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Regarding silicone implants and rheumatic disorders.

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LETTERS
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silicone gel on antibody formation in rats. Immunol Invest
22:151-161, 1993
Claman HN, Giorno RC: Silicone and antinuclear antibodies
(abstract). J Allergy Clin Immunol 92:212, 1993
Bridges AJ, Conley C, Wang G, Burns DE, Vasey FB: A
clinical and immunologic evaluation of women with silicone
breast implants and symptoms of rheumatic disease. Ann Intern
Med 118:929-936, 1993
Peters W, Keystone E, Snow K, Rubin L, Smith D: Is there a
relationship between autoantibodies and silicone gel implants?
Ann Plast Surg 32: 1-7, 1994
Wells AF, Daniels S, Gunasekaran S, Wells KE: Increased
hyaluronan and IL-2 in capsular biopsies of women with silicone
breast implants. Ann Plast Surg 33:l-5, 1994
deCamara DL, Sheridan JM, Kammer BA: Rupture and aging of
silicone gel breast implants. Plast Reconstr Surg 91S28-834,
1993
Rothfuss S, Clayburne G, Schumacher HR Jr: Light, electron
microscopic and electron probe elemental analysis studies on
the capsule and pericapsular tissues of patients with silicone
breast implants (abstract). Arthritis Rheum 36 (suppl 9):S271,
1993
Young VL, Nemecek AR: How safe are silicone breast implants? South Med J 86:932-944, 1993
Vasey FB, Bocanegra TS, Havice DL, Seleznick MJ, Bridgeford PH, Germain BF: Silicone associated connective tissue
disease: onset of systemic signs and symptoms after traumatic
rupture of silicone gel filled breast implants (abstract). Arthritis
Rheum 35 (suppl 9):S242, 1992
Vasey FB, Havice DL, Bocanegra TS, Seleznick MJ, Bridgeford PH, Martinez-Osuna P, Espinoza LR: Clinical findings in
symptomatic women with silicone breast implants. Semin Arthritis Rheum 24 (Suppl 1):22-28, 1994
Brozena SJ, Fenske NA, Cruse CW, Espinoza CG, Vasey FB,
Germain BF, Espinoza LR: Human adjuvant disease following
augmentation mammoplasty. Arch Dermatol 124:1383-1386, 1988
Gabriel SE, O’Fallon WM, Kurland LT, Beard CM, Woods JE,
Melton LJ Ill: Risk of connective tissue diseases and other
disorders after breast implantation. N Engl J Med 330:16971702, 1994
Reply
To the Editor:
We are pleased that Drs. Spiera, Vasey, and their
colleagues have shown interest in our article. We agree with
Spiera and colleagues about the disproportionate representation of scleroderma in case reports of women with silicone
breast implants. The observations they outline make scleroderma the most interesting and plausible condition for which
silicone breast implants may be a cause. Unlike manifestations such as arthralgias, myalgias, cognitive dysfunction,
fatigue, and other symptoms putatively caused by implants,
scleroderma, at least, has objective physical evidence. In
contrast to both groups’ opinions, we are more optimistic
about the possibilities of meaningful epidemiologic studies.
The ongoing multicenter casecontrol study by Hochberg et
al, which shows no increased risk for scleroderma in recipients of augmentation mammoplasty, is an example of a
meticulous study that includes a large number of scleroderma patients (Hochberg MC, Perlmutter DL, White B,
Steen V, Medsger TA, Weisman M, Wigley FM: The association of augmentation mammoplasty with systemic sclerosis: results from a multi-center case-control study [abstract],
Arthritis Rheum 37 [suppl9]:S369, 1994).
72 1
We respectfully disagree with the characterization by
Vasey et a1 of our article as one that “misrepresents the
majority of clinical and immunologic observations made to
date.” The Naim study is cited in our paper. We would point
out that silicone needs to be thoroughly homogenized with
antigen in vitro to have an adjuvant effect. This would not be
expected in the human situation.
Studies of serologic abnormalities in subjects with
implants need to be carefully controlled and the subjects
unselected. Positive ANAs, for instance, are found in 2030% of normal women between 30 and 40 years old. Vasey et
a1 describe their morphologic study and that of Rothfuss et
al, but it should be noted that these findings are seen in all
foreign body reactions; histochemistry findings are remote
evidence for systemic effects.
Vasey and colleagues imply biased citation of the
literature. We used only full-length publications for summarizing the reported cases and laboratory features in our
Tables 1 and 2 because abstracts did not have sufficient
information. Nevertheless, when one includes the published
abstract cases and compares the overall rates of rheumatic
disease with those expected, there is not an increased risk.
The only possible exception, as we state, is scleroderma if
one uses the lowest rates shown in the literature.
Vasey et a1 believe that the best evidence of causality
is that which comes from clinical observations after explantation. This may be true if explantations are performed under
careful study, i.e., ensuring that baseline and followup status
are evaluated under blinded conditions. Currently, there is
likely to be a strong publication bias in which successful
explantations are more likely to be reported than unsuccessful ones.
We do not believe the current data suggest that
breast implants cause either scleroderma or other connective
tissue disease. Whether silicone breast implants cause a
unique disorder is currently under study. However, given
the high prevalence of fibromyalgia and the other subjective
symptoms described, and the current litigious environment,
proving such a relationship would be a formidable task indeed,
Jorge Sanchez-Guerrero, MD, MSc
Istituto Nacional
de la Nutricicin
Mexico City, Mexico
John S . Sergent, MD
S t . Thomas Hospital
Nashville, TN
Peter H. Schur, MD
Matthew H . Liang, MD, MPH
Brigharn and Women’s Hospital
Boston, MA38
Regarding silicone implants and rheumatic disorders
To the Editor:
The expectation of an unearned financial windfall is a
potent analgesic and antidepressant. No scintilla of evidence-clinical, scientific, or statistical-links silicone implants to any rheumatic disease. The entire allegation results
from a combination and concatenation of Berkson’s fallacy,
722
LETTERS
rapacious lawyers, misguided or greedy physicians, and the
feminist agenda, whose gravamen gave impetus to the spurious epidemiology. The media and some well-placed politicians aggravated the problem.
Taking the data from all published findings, one
could conclude that fewer cases of rheumatic disease than
actuarially predicted develop in silicone implant recipients.
To infer that such implants protect against rheumatic diseases would be as preposterous as the obverse. Rather, the
women who seek such implants for cosmetic reasons, even
after surgery, probably are healthier than the average because they obviously care about their appearance, probably
also their health (more wholesome diets, more exercise,
better medical care), and likely come from a more affluent
segment of the population. These speculations need to be
affirmed, but they at least explain the paradox better than
other less likely possibilities. As the majority of alleged
associated diseases fall under the rubric of fibromyalgia and
similar rheumatic syndromes without objective changes, and
most emerged after extensive media hyperbole and panicked
regulatory reaction, with the real possibility of compensation
from manufacturers to avoid even more expensive litigation,
a causal relationship with implants remains to be established. One cannot deduce parallels with the tobacco companies’ denial of harm from smoking; for implants, not even
circumstantial evidence has emerged. The post-removal
improvement (save for local problems from leakage and
rupture) may well be furthered by the dollar poultice.
George E. Ehrlich, MD
Philadelphia, PA
Selection of study population in the development of
rheumatic disease criteria: comment on the article by
the American College of Rheumatology Diagnostic and
Therapeutic Criteria Committee
To the Editor:
We read with interest the clear and concise overview
of criteria for rheumatic diseases by the American College of
Rheumatology (ACR) Diagnostic and Therapeutic Criteria
Committee (1). We would, however, take issue with one
point which reflects a wider problem we see with many of the
published ACR criteria schemes. The authors argue that
when criteria are applied in a population setting, “the
sensitivity will remain the same.” This is, however, only
true for the classification of cases similar to those in whom
the original criteria were derived. If, for example, the
severity profile varied between the specialist centers providing the cases for criteria derivation and the proposed target
study population, then sensitivity may indeed be lost.
Two examples illustrate the point. The first concerns
the 1987 revised criteria for rheumatoid arthritis (RA) (2).
These were derived using patients who were current attenders of academic medical centers or private physician practices and had a median disease duration of 8 years. It is likely
that such patients had more severe and widespread disease
than would be seen either in an early-RA clinic or in the
population setting. Indeed, one study has demonstrated that
the sensitivity of the criteria in patients with early RA is
lower than that reported in the original publication (3).
Second, in relation to systemic sclerosis, the Diagnostic and
Therapeutic Criteria Committee accepts that the criteria (4)
were developed from a population with a “disproportionately high representation of diffuse cutaneous disease.” The
results from population studies suggest that the proportion
with limited cutaneous disease may be substantially higher
than the 10% suggested in this overview (5).
These differences, in part, reflect the earlier access to
specialist care in countries outside the U.S. As an example,
in our population-based prospective incidence study of RA,
74% of cases were seen in a specialist center within 12
months of the appearance of symptoms (6).
The authors complete their overview with the valuable suggestion that methods sections of articles should give
more details of the results achieved when applying the
relevant classification scheme. We would urge the Diagnostic and Therapeutic Criteria Committee, in subsequent studies, to test its criteria in populations of patients seen outside
specialist centers and early in their disease. It is the study of
these individuals that will yield vital information on prognosis and outcome, and with current criteria, there is an
important risk of misclassification.
Alan J. Silman, MD
Deborah P. M. Symmons, MD
ARC Epidemiology Research Unit
Universio of Manchester
Munchester, UK
1. Fries JF, Hochberg MC, Medsger TA Jr, Hunder G G , Bombardier C, and the American College of Rheumatology Diagnostic
and Therapeutic Criteria Committee: Criteria for rheumatic disease: different types and different functions. Arthritis Rheum
37:45#62, 1994
2. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF,
Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS,
Medsger TA Jr, Mitchell Dm, Neustadt DH, Pinals RS, Schaller
JG, Sharp JT, Wilder RL, Hunder GG. The American Rheumatism Association 1987 revised criteria for the classification of
rheumatoid arthritis. Arthritis Rheum 31:315-324, 1988
3. Bernelot Moens HJ, van de Laar MAFJ, van der Korst JK:
Comparison of the sensitivity and specificity of the 1958and 1987
criteria for rheumatoid arthritis. J Rheumatol 19: 198-203, 1992
4. Subcommittee for Scleroderma Criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee: Preliminary criteria for the classification of systemic
sclerosis (scleroderma). Arthritis Rheum 23581-590, 1980
5. Silman A, Jannini S, Symmons D, Bacon P: An epidemiological
study of scleroderma in the West Midlands. Br J Rheumatol
27:28&290, 1988
6. Symmons DPM, Barrett EM, Bankhead CR, Scott DGI, Silman
AJ: The incidence of rheumatoid arthritis in the United Kingdom:
results from the Norfolk Arthritis Register. Br J Rheumatol
33:735-739, 1994
Reply
To the Editor:
We thank Drs. Silman and Symmons for their comments. Their point that the sensitivity of criteria sets may
vary in populations with differing severity of disease is
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