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Lack of association between augmentation mammoplasty and systemic sclerosis scleroderma.

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ARTHRITIS & RHEUMATISM
Vol. 39, No. 7. July 1996. pp 1125-1131
0 1996, American College of Rheumatology
1125
LACK OF ASSOCIATION BETWEEN AUGMENTATION MAMMOPLASTY
AND SYSTEMIC SCLEROSIS (SCLERODERMA)
MARC C. HOCHBERG, DONNA L. PERLMLTITER, THOMAS A. MEDSGER, JR., KATHERINE NGUYEN,
VIRGINIA STEEN, MICHAEL H. WEISMAN, BARBARA WHITE, and FREDRICK M. WIGLEY
Objective. To examine the possible association
between augmentation mammoplasty and systemic sclerosis (SSc; scleroderma).
Methods. Eight hundred thirty-seven women with
a clinical diagnosis of SSc, recruited a s a volunteer
sample from 3 university-based, tertiary care scleroderma clinical research centers, and 2,507 race-matched
local control women, recruited by the technique of
random-digit-dialing and frequency-matched on age,
completed a questionnaire providing data on history of
augmentation mammoplasty, including possible complications of the procedure. The odds ratio (OR) and 95
percent confidence interval (95%CI) for the association
of augmentation mammoplasty with SSc were estimated
Presented in part at the 56th National Meeting of the
American College of Rheumatology, .4tlanta, GA, October 1 9 2 , the
57th National Meeting of the American College of Rheumatology, San
Antonio, TX, November 1993, and the 58th National Meeting of the
American College of Rheumatology, Minneapolis, MN, October 1994.
Supported in part by NIH grants AM-00056 and AR-21393,
and by grants from the Plastic Surgery Educational Foundation and
the Arthritis Foundation, Western Pennsylvania Chapter (Shoemaker
Fund).
Marc C. Hochberg, MD, MPH, Donna L. Perlmutter. MSc,
Barbara White, MD: University of Maryland School of Medicine. and
Veterans Affairs Medical Center, Baltimore, Maryland; Thomas A.
Medsger, Jr., MD, Virginia Steen, MD: University of Pittsburgh
School of Medicine, Pittsburgh, Pennsylvania; Katherine Nguyen, MD,
Michael H. Weisman, MD: University of California San Diego School
of Medicine, San Diego; Fredrick M. Wigley, MD: The Johns Hopkins
University School of Medicine, Baltimore, Maryland.
Dr. Hochberg served as a consultant to the law firm McCarter
and English in the development of classification criteria for compensation in the proposed global breast implant settlement; Dr. Weisman
has served as a consultant and expert witness for law firms representing
manufacturers of breast implants; Dr. White has sewed as a consultant
for law firms representing manufacturers of breast implants; Dr.
Wigley has presented educational programs regarding a possible
relationship between breast implants and rheumatic disease to law
firms representing insurers and manufacturers.
Address reprint requests to Marc C. Hochberg. MD, MPH.
University of Maryland School of Medicine, 10 South Pine Street,
MSTF 8-34, Baltimore, MD 21201.
Submitted for publication September 27, 1995; accepted in
revised form January 17, 1996.
by multivariate logistic regression analysis with adjustment for age, race and center, and by conditional
logistic regression analysis with adjustment for age.
Results. Eleven (131%)of the 837 cases reported
a history of augmentation mammoplasty prior to diagnosis of SSc, compared with 31 (1.24%) of the 2,507
controls. The adjusted OR from the unmatched analysis
was 1.07 (95% CI 0.53-2.13), while that from the
matched analysis was 1.11 (95% CI 0.55-2.24).
Conclusion. These results fail to demonstrate a
significant association between augmentation mammoplasty and SSc, and are consistent with those reported
from other epidemiologic studies.
Thirty years ago, Miyoshi and colleagues published the first report of patients with a presumed
connective tissue disease following cosmetic breast augmentation by direct injection of liquid paraffin and
silicone (1). In 1984, Kumagai and colleagues described
11 patients with definite connective tissue disease and 7
with possible connective tissue disease and reviewed 28
additional cases from the Japanese literature (2). All of
these patients had breast augmentation by injection of a
foreign substance, most commonly paraffin or silicone,
and 8 had a diagnosis of systemic sclerosis (SSc; scleroderma). The first report of patients developing definite
connective tissue disease following augmentation mammoplasty with silicone gel-filled breast implants was
presented by van Nunen and colleagues in 1982 (3).
Numerous case reports and case series describing
patients with rheumatic disease symptoms and connective tissue diseases following augmentation mammoplasty with silicone gel-filled breast implants were published during the ensuing decade (4-20). In a review of
the English-language literature published from 1979
through June 1993, Sanchez-Guerrero and colleagues
identified reports of 293 patients with rheumatic disease
symptoms following augmentation mammoplasty with
silicone gel-filled breast implants; of 57 patients with a
HOCHBERG ET AL
1126
definite connective tissue disease, 38 (66.7%) had a
diagnosis of SSc (21). Subsequent to that review, data on
376 patients with rheumatic symptoms following augmentation mammoplasty with silicone breast implants,
some of whom had previously been reported, were
published (22-25).
SSc is an uncommon connective tissue disease of
unknown etiology(ies). Several occupational and environmental factors, including exposure to silica dust, have
been found to be associated with SSc in epidemiologic
studies (for review, see refs. 26 and 27). Because of the
clinical observations suggesting a possible relationship
between augmentation mammoplasty with silicone gelfilled breast implants and SSc, we conducted the present
multicenter case-control study to test the hypothesis
that augmentation mammoplasty with silicone gel-filled
breast implants is associated with the subsequent development of SSc.
SUBJECTS AND METHODS
Cases. Women with a clinical diagnosis of SSc were
identified at 3 university-based scleroderma clinical research
centers: The Johns Hopkins-University of Maryland Scleroderma Center, the University of Pittsburgh Scleroderma Data
Bank, and the University of California San Diego. The means
of identification of cases at the Baltimore site has been
described previously (28); briefly, the cases included patients
seen at The Scleroderma Center, patients referred by rheumatologists in the Baltimore-Washington metropolitan area, and
patients who were members of the Greater Washington DC
chapter of the Scleroderma Foundation. The cases from the
Pittsburgh site were all seen by faculty members at the Division
of Rheumatology and Clinical Immunology, University of
Pittsburgh School of Medicine: and were consecutively enrolled in a longitudinal outcome study. Patients from the San
Diego site were followed up either by members of the Division
of Rheumatology, University of California San Diego o r by
community-based rheumatologists in San Diego and Orange
County, CA.
Controls. Race- and sex-matched local controls,
frequency-matched to the cases on age, were identified
through the technique of random-digit-dialing (29). Telephone
numbers, matched to case numbers on area code and the first
3 of 7 digits, were obtained from Survey Sampling, Inc.
(Fairfield, CT). Controls were age-matched to cases in 3 strata:
age <45, age 45-64, and age 265.
A total of 16,607 telephone numbers were called to
identify eligible controls. Of those, 7,487 (45.1%) were either
nonworking or business numbers, o r there was no answer or a
busy signal on repeated attempts. A further 4,903 numbers
(29.5%) identified ineligible subjects: 2,181 were age-ineligible
women, 1,173 were households that had no women, 896 were
race-ineligible women, 365 were both age- and race-ineligible
women, 168 were women who spoke a foreign language, 84
were women with a cognitive o r hearing impairment, and 36
were women with self-reported diagnoses of connective tissue
diseases. The latter group included 15 women with systemic
lupus erythematosus, 14 with Raynaud’s phenomenon alone, 3
with polymyositis or dermatomyositis, 2 with SSc, and 2 with
Sjogren’s syndrome. The overall refusal rate among eligible
women who were screened was 10.4%.
Questionnaire. The questionnaire included sections on
sociodemographic factors, detailed gynecologic and obstetric
history, history of breast surgery including augmentation mammoplasty, and history of other cosmetic surgical procedures.
Women who reported breast surgery were further queried as
to the indication for the surgery. Those who reported augmentation mammoplasty were asked the year of the procedure,
information on the subsequent development of complications,
and the year of and indication for explantation, if it occurred.
The questionnaire included items from one that had been
previously used in a population-based study of factors associated with connective tissue disease (30), with supplementary
questions on augmentation mammoplasty that were reviewed
by a group of plastic and reconstructive surgeons.
Data collection. Among the cases, data were collected
by completion of self-administered questionnaires. All cases
had an equal likelihood of being included in the study. The
data collection method for the Baltimore cases has been
described previously (28). A total of 339 eligible cases were
mailed questionnaires in July 1990, and completed responses
were obtained from 210 women (61.9%); data on an additional
18 of these eligible cases were obtained in 1993. A total of 652
women with SSc included in the registry of the University of
Pittsburgh Scleroderma Data Bank were mailed questionnaires in either January or July of 1991, and 511 (78.4%)
returned questionnaires with data on augmentation mammoplasty. A total of 156 cases from San Diego were mailed
questionnaires in the summer of 1991; the response rate
among the San Diego cases was 100%. All cases with completed questionnaires whose age at diagnosis was <18 years,
who were diagnosed after December 1991, or who resided
outside the continental US were excluded from further analyses.
Among the controls, data were collected by telephone
interview by trained interviewers using the identical questionnaire, during the period July 1993 through December 1994.
Using the technique of random-digit-dialing, each phone number was screened by an interviewer for eligibility. Once an
eligible household was found, a woman in the household was
chosen at random and screened. The screening questions
included information o n age, race, and history of physiciandiagnosed connective tissue disease. If the woman was eligible,
a confidentiality statement was read to obtain informed consent; then the interviewer administered the questionnaire.
Data analysis. Data were keypunched with a P C 100-4
Data Entry Workstation, using OS/2000 software for data entry
(Scan-Optics, Falls Church, VA). Data were transferred for
analysis to an IBM 4381 mainframe. All analyses were conducted with SAS version 6.0 (Cary, NC). Means and standard
deviations were calculated for continuous variables ( e g , age),
and frequencies were determined for categorical variables
(e.g., race). Univariate comparisons between cases and controls, using unmatched data, were performed using Student’s
t-test for continuous variables and chi-square tests for categorical variables, to detect possible confounding variables. Odds
ratios (OR) for the association of augmentation mammoplasty
1127
AUGMENTATION MAMMOPLASTY AND SCLERODERMA
with SSc were calculated from multiple logistic regression
models using PROC LOGIST, with all available data and
adjustment for age, race, and site. In addition, a matched
analysis was performed using P R O C PHREG, with adjustment
for age; in this analysis, data on cases without any matched
controls were excluded. Statistical significance was inferred
when 95% confidence intervals (95% CI) did not include unity
or P values were less than or equal to 0.05.
Table 2. Frequency of breast surgery and augmentation mammoplasty in 837 women with systemic sclerosis (cases) and 2,507 age-,
race-, and sex-matched local controls
Breast surgery. no. (%)*
Augmentation mammoplasty, no. (%)
Cases
Controls
117 (17.9)
11 (1.31)
463 (18.5)
31 (1.24)t
* Data available on 653 cases and 2,507 controls.
t Odds
RESULTS
We identified and interviewed a total of 837 cases
with systemic sclerosis whose age at diagnosis was 218
years, or year of diagnosis was 1991 or earlier, and who
resided in the continental US. A total of 2,507 controls
were successfully interviewed; the number of controls
per case ranged from 0 to 4 (median 3). There were no
significant differences in distributions of sociodemographic factors between cases and controls (Table 1).
The mean 2 SD age of the cases was 55.3 2 12.9 years
at the time of interview. The mean age at diagnosis was
44.9 ? 12.9 years, and the mean duration of SSc at the
time of interview was 10.0 2 7.2 years. Data on history of
breast surgery other than augmentation mammoplasty
were not obtained from 184 cases in the Pittsburgh
Scleroderma Data Bank, due to a clerical oversight. One
hundred seventeen (17.9%) of the 653 cases with available data and 463 (18.5%) of the controls reported a
history of breast surgery (Table 2). There was no significant difference in the distribution of indications for
surgery between cases and controls (data not shown);
indications (in descending order of frequency) included
benign breast masses, breast cancer, fibrocystic breast
disease, and mastitis.
Table 1. Sociodemographic factors in 837 women with systemic
sclerosis (cases) and 2,507 age-, race-, and sex-matched local controls
Age at interview, years
Mean ? SD
Range
Age at diagnosis, years
Mean i- SD
Range
Duration of disease, years
Mean 2 SD
Range
White, no. (%)
Currently married, no. (%)*
High school graduates, no. (%)t
Cases
Controls
55.3 t 12.9
23- 89
55.6 t 15.5
18-81
44.9 2 12.9
18-81
10.0 ? 7.2
0-41
757 (90.4)
556 (67.7)
520 (86.8)
* Data available on 821 cases and 2,496 controls.
t Data available on 599 cases and 2,502 controls.
2,278 (90.9)
1,567 (62.8)
2,133 (85.3)
ratio (95% confidence interval) estimated from multiple
logistic regression model with adjustment for age, race, and site was
1.07 (0.53-2.13), while that estimated from conditional logistic regression model with adjustment for age was 1.11 (0.55-2.24).
Only 11 (1.31%) of the 837 cases reported having
undergone augmentation mammoplasty with placement
of silicone gel-filled prostheses prior to physician diagnosis of SSc (Table 2). The interval between augmentation mammoplasty and the diagnosis of SSc ranged from
4 years to 21 years, with a median of 11years; 6 cases had
their implants 10 or more years before the diagnosis of
SSc. None of the 11 reported having complications of
their implants. Four, however, subsequently underwent explantation; reasons stated were the diagnosis
of scleroderma in 2, hardening in 1, and hardening
and leakage in 1.
In comparison, 31 (1.24%) of the 2,507 controls
reported having had augmentation mammoplasty with
silicone gel-filled prostheses; the adjusted OR estimated
from multiple logistic regression analysis was 1.07 (95%
CI 0.53-2.13) (Table 2). The adjusted OR estimated
from the conditional logistic regression analysis was 1.11
(95% CI 0.55-2.24). The controls had undergone implantation between 1 year and 23 years prior to interview, with a median of 10 years and a mean 2 SD of 10.2
t 6.5 years prior to interview; 17 had implants for 10 or
more years prior to interview. Complications of implantation were noted by 5 controls; these included hardening and implant shift in 2 each, and capsular contraction
and rupture in 1 each. Only 1 control reported explantation of her prostheses; the reported reason was breast
pain.
Finally, because augmentation mammoplasty
with silicone gel-filled breast implants has been available in the US only since 1962 (31), we repeated the
analysis after excluding data on 35 cases whose diagnosis
occurred prior to 1963, since they would not have been
at risk for exposure, and on their matched controls. The
adjusted OR for the association of augmentation mammoplasty with SSc in the remaining subgroup was 1.08
HOCHBERG ET AL
1128
(95% CI 0.53-2.17) and 1.10 (95% CI 0.54-2.23) in the
unmatched and matched analyses, respectively.
DISCUSSION
These data, obtained from the largest casecontrol study of patients with systemic sclerosis conducted to date, fail to support the hypothesis that
exposure to augmentation mammoplasty with silicone
gel-filled breast implants is associated with a significantly increased risk of development of SSc. These
results are consistent with those of other epidemiologic
studies which also have failed to demonstrate a significantly increased risk of developing SSc or other definite
connective tissue disease among women with silicone
gel-filled breast implants (31-36).
Silicone is a polymer consisting of alternating
atoms of silicon and oxygen, with methyl groups attached to the other binding sites of the silicon atom. By
varying the number of crosslinks between chains of
polydimethylsiloxane, the compound can be made to
assume various physical forms: liquid, gel, or solid
elastomer. Augmentation mammoplasty with silicone
gel-filled breast implants is a common surgical procedure in the US. Recent estimates, based on either
surveys of representative samples of the US population
(37-39) or identification of all women with breast implants in a defined region (40), show that -8 per 1,000
women age 15 and older reported breast implantation in
1989 (39), and -1% of women age 15 and older living in
Rochester, MN had implants as of January 1992 (40).
Breast implantation is more common among white than
black women, more common in the southern and western US compared with the eastern and northern US, and
more common in women with higher socioeconomic
status; the greatest prevalence is found among white
women in the 45-54-year age group (37-39).
The possible relationship between augmentation
mammoplasty and both definite and atypical connective
tissue disease has been the subject of many case series,
review articles, editorials, and symposia (1-25,41-43).
Based on the case series, a hypothesis that women with
silicone gel-filled breast implants are at increased risk of
developing both definite and atypical connective tissue
diseases was constructed; however, few epidemiologic
studies have been conducted to formally address this
hypothesis. Two epidemiologic studies have focused on
the entire spectrum of connective tissue diseases (33,34),
while 2 others have addressed the potential association
with SSc (35,36).
Gabriel and colleagues performed a retrospective
cohort study of 749 women with breast implants and
1,498 age-, sex-, and race-matched controls (33). Only 5
exposed and 10 unexposed women developed a definite
connective tissue disease over a mean followup of 8
years; the adjusted relative risk, derived from multivariate Cox proportional hazards models, was 1.10 (95% CI
0.37-3.23). None of the exposed or unexposed women
developed SSc.
Sanchez-Guerrero et a1 analyzed longitudinal
data from 87,501 female participants in the Nurse’s
Health Study for whom information on exposure to
breast implants was available (34). They identified a
total of 516 women who developed a definite connective
tissue disease diagnosed between July 1976 and May
1990 and compared the incidence rate of definite connective tissue disease between those with breast implants
and the unexposed group. Only 3 of the 1,183 women
who had undergone augmentation mammoplasty developed a definite connective tissue disease, compared with
513 of the 86,318 unexposed women; the adjusted relative risk was 0.6 (95% CI 0.2-2.0). The mean +- SD time
from implantation to diagnosis of connective tissue
disease was 9.9 t 6.4 years in the cases; the mean time
from implantation to interview was identical in the
unexposed women. Of interest, all 3 women with implants
who developed a definite connective tissue disease had
rheumatoid arthritis; none of the 14 women who developed SSc had undergone augmentation mammoplasty.
Thus, neither the cohort study by Gabriel et a1
(33) nor that by Sanchez-Guerrero and colleagues (34)
was able to adequately address the hypothesis of a causal
association of breast implantation with SSc, because of
inadequate power.
Englert and Brooks conducted a case-control
study of 215 women with SSc and 289 age-matched
control women living in Sydney, Australia (35). Four
cases and 5 controls reported augmentation mammoplasty; the O R for the association of augmentation
mammoplasty with SSc, adjusted for socioeconomic
status, was 0.89 (95% CI 0.23-3.41). The median duration between implantation and diagnosis of SSc among
the 3 cases with available data was 2 years. Those
authors also failed to find any significant difference in
the frequency of breast surgery between cases and
controls.
Burns performed a case-control study of 274
women with SSc and 1,184 age- and race-matched
controls living in Michigan (36). Two cases and 14
controls reported augmentation mammoplasty; the OR,
adjusted for age, race, and income, was 0.35 (95% CI
AUGMENTATION MAMMOPLASTY AND SCLERODERMA
0.05-2.74). The duration between implantation and diagnosis of SSc was 1 year and 12 years in the 2 cases,
while the median duration between implantation and
interview in the controls was 10.4 years; 1 of the cases,
but none of the controls, reported a rupture of her
implant.
The present study utilized the case-control design since SSc is an uncommon disease with low incidence and prevalence rates (26,27). Because the frequency of augmentation mammoplasty in women is
-l%, as noted above, it was estimated that about 1,000
SSc cases and 3,000 controls would be needed in order to
detect an association between augmentation mammoplasty and SSc with an odds ratio of 2.0 with 90% power.
Given the sample size of 837 cases analyzed in the
present study, there was 80% power of detecting an odds
ratio of 1.8 for the association between augmentation
mammoplasty and SSc. In addition, the potential confounding variables of age, race, and region of the
country were adjusted for in both the design of the study
and in the analysis. There was no difference between
cases and controls in socioeconomic status as measured
by marital status and proportion who were high school
graduates.
There are several potential limitations to inferences drawn from these results. The cases studied were
from 3 prevalence cohorts of patients identified from 3
university-based clinical research centers; they were not
a random sample of all women with scleroderma in the
general population. Furthermore, the cases had a mean
disease duration of 10 years at the time of interview. If
augmentation mammoplasty with silicone gel-filled
prostheses were associated with the development of a
rapidly fatal form of SSc, then such patients might not
have survived to be referred to either a practicing
rheumatologist or a university-based scleroderma center
for evaluation and longitudinal followup care. Such an
occurrence is unlikely, however, based on reports suggesting a long latency period, approaching or exceeding
10 years, in cases of SSc following augmentation mammoplasty with paraffin or silicone injections (2).
The frequency of augmentation mammoplasty
reported by the SSc patients in the present study, 13 per
1,000, is comparable with that noted by other investigators (10,16,19,35,36). Similarly, the frequency of augmentation mammoplasty reported by the controls in the
present study is comparable with that found in other
studies (39,40), despite the fact that the controls in the
present study were not a random sample of all women in
the general population without definite connective tissue
disease. Furthermore, despite the difference in response
1129
rates between cases and controls, and among the cases
from different centers, it is unlikely that there was biased
underreporting of augmentation mammoplasty in the
cases compared with the controls in the present study.
Because of the differences in methodology of data
collection between cases and controls, a validation study
was performed among a 5% random sample of controls,
and responses to the question concerning breast surgery
had an agreement rate of 96.7%. Underreporting in
response to sensitive questions is more likely to occur
with face-to-face interviews than with either mailed
questionnaires or telephone interviews. The survey by
the National Center for Health Statistics, which used
face-to-face interviews, showed a prevalence rate of 3.3
implant recipients per 1,000 women age 18 and older
(38). In a study using postal questionnaires, the prevalence was 8.2 implant recipients per 1,000 white women
age 14 and older (39).
In this study, we were unable to address the
question of whether only implants complicated by rupture and leakage are associated with the subsequent
development of SSc. Several authors have suggested that
silicone gel released after rupture,of the implant may be
immunogenic in rodents and humans (44-47). Based on
these findings, it might be hypothesized that only women
with ruptured implants are at increased risk of developing connective tissue disease, specifically SSc. None of
the cases in the present study reported having complications of their implants, although 1 reported having
explantation due to hardening and leakage. Our study
did not have adequate power to address this alternate
hypothesis.
Finally, this epidemiologic study was not designed to investigate the association of augmentation
mammoplasty with other definite connective tissue diseases, such as rheumatoid arthritis or systemic lupus
erythematosus, or atypical connective tissue diseases or
rheumatic syndromes. In order to study the association
between augmentation mammoplasty and atypical connective tissue disease, a case definition of the latter must
first be developed by rheumatologists and epidemiologists working in concert, and then studies designed with
the choice of appropriate controls.
In conclusion, the results from the present investigation fail to demonstrate a significant association
between augmentation mammoplasty with silicone
breast implants and the development of systemic sclerosis. These findings are consistent with those of other
published epidemiologic studies.
HOCHBERG ET AL
1130
ACKNOWLEDGMENTS
T h e authors wish to thank Dr. Betsy B. Singh, Director, EPM Research Services, Karen Volpini, D a t a Management Supervisor, EPM Research Services, Dr. Patricia Langenburg for statistical consultation, and Rennert Kane for
conducting the statistical analysis. In addition, we thank Marian Bushel, Cathy Cohen, L e a h Jacobson, Jane Kligman,
Elizabeth Krissoff, Nancy Lawhon, Elizabeth Leatherman,
Suzanne Markowitz, Sara Morgan, Edith Moses, Rosemary
Pina, Judy Stein, Nancy Wilson, and Sharon Wolfson for
conducting the interviews of the controls. I n Pittsburgh, Claudia Conte, MPH and Gig Allia, RN aided in data collection.
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