Date: Fri, 25 Feb 2000 09:14:01 -0600

I Some have questioned whether implants cause disease. Well defined epidemiology studies have examined potential associations between breast implants and a variety of diseases including neurologic conditions, autoimmune disease and cancer.

FDA continues to be interested in the scientific questions regarding breast implants. They have published three reviews of the literature: the first on potential complications associated with breast implants,85 the second on breast implants and breast cancer86 and the third on breast implants and autoimmune disease.87

Germany’s Federal Institute for Medicine and Medical Products concluded in April, 1998 that there is no need for the prohibition of breast implants according to the available scientific knowledge. Further, they state that a prohibition would not be useful given the lack of alternative materials.88

In their consensus declaration, the German Society for Senology states that the "...analysis of research show that silicone breast implants neither cause breast cancer nor other cancerous diseases...silicone breast implants neither cause auto-immune diseases nor rheumatic diseases and have no disadvantageous effects on pregnancy, breast feeding capability or the health of children who are breast fed. There is no scientific evidence for the existence of silicone allergy, silicone poisoning, atypical silicone diseases or a new silicone disease."89

Health Canada offers the following information regarding breast implants, "over twenty studies have been carried out at prominent medical research institutions...All of these studies have concluded that implant patients are not at an increased risk for these [autoimmune] diseases...There is no scientific evidence that women with saline-filled, silicone gel-filled or polyurethane foam covered silicone gel breast implants are more susceptible to cancer than other women...there is no evidence that cancer, if it develops, is detected later in patients with implants...There is no approved, standardized test to detect silicone in the body...even if...antibodies are detected, the significance is unclear."90

The Therapeutic Goods Administration of Australia states, "Several large studies have failed to establish a link between silicone breast implants and well-defined connective tissue diseases including scleroderma. ...current high quality literature suggest that there is no association between breast implants and connective tissue disease-like syndromes (atypical connective tissue diseases)." Further, they state, "There is no medical evidence to date to show that women with breast implants have a higher chance of getting cancer, including breast cancer. …There is no medical evidence to show that breast implants interfere with breast feeding. …There is no evidence that silicone gel-filled breast implants cause birth defects."91

In their consensus declaration, the European Committee on Quality Assurance and Medical Devices in Plastic Surgery stated, "…studies continue to show that silicone gel-filled breast implants do not cause cancer... There are conclusive scientific - clinical, immunological, epidemiological - data, that silicone gel-filled breast implants do not cause any auto-immune nor connective tissue diseases. There is no scientific evidence that such things as silicone-allergy, silicone intoxication, atypical disease, or a 'new silicone disease' exist...Silicone implants do not adversely affect pregnancy nor breast-feeding nor the health of breast-fed children."92

A variety of reports have alleged an association between gel-filled breast implants and neurologic problems.93 94 95 96 Methods of diagnosing such conditions have not generally followed standards that are accepted by the community of physicians who specialize in neurology.97 In a review of available published literature, the American Academy of Neurology found that the literature linking breast implants with neurologic disease was generated from one group of authors who generally studied only a select group of patients. Further, they concluded that such studies do not support any association or causal relation between gel-filled breast implants and neurologic disorders.98 A review of 55 nerve and muscle biopsy slides allegedly showing abnormal results among women with breast implants concluded there was no specific association between breast implants and a condition known as demyelating peripheral neuropathy.99 The two population-based epidemiology studies to examine the possible association between breast implants and neurologic conditions found no difference in the occurrence of neurologic conditions among women with breast implants compared to women who had breast reduction surgery.100 101 102

The body’s natural defense, the immune system, recognizes and attacks foreign materials in the body. However, if the immune system goes awry, it can attack the body’s own cells, such as those in connective tissue (which binds together and supports the various organs and structures of the body), possibly producing various ailments known as autoimmune diseases.

Based on a limited number of cases, some physicians have suggested that women with gel-filled breast implants may be at increased risk for a group of disorders called autoimmune connective tissue diseases.103 Some of the women with connective tissue disease (CTD) or CTD-like syndromes are reported to have recovered or improved after their breast implants were removed.104 105 The condition of other patients, however, did not change after removal of the implant and surrounding tissue.106 107 In contrast, the preponderance of the evidence from epidemiologic studies* does not support the premise that breast implants cause a large increase in the risk of disease. Rather, these studies demonstrate that women with breast implants are not at substantially greater risk of these diseases than non-implanted women.

Based on published epidemiology studies, on August 1, 1995, Dr. Kessler, the Commissioner of the US Food and Drug Administration, told a congressional committee: "We now have, for the first time, a reasonable assurance that silicone gel implants do not cause a large increase in traditional connective tissue disease."108

Based on their comprehensive review, and consistent with the previous British Medical Devices Agency (MDA) reviews,109 110 the Independent Review Group stated in July, 1998, that, "There is no epidemiological evidence for any link between silicone gel breast implants and any established connective tissue disease." Further, they state there is no good evidence for the existence of atypical connective tissue disease, undefined conditions such as silicone poisoning or increased risk of connective tissue disease among children of women with breast implants. In addition, they conclude, "The overall biological response to silicone is consistent with conventional forms of response to foreign materials, rather than an unusual toxic reaction." It is possible, however, that other conditions such as low grade chronic infection may account for some of the non-specific symptoms reported by some women with gel-filled breast implants.111

* Epidemiologic studies examine factors determining and influencing the frequency and distribution of disease and their causes in defined human populations.

Rheumatoid arthritis is a systemic disease which includes swelling and inflammation of the tissue around the joints.

Lupus, short for systemic lupus erythematosus (SLE), is a rare disease associated with inflammation and damage of a variety of organs and tissues. It is classically associated with an unusual butterfly-shaped rash across the face and a positive laboratory test for autoantibodies (antibodies against self).

Scleroderma is a rare disease, sometimes called systemic sclerosis (SSc), and is associated with a hardening and thickening of the skin often on the legs and arms. There can also be changes in internal organs.

Although the cause(s) of these connective tissue diseases is not definitively established, medical doctors have postulated autoimmune mechanisms and called them autoimmune diseases.112 113

All of these diseases occur more frequently in women than men. About 1 in 10 women will develop an autoimmune disease in her lifetime, and this incidence appears to be on the rise.114

Millions of women, both those with and without implants, suffer from connective tissue diseases. Of those diseases listed, rheumatoid arthritis is the most common. It affects about two million Americans115 and strikes women three times more frequently than men. Scleroderma, which attacks women three times more frequently than men and lupus, which attacks women ten times more frequently than men, are less common than rheumatoid arthritis.114 FDA estimates that scleroderma affects about 300000 and lupus (SLE or another variant of lupus) about 500000 Americans.115 Connective tissue disease statistics vary.116

The following is a summary of the epidemiology studies of connective tissue disease (CTD) and breast implants conducted by prominent researchers at prestigious institutions. Unlike the reports of individual women (often called case reports or case series), the following studies were designed to make comparisons between groups of women with and without implants. In contrast to case reports, these more rigorous epidemiology studies provide the opportunity to determine whether CTD among women with implants is occurring more frequently than might be expected.

These studies provide reassurance to women with implants, consistently showing that implants pose very little, if any, increase in risk of connective tissue disease.

University of Michigan, School of Public Health, Lacey, MPH; Laing, MD; Gillespie, PhD; et al.; Ann Arbor, MI - 1997117

This large-scale population based study looked at all women in the state of Ohio diagnosed with scleroderma (SSc) between 1985 and 1992.

The analyses compared the 189 women diagnosed with scleroderma to the 1043 women in a control group who did not have scleroderma. The authors stated, "There was no association between SSc and silicone gel breast implants [adjusted odds ratio (aOR) 1.01, 95% confidence interval (CI) 0.13 to 8.15], any breast implants (aOR 1.48, 95% CI 0.34 to 6.39), or all silicone breast and facial implants (aOR 1.44, 95% CI 0.33 to 6.22)." These investigators conducted a comparable study in Michigan and found similar results.118

University of Maryland, School of Medicine; University of Pittsburgh, School of Medicine; and University of California San Diego, School of Medicine; Hochberg, MD; Perlmutter, MSc; Medsger, MD; et al.; Baltimore, MD - 1996119

This multi-center study compared the frequency of augmentation mammaplasty among 837 women with scleroderma to 2507 women without scleroderma (SSc). The authors concluded, "These results fail to demonstrate a significant association between augmentation mammoplasty and SSc, and are consistent with those reported from other epidemiologic studies."

Funded in part by the Plastic Surgery Educational Foundation. Dow Corning has contributed to this Foundation but has no control over what research the Foundation chooses to fund.

Brigham and Women’s Hospital and Harvard Medical School, Hennekens, MD, DrPH; Lee, MBBS, ScD; Cook, ScD; et al.; Boston, MA - 1996120

This study of female health professionals assessed self-reported data on six connective tissue diseases and breast implants. It included 10830 women with breast implants and 384713 women without breast implants. The authors concluded that based on the self-reported data, the study’s major contribution was to exclude large risks of connective tissue disease following breast implant surgery. Although the research raised the possibility of a small increased risk for women with implants, the investigators said the study could not reliably distinguish between this possibility and no risk. The study also found no difference in risk according to how long an implant was in place. According to Dr. Charles Hennekens, the lead investigator, "Considering all available evidence, women with breast implants should be reassured that there is no large risk of connective tissue disease."121 The authors stated that the next phase of this study will attempt to validate the self-reported diagnoses of connective tissue diseases by independent medical record review.

University of Michigan, School of Public Health, Laing, MD; Gillespie, PhD; Lacey, et al.; Ann Arbor, MI - 1996122

This study identified 206 women in Michigan and Ohio with undifferentiated connective tissue disease (UCTD) and compared them with 2239 women without the condition. No association was found with breast implants. When considering medical devices in general, however, (both those containing silicon-based materials as well as other materials), the authors found a statistically significant association with this condition. UCTD is a condition with signs and symptoms that may evolve over time to a recognizable connective tissue disease, may never progress or may disappear.

Brigham and Women’s Hospital and Harvard Medical School, Sánchez- Guerrero, MD; Colditz, DrPH; Karlson, MD; et al.; Boston, MA - 1995123

This study examined the incidence of connective tissue disease and 41 signs, symptoms or laboratory findings of connective tissue disease among registered nurses followed from 1976 to 1990. The study compared the findings in 1183 women with implants to the findings in 86318 women without implants. The authors concluded, "In a large cohort study, we did not find an association between silicone breast implants and connective-tissue diseases, defined according to a variety of standardized criteria, or signs and symptoms of these diseases."

Emory University, Goldman, MD; Greenblatt, MD; Joines, MD; et al.; Atlanta, GA - 1995124

A study of 4229 women with and without breast implants from a rheumatology clinic found "no evidence that women with breast implants are at an increased risk for having rheumatoid arthritis or other diffuse connective tissue disease."

University of Kansas, Arthritis Center, Wolfe, MD; Wichita, KS - 1995125

This study compared 637 women with rheumatoid arthritis to 1134 controls (479 women with osteoarthritis and 655 women selected at random from the general population). The author stated, "No associations between SBI [silicone breast implants] and RA [rheumatoid arthritis] were identified."

Mayo Clinic, Gabriel, MD; O’Fallon, PhD; Kurland, MD; et al.; Rochester, MN - 1994126

This study looked at medical records for all women in Olmsted County, Minnesota who received breast implants between l964 and 1991, identified 749 women who had received breast implants and compared them with 1498 women who had not received implants. The investigators stated, "We found no association between breast implants and the connective-tissue diseases and other disorders that were studied."

Funded in part by the Plastic Surgery Educational Foundation. Dow Corning has contributed to this Foundation but has no control over what research the Foundation chooses to fund.

Mayo Clinic, Duffy, MD; Woods, MD; Rochester, MN - 1994127

This study looked at the medical records for 200 women who had 681 implants replaced or removed between 1970 and 1992. Eighty-five percent of the implants were intact. The investigators stated, "In our 30-year experience with silicone gel breast implants for augmentation mammaplasty or breast reconstruction, the data from this study suggest that no clinically evident adverse health problems were incurred by those women who subsequently experienced a silicone gel implant failure."

These women may be included in the Gabriel Mayo Clinic study noted previously.

University of Michigan, School of Public Health, Burns, PhD;

Schottenfeld, MD; et al.; Ann Arbor, MI - 1994128

This large-scale population based study looked at all women in the state of Michigan diagnosed with scleroderma between 1980 and 1991. Most of the analyses compared the 274 women diagnosed with scleroderma between 1985 and 1991 with the 1184 women in a control group who did not have scleroderma. The 1994 dissertation by Burns stated, "There was no association between any contact with silicone and scleroderma." Their subsequent 1996 publication of this work concluded, "Consistent with other studies, we found no increased risk of SSc [scleroderma] among women with silicone breast implants…"118

University of South Florida, College of Medicine and College of Public Health, Wells, MD; Cruse, MD; Baker, MD; et al.; Tampa, FL - 1994129

The authors examined the incidence of 23 symptoms and four connective tissue diseases among 222 women who had breast implant surgery compared to 80 women who had other cosmetic surgery procedures. While the symptoms of tender and swollen glands under the arms were more frequent among the women with breast implants, the symptom of change in skin color was more frequent among those with non-breast implant cosmetic surgery. The study reported, "No cases of scleroderma or lupus were found, and the incidence of arthritis was not significantly different between the implant and control groups."

University of Pennsylvania, School of Medicine, Strom, MD; Reidenberg, MD; Freundlich, MD; et al.; Philadelphia, PA - 1994130

The researchers interviewed 133 women with systemic lupus erythematosus (SLE) and 100 age-matched friend controls who did not have SLE. From this study, the authors concluded, "...no association was seen between silicone breast implants and the subsequent development of SLE."

University of Texas M. D. Anderson Cancer Center, Schusterman, MD; Kroll, MD; Reece, MD; et al.; Houston, TX - 1993131

Results from this study of 603 patients (250 with breast implants and 353 with reconstruction from their own tissue) showed, "The incidence of autoimmune disease in mastectomy patients receiving silicone gel implants is not different than in patients who had reconstruction with autogenous tissue."

The Johns Hopkins Medical Institutions, Wigley, MD; Miller; Hochberg, MD; et al.; Baltimore, MD - 1992132

Among 210 Baltimore respondents and 531 from Pittsburgh with scleroderma (SSc), the frequency of breast implants was about the same as that estimated for the US adult female population. The investigators concluded, "These data fail to support the hypothesis that augmentation mammoplasty with silicone gel-filled prostheses is a risk factor for the development of SSc."

This is part of the Hochberg study conducted at the University of Maryland School of Medicine noted previously.

University of Washington, Fred Hutchinson Cancer Research Center, Dugowson, MD; Daling, PhD; Koepsell, MD; et al.; Seattle, WA - 1992133

A population based study of 300 women with rheumatoid arthritis and 1456 similarly aged control women showed, "These data do not support an increased risk for rheumatoid arthritis among women with silicone breast implants."

University of California, Weisman, MD; Vecchione, MD; Albert, MD; et al.; San Diego, CA - 1988134

The authors followed a group of 125 women from a plastic and cosmetic surgical practice in San Diego and stated, "Our survey did not reveal a single subject with an inflammatory rheumatic disease or condition following breast augmentation." They added, "...it does not appear likely that augmentation mammaplasty is a significant or major inducer of inflammatory connective-tissue diseases in general."

Karolinska Institute and International Epidemiology Institute, Nyrén, MD, PhD; Yin, PhD; Josefsson, BS; et al.; Stockholm, Sweden and Rockville, MD - 1998135

This study, conducted in Sweden, included 7442 women who received breast implants for either augmentation or reconstruction between 1964 and 1993 and 3353 women who had breast reduction surgery. Hospitalization rates for definite CTD and related conditions were compared between these groups of women and to the general population. The authors concluded, "This large nationwide cohort study shows no evidence of association between breast implants and connective tissue disease."

St. John's Hospital, National Health Service and Western General Hospital, Park, MD; Black, MA; Sarhadi, MD; et al.; Livingston and Edinburgh, Scotland - 1998136

This study, conducted in Scotland, compared 317 women who had gel- filled breast implants for either augmentation or reconstruction between 1982 and 1991 to 216 women without implants. All women were given a medical exam for evidence of specific CTD or relevant signs and symptoms. The authors concluded, "No differences were found in symptoms or physical signs of connective tissue diseases between the study patients and their controls. This study has failed to find any case for a link between silicone gel-filled breast implants and connective tissues diseases."

University of Calgary, McCraig Centre for Joint Injury and Arthritis Research, Edworthy, MD; Martin, MD; Barr, MD; et al.; Calgary, Alberta, Canada - 1998137

This Canadian study included 1576 women who received breast implants for augmentation between 1978 and 1986 and 726 women who had non-implant related cosmetic surgery. Women who self-reported any signs or symptoms of CTD were given a complete medical exam. Although implant recipients self-reported significantly greater rates of signs and symptoms than the control group, results of the medical exams did not indicate an increased frequency of specific CTDs or atypical CTD. The researchers reported, "The concern that an atypical autoimmune disease may be occurring is not supported by our results." They concluded, "The results of the study do not support the hypothesis that silicone gel-filled implants induce or promote CTD."

Danish Cancer Society, International Epidemiology Institute and Holte Clinic of Plastic Surgery, Friis, MD; Mellemkjær, MSc; McLaughlin, PhD; et al.; Copenhagen, Denmark, Rockville, MD and Holte, Denmark - 1997138

This study included more than 14000 Danish women who had breast implants, breast reduction surgery or breast cancer without implants. Among these women, 2570 received breast implants for either augmentation or reconstruction between 1977 and 1992. The researchers found no association between breast implants and CTDs. However, the investigators did report an excess of muscular rheumatism among these 14000 women regardless of whether or not they had breast implants. The authors concluded, "All cohorts in our study had an excess of the nonspecific diagnostic code of muscular rheumatism, which includes fibrositis and myalgia. A likely explanation of this finding would be that the excess of muscular symptoms is related to breast surgery per se, rather to any systemic effect of silicone breast implants."

With respect to their two previous reports,139 140 the researchers stated, "We found no significant excess of definite CTDs among women with breast implants. This is in accordance with the results from our earlier reports based on a smaller group of 824 women with cosmetic implants identified from the HDR [Hospital Discharge Registry] and followed through 1989."

The 1997 and 1995 work were funded in part by Dow Corning Corporation.

Royal North Shore Hospital, Rheumatology Unit and St. Vincent's Hospital, Department of Medicine, Englert, MD; Brooks, MD; Sydney, Australia - 1994141

This was a study of 251 women with scleroderma and 289 women without scleroderma in the Sydney, Australia area. A subsequent validation study142* confirmed the dates for the onset of disease and augmentation mammaplasty and reconfirmed the original study’s conclusion, "This study failed to demonstrate an association between silicone breast implantation and the subsequent development of scleroderma..."

* The validation study was directly funded by Dow Corning Corporation. Free University Hospital, Departments of Internal Medicine and Plastic Surgery, Giltay; Moens, MD; Riley; et al.; Amsterdam, The Netherlands - 1994143

This study included 235 women with breast implants and 210 women without breast implants. The authors concluded, "Women with silicone breast prostheses report more rheumatic complaints after silicone implantation than controls, but there is no evidence of increased prevalence of common rheumatic diseases."

Some reports have suggested an immune system response to breast implants and other materials called human adjuvant disease (HAD).144 145 The symptoms for HAD reportedly include inflammation and irritation at the implant site, fluid accumulation, rash, swelling of the joints, weight loss, fever, skin sores, and/or non-specific complaints of memory loss, muscle pain, joint pain, hair loss or general tiredness. The first case of adjuvant-like disease in humans was published by a Japanese research worker in 1964.146

A task force comprised of representatives of the American Medical Association (AMA) and the plastic surgery, epidemiology and rheumatology communities have concluded and reported that there is no definite diagnosis for Human Adjuvant Disease, that the term is non-descriptive and that its use should be avoided. 147 148 149

An antibody is a special kind of molecule known as an immunoglobulin.

Antibodies are made in the body and are part of the immune system. The immune system has the primary function of differentiating self from non-self, helping the body recognize and fight infection and foreign material. When an antibody is made, it is in response to, and helps the immune system deal with, the presence of a material known as an antigen. Common examples of antigens are bacteria, foreign proteins (such as from parasites) or viruses.

Once produced, the antibody typically reacts with the same type of antigen which caused its generation. Like most things in nature, the differentiation of self from non-self is not absolute. The immune system can recognize many of the body’s own tissues and produce antibodies against them. When this happens, the antibody is called an autoantibody (antibody against self). Dependent on a number of variables, including the type of autoantibody and its concentration, autoimmune disease may or may not occur.

Testing has shown autoantibodies are often present in high levels in the blood of people with connective tissue diseases. Typically, this testing involves a type of antibody called antinuclear antibodies (ANA). Antinuclear antibodies react with antigens in the nucleus (center) of cells. Antinuclear autoantibodies are almost invariably found in cases of systemic lupus erythematosus and are frequently found in cases of rheumatoid arthritis, scleroderma and other connective tissue diseases.150

High levels of autoantibodies such as ANAs do not necessarily mean that these individuals have a high risk of developing an autoimmune disease.151 Researchers performing autoantibody screening often find ANAs at significant levels among healthy patients.152 153 154 155 156 157 A number of elements including diet, genetic traits, infection and hormonal balance may influence the likelihood that disease will develop.158

Some researchers have observed autoantibodies in women with breast implants,159 160 161 162 and the children of women with breast implants.163 These reports largely did not include women without implants as comparative controls.

A study was conducted at the University of Toronto to answer the important question: "Is there a relationship between autoantibodies and silicone-gel implants?"164 The researchers studied 200 women with gel-filled breast implants and 100 age-matched similar women without implants. Twenty-nine of the 200 implant patients were believed to have ruptured implants. When comparing the autoantibody levels, the researchers found no significant difference among the three groups of women (those with intact, ruptured, and no implants).

In another Canadian study, researchers at the University of Calgary investigated the prevalence of autoantibodies in 1576 patients who had breast implants in the province of Alberta between 1978 and 1986 compared to a control group of 726 patients who had cosmetic surgery without breast implantation during the same time frame. The results did not show "any significant differences between the implant group and the controls." Further, the authors stated, "The concern that an atypical autoimmune disease may be occurring is not supported by our results."137

In the Harvard Nurses’ Health study, researchers looked for a variety of immune abnormalities in 200 women with silicone breast implants (SBI) and 500 women without implants. They concluded, "We find no increased frequency of any immunologic abnormalities in women exposed to SBI, except for anti-ss-DNA which has unknown clinical relevance."165

One researcher, Dr. Kossovsky, has developed tests that he claims can detect "autoreactive antibodies," which he says result from the spontaneous "combination of silicone and native proteins."166 However, FDA issued a warning letter to the laboratory performing that testing, citing improper promotion of the test,167 and as of July 6, 1995, the laboratory stopped such testing of blood samples pending FDA review.168 In a report on Dr. Kossovsky and his blood test, the publication Discover–The World of Science revealed that, "Kossovsky couldn’t say what disease his high scoring women had. Their symptoms were little different from those of low-scoring women. …But whether Kossovsky’s test really tests anything is open to question."169

Another hypothesis that has been put forth by several investigators is that gel-filled implants can cause an immune reaction to silicone itself (i.e. an anti-silicone immune response) or an antipolymer immune response rather than an autoreactive immune response to proteins in the body.170 171 172 In large part, these theories have been subsequently withdrawn by the principal scientist in charge of the research,173 directly repudiated,174 and/or disallowed in testimony by Federal and State judges because the studies which form the basis of these hypotheses were judged to be poorly performed and not reliable.175 176

Researchers at Tulane University published a study that was designed to assess the efficacy of a blood test to check for antibodies to a synthetic polymer (antipolymer antibody test or APA).177 This test is based on partially polymerized polyacrylamide, a chemical unrelated to silicones. They hoped to differentiate several groups: women with breast implants and mild symptoms, women with breast implants and severe symptoms and women without breast implants who had autoimmune diseases. Several letters to the editor have been critical of the Tulane work.178 179 180 181 182 A common criticism is that a positive response to this blood test is not unique to women with breast implants; women who were healthy and without implants were also positive for this test and women without implants who had fibromyalgia also had positive test results.183

A 1996 review of silicone immunology by Dr. Marcus of Baylor University concluded, "The papers that claim to demonstrate specific immune responses to silicone exhibit obvious, fundamental defects in methodology and interpretation. ...I do not believe there is any valid experimental evidence that silicone elicits specific immunity in humans or in experimental animals."184

In addition, the British Medical Devices Agency says, "The fact that anti-silicone antibodies have been detected both in silicone implant recipients and…in people who had not received medical silicones, raises doubts about their significance."109

Others have conducted tests which are purported to measure silicon or organosilicon content of blood and other body fluids and tissues.185 186 187 The usefulness of such tests in the diagnosis or management of illnesses is questionable as indicated by the College of American Pathologists which states, "…laboratory tests measuring blood, urine, or tissue silicon, silicone, toluenediamines, or related substances are not currently indicated or useful for purposes of medical management of individual breast implant recipients. …such tests provide no findings uniquely indicative or supportive of purported silicone induced autoimmune disease in implant recipients. Interpretation of such panels as ‘consistent with silicone reaction’ for example, is not supported by the current medical literature."188

FDA states, "There is no widely available, standardized test to detect silicone in the body. Some large, sophisticated research laboratories are able to detect the presence of silicone or silicon (an indirect measure of silicone) in the blood, tissue and urine, but the meaning of these test results is unknown. …Further, since silicone is found in food and many other products, including commonly used medicines and cosmetics, it would be hard to determine whether the silicone came from the implant or another source."189

As mentioned by FDA, many of these tests purporting to measure organosilicon do so by measuring silicon and inferring that the silicon in the body fluid or tissue came from the breast implant. Besides being present in foods,190 medicines and cosmetics, silicon is native to many body fluids and tissues. It has been measured in body fluids and tissues for more than one hundred years.191

The body’s natural reaction to any foreign matter, be it a pacemaker or a splinter, is to surround the material with white blood cells which in turn form a scar-like tissue capsule at the site. Although one could expect that a granuloma may form around a breast implant, some researchers believe that the presence of a granuloma indicates an immune reaction. (For more information, see Granulomas.) However, a number of noted immunologists (doctors who specialize in the body’s immune system) disagree. These experts conclude that the local tissue reaction is just inflammation followed by the formation of the granulomatous scar tissue.192 Although the presence of a granuloma may cause uncertainty in breast self-examination, it is important to note that the formation of a granuloma is a normal response to some types of tissue stimulation.193

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