doctors continuing to inject silicone despite f.d.a. warnings, agency says
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Although the Food and Drug Administration warned that the practice was illegal, dozens of doctors continued to inject silicone directly into women, agency officials said, the most common situation is to powder the part of the face or make the wrinkles smooth.
The agency is investigating the most famous doctors, including dermatologists in New York, and trying to track down the silicone trade in which middlemen are believed to have bought materials from manufacturers under false excuses, to resell to a doctor.
F silicone injection is not approved. D. A.
And only those doctors who are authorized to conduct experiments on patients are allowed to use or obtain silicone during surgery;
At present, no doctor has this power.
Unlike silicone in breast implants enclosed in a rubber bag, the injected silicone is easier to migrate to other parts of the body.
There have been constant reports since the 1960s that injections have resulted in ulcers, lumps, tissue damage, and even lung failure and death. In June, Dr. David A.
Kessler, Food and Drug Commissioner, warned doctors that silicone injections are illegal and must be stopped.
For the first time in 1965, the agency said that when a doctor who did not have a license to conduct human experiments used liquid silicone, the injection was illegal.
But over the next few years, doctors continue to inject, and lawyers from their medical association often suggest that if Silica gel is obtained in the state where it is used, F. D. A.
There is no jurisdiction over its use. The F. D. A. disagrees.
\"Uncontrolled experimental advertising\" more than 25 years ago\"D. A.
Manhattan Democratic Representative Ted Weiss said: \"He concluded that silicone injections are unsafe and illegal . \" He investigated the medical use of silicone last year.
\"In the 1940s, women were exposed to liquid silica gel without any prior safety tests.
Evidence of danger has accumulated over the past 40 years, but uncontrolled experiments on women continue.
Many plastic surgeons and dermatologists admit that they continue to inject silicone, mainly on women, until the doctor
They say they see very few serious side effects in patients, and many say that while a large amount of silicone may be dangerous, they usually only inject drops of colorless liquid.
The American Society of Cosmetic Surgery said a survey of 2,000 doctors found that silicone injections were the ninthmost-
The most popular surgery in cosmetic surgery, with 59,285 injections in just 1990 cases.
I don\'t know how many people represent this number, because patients usually receive several treatments and how many injections were received in total.
New York dermatologist under investigation by the FBID. A. , Dr.
Norman Orentreich said in an interview last summer that for more than 40 years he has injected silicone for 75,000 patients, including himself and many celebrities.
He said at the time that the operation was safe and that women should have the option to receive such treatment.
He recently declined to be interviewed again.
Under federal law, doctors are not allowed to use silicone that is considered to be unapproved medical devices unless they obtain a human experiment permit. Dr.
Orentreich insists that he is acting legally under a clause of the law exempting doctors who manufacture equipment specifically for individual patients and that he has purchased silicone in New York state. Dr.
Orentreich is also a clinical professor in dermatology at New York University School of Medicine, and F. also investigated him. D. A.
In 1977 and 1984;
Every investigation was withdrawn.
Plastic surgeons say the impulse to use silicone comes from its positive results.
For example, for those with facial deformation, \"how great the results are is notable,\" said Dr.
Milton Edgerton, at the University of Virginia Medical Center in Charlottsville, has been involved in experiments with silicone injections since 1965.
\"We are very impressed.
Liquid silica gel may be a useful health product.
He said: \"But if it is legal,\" it is absolutely right that everyone and his brother will start injecting people and we will get stuck. \".
A few years ago, he and other plastic surgeons worked with F. D. A.
And make sure because the product is not life
He said there is no risk in saving and widespread use.
Advertising is an example of abuse of the product, he said.
Orentreich, he did not treat severe deformity, \"but only wrinkles and fine wrinkles, not even complete
\"At one time or another, we all tried to work on the frowning lines, but that was the least impressive result we had,\" he added . \".
Most of us don\'t think what he does is a good idea and we won\'t do it even if it\'s legal.
\"In contrast, Dr. Howard A.
Tobin, an official at the American College of Cosmetic Surgery, said he had given eight years of silicone injections of wrinkles until a doctor
He said: \"We don\'t recommend our members to continue using it at all, but it doesn\'t show that it\'s not a very good treatment and we would welcome it if F. D. A.
Some methods for establishing clinical experiments can be found to determine what side effects are.
In the late 1940s S, plastic surgeons of lump and ulcer in independent action began to use liquid silicone injections.
Sometimes the results are disastrous.
Some women have rough faces and ulcers, and their features are distorted.
In other cases, there will be sore in the breast tissue and the breast must be removed.
Sticky silicone blocks that have been migrated can cause inflammation and sometimes cannot be removed because they adhere to the body tissue like glue.
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A brief review of the medical literature shows that more than 50 cases of serious reactions
Liquid silicone injections, mostly in the breast, include at least three deaths.
An uncertain risk is whether an injection in a small group of women can lead to autoimmune diseases such as arthritis.
There are many reports of the situation, but no systematic studies have been conducted to show the link between the disease and silica gel.
Dow Corning, a silicone manufacturer, persuaded F in 1965. D. A.
Authorized several doctors, including doctors.
Orentreich, a silicone injection experiment was performed on 1,334 women. F. D. A.
Officials now say that the experiments were done poorly and did not produce valuable data, mainly because doctors did not report the condition of all women and did not track more than half of the patients, look at their performance after surgery.
A smaller study was started in 1978, with approximately 145 women participating in the study, of which data from about 128 patients were provided to F. D. A. last year.
The study also failed to produce useful scientific data, according to government documents, because doctors did not provide the requested information.
Doctors should also follow the patient\'s progress for seven years, but more than half of the women were abandoned four years ago.
In this study, 30 people reported complications.
7% of cases. The F. D. A.
\"4% of patients may have serious complications such as severe infection, tissue rupture, silicon fluid migration and pain,\" the report said. \"The F. D. A.
The conclusion is \"silicone injection cannot be recommended without reservation.
\"A central figure in the history of silicone injection is the doctor.
Orentriich has more patients than any other doctor, including many celebrities.
Ask a lawyer for a doctor
Peter Safir\'s Orentreich admitted in a telephone interview that the doctor experimented with about 700 women between 1965 and 1972, and did not follow 400 of the women to see what the injection ultimately caused.
The lawyer said he had some information in the case of 300 women. Mr.
The doctor continued to inject filtered but low, Safir said.
Grade the silicone used in the transformer to the female face and keep FD. A.
Because he filtered the materials in the office, he could not be sued. But Dr.
Orentreich recently lost an important debate in court, and in the proceedings brought by Rosalyn Retkwa, she said at the pre-trial hearing that she was not informed of his
In several proceedings against him by his patient, the New York State Supreme Court dismissed his appeal.
Orentreich\'s argument, and said that the silicone he uses is a medical device that has been in interstate commerce all the time.
Lawsuit filed by the Lady
Retkwa said that the silicone injected around her nose had migrated to her lips, causing her lips to drooping, and she planned to be tried on Tuesday. F. D. A.
Scientists have tested the silicone used by doctors.
In an internal memo, Orentreich said that the filtered material \"shows about the same impurities as the non-filtered material
Filter industrial grade silicone.
\"In the earliest authorized studies, some women were never told they were the subjects of the experiment.
Celia Anderson in Utah is such a patient.
She sued her doctor for having big sore on her face that could not heal due to the silicone in the tissue.
After many attempts to save her face, the doctor ended up leaving only a lot of scars. .
In an early experiment, another woman, Leia zedeman, was born without a big chest muscle, so her right side was unable to develop a breast.
Two months before her 18 th birthday, a plastic surgeon in California treated her with gel implants and direct injection of silicone.
Now her right side is hard and deformed.
She could feel a lump in the scar tissue on her ribs.
Although the operation was in 1965, she did not find herself part of the experiment until this year.
\"I was totally shocked when I found out about this,\" she said in a telephone interview . \".
\"It feels terrible.
\"Another patient, Laurie Lehman, received an injection of his chin during a nose reconstruction.
Silicone moves from her face to the top of her ears, neck and chest.
She has redness, pain and arthritis.
Like the symptoms on her arm.
Advertising \"What shocked me about all this is watching plastic surgeons on TV now, surprised that this has become a problem as if they have never heard of it before, she said.
A version of this article appears on page 1001018 of the national edition of February 2, 1992, with the title: although F. D. A.
Warning, the agency said.