Erratum. Self-reported signs and symptoms in breast implant patients with novel antibodies to silicone surface associated antigens [anti-SSAA(x)] (original) (raw)
Related papers
The association between silicone implants and both antibodies and autoimmune diseases
Clinical Rheumatology, 2008
Silicones are widely used materials in many fields of medicine and largely are believed to be biologically inert. However, some investigators have reported that silicone implants are associated with an increased incidence of autoimmune disorders. In this study, we evaluated the capsular tissue of silicone implants and the sera of implant patients and controls for antisilicone antibodies and nonspecific immunoglobulins (IgG, IgA, IgM, and IgE). Our study group included 15 patients (eight men and seven women) undergoing reconstructive procedures for burn scars, in whom we used silicone implants, and 15 sex-matched controls undergoing reconstructive surgery for burn scars without using silicone implants. By immunofluorescence, we discovered strong capsular binding of IgG and weak capsular binding of IgM; antisilicone antibody levels were significantly higher in capsular tissue than elsewhere. Serum IgE also was higher in patient vs control subject sera. In conclusion, silicone materials do lead to an immune response consisting of antisilicone antibodies most evident immediately adjacent to the implant itself.
Long-term exposure to silicone breast implants does not induce antipolymer antibodies
Biomaterials, 2004
The focus of our studies was to determine whether the antipolymer antibody assay (APA) as an objective laboratory assay could contribute to the diagnosis in women with a silicone breast implant (SBI) and complaints/symptomatic disease. We investigated whether a population of symptomatic SBI recipients exists with a high prevalence of APA in the Netherlands. The study participants were selected based on self-reported complaints. In one study their physician was approached for additional information on their disease status. Two groups of 42 women were included in the studies, with a mean SBI exposure of 17 and 16 years, respectively. The participants were clinically examined, and the APA level in serum samples determined. The study population of SBI recipients was categorised in severity subgroups based on the functional capacity, and the study physicians general assessment of pain and disease activity. Positive APA levels were found in 10% of the SBI recipients. Also in control groups 8% showed a positive APA response. After categorisation most (65 of 84) SBI recipients belonged to the limited severity subgroup on an increasing scale of limited, mild, moderate and advanced. Eight were categorised in the mild, four in the moderate, and seven in the advanced severity subgroup. None of the APA positive women were found to belong to the moderate or advanced severity subgroup. Seven of the APA positive women belonged to the limited, and one woman to the mild severity subgroup. In conclusion, we were unable to include a large proportion of severely symptomatic SBI recipients in our study populations. So, we cannot confirm the results of Tenenbaum et al.
Clinical and Vaccine …, 1996
Silicon, in the form of sodium silicate (Na 2 SiO 3), 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 SiO 2) demonstrated that the IgG and IgM antibodies bound specifically to silicate, because preincubation with Na 2 SiO 3 inhibited more than 90% of the activity, whereas CrO 3 , Li 2 SO 4 , MgSO 4 , NiSO 4 , HgCl 2 , ZrOCl 2 , BeSO 4 , and SiO 2 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.
Silicone-specific blood lymphocyte response in women with silicone breast implants
Clinical and Vaccine …, 1994
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 [3 H]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%1 of group I, 15% of group 1, 29%o of group Ill, and 30%o 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. Flow cytometric and cell depletion
Clinical Rheumatology, 2000
This cohort study evaluates the postoperative prevalence of antinuclear antibodies (ANA) in relation to symptoms related to the so-called silicone-related symptom complex (SRSC). A total of 63 women who underwent mastectomy followed by immediate breast reconstruction with a silicone implant (SBI) between Septembber 1990 and May 1995 at the University Hospital Rotterdam/Daniel den Hoed Cancer Center, participated voluntarily in the study. Their sera were tested for the presence of antinuclear antibodies (ANA) and at the same time they were screened for the prevalence of SRSC-related symptoms by questionnaire. All patients were also examined physically. Sixteen per cent of the women were ANA positive. There was no difference in SRSC expression between ANA-positive and ANA-negative women. The lack of difference in symptom expression between the ANA-positive and ANA-negative women and the rather low complaint percentage proves that if ANA positivity is related to the SRSC, we found no evidence that patients with a SBI with a positive ANA differed from the ANA-negative patients.
Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study
The Netherlands journal of medicine, 2013
Since their introduction, the safety of silicone breast implants has been under debate. Although an association with systemic diseases was never established, women continuously blamed implants for their unexplained systemic symptoms. In 2011, a pattern of symptoms caused by systemic reactions to adjuvants (e.g. vaccines, silicone) was identified: 'autoimmune syndrome induced by adjuvants' (ASIA). Our aim was to collect a cohort of women with silicone breast implants and unexplained systemic symptoms to identify a possible pattern and compare this with ASIA. Women with silicone breast implants and unexplained systemic symptoms were invited through national media to visit a special outpatient clinic in Amsterdam. All were examined by experienced consultant physicians and interviewed. Chest X-ray and laboratory tests were performed. Between March 2012 and 2013, 80 women were included, of which 75% reported pre-existent allergies. After a symptom-free period of years, a pattern ...
Seminars in Arthritis and Rheumatism, 1994
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 biireactivity of silicone; reports of adverse inflammatory and immunological complications that may be evoked by silicone breast implants have appeared in the medical liierature 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 most common complication of silicone breast implants is capsular contracture (massive scar formation around the implant). We postulate that capsular contracture is always a sequel to inflammatory processes, with both innate and adaptive immune mechanisms participating. In general, fibroblasts and macrophages have been used as cell types to evaluate in vitro the biocompatibility of breast implant surfaces. Moreover, also T cells have been found at the implant site at the initial stage of fibrous capsule formation. However, only few studies have addressed the influence of surfaces with different textures on T-cell responses. The aim of the present study was to investigate the immune response of human peripheral blood mononuclear cells (PBMC) to commercially available silicone breast implants in vitro. PBMC from healthy female blood donors were cultured on each silicone surface for 4 days. Proliferation and phenotype of cultured cells were assessed by flow cytometry. Cytokine levels were determined by multiplex and real-time assay. We found that silicone surfaces do not induce T-cell proliferation, nor do they extensively alter the proportion of T cell subsets (CD4, CD8, naïve, effector memory). Interestingly, cytokine profiling identified matrix specific differences, especially for IL-6 and TNF-α on certain surface topographies that could lead to increased fibrosis.