European Stars and Stripes (Newspaper) - February 4, 1992, Darmstadt, Hesse                                History of silicone were problems ignored by Philip j. Hilts the new York times for decades doctors and scientists have thought it unlikely anything As inert As Silicon could cause significant health problems. Besides breast implants silicone plastics made from Silicon have been used in valves tubes and artificial parts in the body. How did the safety of silicone come to be taken for granted if indeed it should not have been looking Back at the Long medical history of silicone it is now Clear there were Many warning signs some of which were acted on some of which May have wrongly been overlooked in the medical literature of the past 20 years there has been a rising number of papers on Silicon the element silicone the flexible Chain built of Silicon molecules and human illness. Although implant makers maintain that their products Are Safe some doctors link silicone in breast implants to a variety of Auto immune conditions like arthritis scleroderma and Lupus. Last month the Federal drug administration effectively banned the use of silicone gel implants pending a review of new safety data. According to company documents even Dow Corning the leading implant maker thought silicone might provoke some kind of immune response. One division of the company tested numerous silicone compounds for use As a Booster to vaccines. Such boosters Are used to heighten the immune response beyond that of the vaccine itself. The tests did show the compounds had some immune boosting effect. A scientist who Lound some of the first direct links Between the silicone in breast implants and Auto immune diseases said two weeks ago that for More than a decade he had tried to persuade Dow Corning to carry out such research but was rebuffed. In studies begun in the 1970s or. John Paul Heggers of the University of Texas medical Campus at Galveston showed that the human immune system reacted to the silicone in breast implants by making antibodies against it. The antibodies attack the silicone and the body s own tissues associated with it an Auto immune reaction. Starting in 1978, Heggers said he wrote and talked to officials of Dow Corning asking them to take an interest in the possibility that Auto immune problems resulted from the implants Quot they just weren t interested Quot he said. Or Robert Levier technical chief of Dow Corning corp s health care businesses said Quot that he could t get us interested is a pretty accurate statement. We prefer to do our own immunological work Here we disagree with Heggers on the scientific approach to the  instead the company has looked at symptoms that might develop when animals Are exposed to silicone the company s Large scale studies comparing women who have implants and women who do not began Only a few months ago after the recent wave of publicity about implants. When asked Why the company did not get started earlier Levier said Quot that is subject to judgment. Just How Early would have been reasonable i Don t  Heggers said that the meaning of his immune system research is Quot difficult to say because we Don t have a Large enough Sample of  he said it is possible that some women Are especially prone to immune problems that silicone could trigger while others could have implants with few ill effects. Quot but just because penicillin causes Asaph lactic Shock sometimes does t mean you take penicillin Oft the Market Quot he said. Quot we need to identify the sensitive  at a guess he said there May be a few thousand women who have had these problems. Scientists on both sides of the implant debate say it is critical for researchers to establish a registry of women with implants. Large scale comparison of them to women without implants is the Only Way to establish definitely if they Are Safe these scientists say but As a review of scientific articles and interviews with researchers suggest it is already Clear that there Are a number of unquestionable hazards of gel filled silicone breast implants. One it that the insertion of silicone into the body causes a Strong reaction in the tissue that causes the body to weave a bag of fibrous tissue around the implant to Wall it off from the rest of the system. This condition called capsular contracture can be painful and unsightly and can make the breasts hard. Some researchers say the condition occurs to some degree in perhaps 10 percent of women with implants. A potentially More deadly Hazard is that silicone is opaque to a rays and thus makes mammograms to find Early breast cancer very difficult. Or. Melvin j. Silverstein of the breast Center in Van Guys calif., who has studied the problem extensively said that on average by the time cancer is discovered in a women with implants the tutors Are five to six times the volume of the tutors found in women without implants. Worse among patients he studied 45 percent with implants had cancer that had already spread to the Lymph nodes at the time of diagnosis. In women without implants whose cancer was caught by mammography the cancer had spread Only in 6 percent of the cases. Millions of women around the world have had silicone gel breast implants and Are delighted with them and the Fra advises women to leave implants in place unless they Are causing trouble. In fact researchers like or. Kenneth Mccarty of Duke University medical Center who has studied 3,880 women with breast implants said that the biggest problem most of them face is a Dis ease Quot caused by unnecessary alarm Over implants. And he said some women May put off breast surgery because they fear they would not get the Best reconstruction and implants. And even researchers like Silverstein think women should be Able to weigh the risks and choose breast implants if they want them. The Story of silicone began in the 1930s, when scientists at Corning Glass were looking for a caulking material to use As mortar Between its fashionable Glass blocks. Silicone was considered because it withstood extremes of temperature and retained its properties remarkably Well. Silicone Are chains of Silicon molecules with Side groups of other molecules. Silicone Are versatile the molecules can be linked up in relatively Short chains which make rather Runny liquid or into much longer reconstructive surgery an alternative the silicone by Bill Kole the associated press More women who want their breasts reconstructed after mastectomies a but who worry about artificial implants a Are considering using their own abdominal tissue a surgeon says. Quot women love it. They re my happiest patients Quot or. Herman p. Hoi i of Detroit a Henry Ford Hospital said in mid january. I be got five scheduled for this new procedure already this  surgeons at Henry Ford have performed about two dozen transverse rectus a Dominus my cutaneous flaps procedures Over the past two years. The operation developed in 1980 by or. Carl Hartrampf of St. Joseph Hospital in Atlanta involves using a woman s own abdominal muscle and fat tissue to reconstruct her breasts. The Hospital says it has fielded Many More inquiries about the procedure since the . Food and drug administration asked doctors to temporarily Stop using silicone gel implants in breast surgery. The Hospital has stopped using the silicone gel implants for now Houin said but continues to perform breast surgery using Saline gel implants As Well As doing the so called Tram Flap surgery. In the Tram Flap procedure a Flap of tissue is taken from a woman s lower Abdomen and inserted beneath the skin of the upper Abdomen to create a new breast Mound. Later the patient returns to have the nipple reconstructed and tattooed to a natural color. One patient who came in the other Day said its like the Best of both worlds Quot said Hospital spokeswoman Doreen Buckland. Quot she said now i have a hat stomach and breasts too Quot the surgery leaves a hip to hip scar but Houin said that can be concealed beneath the Bottom of a two piece bathing suit. Because the surgery is More extensive than for breast implants patients face a longer More painful recovery. Quot it s a major piece of surgery a said Robert t. Rylee vice president of Dow Corning Wright corp., which makes silicone implants. Quot whenever you have a Choice Between a greater procedure and a lesser procedure you re going to choose the lesser  alternative to silicone women who have Hail mastectomies can have their breasts reconstructed their lower Abdomen. Chains which Are More rigid and make materials like rubber bands or solid rubber blocks silicone turned out not to be a Good substitute for mortar and silicone in that form remained a Laboratory curiosity until the 1950s, when it went on the Market As Quot silly  but scientists had taken another look at silicone in world War ii when the military asked Corning Glass and Dow chemical to seek substitutes for scarce rubber. One of the first forms of silicone developed in this Effort was a liquid used As an insulator in transformers. At the end of the War the silicone was used in transformers throughout the nation s electrical network. The next step in the Odyssey detours through the realms of sex and psychology. Silicone was used to increase the breast size of japanese prostitutes. Or. Edward Kopf a plastic surgeon in Las vegas who has made a Hobby of the history of silicone said japanese cosmetologists realized that american servicemen preferred women with larger breasts than was common among japanese women. After experimenting with goats milk paraffin and a variety of other substances they tried silicone injecting it directly into the breast. Soon transformer fluid began disappearing from the Navy s docks in Japan Kopf said american plastic surgeons began to pick up the japanese practice and during the 1960s and 70s, United states literature became littered with grotesque stories and pictures of women with Lumpy ulcerated breasts and scars and other problems in their Abdomen Chest arms and Back from the Drifting Sticky bits of silicone. In a few cases in which the silicone migrated to the lungs the result was death often the liquid silicone was mixed with other materials in Hope that the resulting inflammation and scar tissue would prevent the formation and migration of lumps. Doctors working for Dow Corning corp. Contended that problems associated with the injections arose from the other materials and the company continued to make silicone for injection until it was made illegal first in Nevada where Many of the worst cases were then in California and finally by the food and drug administration. But researchers continued to seek medical uses for silicone. In 1962, or Frank Gerow and or. Thomas Cronin who later joined Dow Corning combined rubbery and liquid silicone to create a gel that was soft but firm. They wrapped this gel in a thin envelope of the rubbery silicone polymer usually referred to As the "elastomer,�?T1 this was the first silicone gel breast implant. Though the implant has been modified the Basic form is the one that was in use until the Fra effectively banned the Sale of silicone gel implants last week. Many other medical products were developed from silicone mostly from the Elastomer including tubes and valves clips that close fallopian tubes in sterilization surgery penile prostheses intraocular lenses and tubing for blood oxygen tors and dialysis machines. Overall these products worked Well. But Over the years there were disturbing signs that the silicone they contained could cause problems one study involved patients on kidney dialysis in which machines purify the patients blood which was pumped through silicone tubing. The researchers found that the patients were getting liver disease at an unusually High rate and some died of it autopsies showed their livers had a Large number of silicone particles later shown to have come from the silicone tubing. When the tubes were replaced with another Type the problem stopped. Similar problems appeared in cardiac bypass surgery when silicone was used As an anti foam agent in the device that oxygenates patients blood it was found that tiny particles of silicone had entered the body and blocked capillaries causing tissue damage where to Call also significant from the perspective of the current juror is the incidence of scleroderma an Auto immune disease critics of implants say is linked to the devices scleroderma in which the growth of fibrous tissues leads to thickening of the skin has historically been associated with Silica or Silicon the natural element irom which silicone is derived. Of 120 men with scleroderma studied in Germany Between 1981 and 1988, 93 of them had direct exposure to Silica either As miners sandblasters or similar occupations. In animal studies it is Clear that tissues around implants or injections become permanently inflamed with the occasional development of benign tutors and other tissue reaction. These reactions were recorded by Dow Corning scientists studying dogs but the information was never accurately presented to the food and drug administration a top Agency official said people seeking information about silicone implants May write or Call these organizations a breast implants. The food and drug Annm stantion. Hfe88, 5600 Fisher s Lane Rockville my 20857 a the american society of plastic and reconstructive surgeons 800 635-0635, 444 East Algonquin Avo Arlington Heights Iii 60005 a command Trust network breast implant it Ormarion service 213 556-1738, 256 South Linden or Beverly Hills Calif 90212. A National women s health network National office 202 347-1140, 1325 g Street Northwest lower i Evel Washington d c 20005 questions and answers by Richard l. Vernaci the associated press the food and drug administration is gathering More information on the safety of silicone gel breast implants. In the meantime it has asked doctors to Stop using the devices. Here Are some questions and answers about the breast implants and the Fra action q. Are silicone gel breast implants sate a. That depends on who you ask the american medical association says that after 30 years of experience with these devices there has been no scientific evidence connecting breast implants to cancer. But Ralph Nader s group Public citizen health research says the Fra did not go far enough in requesting a moratorium and should have recalled he implants. The american society of plastic an silicone implants up to 2 million american women have had silicone gel breast implants for cosmetic or reconstructive reasons. The implants Are now being studied to determine their safety reconstructive surgeons said ils members would go along with the Fra request. The manufacturers say the devices Are Safe. Q. What can go wrong with breast implants ? a. Among the known risks of silicone breast implants Are hardening of the breast pain numbness loss of nipple sensation gel migration and delayed cancer detection. It has been suggested that silicone leaking through the implant Shell or released through rupture can cause Auto immune or connective tissue diseases such As Lupus scleroderma or rheumatoid arthritis questions also have been raised about whether silicone increases cancer risks or poses a threat to the fetus the Fra has received 3,400 complaints about silicone gel implants. O. Does the Fra s action moan the Agency thinks the implants Are dangerous a. The Agency in t saying one Way or the other. Quot we do not have the data to prove that they Are not Safe or that they Are Safe Quot said Betsy Adams an Fra spokeswoman. Q. How Many women in the United Stales have had the implants ? a a. The Fra says about 1 million although estimates Range up to 2 million q. Why do women have this operation ? a. Eighty percent of them Are for cosmetic reasons the rest Are to replace diseased or damaged breasts an average of 10,000 women a month have this operation q. Why is the Fra doing this now a. The Agency says it is acting on the basis of new information received since an advisory panel recommended in november that the implants stay on the Market while additional information is gathered by the manufacturers Fra commissioner David Kessler says the new Linlor Malioris is anecdotal but that it contains reports from medical specialists that they Are seeing an increasing number of Auto immune disorders among breast implant patients q. Whal happens now a. The matter was referred on Jan. 6 to the Fra s advisory panel which has 45 Days to consider the evidence. The panel s decision is not binding on the Agency but it is taken seriously q. Does this Al feel All implants ? a. No the Fra decision does not affect the use of breast implants filled with a Saline solution Page 14 the stars and stripes tuesday february 4, 1992 the stars and stripes Page 15