ABSTRACT: To study the possible association of silicone-breast-implant exposure and immunologic abnormalities within the Nurses' Health Study, an ongoing prospective cohort study of women. From this cohort, we randomly selected 200 women who had been exposed to silicone breast implants and who had never reported connective tissue diseases during 14 years of follow-up, and 500 age-matched, nonexposed women, including 100 with definite connective tissue diseases validated by medical record review, 100 with at least one symptom of a connective tissue disease, 100 with diabetes, and 200 healthy controls. Assays for antinuclear antibodies (ANA), including anti-dsDNA, anti-ssDNA, anti-Sm/RNP/Ro/La, and anti-Scl-70, rheumatoid factor, immunoglobulins, serum complement, and C-reactive protein level, and anticardiolipin, antithyroglobulin, antithyroid microsomal, and antisilicone antibodies were performed by standard techniques in blood samples collected in 1989 or 1990 before collection of silicone-breast-implant exposure data in 1992. ANA was positive (> or = 1:40) in 14% of women with silicone breast implants compared with 20% of healthy women (P = 0.11). Rheumatoid factor was positive (> or = 1:40) in 5% of women with silicone breast implants and 2% of healthy women (P = 0.16). Women with silicone breast implants had a significantly higher frequency of anti-ssDNA antibodies than healthy women (41% and 29%, P = 0.012). Duration of implant was associated with a higher frequency of anti-ssDNA antibodies (P = 0.03) but not with ANA or rheumatoid factor. No other significant differences in the frequencies of autoantibodies were observed in silicone breast implant-exposed women. Antisilicone antibodies were not found in any sample. We found no increased frequency of any immunologic abnormalities in women exposed to silicone breast implants, except for anti-ssDNA, which has unknown clinical relevance.
The American Journal of Medicine 01/1999; 106(1):11-9. · 5.43 Impact Factor
ABSTRACT: OBJECTIVE: The evaluation of breast implants for rupture is currently the domain of ultrasound and MRI, while mammography is of very limited diagnostic value. Recently, specific visualisation of silicone has become feasible using dual-energy CT. Our objective was to evaluate whether it is feasible to identify silicone in breast implants by dual-energy CT and to reliably diagnose or rule out ruptures. METHODS: Seven silicone breast implant specimens were examined on dual-source CT at 100- and 140-kV tube potential with a 0.8-mm tin filter (collimation 128 × 0.6 mm, current-time products 165 and 140 mAsref with modulation, rotation time 0.28 s, pitch 0.55). Two patients scheduled for implant removal or replacement were examined with identical parameters. RESULTS: The silicone of the implant specimens showed a strong dual-energy signal. In one patient, both implants were intact, while a rupture was identified in the other patient. Ultrasound, MRI, surgical findings and histology confirmed the dual-energy CT diagnosis. CONCLUSION: Dual-energy CT may serve as an alternative technique for speedy evaluation of silicone breast implants. Specific clinical studies are required to determine the diagnostic accuracy and define indications for this technique. KEY POINTS: • Dual-energy CT makes it possible to visualise silicone in breast implants. • Silicone provides a strong photoelectric effect that can be detected. • Initial experience suggests that implant ruptures can be identified or ruled out.
European Radiology 10/2012; · 3.22 Impact Factor
ABSTRACT: Calcification of the fibrous capsule surrounding silicone breast implants is a well-recognized occurrence that increases with time following implantation. These mineralized deposits potentially confound mammographic breast cancer surveillance already made difficult by the obscuring effects of silicone breast implants. The authors performed elemental analysis of silicone breast implant-associated calcifications to define better their chemical composition as related to mammographic and clinical significance. Electron probe microanalysis and infrared spectroscopy revealed all of the calcification deposits to be calcium complexed with tribasic phosphate. No evidence of calcium oxalate, calcium carbonate, silicone, or talc was observed. Caution must be employed in interpreting mammograms in women with silicone breast implants as well as those who have had their silicone breast implants removed. High-density mammographic calcifications indicative of calcium phosphate associated with a silicone breast implant may represent an accepted consequence of implantation or nearby carcinoma. We recommend baseline mammography on women who have had their silicone breast implants removed to prevent unnecessary fine-needle aspiration or tissue biopsy of retained breast capsule calcifications during subsequent routine surveillance for carcinoma.
Annals of Plastic Surgery 03/1999; 42(2):117-23. · 1.32 Impact Factor
ABSTRACT: Silicon, in the form of sodium silicate (Na2SiO3), adsorbed onto bovine serum albumin (BSA)-precoated plates served as the solid-phase antigen in an enzyme immunoassay to detect silicate-reactive antibodies in the plasma of 40 symptomatic women with silicone breast implants, 91 asymptomatic women with silicone breast implants, 50 healthy control women, and 52 women with rheumatic diseases and without silicone breast implants, Silicate-reactive antibodies of immunoglobulin G (IgG) or IgM isotypes were detected in the plasma of 30% (12 of 40) of the symptomatic women with silicone breast implants; 9% (8 of 91) of the asymptomatic women with silicone breast implants; 5% (1 of 20) of the women without implants who had systemic lupus erythematosus; and 0% (0 of 32) of the women without implants who had either Sjögren syndrome, scleroderma, or rheumatoid arthritis. Only 2% (1 of 50) of the sera from the healthy control women contained silicate-reactive antibodies. Preincubation of sera with silicate and eight other metal compounds (including SiO2) demonstrated that the IgG and IgM antibodies bound specifically to silicate, because preincubation with Na2SiO3 inhibited more than 90% of the activity, whereas CrO3, Li2SO4, MgSO4, NiSO4, HgCl2, ZrOCl2, BeSO4, and SiO2 failed to inhibit the IgG or IgM antibody binding to the silicate-BSA plates. Furthermore, the F(ab')2 portion and not the Fc portion of the silicate-reactive IgG was reactive with BSA-bound silicate in the enzyme immunoassay. The assay for silicate-reactive antibodies was quantified by assigning arbitrary units to a standard curve composed of serial twofold dilutions of high-positive (ten times higher than the cutoff) silicate antibody sera. This novel assay is a useful method for detecting and quantifying humoral immune response to silicate.
Clinical and Diagnostic Laboratory Immunology 04/1996; 3(2):162-6. · 2.51 Impact Factor
ABSTRACT: Recent evidence suggests that immunologic abnormalities are not uncommon in individuals with silicone breast implants. The purpose of our study was to evaluate in a consecutive manner, the prevalence of autoimmunity as assessed by the presence of antinuclear antibodies in a larger number of patients with silicone breast implants. Antinuclear antibody (ANA) testing using an indirect immunofluorescence technique was performed on 813 individuals with silicone breast implants. All subjects except for 3 transsexual males, were female. The overwhelming majority, over 99%, were white. The average age of the subjects was 46.2, with a range of 17 to 72 years. ANA positivity was found in 244 of 813 individuals (30%) using a mouse kidney substrate; and in 470 of 813 (57.8%) using a HEp-2 cell line. The most common immunofluorescent pattern found using HEp-2 was speckled, present in 341 (72.5%) individuals, followed by homogeneous pattern in 113 (24%), nucleolar in 63 (13.4%), and 5 (1.06%) were anticentromere. Anti-dsDNA antibodies measured by an ELISA assay were found in 6 of 71 patients (8%). Rheumatoid factor and C-reactive protein were found above healthy controls in less than 10% of cases studied. The high prevalence of ANA found in patients with silicone breast implants agrees with similar observations by others. The finding of anticentromere and nucleolar patterns has great interest and relevance. These fairly distinct ANA patterns are most commonly seen in the idiopathic form of scleroderma and related conditions. These findings suggest that ANA positivity is relatively common in individuals with silicone breast implants, and may support the existence of autoimmune mechanisms in the pathogenesis of the clinical manifestations seen in this population.
The Journal of Rheumatology 03/1995; 22(2):236-40. · 3.69 Impact Factor
ABSTRACT: There have been several anecdotal reports that silicone breast implants are associated with an increased incidence of autoimmune disease. Based upon these data as well as the theoretical potential of silicon and silicone immune interactions, we hypothesized that an immune response to a silicone breast implant would include host reactivity against components of the microenvironment within the implant milieu. To test this hypothesis, we obtained detailed histories and performed examinations of 57 consecutive, self-referred patients concerned about their breast implants. Eleven of these women were excluded for various reasons including previous exposure to bovine collagen. The remaining 46 women, as well as 45 normal women of approximately the same age and living in the same geographic region, were tested using a sensitive ELISA for the presence of autoantibodies to human native type I collagen, denatured type I collagen, native type II collagen and denatured type II collagen. Known positive and negative sera were included in all assays and the ELISA was performed and interpreted blindly. Positive sera were defined as an ELISA value of three standard deviations above the mean of the normal controls. Using these stringent criteria, there was a statistically significant incidence of antibodies to collagen in women with silicone breast implants. In fact, 35% of women with silicone breast implants had such antibodies; this is higher than we have observed in any other autoimmune disease and is similar to that of chronic erosive rheumatoid arthritis. We believe that silicone breast implants, in genetically susceptible hosts, may pose a significant risk for immunopathology.
Journal of Autoimmunity 07/1993; 6(3):367-77. · 7.37 Impact Factor
ABSTRACT: The possible association of silicone breast implants and disease is a subject of continuous debate and concern. Our purpose was to examine microscopically and ultrastructurally the periprosthetic fibrous capsules and reconstruction scars of women with silicone breast implants. Representative samples from the periprosthetic capsules and reconstruction scars from six women with silicone breast implants were examined by a variety of light microscopy techniques, transmission electron microscopy, and electron probe microanalysis. Silicone globules of various sizes were identified in every periprosthetic capsule and reconstruction scar. Extrusion and seeding of the incision tract during surgery most likely accounts for the presence of silicone in the reconstruction scar specimens. This observation suggests that the identification of silicone in the reconstruction scars of women with silicone breast implants does not necessarily implicate rupture of the silicone breast implant with systemic dissemination of silicone gel.
Journal of the American Academy of Dermatology 08/1996; 35(1):32-6. · 3.99 Impact Factor
ABSTRACT: As there is still controversy regarding the effects of silicone breast implants on the immune system, the current study investigated the composition of peripheral blood lymphocytes of patients after augmentation mammaplasty with silicone breast implants. The authors' prospective study included 41 female patients (average age, 40 +/- 12 years) with unilateral/bilateral capsular contracture (Baker types I through IV) after cosmetic breast augmentation. Other fibrosing or autoimmunologic diseases were excluded at the time of implantation. Peripheral blood samples from all patients were examined (n = 41). Cells positive to antigens CD3, CD4, CD8, CD19, and CD16/CD56 were assessed by flow cytometric analysis and compared with a reference range of hematologically normal adults. The vast majority of the peripheral blood lymphocytes were T lymphocytes (CD3+; mean, 74.4 percent; range, 21.1 to 76.6 percent). The mean percentage of B lymphocytes (CD3-/CD19+) was 11.3 percent (range, 9.9 to 12.6 percent). A small percentage (mean, 11 percent; range, 9.1 to 12.9 percent) consisted of natural killer cells (CD3-/CD16+/CD56+). The peripheral blood T-lymphocyte subsets were CD3+/CD4+ with a mean of 45.7 percent (range, 42.9 to 48.5 percent) and CD3+/CD8+ with a mean of 22.1 percent (range, 19.8 to 24.3 percent), similar to those in healthy controls. No statistically significant difference in the distribution of peripheral blood lymphocytes could be detected in patients with silicone breast implants in comparison with other Caucasian adults. As far as lymphocytes are concerned, there was no evidence of systemic proinflammatory effects of silicone breast implants.
Plastic and reconstructive surgery 02/2008; 121(1):25-30. · 2.74 Impact Factor
ABSTRACT: The purpose of this study is to review the background, safety, and potential complications of silicone breast implants. Relevant studies were identified using a MEDLINE search of the English-language literature, followed by a manual search of the references of all identified articles and a review of abstracts from the 1992 American College of Rheumatology meeting. Review of the literature suggests that silicone does not appear to fulfill the characteristics of an ideal synthetic soft-tissue substitute, although it may be the best substitute available. Silicone breast implants are associated with local inflammation and tissue fibrosis with breast fibrous capsule contracture developing in 10% to 40% of the patients. There are no epidemiologic data that establish a direct link between silicone and cancer or rheumatic disease. However, scleroderma appears to be overrepresented among the published articles on patients with silicone breast implants and rheumatic disease. Autoantibodies of unclear significance may be found in 5% to 30% of women with silicone breast implants. Large, longitudinal, population-based studies that include patients who have had implants for 5 to 15 years may be necessary to fully understand the relationship of silicone implants and immune dysfunction.
Archives of Internal Medicine 01/1994; 153(23):2638-44. · 11.46 Impact Factor
ABSTRACT: To clarify the carcinogenic potential of silicone breast implants, 680 implant procedures performed on women in Connecticut with no prior history of cancer were correlated with the subsequent development of primary breast and nonbreast cancers. Neoplastic events after the placement of silicone breast implants during the 13-year interval from October 1, 1980, through September 30, 1993, were quantified using a retrospective, linked-registry method. ICD-9-CM discharge codes contained in the Uni formed Hospital Discharge Data Sets (UHDDS) from 34 hospitals across Connecticut were linked to procedure codes for unilateral and bilateral implants, and to medical histories for new malignancies after the implant procedures. Data were cross-linked to the Connecticut Tumor Registry to confirm the clinical history of each cancer. The rates of breast and nonbreast cancers in patients with silicone breast implants were compared with those of a control population drawn from the UHDDS of 1022 women undergoing sterilization by tubal ligation between 1981 to 1985. Ages (mean +/- SD) were similar in the implant group (34 +/- 10 years) and in the sterilization group (32 +/- 6 years). The mean follow-up in the implant group (4.6 years) was also similar to that of the control group (5.4 years). Compared with the control group, the implant group demonstrated lower rates of breast cancer (0.59 versus 0.88 percent, p = 0.35) and nonbreast cancer (0.59 versus 2.7 percent, p = 0.001). Correspondingly, the implant group had a lower relative risk of breast cancer (relative risk = 0.67, 95 percent, confidence interval = 0.20 to 2.17) and nonbreast cancer (relative risk = 0.21, 95 percent, confidence interval = 0.07 to 0.60). Based on these data, it was concluded that silicone breast implants are not carcinogenic, because they are not associated with increased rates of either breast or nonbreast cancers. The validity and threats to the conclusions are discussed, and the results are placed into context with similar findings from other studies.
ABSTRACT: Silicone breast implants have been used for decades and are arguably the most studied implantable device. However, the vast body of scientific literature has been unable to establish a definitive rupture rate. Various studies have evaluated implant rupture, but the meaningfulness of these data was confounded by the inclusion of different generations of implants and multiple manufacturers' implants and the selection of subjects who were already suspected of having ruptured implants. The authors' study was designed to acquire long-term rupture data specific to Inamed's third-generation silicone breast implants using magnetic resonance imaging technology. A total of 106 women with at least one Inamed silicone breast implant (styles 40, 110, and 120) were enrolled in this multicenter, cross-sectional study. The majority received implants for cosmetic augmentation (n = 77, 72.6 percent), with a smaller number having undergone breast reconstruction (n = 11, 10.4 percent) or revision of previous breast implant operations (n = 18, 17.0 percent). Most subjects were Caucasian (n = 99, 93.4 percent) with a median age at implantation of 34 years (range, 18 to 70 years). Enrolled subjects underwent a physical examination and magnetic resonance imaging screening at one of five sites to determine the prevalence of asymptomatic rupture. A total of 199 implants were evaluated, with a median implantation time of 10.9 years (range, 9.5 to 13.2 years). Overall, 183 implants (92.0 percent) showed no evidence of rupture, 12 (6.0 percent) showed evidence of rupture, and four (2.0 percent) were indeterminate. All indeterminate evaluations were considered ruptures, providing a worst-case rupture prevalence of 8.0 percent. The study results establish a rupture prevalence rate of 8.0 percent at 11 years for Inamed's silicone breast implants.
Plastic and reconstructive surgery 09/2006; 118(2):303-8; discussion 309-12. · 2.74 Impact Factor
ABSTRACT: Silicone elastomers are widely used in implantable devices, including silicone breast implants. These rubbers are generally formed/cured using platinum-catalyzed hydrosilylation. The current scientific literature on the chemistry of platinum is reviewed, as it applies to the use of platinum catalysts for cure of silicone elastomers destined for use in silicone breast implants. These discussions serve as a basis to examine the recent literature describing release of platinum into tissues adjacent to silicone breast implants, the chemical nature of the platinum present in breast implants and the possible association between platinum and clinical outcomes.
Biomaterials 07/2006; 27(17):3274-86. · 7.40 Impact Factor
ABSTRACT: We previously reported an increased preponderance of a broad range of autoantibodies in symptomatic women with silicone breast implants. The objective of this study was to investigate the frequency of autoantibody production in asymptomatic compared to symptomatic women with silicone implants. One hundred twenty-two asymptomatic women were recruited to our center for autoantibody detection through an advocate dealing with breast implant liabilities. Autoantibody detection in 86 asymptomatic women was done blindly on a panel of 15 different antibodies (dsDNA, ssDNA, histones, SSA/Ro, SSB/La, RNP, cardiolipin, phosphatidylserine, pyruvate dehydrogenase, Scl-70, NC-1, silicone, collagen I, II, and IV). Clinical variables, specific questioning about related silicone implant symptoms, and a rheumatological examination were performed blindly by a certified rheumatologist. The findings were recorded and at a later stage compared with positive autoantibody detection. The normal control group consisted of age and sex matched Israeli women without known autoimmune disease. In the positive control group were symptomatic women previously tested for antibody production. The autoantibodies were assessed by ELISA. Values from individual patients were considered positive only when greater than 3 standard deviations above the control mean. The mean ages of 86 asymptomatic and 116 symptomatic women were 46.2+/-11.2 and 45.7+/-8.3 years, respectively. Breast implants were in place for a mean period of 8.2+/-5.0 years in the asymptomatic group and 15.0+/-5.6 years in the symptomatic group. The incidence of increased titers of autoantibodies ranged from 2 to 13% for 13 different autoantibodies among asymptomatic women. Among symptomatic women, 20% harbored 4 autoantibodies and 8% had 6 autoantibodies. The most common antibodies in the asymptomatic group were: dsDNA 8%; ssDNA 9%; SSB/La 13%; silicone 9%; collagen II 9%. No autoantibodies were found for NC-1, Scl-70, or RNP. Among the symptomatic group, the most common autoantibodies were histone ribosomal phosphate, SSA, SSB, Scl-70, cardiolipin, phosphatidylserine, GM2-ganglioside, and NC-1. Comparison of autoantibody incidence in asymptomatic and symptomatic women with silicone breast implants revealed an increased incidence of anti-SSB/La and anticollagen II in both groups. Polyclonality was more prominent in the group of symptomatic women with silicone breast implants, but also evident in 3 asymptomatic women. The mean duration of implant in the asymptomatic group was significantly less compared with the symptomatic group (p<0.01). The development of autoantibodies may be related to implant duration.
The Journal of Rheumatology 02/1999; 26(1):73-7. · 3.69 Impact Facto
ABSTRACT: The purpose of this study was to determine the value of MR imaging with a silicone-selective pulse sequence for detecting leakage from silicone breast implants. Women with silicone breast implants were referred for this study on the basis of clinical or imaging findings suggestive of implant rupture. Twenty-eight patients with 38 implants were examined with silicone-selective MR imaging and also underwent surgical removal of the studied implant. All but four also had mammography before MR imaging. Results of silicone-selective MR imaging for the detection of silicone leakage were compared with mammographic and surgical findings. Surgical proof was considered the gold standard. Silicone-selective MR imaging showed an apparently intact implant in 21 cases; 20 of these were found to be intact at surgery. Silicone-selective MR imaging showed evidence of leakage in 17 implants, all of which showed leakage at surgery. The sensitivity for detection of leakage was 94%; the specificity was 100%. The findings of silicone-selective MR imaging and mammography were in agreement in 30 of 34 cases in which both studies were performed. In the four cases of disagreement, surgical findings agreed with MR findings in three and with mammographic findings in one. When the findings of mammography and silicone-selective MR imaging were combined, the correct status (leakage or no leakage) of all implants examined was determinable. Silicone-selective MR imaging is highly effective for detecting leakage from silicone breast implants. Accuracy is improved when mammographic and MR findings are considered together.
American Journal of Roentgenology 08/1994; 163(1):51-6. · 2.78 Impact Factor
ABSTRACT: In vivo and in vitro studies, case reports and population studies show that: (1) silicone is immunogenic; (2) silicone is biodegradable and transported via the reticuloendothelial system to distant locations; (3) silicone breast implants "leak" and in turn silicone migrates outside the breast tissue; (4) case reports and population studies document an autoimmune reaction and immunological dysfunction in patients with silicone breast implants; (5) these immunological abnormalities and symptoms are reversible upon removal of the breast implants (in 50-70% of cases). The criteria to establish medical causation are defined, and based on those criteria it is concluded that silicone breast implants cause immunological disease.
Journal of Biomaterials Science Polymer Edition 02/1995; 7(2):133-45. · 1.69 Impact Factor
ABSTRACT: Ultrasound is useful in evaluating the integrity of silicone breast implants, but is highly operator dependent. A system for computer assisted image interpretation is being developed to reduce operator dependability. Feasibility was examined by measuring the ultrasonic properties of breast implants in vitro. Silicone gel from 17 explanted devices (11 intact and 6 ruptured) were placed in sealed acoustic test chambers and 60 RF A-lines were acquired from each. The mean speed of sound was 1073 m/s±53.76 m/s in intact implants and 1120 m/s±32.34 m/s in ruptured ones (p<0.05). The difference in attenuation between intact and ruptured devices was not statistically significant. The mean integrated backscatter was -68.7 dB±8.98 dB in intact prostheses and -62.8 dB±7.46 dB in ruptured implants. This result shows statistical significance on a 10% level. Changes in speed of sound and integrated backscatter of silicone breast implants have been demonstrated in vitro. While more implants need to be evaluated, the results do indicate the potential for quantitative assessment of the integrity of silicone breast implants performed in vivo
Ultrasonics Symposium, 1993. Proceedings., IEEE 1993; 12/1993
ABSTRACT: Surgical implantation of silicone breast prostheses has been conducted and considered safe for over 30 years. Some implant recipients, however, complain of a group of symptoms similar to those observed in connective tissue disorders, rheumatoid arthritis, systemic lupus erythematosus, or polymyositis. To date, immunologic sequelae have not been confirmed and remain controversial. To examine an autoimmune-like basis for the "silicone associated disease" reported by some women with silicone breast prostheses. Proliferative responses of peripheral blood mononuclear cells against a panel of control and connective tissue proteins and to compounds common to silicone prostheses were measured in 26 women who received silicone breast implants (with implants in place an average of 166.4 [standard deviation (SD) 58.3] months), and 23 age-matched and sex-matched healthy controls. The frequency and intensity of cellular immune responses against collagen I, collagen III, fibrinogen, and fibronectin were significantly increased in silicone breast implant recipients versus controls. In implant subjects, the highest frequency of immune reactivity was directed against collagen I (11/26, 42%) with collagen III being the most immunostimulatory self-antigen with a mean stimulation index (SI) of 8.2 [95% confidence interval (95% CI) 3.2]. In addition, 10/26 (39%) of the implant recipients responded to more than one of the connective tissue antigens versus 0/23 (0%, P = .0007) healthy controls. Immunologic reactivities to other antigens, including silicone-based compounds, were remarkably similar. The identification of self-reactivity towards these connective tissue antigens may provide important information for attempts at associating silicone breast implants with disease.
Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 09/1997; 79(2):151-4.· 2.83 Impact Factor
ABSTRACT: Platinum is used as a catalyst in the manufacture of silicone breast implants. Because platinum is recognized as a potent sensitizer in certain circumstances, some have expressed concern that women with silicone breast implants are exposed to platinum, which is causing allergic reactions. We searched the literature for information on the level of platinum in breast implants and reports of sensitization that clearly related to platinum in women with breast implants. We found no published report with convincing evidence that platinum causes allergic reactions in women with breast implants or that women with breast implants are any more likely to have allergic reactions than women without breast implants.
Journal of Long-Term Effects of Medical Implants 02/2002; 12(4):299-306.
ABSTRACT: Previous studies on the interaction of textured silicone breast implants has analyzed tissue expanders or used animal models. To date, the data on long-term results of the textured silicone breast implants have not examined permanent implants or in vivo effects in the human. A prospective study was designed to examine the interaction of textured silicone breast implants in a human over several years. A single surgeon, standard surgical technique, and single-type implant design were included. The results revealed 78% had silicone particles in the tissue immediately adjacent to the implant interface. No distant migration, metaplasia, or adverse effects were noted. Our results indicate that silicone fragmentation is common but appears to be confined to the local environment.
Aesthetic Plastic Surgery 02/1997; 21(2):93-6. · 1.41 Impact Factor
Eric Swarts, Alan M Kop, Anastasia Nilasaroya, Catherine V Keogh, Timothy Cooper
ABSTRACT: BACKGROUND:: Poly Implant Prothèse (PIP) implants were recalled in Australia in April 2010 following concerns of higher than expected rupture rates and the use of unauthorised industrial grade silicone as a filler material. Although subsequent investigations found that the gel filler material does not pose a threat to human health, the important question of what caused a relatively modern breast implant to have such a poor outcome compared to contemporary silicone breast implants is yet to be addressed. METHODS:: From a cohort of 27 patients, 19 ruptured PIP breast implants were subjected to a range of mechanical tests and micro/macro-investigations to evaluate possible changes in properties as a result of implantation. New PIP implants were used as controls. RESULTS:: All samples, explanted and controls, complied with the requirements for shell integrity as specified in the International Organisation for Standardization ISO 14607. Compression testing revealed rupture rates similar to that reported in the literature. Shell thickness was highly variable with most shells having regions below the minimum thickness of 0.57mm that was specified by the manufacturer. Potential regions of stress concentration were observed on the smooth inner surfaces and outer textured surfaces. CONCLUSIONS:: The high incidence of PIP shell rupture is most likely a result of inadequate quality control with contributory factors being shell thickness variation and manufacturing defects on both inner and outer surfaces of the shell. No evidence of shell degradation with implantation time was determined.
Plastic and reconstructive surgery 12/2012; · 2.74 Impact Factor
Louise A Brinton
ABSTRACT: Although most attention regarding the effects of silicone breast implants on cancer risk has focused on breast cancer, there have also been concerns regarding effects on other cancers. This includes malignancies that could occur as a result of foreign-body carcinogenesis (sarcomas) or immune alterations (hematopoietic malignancies), or cancers suggested as possibly elevated on the basis of previous epidemiologic studies (cancers of the cervix, vulva, lung, and brain). Searches of the English language literature on the topic of silicone breast implants and cancer risk were conducted and reviewed to determine relationships that might have etiologic relevance. Epidemiologic studies provide no support for an increased risk of either sarcoma or multiple myeloma among breast implant recipients, disputing clinical and laboratory findings suggesting such a link. Although a number of epidemiologic studies have demonstrated elevated risks of cervical, vulvar, and lung cancers among breast implant patients, it is likely that these excesses relate more to lifestyle characteristics (e.g., cigarette smoking, sexual behavior) than to the effects of the implants. Brain cancer excesses, suggested in one study, have not been confirmed in either an update of the mortality experience in this study or on the basis of other investigations. At present, there is no convincing evidence that breast implants alter the risk of nonbreast malignancies. Breast implant patients should continue to be monitored for longer term risks and to assess whether cancer risk is influenced by various patient and implant characteristics.
Plastic and reconstructive surgery 01/2008; 120(7 Suppl 1):94S-102S. · 2.74 Impact Factor
ABSTRACT: Connective tissue disease-like illness has been associated with silicone breast implants. However, no data are currently available on the immunopathology of the capsule surrounding the breast implants. Sera from women with breast implants were collected and assayed for interleukin-6 (IL-6), IL-2, and hyaluronic acid. Capsular biopsies were stained with a probe for HYA or with monoclonal antibodies specific for human macrophages (CD68), T cells (CD4), IL-6, and IL-2. Control specimens consisted of breast biopsies from women undergoing reduction mammoplasty. Our results revealed an increased local amount of hyaluronic acid in the capsule of patients with breast implants compared with control breast tissue. The HYA was localized extracellularly in areas containing fibrosis and cellular infiltrates. The infiltrating cells were determined to be primarily macrophages and T cells. No IL-6 was localized in any of the tissue sections. In contrast, large amounts of IL-2 were found in regions of infiltrating lymphocytes. No significant increase in IL-6, IL-2, or hyaluronic acid was found in the sera. The role of hyaluronic acid and cytokines in the inflammatory response in the capsules of silicone breast implants is discussed.
Annals of Plastic Surgery 08/1994; 33(1):1-5. · 1.32 Impact Factor
ABSTRACT: Known complications of silicone breast implants are rupture and silicone leakage, complications that are related not only to generation and implant age but also to the manufacturer. Implants from the French manufacturer Poly Implant Prothèse showed more rupture than expected and were banned from the European market in 2010. Clinics in Europe recalled their patients, but prevalence of rupture in these implants has not been previously reported. All women who underwent breast augmentation in 2000 and 2001 in the Jan van Goyen Clinic, Amsterdam, The Netherlands, were informed about concerns regarding the quality of their implants. Medical records were used to trace manufacturer and implantation specifics. One hundred twelve women with proven Poly Implant Prothèse implants were enrolled in this study. All women underwent physical examination and magnetic resonance imaging and were interviewed for complaints to determine the prevalence of symptomatic and asymptomatic rupture. Two hundred twenty-four Poly Implant Prothèse implants were evaluated with a mean implant age of 122 months. Of these 224 implants, 54 had ruptured. Magnetic resonance imaging showed that 33 percent of women had at least one ruptured implant. There was no significant difference in rupture rate of implants manufactured in 2000 and 2001. One third of the women who had undergone breast augmentation with Poly Implant Prothèse implants were shown to have at least one ruptured implant after 10 years; 45.9 percent had bilateral rupture and 13.5 percent had extracapsular leakage. These were mostly asymptomatic ruptures. The rupture prevalence rate for Poly Implant Prothèse implants after 10 years is 24 percent. Therapeutic, IV.
Plastic and reconstructive surgery 06/2012; 129(6):1372-8. · 2.74 Impact Factor
ABSTRACT: Silicone gel implants for breast augmentation and reconstruction have been in use since 1962. Significant local complications include capsular contracture, rupture, gel "bleed", and spread of the implant material to regional lymph nodes (1-7) as well as histologic findings of foreign body granulomas in the capsular tissue and in lymph nodes (7-9). Through magnetic resonance spectroscopy and atomic emission spectroscopy, silicon compounds were found in the blood of some women with silicone breast implants; silicone and silica have also been found in liver (10). Well-publicized case reports have raised significant concerns regarding an association between implants and systemic disease. However, despite the availability of silicone implants for over 30 years, controlled epidemiological studies were not carried out until 1992. Currently available epidemiologic data are extremely limited. In part, because the majority of implants were used after 1981, the incidence of long-term problems is not yet known. In 1992, due to the unavailability of studies demonstrating the safety of implants, the U.S. Food and Drug Administration advised that silicone breast implants should be used only in reconstructive surgery and as part of clinical trials (11). This decision spurred a wave of research on the bioreactivity of silicone and clinical observations of patients with implants. Herein, we review the adverse immune effects following contact with silicone as well as the epidemiologic data available.
Life Sciences 04/1995; 56(16):1299-310. · 2.53 Impact Factor
ABSTRACT: To determine the impact of implant integrity on clinical symptoms and antibody status in women with silicone breast implants (SBIs). Ninety consecutive women were examined by means of magnetic resonance imaging (MRI) to assess the integrity of their silicone breast implants. The presence of silicone in the liver was estimated by (1)H localized stimulated echo acquisition mode (STEAM) magnetic resonance spectroscopy (MRS). Results were correlated with patients' complaints, as evaluated by a standardized questionnaire, physical examination by a rheumatologist and antibody screening. Breast MRI revealed defects in 24 patients (26.6%); in 13 (54.2%) of these women, silicone was detected in the liver by MRS. Of the 66 patients with MRI-estimated intact implants, 15 (22.7%) had apparent silicone in their liver, arguing for gel bleeding. Clinically, two patients had had rheumatoid arthritis before SBIs, whereas the other patients revealed no typical symptoms of arthritis or connective tissue disease (CTD). The patients with MRS evidence of silicone in the liver had no statistically significant differences in their complaints with the exception of the most frequent symptom, tingling/numbness of the fingers (82.1 vs 51.6%, P=0.006). A positive pattern of antinuclear antibodies (ANA) was obtained in 13 of the 28 MRS-positive patients (46.4%) and in 15 of the 62 MRS-negative patients (24.2%, P=0.033). However, in only one of these 28 ANA-positive patients was a specific weak antibody titre against SS-A detected by ELISA. Implant integrity has no major impact on rheumatic symptoms of women with SBIs. This finding supports the standpoint that silicone does not cause either a specific CTD or any other distinct disease entity. However, the moderately increased incidences of ANA-positivity and neuropathy-associated symptoms require explanation.
Rheumatology 03/2002; 41(2):129-35; discussion 123-4. · 4.06 Impact Factor
ABSTRACT: During the past 30 years, much debate has centered around side effects of silicone breast implants. Meta-analyses rejected the presumed relationship between silicone breast implants and connective tissues diseases but, in seeming contradiction, case reports about connective tissue diseases and rheumatoid symptoms continue to be published. We analyzed the cellular and molecular composition of fibrous capsules removed from patients at various times after surgery for diagnostic purposes (breast cancer relapse) or to relieve painful constrictive fibrosis. Frozen sections of capsule tissue were immunohistochemically stained for subsets of lymphocytes, macrophages, dendritic cells, fibroblasts, smooth muscle cells, for collagenous and non-collagenous extracellular matrix proteins, for heat shock protein 60 (HSP60) and for adhesion molecules. Massive deposition of fibronectin and tenascin was observed adjacent to the implant surface. The capsule/silicone implant contact zone was consistently characterized by a palisade-like single or multilayered cell accumulation consisting of HSP60+ macrophages and HSP60+ fibroblasts. Mononuclear cell infiltrates consisting of activated CD4+ T-cells, expressing CD25 and CD45RO, as well as macrophages were detected beneath the contact zone as well as perivascularly. Importantly, many Langerhans-cell like dendritic cells (DCs) were found with a predilection at the frontier layer zone abutting the silicone implant. Also, at this site, massive expression of ICAM-1, but not VCAM-1 or ELAM-1 emerged. Endothelial cells of the intracapsular neovasculature were P-Selectin+. Our results show that silicone induces a strong local T-cell immune response and future studies will determine the specificity and function of these T-lymphocytes.
Journal of Autoimmunity 09/2004; 23(1):81-91. · 7.37 Impact Factor
ABSTRACT: During sonographic evaluation of silicone breast implants for possible rupture, we have frequently encountered several patterns of linear echoes within the implants. To our knowledge, the significance of this finding has not been established in the literature. The purpose of this study was to determine whether internal echoes are significant in predicting implant rupture. Thirty-three patients with 64 silicone implants were prospectively entered into a study that included gray-scale sonography of the implants and subsequent surgical removal. Echo patterns within the implants were retrospectively evaluated on hard-copy films and compared with the integrity of the implant at surgery. Three categories of internal echo patterns were identified: "thick linear echoes." "thin linear echoes," and "commas." One or more of these echo patterns were seen in 57 (89%) of the 64 implants. Thick linear echoes were seen in 23 (36%) of the 64 implants, thin linear echoes were seen in 33 (52%) of the 64 implants, and commas were seen in 47 (73%) of the 64 implants. All echo patterns were seen in intact and ruptured implants with nearly equal frequency. We found no statistical significance for any echo pattern in predicting whether an implant was ruptured or intact. Of the 64 implants, four were entirely free of internal echoes. All four implants were intact. A variety of linear echoes can be seen in most silicone breast implants on gray-scale sonography. The presence or absence of linear echoes is not useful in predicting implant rupture. Complete absence of internal echoes, while highly predictive of an intact implant, is infrequently seen.
American Journal of Roentgenology 07/1997; 168(6):1595-8. · 2.78 Impact Factor
ABSTRACT: Silicone gel implants for breast augmentation and reconstruction have been in use since 1962. Significant local complications include capsular contracture, rupture, gel “bleed”, and spread of the implant material to regional lymph nodes (1–7) as well as histologie findings of foreign body granulomas in the capsular tissue and in lymph nodes (7–9). Through magnetic resonance spectroscopy and atomic emission spectroscopy, silicon compounds were found in the blood of some women with silicone breast implants; silicone and silica have also been found in liver (10). Wellpublicized case reports have raised significant concerns regarding an association between implants and systemic disease. However, despite the availability of silicone implants for over 30 years, controlled epidemiological studies were not carried out until 1992. Currently available epidemiologic data are extremely limited. In part, because the majority of implants were used after 1981, the incidence of long-term problems is not yet known. In 1992, due to the unavailability of studies demonstrating the safety of implants, the U.S. Food and Drug Administration advised that silicone breast implants should be used only in reconstructive surgery and as part of clinical trials (11). This decision spurred a wave of research on the bioreactivity of silicone and clinical observations of patients with implants. Herein, we review the adverse immune effects following contact with silicone as well as the epidemiologic data available.
ABSTRACT: Women with silicone breast implants have a significantly increased frequency of antibodies to collagen types I and II. To characterize the specificity of these antibodies, 70 women without a specific autoimmune disease, according to the criteria of the American College of Rheumatology, but who had silicone breast implants were studied for the presence of serum antibodies to native and denatured human types I and II collagen by ELISA. Positive sera were further studied by immunoblotting using peptides derived by cyanogen bromide digestion of the collagens. Samples of 82 women with systemic lupus erythematosus (SLE), 94 women with rheumatoid arthritis (RA), and 133 healthy controls were studied concurrently. There was a high frequency of autoantibodies to collagen in each of the study groups when compared to the healthy controls. However, and of particular interest, the epitope specificity of the autoantibodies differed markedly. Sera from women with silicone implants reacted strongly in an individual-specific manner with multiple peptides of type I collagen, whereas sera from women with SLE and RA reacted only weekly with a restricted range of peptides of type I collagen. Sera from women with RA reacted strongly with multiple peptides of type II, whereas sera from women with silicone implants or SLE reacted only weakly. The reactivity of women with silicone implants suggests that silicone or its biodegradation products can act as adjuvants in situ to enhance the immunogenicity of type I collagen, or protein-silicone conjugates.
Journal of Autoimmunity 01/1995; 7(6):775-89. · 7.37 Impact Factor
ABSTRACT: This investigation of capsular tissue adjacent to silicone breast implants concerns the long-term tissue response to the implant environment. Fifty-three silicone breast implants have been analyzed at the time of explantation. The implant duration ranged from 2 months to 153 months. The reason for explantation was capsular contracture (57%), dissatisfaction with the effect (11%), local inflammation (6%), implant rupture (4%) and exchange of tissue expanders (21%). The cell turnover within the interface of the silicone device and the fibrous capsule was detected by specific antibodies against Ki67 for cell proliferation, by TUNEL for apoptosis, and by DNA strand breaks and heat shock protein 70 (HSP70) for cell stress. We found a negative correlation between the expression of HSP 70 and the capsular thickness (p < 0.043) and decreased levels in specimens obtained from Baker IV implant capsules. Ki67, and TUNEL were significantly positive (p < 0.001 for both) and HSP 70 were significantly negative (p < 0.001) with signs of inflammation. Both Ki67 and TUNEL indicated decreasing values over time. Ki67 and TUNEL showed no correlation with clinical signs of implant failure, such as the Baker score. The expression of HSP70, on the other hand, was connected with structural changes of the implant capsule, in terms of capsular thickness and the Baker score.
Journal of Materials Science Materials in Medicine 01/2005; 15(12):1355-60. · 2.32 Impact Factor
ABSTRACT: We describe 2 HLA-identical sisters who both received silicone breast implants and subsequently developed polyarticular arthritis and neurologic symptoms. In both patients, HLA typing revealed 3 alleles typically associated with rheumatic diseases: HLA-DRB1*0405 and HLA-DQB1*0302 (associated with RA), and HLA-DRB4*01 (associated with mixed connective tissue disease and autoimmune reactions in patients with silicone breast implants. After removal of the implants, rheumatic as well as neurologic symptoms improved dramatically in both patients. One patient achieved complete remission. The other patient, who initially had more progressive disease, retained mild residual symptoms, but had significant improvement in radiological erosions. We believe that our cases support the theories that silicone may act as a triggering factor in genetically susceptible individuals, and that silicone may represent an adjuvant for the development of autoimmune disease. We discuss the possibility that a manifested spectrum of symptoms after silicone exposure might be more specific for a patient's genetic background than unique for silicone.
The Journal of Rheumatology 10/1997; 24(9):1838-41. · 3.69 Impact Factor
ABSTRACT: We determined systematically the prevalence of autoantibodies in children born to mothers with silicone breast implants and the relationships with clinical symptoms and methods of exposure. Autoantibody expression was determined in 80 children born to mothers with silicone implants and in 42 controls. A clinical assessment score was assigned to each patient. Antinuclear antibodies as well as antibodies to mitochondrial, smooth muscle, striational, myocardial, parietal cell, reticulin tissues, or subcellular compartments were measured by indirect fluorescent assay. Antibodies to nRNP (U1-RNP/snRNP); Sm; SS-A; SS-B; Scl-70; thyroid microsome; immunoglobulin (Ig)G, IgM, and IgA antibodies to cardiolipin; and antibodies to native and denatured human types I and II collagen were measured by enzyme-linked immunosorbent assay. Serum complement components C3 and C4 and IgM rheumatoid factor were measured by nephelometry. Autoantibody prevalence was not significantly different between children born to mothers with silicone implants and controls. The presence of autoantibodies was not related to the children's clinical symptoms or to the method of exposure. Determination of autoantibody production is of limited clinical utility in the evaluation of children born to mothers with silicone breast implants.
Pediatrics 03/1996; 97(2):243-5. · 5.44 Impact Factor
ABSTRACT: Exposure of breast tissue to silicone has been associated with autoimmune diseases in the medical literature since the 1960's. Japanese women injected with raw silicone had features of a collagen vascular disease but did not meet criteria for a specific diagnosis. Subsequently, we have seen women with silicone breast implants that have similar problems. We performed a prospective noncontrolled study on women with silicone breast implants. Results from the first 50 consecutive women revealed the most prominent complaints in this group were fatigue (89%), generalized stiffness (75%), poor sleep (71%), and arthralgias (78%). Other problems included Raynaud's phenomenon, alopecia, adenopathy, night sweats, and frequent sore throats. Unexpectedly, half of these women complained of dry eyes and dry mouths. Positive antinuclear antibodies and or rheumatoid factors were discovered in 38% of patients although the anti-SSA antibody was found in only one patient and anti-SSB in none. Labial salivary gland biopsies in 5 cases showed mononuclear cell infiltrates compatible with Sjögren's syndrome in 4. The infiltrating cells were predominantly CD68 positive monocyte/macrophages, which is different from what is found in Sjögren's syndrome. These findings may indicate the presence of a unique syndrome associated with silicone implants that is characterized by musculoskeletal pain and autoimmune features.
Seminars in Arthritis and Rheumatism 09/1994; · 4.97 Impact Factor
ABSTRACT: The influence of silicone breast implants on patients who develop systemic lupus erythematosus (SLE) and scleroderma are not known. Thirty SLE and 15 scleroderma patients who developed their diseases after under-going augmentation mammoplasty with silicone breast implants were studied. Clinical, laboratory, and treatment features for SLE were compared with age-, sex-, and race-matched controls from our 570-patient cohort. Comparisons were also made with a 75-patient university medical center scleroderma cohort. The SLE implant patients had milder disease but greater frequencies of cutaneous findings, cognitive impairment, and fibromyalgia than SLE patients without implants (p < 0.05). The scleroderma implant group also tended to have milder disease. Of the 45 patients, 26 had their implants removed. Subjective, clinical, and serologic remission after explantation occurred in two of the patients (both with SLE). Twenty-four additional patients had transient subjective improvement or no improvement after explantation; one patient developed malignant hypertension and a scleroderma kidney weeks after explantation.In conclusion, most lupus and scleroderma patients with implants experienced milder, although apparently classical, disease. Dramatic changes in disease course occurred in 3 of the 26 patients immediately after explantation. Because idiopathic disease patients have a 2-10% spontaneous remission rate, more time will be needed to evaluate the natural disease course in the remaining explanted patients.
JCR Journal of Clinical Rheumatology 10/1996; 2(5):257-61. · 1.36 Impact Factor
ABSTRACT: We have previously shown that natural killer (NK) cell activity is significantly suppressed in patients with silicone breast implants. These patients were symptomatic and the suppression of natural killer cell activity was associated with additional significant immunological abnormalities (Vojdani et al., 1992a). Our studies have recently been confirmed by Smith et al. (1994), who described natural killer cell activity suppression following exposure to silicone gel, and reversal upon removal of the gel. This study has been designed to evaluate natural killer cell activities in symptomatic women with silicone breast implants and again after explantation of the implants. Each patient served as her own control. Our findings show a marked significant increase in previously suppressed natural killer cell activity in 50% of the patients. In the other 50%, no change or suppressed NK activity was observed. These findings are compatible with recent studies in experimental animals, which show that administration of silicone reduces natural killer cell activity, and that this is reversible upon removal of the silicone. Since NK cells are important in the control of tumor cell growth, we propose here that patients with reduced NK cell activity are at a higher risk of developing cancer, a concept recently described in experimental animals (Potter et al., 1994; Salhon et al., 1994).
Toxicology and Industrial Health 10(3):149-54. · 1.42 Impact Factor
N Kossovsky, J Stassi
ABSTRACT: Historically, silicones have been considered biologically inert materials, and have therefore been used widely in a variety of medical applications. Recently, controversy has arisen concerning the bioreactivity of silicone; reports of adverse inflammatory and immunological complications that may be evoked by silicone breast implants have appeared in the medical literature and have received great attention from the lay press. The phenomena said to be associated with silicones may be attributed pathophysiologically to the inherent surface activity of silicone. The human body's initial response to the silicone of breast implants is the adsorption of various plasma proteins, including clotting and complement proteins, to the implant surface. Other macromolecules in the biological milieu may follow. The conformational integrity of this adsorbed macromolecular layer affects much of the subsequent biological reaction. Clinically silent inflammation, locally significant inflammation, inflammation with constitutional symptoms, and inflammation with immunological activation are possible consequences.
Seminars in Arthritis and Rheumatism 09/1994; 24(1 Suppl 1):18-21. · 4.97 Impact Factor
ABSTRACT: In the United States alone, an estimated 1-2 million women have used silicone breast implants. Many of these women are of reproductive age. Given the current controversy over the safety of silicone breast implants, medical care providers should be able to advise women if use of these implants affects the use of any of the available contraceptive methods, whether pregnancy is in any way contraindicated and/or might be associated with special complications, whether there are potential risks to the fetus and neonate, and whether breast feeding might be compromised. A review of the literature on these topics yielded very little useful information.
Advances in Contraception 10/1994; 10(3):187-93.
Camila M Yamaguchi, Joel Faintuch, Maira M Silva, M Modolin,Silvia Y Hayashi, I Cecconello
ABSTRACT: No study targeting the impact of silicone breast implants on body composition measured by bioimpedance analysis was identified. Aiming to clarify this question a prospective clinical study was designed. Adult candidates were submitted to conventional analysis at baseline and two months after the surgical intervention. In addition, unwrapped prostheses were positioned in the axillary cavity before operation and bioimpedance was measured, both with and without application of ultrasound gel for improved conductivity (sham implantation). Patients (N = 20) were young and healthy (26.8 ± 3.6 years old, BMI 22.1 ± 3.7 kg/m(2)). In comparison with preoperative results, sham procedures pointed out increased body fat and body resistance (13.2 ± 5.6 vs 13.6 ± 5.4 kg, P = 0.017 and 523 ± 54 vs 569 ± 53 Ω, P = 0.003, respectively). Two-month follow-up confirmed the same pattern after surgical intervention, with minor discrepancies (13.2 ± 5.6 vs 13.8 ± 5.7 kg, P = 0.011 and 523 ± 54 vs 549 ± 62 Ω, P = 0.032, respectively). BMI remained stable and did not correlate with bioimpedance changes. Silicone was recognized as adipose tissue. Difference in total body fat (approximately 600 g) was consistent with used amount.
Clinical nutrition (Edinburgh, Scotland) 02/2012; 31(4):574-6. · 3.27 Impact Factor
F B Vasey, D L Havice, T S Bocanegra, M J Seleznick, P H Bridgeford, P Martinez-Osuna, L R Espinoza
ABSTRACT: We report the clinical findings in a series of women with silicone breast implants (SBI) and rheumatic disease. These findings represent the first 50 patients seen at the University of South Florida Medical Clinic between March 1977 and January 1991. The average age was 44 years with a range of 30 to 66 years. The most common clinical findings included chronic fatigue, muscle pain, joint pain, joint swelling, and lymphadenopathy. Seventeen women with an average Steinbrocker functional class of 1.8 decided not to remove the implants. An average of 14 months later, follow-up showed no change in their condition. Thirty-three women, with an average functional class of 2.5 underwent implant removal. Twelve of the 33 had documented implant rupture. During an average follow-up of 22 months after implant removal, 24 women improved clinically, 8 did not change, and 1 worsened. We believe this series supports a relationship between silicone breast implants and rheumatic disease signs and symptoms. Although this report is not a definitive epidemiological study, findings suggest that physicians should inform women about the possible benefit of implant removal.
Seminars in Arthritis and Rheumatism 09/1994; 24(1 Suppl 1):22-8. · 4.97 Impact Factor
Larry W Hunter, John C Lieske, Nho V Tran, Virginia M Miller
ABSTRACT: Implanted silicone medical prostheses induce a dynamic sequence of histologic events in adjacent tissue resulting in the formation of a fibrotic peri-prosthetic capsule. In some cases, capsular calcification occurs, requiring surgical intervention. In this study we investigated capsules from silicone gel-filled breast prostheses to test the hypothesis that this calcification might be regulated by the small vitamin K-dependent protein, matrix Gla protein (MGP), a potent inhibitor of arterial calcification, or by Fetuin-A, a hepatocyte-derived glycoprotein also implicated as a regulator of pathologic calcification. Immunolocalization studies of explanted capsular tissue, using conformation-specific antibodies, identified the mineralization-protective γ-carboxylated MGP isomer (cMGP) within cells of uncalcified capsules, whereas the non-functional undercarboxylated isomer (uMGP) was typically absent. Both were upregulated in calcific capsules and co-localized with mineral plaque and adjacent fibers. Synovial-like metaplasia was present in one uncalcified capsule in which MGP species were differentially localized within the pseudosynovium. Fetuin-A was localized to cells within uncalcified capsules and to mineral deposits within calcific capsules. The osteoinductive cytokine bone morphogenic protein-2 localized to collagen fibers in uncalcified capsules. These findings demonstrate that MGP, in its vitamin K-activated conformer, may represent a pharmacological target to sustain the health of the peri-prosthetic tissue which encapsulates silicone breast implants as well as other implanted silicone medical devices.
Biomaterials 08/2011; 32(33):8364-73. · 7.40 Impact Factor
E A Ojo-Amaize, V Conte, H C Lin, R F Brucker, M S Agopian, J B Peter
ABSTRACT: A blinded cross-sectional study was carried out with 99 women, 44 of whom had silicone breast implants. Group I consisted of 55 healthy volunteer women without breast implants; group II comprised 13 volunteer women with breast implants or explants who felt healthy; group III comprised 21 volunteer women with breast implants who had chronic fatigue, musculoskeletal symptoms, and skin disorders; and group IV comprised 10 women who had their prostheses explanted but still presented with clinical symptoms similar to those of the women in group III. Proliferative responses of peripheral blood mononuclear cells from all 99 women were measured by [3H]thymidine uptake after exposure to SiO2 silicon, or silicone gel. The levels of proliferative responses were expressed as stimulation indices, which were obtained by dividing the counts per minute of stimulated cells by the counts per minute of unstimulated cells. Abnormal responses to SiO2, silicon, or silicone gel were defined as a stimulation index of > 2.8, > 2.1, or > 2.4, respectively. Abnormal responses were observed in 0% of group I, 15% of group II, 29% of group III, and 30% of group IV (P < 0.0005 for group I versus groups II and IV). Thirty-one percent of symptomatic women with silicone gel breast implants had elevated serum silicon levels ( > 0.18 mg/liter); however, there was no significant correlation between abnormal cellular responses and silicon levels in blood serum, type of implant, time since first implantation, prosthesis explantation, number of implants, or report of implant leakage or rupture.(ABSTRACT TRUNCATED AT 250 WORDS)
Clinical and Diagnostic Laboratory Immunology 12/1994; 1(6):689-95. · 2.51 Impact Factor
M Duvic, D Moore, A Menter, E C Vonderheid
ABSTRACT: Cutaneous T-cell lymphoma (CTCL) is a chronic malignancy of helper T cells with the CD4 phenotype. It occurs less frequently in young women but is increasing in incidence for unknown reasons. Silicone breast implants have been associated with T-cell-mediated autoimmune reactions. Our purpose was to suggest the hypothesis that CTCL may arise after breast implants and that different patients with CTCL may be stimulated by different antigens. Investigators with many patients with CTCL were queried regarding the occurrence of CTCL in women after breast implants. Three cases of confirmed CTCL after breast implants were identified and are reported. In one patient with Sézary syndrome and CTCL, the disease went into remission after removal of implants, resolution of chronic staphylococcal infection, and initiation of photopheresis and interferon alfa therapy. Another patient had progressive disease. CTCL may occur in association with breast implants in young female patients, but causality is unknown. If CTCL is antigen driven, then it is likely to result from several different antigens in different groups of patients.
Journal of the American Academy of Dermatology 07/1995; 32(6):939-42.· 3.99 Impact Factor
W Siggelkow, B Klosterhalfen, U Klinge, W Rath, A Faridi
ABSTRACT: A study was undertaken to analyse local complications in patients with breast implants and the total number of implant-related interventions when silicone breast implants were explanted. We studied 53 patients who had received breast implants for cosmetic augmentation or breast reconstruction following surgery for breast cancer at the time of explantation. The clinical records of all these patients were analysed, and clinical information on reason for implantation, implant properties, number and kind of implant-related interventions and reason for explantation was elicited. A complication was defined as a surgical procedure performed for any of the following reasons: capsular contracture, loss of implant integrity, haematoma or seroma, infection of the implant site, extrusion or wound dehiscence, and dissatisfaction with the result. The mean numbers of implant-related operations were 3.1 in patients who had undergone breast reconstruction and 2.3 in patients who had cosmetic augmentation (P < 0.03). We found a total of 35 complications in 28 patients, 21 patients (75%) each had one complication, five patients (18%) had two and two patients (7%) had three complications. A significantly higher incidence of early complications in patients who had undergone breast reconstruction (P < 0.03) marks the difference from complications in the cosmetic group, most of which arose after a longer time (P < 0.02). A complication analysis is presented. At the time of explantation, 78% of the patients decided to have a new implant, while 12% requested permanent removal of the implant without replacement. In the present study we saw no patients with connective tissue or other autoimmune disorders. When breast reconstruction or augmentation with silicone devices is considered, patients must be informed of the possible complications and of the potential choices in later implant-related revision surgery.
The Breast 05/2004; 13(2):122-8. · 2.49 Impact Factor
Bente Jensen, Irene Hechmann Wittrup, Allan Wiik, Søren Friis,Henning Bliddal, Birthe Thomsen, Joseph K McLaughlin, Bente Danneskiold-Samsøe, Jørgen H Olsen
ABSTRACT: To use a new immunologic assay to evaluate antipolymer antibody (APA) levels among women with silicone breast implants (SBIs). Women (n = 186) were identified through Danish population-based registers and categorized into six groups defined by prior breast surgery (silicone breast implantation/breast reduction/no breast surgery) and by the presence or absence of a prior hospital diagnosis of soft-tissue rheumatism (muscular rheumatism, ICD-8 codes 717.90 and 717.99). The women underwent blood tests, including an APA test, a clinical examination, and an interview focusing on rheumatic complaints. Blood samples were tested blindly. The severity of rheumatic symptoms/signs was scored from 1 (none) to 5 (severe) based on the clinical examination and interview. Women with SBIs did not have higher levels of APA than women without SBIs. The majority of women with SBIs had mild rheumatic complaints, and the severity of their symptoms was not related to APA levels. Among women who had previously been hospitalized because of soft-tissue rheumatism, there were more fibromyalgia cases, and their symptoms were more severe compared with those women without prior soft-tissue rheumatism; however, APA levels were not higher among these women. There was a significant difference in APA measurements resulting from between-kit variation (p less 0.01). Our data did not demonstrate higher APA levels among women with SBIs compared with controls. The large variation observed between the individual plates in the APA test should be evaluated in future studies.
Journal of Long-Term Effects of Medical Implants 02/2004; 14(2):73-80.
Roger N Wixtrom
ABSTRACT: Platinum, in a specific form, is used as a catalyst in the cross-linking reactions of the silicone gel and elastomer in breast implants. After manufacture, it remains in the devices at low-parts-per-million levels. Potential concerns have been raised as to whether this platinum might diffuse from silicone breast implants into the body and result in adverse health effects. The weight of evidence indicates that the platinum present is in its most biocompatible (zero valence) form, and the very minute levels (<0.1 percent) that might diffuse from the implants do not represent a significant health risk to patients.
Plastic and reconstructive surgery 12/2007; 120(7 Suppl 1):118S-122S. · 2.74 Impact Factor
A Vojdani, N Brautbar, A W Campbell
ABSTRACT: Silicone implants have been associated with the development of multiple organ system abnormalities, including rheumatic disorders, nervous system, pulmonary dysfunction associated with autoantibodies and abnormalities of cellular immunity. In this regards a number of case reports and series of articles have been described. We hypothesized that an immune reaction to silicone breast implants would include the host reactivity against silicone and the macromolecules within the microenvironment of the implant, and these autoantibodies may react with other tissue antigens far from the site of the implant. To test this hypothesis 520 Symptomatic women with Silicone Implants which have developed Silicone related Immunological disorders and have typically complained of breast pain, Myalgia-Arthralgia, fatigue, or generalized pain, were examined by their physician. Blood samples were obtained and examined for the presence of Silicone antibodies, Myelin Basic Protein and human serum albumin antibodies. These samples were then compared to 520 matched controls without implants. At least at the level of two standard deviation silicone specific antibodies, IgG, IgA IgM, IgE and IgG+IgA+IgM antibodies were detected above the mean of normal controls. When these antibodies were classified based on the specialty of the examining physician, the % of patients with Silicone Antibodies were varied; general practice 51.6, Rheumatology 58.7, and Plastic Surgery 83.3, which may relate to the severeness of the disease. Being that a large % of patients demonstrated very high levels of Myelin Basic Protein Antibodies, possible cross reactive antibodies were sought. However, absorption of highly positive sera for Silicone Antibodies with MBP did not change the levels of Silicone Antibodies. On the other hand, Silicone-HSA was able to reduce the antibody values significantly. This reduction in antibody levels by Silicone is the best indication for the specificity of these antibodies. Moreover when data for silicone antibodies and MBP antibodies was analyzed in patients some with high and others with medium or low levels of silicone antibodies, MBP antibodies did not correspond to the silicone antibody levels. Similarly human serum albumin antibodies which was significantly higher in patients with silicone implants did not correlate with levels of silicone antibodies. These results indicate that immune reaction to silicone and different tissue antigens do occur and they are initiated through different mechanisms. And since predominant antibody class against silicone, MBP and HSA was IgM, clonal activation of IgM is possible which certainly warrants further investigation.
Immunopharmacology and Immunotoxicology 12/1994; 16(4):497-523. · 1.83 Impact Factor
ABSTRACT: Previous work has shown that women with silicone gel breast implants have an increased frequency of autoantibodies to collagen types I and II. 70 women without a specific autoimmune disease, using criteria of the American College of Rheumatology, but who had silicone breast implants were studied for the presence of serum antibodies to native and denatured human types I and II collagen by ELISA. 82 women with systemic lupus erythematosus (SLE), 94 women with rheumatoid arthritis (RA), and 133 healthy controls were also studied. There was a high frequency of autoantibodies to collagen in each of the groups when compared to the healthy controls. The specificities of these antibodies were found to differ markedly when examined by immunoblotting using peptides derived by cyanogen bromide digestion of the collagens. Sera from women with silicone implants reacted with multiple peptides of type I collagen in an individual-specific manner, but sera from women with SLE or RA reacted weakly with a restricted range of peptides. Against type II collagen, sera from women with RA reacted strongly with multiple peptides, while sera from women with silicone implants or SLE reacted only weakly or not at all. The patterns of reactivity against collagens by sera from women with silicone implants suggest that silicone can act as an adjuvant to enhance the immunogenicity of type I collagen.
Current topics in microbiology and immunology 02/1996; 210:307-16. · 4.93 Impact Factor
S H Lamm
ABSTRACT: The epidemiological literature examining the possible association between silicone breast implants and breast cancer or rheumatological conditions or diseases is far greater today than it was when, in early 1992, FDA determined that the data were not adequate for the assessment of their safety. A literature data base exists for assessing the magnitude of risk for certain diseases that might be associated with silicone breast implantation and for narrowing the uncertainty in those estimates. The studies reported in this series make a major contribution to that database. As for future research needs, some general observations can be made. First, it is likely that completed, ongoing and planned studies will prove more than adequate in accurately delineating any cancer risks that might be associated with breast implantation. Second, the risks of developing scleroderma will also be reasonably well established. Further study may be desirable for other specific connective tissue diseases and for connective tissue disease considered as a whole.
Journal of Clinical Epidemiology 05/1995; 48(4):507-11. · 4.27 Impact Factor
ABSTRACT: To determine whether breast-fed children of mothers with silicone implants are at increased risk for the development of sclerodermalike esophageal involvement compared with children not exposed to silicone implants. Case-series [corrected]. Referral-based pediatric gastroenterology clinic. Eleven children (mean age, 6.0 years; range, 1.5 to 13 years; six boys and five girls) referred for abdominal pain who were born to mothers who had silicone breast implants (eight breast-fed children and three bottle-fed) were compared with 17 patients (mean age, 10.7 years; range, 2 to 18 years; 11 boys and six girls) with abdominal pain who were not exposed to silicone implants. All children underwent esophageal manometry and upper intestinal endoscopy with esophageal biopsy and were tested for antinuclear antibody and autoantibodies to Scl-70, centromere, ribonucleoprotein, Sm, Ro, La, and phospholipid. Six of the eight breast-fed children from mothers with silicone implants had significantly abnormal esophageal motility with nearly absent peristalsis in the distal two thirds of the esophagus and decreased lower sphincter pressure. Upper esophageal pressures and motility were normal. Compared with controls, the breast-fed children had significantly decreased lower sphincter pressure and abnormal esophageal wave propagation. These manometric abnormalities were not seen in the three bottle-fed children. There was no difference in the expression of autoantibodies in the breast-fed children compared with the bottle-fed children or controls. A relationship appears to exist between breast-feeding by mothers with silicone implants and abnormal esophageal motility. Studies evaluating larger numbers of children are needed to determine the extent of the risk.
JAMA The Journal of the American Medical Association 02/1994; 271(3):213-6. · 30.03 Impact Factor
S L Spear, M Elmaraghy, C Hess
ABSTRACT: The earliest silicone breast implants were smooth-surface, silicone rubber devices filled with either silicone gel or saline. Because of persistent problems with capsular contracture, polyurethane-covered silicone implants were developed as an alternative. Particularly in the short run, these alternatives proved highly successful at reducing the incidence of capsular contracture. By 1990, polyurethane-covered implants were rapidly becoming the preferred implant choice of many plastic surgeons, but for legal, regulatory, financial, and safety reasons they were withdrawn from the market by Bristol-Myers in 1991. Meanwhile, during the late 1980s, surface texturing and improved materials became available on other silicone breast implants and expanders. Most studies suggest that textured-surface silicone gel-filled implants, saline-filled implants, and tissue expanders have less frequent capsular contracture than their smooth-surface counterparts.
Plastic & Reconstructive Surgery 05/2000; 105(4):1542-52; discussion 1553-4. · 3.38 Impact Factor
N L Rosenberg
ABSTRACT: To define neurologic problems that may occur in women with silicone breast implants. Background: The association between silicone breast implants (SBIs) and certain rheumatologic disorders has been discussed since the 1980s. Recent uncontrolled case series have reported neurologic problems believed to be associated with SBIs. Case series based on a retrospective data analysis of medical records from 131 women diagnosed as having a neurologic problem related to SBIs. Data extracted from the medical records and analyzed included neurologic symptoms, neurologic examination findings, and a variety of laboratory studies. Symptoms, examination findings, and laboratory studies were analyzed using methods that would purposely overreport false-positive results in order to negate possible bias accusations. Finally, prior diagnoses made by evaluating physicians and thought to be related to SBIs were also recorded. An independent assessment was also made for alternative diagnoses using standards accepted by the medical and neurologic communities which did not necessarily accept a causative link between SBIs and their alleged complications. Neurologic symptoms were frequently endorsed, including fatigue (82%), memory loss and other cognitive impairment (76%), and generalized myalgias (66%). Despite multiple complaints, most patients (66%) had normal neurological examinations. Findings reported as abnormal were mild and usually subjective, including sensory abnormalities in 23%, mental status abnormalities in 13%, and reflex changes in 8%. No pattern of laboratory abnormalities was seen, either in combination or in attempts to correlate them with the clinical situation. Laboratory studies appeared to be random without an attempt to confirm or correlate with a particular diagnosis. Diagnoses by physicians endorsing the concept that SBIs cause illness included "human adjuvant disease" in all cases, memory loss and other cognitive impairment ("silicone encephalopathy") and/or "atypical neurologic disease syndrome" in 73%, "atypical neurologic multiple sclerosis-like syndrome" in 8%, chronic inflammatory demyelinating polyneuropathy in 23%, and some other type of peripheral neuropathy in 18%. There was no coherence in making these diagnoses; the presence of any symptoms in these women was sufficient to make these diagnoses. Alternatively, after review of the data, no neurologic diagnosis could be made in 82%. Neurologic symptoms could be explained in some cases by depression (n=16), fibromyalgia (n=9), radiculopathy (n=7), anxiety disorders (n=4), multiple sclerosis (n=4), multifocal motor neuropathy (n=1), carpal tunnel syndrome (n=1), dermatomyositis (n=1), and other psychiatric disorders (n=3). There is no evidence that SBIs are causally related to the development of any neurologic diseases. Methods of diagnosis that have been used to make the diagnosis of neurologic disease in these patients are contrary to standards accepted by the neurologic community. Several possible explanations exist for the neurologic and other symptoms in women with breast implants.
Neurology 03/1996; 46(2):308-14. · 8.31 Impact Factor
E C Janowsky, L L Kupper, B S Hulka
ABSTRACT: The postulated relation between silicone breast implants and the risk of connective-tissue and autoimmune diseases has generated intense medical and legal interest during the past decade. The salience of the issue persists, despite the fact that a great deal of research has been conducted on this subject. To provide a stronger quantitative basis for addressing the postulated relation, we applied several techniques of meta-analysis that combine, compare, and summarize the results of existing relevant studies. We searched data bases and reviewed citations in relevant articles to identify studies that met prestated inclusion criteria. Nine cohort studies, nine case-control studies, and two cross-sectional studies were included in our meta-analyses. We conducted meta-analyses of the results of these studies, both with and without adjustment for confounding factors, and a separate analysis restricted to studies of silicone-gel-filled breast implants. Finally, we estimated the annual number of new cases of connective-tissue disease that could be attributed to breast implants. There was no evidence that breast implants were associated with a significant increase in the summary adjusted relative risk of individual connective-tissue diseases (rheumatoid arthritis, 1.04 [95 percent confidence interval, 0.72 to 1.51]; systemic lupus erythematosus, 0.65 [95 percent confidence interval, 0.35 to 1.23]; scleroderma or systemic sclerosis, 1.01 [95 percent confidence interval, 0.59 to 1.73]; and Sjögren's syndrome, 1.42 [95 percent confidence interval, 0.65 to 3.11]); all definite connective-tissue diseases combined (0.80; 95 percent confidence interval, 0.62 to 1.04); or other autoimmune or rheumatic conditions (0.96; 95 percent confidence interval, 0.74 to 1.25). Nor was there evidence of significantly increased risk in the unadjusted analyses or in the analysis restricted to silicone-gel-filled implants. On the basis of our meta-analyses, there was no evidence of an association between breast implants in general, or silicone-gel-filled breast implants specifically, and any of the individual connective-tissue diseases, all definite connective-tissue diseases combined, or other autoimmune or rheumatic conditions. From a public health perspective, breast implants appear to have a minimal effect on the number of women in whom connective-tissue diseases develop, and the elimination of implants would not be likely to reduce the incidence of connective-tissue diseases.
New England Journal of Medicine 04/2000; 342(11):781-90. · 53.30 Impact Factor