strange history of silicone held many warning signs
By PHILIP J. HILTSJAN. 1992 this is a digital version of an article from The Times Print Archive, before it starts online in 1996. To keep these articles as they appear initially, the Times will not change, edit, or update them. There are occasional copywriting errors or other problems during the digitization process. Please send a report of such issues to archid_feedback @ nytimes. com. For decades, doctors and scientists have argued that inert things like silicon are unlikely to cause major health problems. In addition to breast augmentation, silicone plastic made of silicon is also used for valves, pipes and artificial parts of the body. They seem benign. But the nature of science is surprising, and in recent weeks doctors and scientists have been surprised by reports of the various adverse effects of this rich element. If the safety of the silicone really shouldn\'t be taken for granted, how is its safety considered? Looking back on the long history of silicone, it is now clear that there are many warning signs, some of which have been implemented and some of which may have been wrongly ignored. In the medical literature of the past 20 years, there have been more and more papers on Silicon elements; Silicone is a flexible compound composed of silicon molecules, which is related to human diseases. Advertising although implant manufacturers insist that their products are safe, some doctors associate silicone in breast implants with a variety of immune system diseases such as arthritis, hard swelling and erythema. Last week, before reviewing the new safety data, the Federal Drug Administration actually banned the use of silicone gel implants. According to company documents, even Dow Corning, a leading implant manufacturer, believes that silicone may cause some kind of immune response. A division of the company tested a number of silicone compounds for use as an booster for vaccines. This booster is used to enhance the immune response other than the vaccine itself. The tests show that these compounds have certain immunity. Improve the effect. A scientist who discovered some direct links between silicone and immune system disease during breast augmentation surgery said today that he had been trying to convince Dow Corning to do the research for more than a decade but was rejected The first choice of their own research started in 1970s John Paul Heggs of the University of Texas Medical School in Galveston shows that the human immune system responds to silicone in breast augmentation by producing antibodies against silicone. The antibody attacks silicone and the body tissue associated with it. From 1978 Heggers said he wrote to officials at Dow Corning and spoke with them asking them to be interested in the possible sexiness that this self-immunization problem may be caused by an implant. \"They are just not interested,\" he said . \"Dr. Robert Levy, technical head of Dow Corning\'s healthcare business, said today: \"He can\'t interest us, which is a very accurate statement. We prefer to do our own immunization work here. We disagree. A scientific approach to this problem \"Instead, the company studied the symptoms that may occur when animals are exposed to silica gel. Big company- The scale study compares women with implants and women who only started months ago after a recent wave of publicity about implants. When asked why the company didn\'t start early, \"It depends on judgment,\" said livyer. I don\'t know how long it will be reasonable. \"Dr. The significance of his immune system research, says Heggs, \"is hard to say because we don\'t have a large enough female sample. \"He said that some women may be particularly prone to immune problems that may be caused by silicone, while others may be implanted with some poorly effective implants. \"But just because penicillin can sometimes cause allergic shock doesn\'t mean you take penicillin off the market,\" he said . \". \"We need to identify sensitive women. \"I guess there may be thousands of women who have had these problems,\" he said. Although happy, clear HazardsScientists scientists from both sides of the implant debate say it is critical for researchers to establish a registration for implanted women. Large- These scientists say comparing them to the size of women who are not implanted is the only way to determine whether they are safe or not. But, as the comments on scientific articles and interviews with researchers have shown, it is already clear that there is some unquestionable danger of the gel Filled with silicone breast implants. First, the insertion of silica gel into the body causes a strong reaction in the tissue, causing the body to weave a bag of fiber tissue around the implant and peel it off the system from the rest of the implant. This condition is known as the bag muscle contraction, which can be painful and ugly and will make the breast hard. Some researchers say this happens to some extent in 10% of women who are implanted. A potentially more lethal hazard is the silicone-to-X- As a result, it is difficult to detect early breast cancer with an X-ray. Dr. Melvin J. Silverstein in the breast center of fanness, California He studied the problem extensively, and on average, when women with implants found cancer, the volume of the tumor was five to six times that of women without implants. To make matters worse, of the patients he studied, 45% of the implanted patients had spread to the lymph nodes at the time of diagnosis. In women who were not implanted, cancer was found by a breast X-ray examination, with only 6% of cases spreading cancer. Millions of women around the world have undergone silicone gel breast implants and are pleased with it, and the Federal Drug Administration recommends women not to implant surgery unless it causes trouble. In fact, researchers like doctors Kenneth mcculty of Duke University Medical Center, who studied 3,880 breast implants women, said today that the biggest problem most of them face is the unnecessary panic caused by breast implants. Some women may delay breast implants because they are worried about not being able to get the best breast implants and breast implants, he said. Advertising even researchers like Dr. Silverstein believes that women should be able to weigh the risks and choose breast implants if they want breast implants. From mortar to prostitution tools, the outer ring of the silicon atom is like carbon, which is the element on which all living things depend. Silicon is also a basic element in the sand, and all animals face it in small quantities every day. Both scientists and science fiction writers have fantasized that a complete parallel universe can be built on silicone rather than carbon. However, between the periodic chart and the industrial profit statement, it is natural to change the shape in a surprising way. The business story of silicone began in the 1930s when scientists at Corning Glass were looking for a caulking material to be used as a mortar between fashionable glass blocks. The silicone is thought to be because it withstand extreme temperatures and maintains its performance very well. Silicone is a chain of silicon molecules with edges A group of other molecules. Silicone is widely used; Molecules can be connected in relatively short chains that produce quite flowing liquids, or form longer chains that are more rigid and produce rubber bands or solid rubber blocks, etc. It turns out that silica gel is not a good alternative to mortar, and until 1950s, this form of silica gel was listed as \"stupid putty\" and has been a curiosity of the laboratory. \"Please click on the box to verify that you are not a robot. The email address is invalid. Please re-enter. You must select the newsletter you want to subscribe. View all New York Times newsletters. But in World War II, when the military asked Corning glass and Dow Chemical to look for alternatives to scarce rubber, scientists took another look at silicone. The first silicone form developed in this work is a liquid used as an insulator in a transformer. At the end of the war, silicone was used in transformers across the national grid. The next step in Odyssey takes a detour in the field of Sex and psychology: Silicone is used to increase the breast size of Japanese prostitutes. Dr. Edward Kopf is a plastic surgeon who is interested in the history of silica gel. Japanese beauticians realize that American soldiers prefer women with bigger breasts than Japanese women, he said. After experimenting with goat milk, paraffin wax and a variety of other substances, they tried silicone and injected it directly into the breast. Soon, the transformer solution disappeared from the dock of the Japanese Navy. Kopf said. Plastic surgeons in the United States began to accept the practice of Japan. in 1960s and 1970s, American literature was filled with bizarre female stories and photos, the breasts and scars of the ulcer, as well as other problems in the abdomen, chest, arms and back, are caused by drifting pieces of sticky silica gel. In the few cases where silicon moves to the lungs, the result is death. The use is active, but the suspicion is also frequent, and liquid silica gel is mixed with other materials, hoping that the resulting inflammation and scar tissue will prevent the formation and migration of the lump. Doctors working for Dow Corning argue that the problems associated with the injection come from other materials, and that the company continues to produce injected silica gel until it is made illegal, first in Nevada, many of the worst things happen in California, and finally the Food and Drug Administration. But researchers are still looking for the medical use of silicone. In 1962, Dr. Frank Gerow and Dr. Thomas Cronin, who later joined Dow Corning, combined rubber with liquid silicone to make a soft but sturdy gel. They wrapped the gel in a thin envelope of a rubber-like silicone polymer, often referred to as a \"elastic material \". \"This is the first silicone gel silicone implant. Although the implant has been modified, the basic form is the one that has been used before F. D. A. Sales of silicone gel implants were effectively banned last week. Many other medical products were developed with silicone, mainly from rubber, included are tubes and valves for closing the fallopian tubes during sterilization, clips, penis prosthesis, artificial crystals and pipes for blood oxygen devices and dialysis machines. All in all, these products work well. But for years, there have been disturbing signs that the silicone they contain may cause problems. A study involved patients who performed renal dialysis, in which the machine sent the purified patient\'s blood through a silicone pipeline pump. The researchers found that the chances of liver disease in these patients were very high, and some people died of liver disease. The autopsy revealed that they had large amounts of silicone particles in their liver, which were later found to come from the silicone duct. When replaced with another type of tube, the problem stopped. A similar problem occurred during heart bypass surgery, when silica gel was used as an anti-foam agent in a device for oxygen filling the patient\'s blood. It was found that the tiny particles of silicone entered the body and blocked the capillaries, causing tissue damage. It is also important that, judging from the current fuhorror, the incidence of hard disease, which has been implanted in an autoimmune disease, critics say is related to these devices. Hard disease, in which the growth of fiber tissue leads to skin thickening, has historically been associated with silicon or silicon, a natural source of silicone. Between 1981 and 120, 93 of the 1988 patients who studied hard skin in Germany had direct contact with silica, whether they were miners, sandblasting workers or similar occupations. Shocking response, but in the years of the popularity of silicone gel injected directly into the body, limited research advertising, many recipients reported a variety of reactions, including some rare cases where silicone causes inflammation of the lungs and causes suffocation. In animal studies, it is clear that the tissue around the implant or the injection is permanently inflamed and occasionally benign tumors and other tissue reactions occur. Scientists at Dow Corning research Dogs recorded the reactions, but a senior agency official said the information was never accurately submitted to the Food and Drug Administration. Dow Corning\'s scientists found in a study of 38 dogs in 1973 that almost all dogs had inflammatory reactions. Implant gel into four dogs; One case of internal organs was damaged, the cause was unknown, one case was benign tumor, and two cases were still inflamed after two years. But officials at the agency said Dow scientists mistakenly reported the study, saying the dog\'s health is normal and there is only mild inflammation. Rheumatism and immunologists say it is not clear whether a response like a benign tumor indicates Immune response of scale. In 1978 Dr. Robert leville of Dow to F. D. A. The immune response should be studied to determine the risk of women using implants, but it did not start until a few years later. Those who do not believe that silicone can lead to a real autoimmune disease say there is no doubt that foreign substances in the immune system can cause some reactions, but they say that the response is mostly local, it is mainly the reaction of cells like macrophages, whose job is to devour foreign substances. They say that unless there is evidence of a large number of silicone antibodies and evidence of lymphocytes, the disease of the whole immune system cannot be proved, and the lymphocytes are full- Immune response of scale. Of course, the basic issues are still clear in the next few years. Research on the scale of women and cars Immune disease, see if there are too many women with implants. For more than a decade, even Dow Corning scientists have recommended such research. But the company started such research only a few months ago. The only large study conducted by advertising companies on women was five studies conducted on about 1,000 women. A Dow Corning consultant said the data were key to Dow Corning\'s claim that the implants were safe and effective. But to a large extent, these studies are not about women at all, but about the records of Plastic Surgeons. Check the records to see if the woman reported the hardness of the breast or other obvious problems. The women themselves were not asked or examined in the study, which did not include symptoms of autoimmune diseases. Dr. Steven Weiner, director of the Department of rheumatism and immunity at UCLA Medical School, said he has treated about 60 implant women with epidural or other autoimmune diseases. He said that while it was far from proven that the implants caused their disease, it was between half and two years old. After the implants were removed, 30 of them showed great improvement. Dr. Nir Kossovsky, American expert in biological materials and pathologyC. L. A. He said it may not be silicone or silicone itself that caused the problem. Once inside the body, the material may attract protein from the body and then be wrapped in silica gel. The body may have its own immune response to these proteins, which may spread to other parts of the body. That is to say, immune cells also attack proteins in other parts of the body. Dr. Noel R. John Hopkins, professor and chairman of the Department of Immunology at the School of Health and Public Health, Ross, testified in court on behalf of Dow Corning, saying Kossovsky may be correct, but it is difficult to prove this. \"Should the company do more things earlier? \" he asked. \"Should the F. D. A. Is it harder for them to get the data? I just don\'t know why we are leaving after 20 years and still say we are sorry and we hope these things will be watched 20 years ago. \"A version of this article appeared in print in January 18, 1992, and on page 1001001 of the national edition, the title is: The Strange History of silicone has many warning signs.