Safety of Silicone Breast Implants (1999) / Chapter Skim
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7 Antinuclear Antibodies and Silicone Breast Implants
7 Antinuclear Antibodies and Silicone Breast Implants
Pages 198-214
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From page 198... ...
Some investigators have reported ~ ., ~ increased frequency and increased titers of ANAs in women with implants and have speculated about the implications of this finding for autoimmune disease or other immunological reactions that might result from exposure to silicone breast implants. Other investigators have not found any difference in ANA titers between otherwise similar groups of women with or without breast implants and have concluded that there is no relationship between implants and autoantibodies.
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From page 199... ...
Strongly positive ANA tests in women with implants who have connective tissue disease undoubtedly reflect the disease. These positive ANA tests should not be ascribed to the presence of the implants.
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From page 200... ...
This is the kind of group whose ANA results should be compared with those reported for symptomatic women with implants who do not have a defined connective tissue disease. In contrast, nearly all patients with systemic lupus erythematosus (SLE)
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From page 201... ...
In addition, some studies of ANA prevalence in women with silicone breast implants suffer from inadequate reporting of the details of the test technology and criteria for a positive test; inadequate descriptions of the signs, symptoms, and presence of defined connective tissue disease in some of the test populations; biased ascertainment of women with implants; inadequate descriptions or absence of control populations; uncertainty regarding adequate blinding of those who perform the assays; and questions of proper matching of control groups, among others. The result has been studies with conflicting findings, which often have flaws suggesting that the results are questionable or, through lack of information, cannot be interpreted with confidence.
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From page 202... ...
Of 95 of these patients who had joint and muscle pain, 15% had positive ANAs; 22% of 32 who had joint swelling were positive; and 45% of 29 who had a defined connective tissue disease were positive. From a review of the literature and 401 patients presented in abstracts at the 1992 American College of Rheumatology Meeting, Bridges identified 5% of mostly symptomatic patients with silicone breast implants and specific autoantibodies, such as anti-Ro and anti-La, anti-Scl-70, anti-Sin, and antidsDNA.
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From page 203... ...
No positive ANAs were found in healthy women; 18% of asymptomatic women, 26% of symptomatic women, and 64% of women with implants and a defined connective tissue disease were positive. There was no correlation between presence of a positive ANA and type of implant, indication for implantation, duration of implantation or implant rupture.
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From page 204... ...
had positive ANAs. Of these patients, 185 were diagnosed as having a defined or undifferentiated connective tissue disease, fibromyalgia, or other rheumatic-like conditions.
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From page 205... ...
In a subsequent abstract report, these U.S. and Israeli groups compared 86 asymptomatic women with implants with these 116 women and reported increased titers of 13 antinuclear autoantibodies in 2%-13% of the asymptomatic group.
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From page 206... ...
Some of these patients had defined connective tissue disease. Positive ANAs were detected in 24% of those patients.
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From page 207... ...
Clinically, 3 of the 70 patients had a defined connective tissue disease (Blackburn et al., 1997~. One-half of approximately 370 consecutive silicone breast implant recipients attending a rheumatology practice between April and September 1994 were asked to enroll in a study, as were 40 nonrecipients with defined connective tissue disease.
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From page 208... ...
In a group of 207 women with implant reconstructions after cancer mastectomy, 5 were positive compared with 4 of 88 control women who had had mastectomy for cancer without reconstruction. In this appropriately controlled study without apparent selection bias, no increase in ANA positivity was found in the women with breast implants even though human tissue culture cells were used and a titer of only 1:40 or more was considered positive (Park et al., 1998~.
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From page 209... ...
ANA and Autoantibody Analysis in Epidemiological Cohort Studies The medical records of all women with silicone breast implants in Olmsted County, Minnesota, were reviewed by Gabriel et al.
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From page 210... ...
were measured in the women with implants and compared with measurements in four age-matched control groups taken from the Nurses' Health Study cohort that had provided blood samples. These groups consisted of 200 healthy women without breast implants; 100 women with insulin dependent diabetes mellitus (presumably exposed to silicone, see discussion in Chapter 4, Chantelau et al., 1986; Collier and Dawson, 1985~; 100 women with defined connective tissue disease; and 100 women with at least one documented symptom or sign of connective tissue disease.
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From page 211... ...
(1991) using mouse liver and kidney and HEp-2 cells and titers of 1:32 or more, reported 205 patients with either isolated Raynaud's phenomenon or unexplained polyarthritis, or undifferentiated connective tissue disease and found ANA positives of 55, 57 and 59%, respectively.
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From page 212... ...
In a study of 231 symptomatic women with silicone gel breast implants, Smalley et al.
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From page 213... ...
This report used controls of three types, although they were not age matched. A high ANA prevalence was reported in fibromyalgia patients, and there was no information on the presence of defined connective tissue disease in the 500 symptomatic breast implant patients.
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From page 214... ...
The committee concludes that the data in support of a finding of increased prevalence, higher titers, or different profiles of antinuclear antibodies in women with gel- or saline-filled silicone breast implants compared to control women without breast implants are insufficient or flawed. The weight of the better-quality evidence suggests the lack of an association between silicone breast implants and positive ANAs.
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