California, New York and New Jersey. “Florida is where this has been exposed because it’s so rampant,” he said. “This is just the tip of the iceberg — within a year we’re gonna find it all over the country.” THE LURE OF A QUICK FIX says clients are seduced by cut-rate prices and the promise of permanency. The effects of approved cosmetic injectables like collagen are short-lived because they are natural substances that the body absorbs after a few months. Koebel, who was injected by a Brazilian cosmetologist at the woman’s apartment, said for $300 it sounded like a good deal: “That’s less than collagen and you have to do that every three months,” she recalled thinking. But Dr. Malcolm , president of the American Society for Aesthetic Plastic Surgery and clinical assistant professor of plastic surgery at the University of California, Irvine, warns women: “You just might get what you wish for. It’ll be permanent but then when there are problems you won’t be able to get rid of it.” “People want a cheap, quick fix and don’t even think about the consequences,” Wolf said.

Related news

More on cosmetic surgery

•

The real 'wonder' bra?

•

Liposuction safety concerns assuaged

The trouble, Busso says, is that no one can predict who will have a bad reaction. He estimates the complication rate at somewhere around 10 percent — “outrageous” for a cosmetic procedure. Unpredictable effects may take years to appear, or can arise almost immediately. The area of the body where the silicone is injected can swell to grotesque proportions. “I’ve seen lips that look like hot dogs sitting on a face,” Busso said. In other cases, the silicone can migrate, causing reactions in other parts of the body. Just before talking with MSNBC, for example, Busso consulted with a patient whose silicone had migrated from her cheeks down to her jaw, where it formed an unsightly lump. But the result most dreaded by plastic surgeons is the chronic inflammatory reaction, in which the body’s immune system recognizes the silicone as a foreign body and mounts an all-out war against it. Large pockets of scar tissue can form around the silicone, creating tumor-like bulges that can continue to grow larger and larger, Busso said. The reaction is similar to that experienced by some women whose silicone gel-filled breast implants leaked or ruptured — migration of the gel with lumps of scar tissue forming around it, according to the Food and Drug Administration. With liquid silicone, the body’s craze to get rid of the substance can trigger sudden swelling, pain, redness and fever, Busso said. “Not long ago, I had a patient who had to be admitted to a hospital eight years after being injected. Her face suddenly blew up like a balloon, turned red like a tomato and she had a fever of 103. She had to get [intravenous] antibiotics and be put on steroids,” he recalled. SILICONE SOIREES The underground silicone network operates on word of mouth, said. Both Koebel and the unnamed woman were referred for silicone injections by aestheticians at beauty salons. Clients go to back-room clinics, private homes and hotel rooms for the procedure. Some practitioners even host “silicone parties.” “Some are real high class, offering Cristal [champagne],” said. The champagne may be expensive, but the hygiene is Third World. said the seizure of one practitioner’s bag revealed dog hair, candy remnants and used needles. He suspects some of the practitioners are even reusing needles — adding AIDS and hepatitis to the list of possible complications of silicone injections.

Health e-newsletter

Click here to sign up for our free e-roundup of the week's health news every Friday afternoon.

The silicone’s purity is doubtful. Often called “biopolymer” in the underground industry, patients often don’t even know what substance they are having injected, noted. He says some of it is medical silicone brought in from outside of the country, illegally; but often it’s industrial-grade silicone — the type used in paints and lacquers or to coat automobile parts. It may not even be silicone at all — Wolf says he has seen a patient with injected paraffin that left her face “hard as a rock.” Doctors say contaminants in non-medical silicone can cause potentially deadly reactions and horrific recurring infections. Rosenberg notes the industrial silicone may also contain carcinogenic materials. “People are playing Russian Roulette,” said. HISTORY OF CONTROVERSY Cosmetic silicone injections have a controversial past. After World War II, the shots became popular among Japanese women who would use liquid silicone to augment their breasts. In the 1960s, the practice became popular among strippers in the United States. The results were disastrous: hardened, lumpy painful breasts, with some women requiring mastectomies. Liquid silicone was never actually approved for any medical use during that time, but the FDA overlooked the practice until the early 1990s when it issued a ban on injecting the substance. Silicone gel breast implants also were banned for cosmetic use in 1992, when their makers could not prove their safety to the FDA’s satisfaction. However, silicone implants remain an option in some medical cases — for breast reconstruction after a mastectomy, for example — and for women enrolled in clinical trials.

But in 1994 a liquid silicone product was approved by the FDA for treating detached retinas. That opened an avenue for doctors to begin using liquid silicone for cosmetic injections again: Once a drug or device is approved by the FDA, doctors can use it as they see fit. Currently, there are two such products on the market for eye surgery. Dr. Orentreich, a dermatologist at the Orentreich Medical Group in New York City — and son of Dr. Norman Orentreich, who helped pioneer cosmetic injections of silicone — currently uses the approved ophthalmologic silicone as a wrinkle, scar and lip filler. However, the American Society for Aesthetic Plastic Surgery opposes cosmetic silicone injections because they are not FDA-approved, according to , the society’s president. Wayne , president of , the developer of Silikon 1000, one of the silicone products approved for eye surgery, said his company does not want physicians using their product for off-label purposes. But the company will begin FDA-approved clinical trials at the end of this month on a new formulation designed specifically for cosmetic injections into facial wrinkles. expressed concern that the illegal activities in Florida may spark unfounded fears about legitimate medical uses of silicone. “Silicone is a very misunderstood substance — you can’t just fill a syringe and inject it. The results can be quite disastrous if it’s not done properly, but labeling silicone as poison is ridiculous.” He points out that silicone has been used successfully for years in many medical devices, from the coating on needles that allows them to slide through the skin, to artificial joints, catheters, shunts and heart valves made of solid silicone rubber. PICKING UP THE PIECES After the charlatans skip town, Florida’s plastic surgeons and dermatologists are often left to pick up the pieces. “Someone who is doing this in the back of a beauty parlor or in a hotel room is not likely to be there for you when you have a problem,” said Wolf, adding that he sees several victims of the fad every week. Removing the silicone is nearly impossible and often involves carving out huge areas of skin and tissue. “You have to treat it like a cancer — excise and reconstruct,” Rosenberg said. Wolf recently performed Koebel’s eighth reconstructive surgery. He is unable to remove the silicone entirely because it has grown into tissues, but Koebel says she’s grateful she can at least come out of hiding now. She returns for steroid injections every several months to keep down the swelling — something she will have to do for the rest of her life. Ironically, she notes, the procedure she opted for to save money has ended up costing her tens of thousands of dollars in reconstructive surgery and lost earnings. But she says the worst part of the ordeal is that she doesn’t really have sympathy of her family and friends. “People say, ‘Well, she was vain, she got what she deserved,’” she said. “But I don’t think anyone deserves this.” Return next Monday for Skin Deep Part 2: Why some cosmetic surgeons are seeking the return of silicone breast implants.

A return to silicone valley?

2 of 4

1. Back-alley beauty injections

2. A return to silicone valley?

3. Sprouting new breast tissue

4. Novel wrinkle fillers in the pipeline

Write a letter to the Editor

Voice your views on the news

Your e-mail address will not be published Your nameYour hometownYour e-mail address