March, 2005
What Does the Institute of Medicine Report
Say About the Safety of Silicone Breast Implants?
By Diana Zuckerman, PhD and Patricia Lieberman,
PhD
The Institute of Medicine (IOM) completed a report in 1999 on the
safety of silicone breast implants.1
The report did not involve any new research - it was a review of
the literature that existed at that time.
The IOM report concluded that breast implants frequently result
in local complications, some of them serious or debilitating, such
as pain, capsular contracture, and rupture. Little attention has
been focused on these findings.
Instead, the major focus has been on the report's chapter reviewing
17 epidemiological studies of classic connective tissue diseases
such as lupus and scleroderma. These were the only epidemiological
studies available in 1999, but most did not evaluate the atypical
connective tissue disease symptoms or fibromyalgia symptoms that
many patients report. Almost all of these studies were funded by
implant manufacturers at a time when they were preparing their defense
against escalating legal challenges from women reporting serious
health problems. These same 17 studies, as well as three additional
studies, were also included in a meta-analysis published in 2000.2
The IOM report and the meta-analysis have been cited as proof that
breast implants do not cause disease, but both were limited by the
quality of the same 17-20 epidemiological studies on connective
tissue disease, only 15 of which were published in peer-reviewed
journals. The IOM report also included a chapter on implants and
cancer, focused almost exclusively on breast cancer. The few studies
that evaluated other types of cancer included large numbers of women
who had implants for less than 10 years or even less than 5 years
- too short a period of time to measure an increased risk of cancer.
Since the IOM report was based on the limited research available
in 1999, it was never meant to be the "final word" on the topic.
The authors concluded that the weight of existing evidence at that
time did not prove that breast implants cause diseases.
Research Evidence After the IOM Study Raises Concerns
Several well-designed epidemiological studies published more recently
have reported statistically significant increases in the risk of
serious diseases among women with breast implants. An epidemiological
study by scientists at the National Cancer Institute (NCI) analyzed
mortality among women who had breast implants for at least seven
years. They found that breast implant patients were twice as likely
to die from brain cancer, three times as likely to die from lung
cancer, and four times as likely to commit suicide, compared to
other plastic surgery patients.3 Two
studies conducted in Scandinavia found an increase in lung cancer
and suicide among women with breast implants.4,
5
A subsequent study of the same data set by many of the same scientists
from NCI found that women with breast implants were significantly
more likely to report several autoimmune diseases, such as rheumatoid
arthritis.6 However, many of the women
made errors in their self-reported diagnoses; for example, many
women who reported having rheumatoid arthritis had osteoarthritis
instead, according to their medical records. This suggests that
there are increased symptoms among these women, but the exact diagnoses
are unclear. As a result, the researchers concluded that the association
between breast implants and arthritis, scleroderma, Sjogren's syndrome,
and other connective tissue diseases need further study.
A study of women who had silicone breast implants for at least six
years, conducted by scientists at the Food and Drug Administration
(FDA), found that women with implants leaking outside the scar capsule
were more likely to report fibromyalgia and several other autoimmune
diseases. The comparison group was women with silicone implants
that were not leaking outside the capsule.7
Why are the research findings from the last few years so different
from the earlier studies included in the IOM report? First, the
IOM review of epidemiological research was focused almost entirely
on classic connective tissue diseases. Second, several of the studies
found increases in connective tissue diseases that would have been
statistically significant if maintained in a larger sample. Overall,
the IOM report was limited by the serious shortcomings of the research
that had been conducted at the time the report was written. One
expert, the chair of the FDA's General and Plastic Surgery Devices
Advisory Panel, pointed out that "what was considered by them [the
IOM] reflected low-quality data in the age of evidence-based medicine."
8
The shortcomings of the epidemiological studies that the
reports summarized include:
• The studies had too few women with
breast implants.
• The case-control studies included very few women with implants,
either as cases or controls. For example, the study by Strom et
al. (see discussion, page 11) compared women with rheumatologic
diseases with women without diseases, and only one woman with
implants was in the study.
• The cohort studies included more women with implants than
the case-control studies, but not enough to study women with rare
diseases. For example, Gabriel et al. (see discussion,
page 5) compared only 749 women with breast implants to a comparison
sample to evaluate the prevalence of several connective tissue
diseases. The authors acknowledged that the sample was too small
to evaluate a doubling of the risks of rare diseases such as scleroderma.
• The women in the studies didn't have implants long enough
to develop most diseases. For example, the study by Schusterman
et al. (see discussion, page 8) did not include any women
who had breast implants for more than 2.5 years. Most autoimmune
diseases take much longer than that to develop and be diagnosed.
Research is needed on women with implants for a longer period
of time to determine if exposure to breast implants increases
health risks.
• Control group or comparison sample was inappropriate. In
one study, the comparison sample was comprised of women with other
rheumatologic diseases (Goldman et al., see discussion,
page 10). In several studies, the comparison sample was comprised
of breast reduction patients, a group that differs significantly
from augmentation patients on several measures, and is apparently
at higher risk of autoimmune diseases than the general population.
• Studies did not include medical exams. All but one of the
case-control studies asked women if they had breast implants (usually
over the telephone) and did not verify if the information was
correct. In the cohort studies, most of the data about illness
relied on medical records, some on hospitalization records, and
a few on self-reported illnesses. Medical exams and diagnoses
by physicians unaware of which women have breast implants would
be the most reliable measure of any link between implants and
illness. Only one study included medical exams - the Schusterman
study, which included women with implants for less than 2.5 years.
• Studies did not evaluate the symptoms that are most widely
reported by women with implants, such as pain, memory loss, and
fatigue. The studies only evaluated a few, classically diagnosed
autoimmune diseases.
Information about the sample sizes, outcome
measures, and other methodological information about the 20 studies
reviewed are attached.
References:
1 Bondurant S, Ernster V, Herdman,
R, eds. Safety of silicone breast implants. Washington, DC: Institute
of Medicine; 1999.
2 Janowsky EC, Kupper LL, Hulka
BS. Meta-analyses of the relation between silicone breast implants
and the risk of connective-tissue diseases. New England Journal
of Medicine. 2000;342:781-90.
3 Brinton LA, Lubin, JH, Burich
MC, et al. Mortality among augmentation mammoplasty patients. Epidemiology.
2001; 12: 321-326.
4 Koot VCM, Peeters PHM, Granath
F, et al. Total and cause specific mortality among Swedish women
with cosmetic breast implants: prospective study. British Medical
Journal. 2003; 326: 527-528.
5 Jacobsen PH, Holmich LR, McLaughlin
JK Mortality and suicide among Danish women with cosmetic breast
implants. Archives of Internal Medicine. 2004, 164: 2450.
6 Brinton, LA, Buckley, LM, Dvorkina,
O et al. Risks of connective tissue disorders among breast implant
patients. American Journal of Epidemiology. 2004, 180:
619-27.
7 Brown SL, Pennello G, Berg WA,
et al. Silicone gel breast implant rupture, extracapsular silicone,
and health status in a population of women. Journal of Rheumatology.
2001; 28:996-1003.
8 Available: www.breastimplantinfo.org/news/whalenlet.htm
Cohort Studies
Cohort studies compare women with breast implants to a group of
women who are similar in terms of age, race, and health who did
not have breast implants.
Edworthy, S.M., Martin, L., Barr, S.G., et al. A Clinical
Study of the Relationship Between Silicone Breast Implants and Connective
Tissue Disease. Journal of Rheumatology 1998; 25: 254-260.
Number of implant recipients: 1,576
Number of controls: 727
Does the study include mastectomy patients receiving implants?
NO
Diseases studied: Any classic connective tissue
disease including rheumatoid arthritis, lupus, scleroderma, and
Sjogren's syndrome.
Minimum length of time with implants included in study:
Unclear
Average length of time with implants: 13.5 years
Additional notes: Women with breast implants were
44% more likely to have a diagnosis of rheumatoid arthritis (relative
risk: 1.44). That difference was not statistically significant.
When interviewed about their health, women with implants were significantly
more likely to have difficulty solving thought problems, have numbness
in their extremities, muscle pain, headache, and hand pain. However,
those symptoms were not included in the meta-analysis. This study
relied on medical records. The authors did not question or examine
patients directly.
Friis, S., Mellemkjaer, L., McLaughlin,
J.K., et al. Connective Tissue Disease and other Rheumatic Conditions
Following Breast Implants in Denmark. Annals of Plastic Surgery
1997; 39: 1-8.
Number of implant recipients: 2,570
Number of controls: 11,023
Does the study include mastectomy patients receiving implants?
YES, 1,435 of 2,570
Diseases studied: Any classic connective tissue
disease, including lupus, Sjogren's syndrome, rheumatoid arthritis,
and scleroderma. Also looked at "other and ill-defined" rheumatic
conditions.
Minimum length of time with implants included in study:
To be in this study a woman could have had implants for less than
one year.
Average length of time with implants: 7.2 years
for reconstruction group, 8.4 years for augmentation group.
Additional notes: Only women who were hospitalized
for connective tissue disease were categorized as ill, not outpatients.
According to the authors, the study had only limited power to detect
an increased risk of any specific connective tissue disease. The
control group consisted of women who had breast reduction surgery
or mastectomy without receiving implants. Although the difference
was not significant, the rate of scleroderma, lupus, and Sjogren's
syndrome in mastectomy patients receiving implants was 30% higher
than expected. The authors found an increase in rheumatic complaints
in all of the groups and therefore concluded that breast surgery
increases the risk of connective tissue disease, and that the implants
themselves do not cause connective tissue disease. The authors did
not question or examine patients directly.
Gabriel, S.E., O'Fallon, W.M., Kurland,
L.T., et al. Risks of Connective tissue Diseases and Other Disorders
after Breast Implantation. New England Journal of Medicine
1994; 330: 1697-1702.
Number of implant recipients: 749
Number of controls: 1,498
Does the study include mastectomy patients receiving implants?
YES, 125 of 749
Diseases studied: Any classic connective tissue
disease, including lupus, Sjogren's syndrome, rheumatoid arthritis,
and scleroderma. Also looked at other disorders such as Hashimoto's
thyroiditis, cirrhosis, sarcoidosis, and cancer.
Minimum length of time with implants included in study:
Women in this study could have had implants for less than one year.
Average length of time with implants: 7.8 years
Additional notes: Women with breast implants had
a 35% higher rate of arthritis, which was not statistically significant
(relative risk: 1.35). Morning stiffness was 81% higher for implant
patients, which was significantly higher than for women without
implants (relative risk: 1.81). The authors estimated that they
would need to have studied 62,000 women with implants for an average
of 10 years to detect a 100% increase (or less) in rare diseases
such as scleroderma. This study relied on medical records. The authors
did not question or examine patients directly.
Giltay, E.J., Bernelot Moens, H.J.,
Riley, A.H., et al. Silicone Breast Prostheses and Rheumatic Symptoms:
a Retrospective Follow Up Study. Annals of Rheumatic Diseases
1994; 53: 194-196.
Number of implant recipients: 235
Number of controls: 210
Does the study include mastectomy patients receiving implants?
YES, approximately 56 of 235, but they were not analyzed separately
Diseases studied: Rheumatic complaints, use of
anti-rheumatic drugs, and medical consultations regarding rheumatic
symptoms. For those reporting rheumatic symptoms, a rheumatologist
made an assessment of the likelihood of a rheumatic disease.
Minimum length of time with implants included in study:
Two years
Average length of time with implants: 6.5 years
with a range of two to 14 years
Additional notes: Women with silicone breast implants
reported significantly more rheumatic complaints than controls,
but there was no evidence of increased prevalence of common rheumatic
diseases, such as fibromyalgia, rheumatoid arthritis, or Sjogren's
disease. The results may not accurately describe the health risks
for mastectomy patients, since they were a small minority of the
women in the study. The control group consisted of women who had
an unspecified cosmetic procedure that did not include silicone
products. The study relied on questionnaires completed by the patients.
The authors did not question or examine patients directly.
Hennekens, C.H., Lee, I.M., Cook,
N.R., et al. Self-Reported Breast Implants and Connective tissue
Diseases in Female Health Professionals. Journal of the American
Medical Association 1996; 275: 616-621.
Number of implant recipients: 10,830
Number of controls: 384,713
Does the study include mastectomy patients receiving implants?
YES, 18% of 10,830
Diseases studied: Any classic connective tissue
disease including lupus, Sjogren's syndrome, rheumatoid arthritis,
and scleroderma. Also included mixed connective tissue disease.
Minimum length of time with implants included in study:
To be in this study, a woman could have had implants for
one year.
Average length of time with implants: Not stated,
but the authors analyzed the women in three groups: up to four years,
five to nine years, and 10 or more years after receiving implants
and showed no increased risk with increased duration of exposure.
Additional notes: Implant patients had a 25% higher
rate of connective tissue disease, whether they were reconstruction
or augmentation patients (relative risk: 1.25). This was statistically
significant, and the researchers concluded that there is a small
increased risk of connective tissue disease among women with implants.
Although it is a cohort study, this study was analyzed with case-control
and cross-sectional studies in the meta-analysis because information
about the disease and the patient's exposure to silicone breast
implants was gathered at the same time. The study relied on questionnaires
completed by the subjects, who were health professionals. The authors
did not question or examine the women directly.
Nyren, O., Yin, L., Josefsson, S.,
et al. Risk of Connective Tissue Disease and Related Disorders Among
Women with Breast Implants: A Nation-Wide Retrospective Cohort Study
in Sweden. British Medical Journal 1998; 316: 417-422.
Number of implant recipients: 7,442
Number of controls: 3,353
Does the study include mastectomy patients receiving implants?
YES, 3,942 of 7,442
Diseases studied: Hospitalizations for classic
connective tissue disease including lupus, Sjogren's syndrome, rheumatoid
arthritis, and scleroderma. Also studied hospitalizations for related
diseases.
Minimum length of time with implants included in study:
One month
Average length of time with implants: Six years
for reconstruction patients, 10.3 years for augmentation patients.
Additional notes: Only women who were hospitalized
for connective tissue disease were categorized as ill, not outpatients.
The authors acknowledge that the sample size was too small to draw
conclusions about links between breast implants and rare diseases
they studied, such as scleroderma. The control group consisted of
women who had breast reduction surgery. Both groups who had breast
surgery had slightly higher than expected rates of connective tissue
disease. This study relied on hospital records. The authors did
not question or examine patients directly.
Park A.J., Black, R.J., Sarhadi,
N.S., et al. Silicone Gel-Filled Breast Implants and Connective
Tissue Diseases. Plastic and Reconstructive Surgery 1998;
101: 261-268.
Number of implant recipients: 317
Number of controls: 419
Does the study include mastectomy patients receiving implants?
YES, 207 of 317
Diseases studied: Signs and symptoms of connective
tissue and autoimmune disease, such as antinuclear antibodies, rheumatoid
factor, joint pain, fatigue, Raynaud's syndrome, etc.
Minimum length of time with implants included in study:
Not specified
Average length of time with implants: Six years
for reconstruction patients, five years for augmentation patients.
Additional notes: Because the sample size was so
small, the authors acknowledge that a health risk would have to
exceed 320% for reconstruction patients and 1600% for augmentation
patients in order to be statistically significant. In addition,
approximately half of the women had implants for less than six years.
Because of these shortcomings, this study does not provide useful
information. The study included two controls for each implantation
patient. Half of the controls were maternity patients and half were
outpatients from the plastic surgery department. The authors did
not specify what types of procedures the plastic surgery controls
received. The study subjects were interviewed and received a medical
examination.
Sanchez-Guerrero, J., Colditz, G.A.,
Karlson E.W., et al. Silicone Breast Implants and the Risk of Connective
tissue Diseases and Symptoms. New England Journal of Medicine
1995; 332: 1666-1670.
Number of implant recipients: 1,183
Number of controls: 86,318
Does the study include mastectomy patients receiving implants?
YES, 525 of 1,183 for cancer or prophylaxis, but they were not analyzed
separately from augmentation patients
Diseases studied: Any classic connective tissue
disease, including lupus, Sjogren's syndrome, rheumatoid arthritis,
and scleroderma. Excluded women with milder or atypical cases of
connective tissue disease.
Minimum length of time with implants included in study:
One month
Average length of time with implants: 9.9 years
Additional notes: According to the authors, the
study does not exclude small health risks of implants that would
be of public health importance. The study was designed to minimize
"reporting bias" of health problems by implant patients by excluding
any health problems diagnosed after May 1990, which was six months
before the major media coverage of implant problems. They did not
minimize bias in the opposite direction; for example, they included
women who only had implants for one month. Also, they should have
excluded women who reported receiving breast implants from 1952
to 1961, since breast implants had not yet been invented. Including
these women and their inaccurate statements increased the average
years of implantation. The study relied on questionnaires completed
by the subjects, who were health professionals. The authors did
not question or examine the women directly, although, for a random
sample of 100 women, they verified whether the women had breast
implants by reviewing their medical records.
Schusterman, M.A., Kroll, S.S.,
Reece, G.P., et al. Incidence of Autoimmune Disease in Patients
after Breast Reconstruction with Silicone Gel Implants Versus Autogenous
Tissue: A Preliminary Report. Annals of Plastic Surgery
1993; 31: 1-6.
Number of implant recipients: 250
Number of controls: 353
Does the study include mastectomy patients receiving implants?
YES, all were mastectomy patients.
Diseases studied: Patients were considered to have
rheumatic disease if they had been seen by a physician who made
the diagnosis on clinical grounds with corroborating laboratory
evidence and had prescribed therapy.
Minimum length of time with implants included in study:
10 months
Average length of time with implants: Does not
specify, but maximum period for any patient is 2.5 years
Additional notes: Length of follow-up was too short
to be meaningful. The authors state that the report must be considered
preliminary because the onset of autoimmune disorders could occur
two to 21 years after implantation.
Wells, K.E., Cruse, C.W., Baker,
J.L. Jr., et al. The Health Status of Women Following Cosmetic Surgery.
Plastic and Reconstructive Surgery 1994; 93: 907-912.
Number of implant recipients: 222
Number of controls: 80
Does the study include mastectomy patients receiving implants?
NO
Diseases studied: Study looked at the incidence of 23 symptoms
and the diagnosis of connective tissue disease such as rheumatoid
arthritis, lupus, scleroderma, and Raynaud's disease.
Minimum length of time with implants included in study:
Not specified
Average length of time with implants: 4-5 years
Additional notes: The authors compared women who
had breast implants to those who had liposuction, rhinoplasty, or
eyelid lifts. The average age of women getting breast implants was
almost 10 years younger than those getting the other cosmetic procedures.
Tender and swollen glands under the arm were more likely in implanted
women. Symptoms that were more frequent in implanted women but did
not achieve statistical significance were: easily tired, muscle
pain, swollen and tender glands in the neck, change in hand color
with cold, weight gain, swollen and painful joints, and general
stiffness. The authors acknowledged that the small sample size could
explain why the differences did not achieve statistical significance.
The authors reported no cases of scleroderma or lupus. Arthritis
was present in 5% of implanted women and 3% of controls. One implanted
woman reported Raynaud's disease. The study relied on questionnaires
completed by the subjects. The authors did not question or examine
the women directly.
Case-control or cross-sectional studies
These studies compare women suffering from a particular disease
(cases) to those who are healthy (controls) and determine whether
breast implants are more common in the ill women.
Burns, C.J., Laing, T.J., Gillespie, B.W., et al. The Epidemiology
of Scleroderma Among Women: Assessment of Risk from Exposure to
Silicone and Silica. Journal of Rheumatology 1996; 23:
1904-1911.
Number of cases: 274 Number
of controls: 1,184
Diseases studied: Scleroderma
Additional notes: This study revealed no increased
likelihood that women with scleroderma reported having silicone
breast implants. However, women with scleroderma were significantly
more likely to report other exposures to silicone. Women with scleroderma
were identified by contacting rheumatologists, hospitals, and a
scleroderma support group. They were then interviewed by telephone
to determine past exposure to silicone or silica.
Dugowson, C.E., Daling, J., Koepsell,
T.D., et al. Silicone Breast Implants and Risk for Rheumatoid Arthritis.
Arthritis and Rheumatism 1992; 35: Suppl: S66.
Number of cases: 300 Number
of controls: 1,456
Disease studied: Rheumatoid arthritis
Additional notes: This study was a non-peer-reviewed
abstract from a scientific meeting. One case and 12 controls had
breast implants before diagnosis. There was no increase in the likelihood
that rheumatoid arthritis patients reported having breast implants.
The study was based on a questionnaire sent to women with rheumatoid
arthritis and age-matched controls asking if they had breast implants.
Englert, H.J., Brooks, P., et al.
Scleroderma and Augmentation Mammoplasty - A Casual Relationship?
Australia and New Zealand Journal of Medicine 1994; 24:
74-80.
Number of cases: 286 Number
of controls: 253
Disease studied: Scleroderma.
Additional notes: This study found no increased
likelihood that women with scleroderma reported having breast implants,
although the authors acknowledged that the study lacked the power
to detect an increased risk of lower than 150-200%. The study was
based on a telephone questionnaire. The information on whether the
women had implants was self-reported to the interviewer on the telephone
and unverified.
Goldman, J.A., Greenblatt, J., Joines,
R., et al. Breast Implants, Rheumatoid Arthritis, and Connective
Tissue Diseases in a Clinical Practice. Journal of Clinical
Epidemiology 1995; 48: 571-82.
Number of cases: 721 Number
of controls: 3,508
Disease studied: Rheumatoid arthritis and other
connective tissue disease.
Additional notes: Instead of comparing sick women to healthy
women, all of the women in this study were patients in a rheumatology
practice. The authors found no increased likelihood that women with
rheumatoid arthritis and other connective tissue disease reported
having breast implants. The women who had breast implants were significantly
younger than those who did not have implants. The authors acknowledged
that since the study took place in the practice of a single clinician,
there is the potential for referral or selection bias. Also, many
patients were seen for only a single assessment. Fewer than half
were seen in that practice for more than one year. Additionally,
the author acknowledged that losing women to follow up could have
resulted in a selection bias. The authors relied on medical records
to determine who had breast implants.
Hochberg, M.C., Perlmutter, D.L.,
Medsger, T.A. Jr., et al. Lack of Association Between Augmentation
Mammoplasty and Systemic Sclerosis (Scleroderma). Arthritis
and Rheumatism 1996; 39: 1125-1131.
Number of cases: 837 Number
of controls: 2,507
Disease studied: Scleroderma.
Additional notes: The study revealed no difference
in the likelihood that women with scleroderma reported having breast
implants, although the authors noted that 1,000 cases and 3,000
controls would be needed in order to detect a two-fold increase
in scleroderma. For women with scleroderma, information about whether
they had breast implants was gathered from a self-administered questionnaire.
Controls were given the identical questionnaire over the telephone.
For both groups, the information was unverified.
Lacey, J.V. Jr., Laing, T.J., Gillespie,
B.W., et al. Reply to Letter: Epidemiology of Scleroderma Among
Women: Assessment of Risk from Exposure to Silicone and Silica.
Journal of Rheumatology 1997; 24: 1854-1855.
Number of cases: 189 Number
of controls: 1,043
Disease studied: Scleroderma
Additional notes: This study was briefly described
in a letter in the Journal of Rheumatology. It was not peer-reviewed.
In a telephone interview, researchers asked women diagnosed with
scleroderma about their exposure to silicone (including silicone
gel breast implants) and compared the likelihood with similarly
aged controls. One case and 10 controls reported having silicone
breast implants. There was no increased likelihood that women with
scleroderma reported having breast implants.
Laing, T.J., Gillespie B.W., Lacey,
J.V. Jr., et al. The Association Between Silicone Exposure and Undifferentiated
Connective Tissue Disease Among Women in Michigan and Ohio. Arthritis
and Rheumatism 1996; 39: Suppl:S150.
Number of cases: 206
Number of controls: 2,239
Disease studied: Undifferentiated connective tissue
disease
Additional notes: This study was a non-peer-reviewed
abstract from a meeting. In telephone interviews, researchers asked
women with undifferentiated connective tissue disease about their
silicone exposure and compared the exposure with similarly aged
controls. Although there were no raw data in the abstract, the authors
state that women with undifferentiated connective tissue disease
were significantly more likely to report having all types of implanted
devices, including breast implants. For silicone breast implants,
the adjusted odds ratio was elevated, but did not achieve statistical
significance (women with undifferentiated connective tissue disease
were 127% more likely to report having silicone breast implants
than controls). Women with undifferentiated connective tissue disease
were significantly more likely to report having other types of devices
containing silicone, such as, internal fixation devices, artificial
joints, pacemakers, non-CNS shunts or catheters.
Strom, B.L., Reidenberg, M.M., Freundlich,
B., et al. Breast Silicone Implants and Risk of Systemic Lupus Erythematosus.
Journal of Chemical Epidemiology 1994; 47: 1211-1214.
Number of cases: 133 Number
of controls: 100
Disease studied: Lupus
Additional notes: Only one woman in the study reported
that she had breast implants. Information was gathered by telephone
interview. The study did not detect an increased likelihood that
women with lupus had breast implants, although the small number
of cases and controls severely limited the statistical power of
this study.
Teel, W.B., A Population-Based Case-Control
Study of Risk Factors for Connective Tissue Diseases. (Ph.D. dissertation.
Seattle: University of Washington, 1997.
Number of cases: 427
Number of controls: 1,577
Disease studied: All connective tissue diseases
Additional notes: Non-peer-reviewed doctoral dissertation.
No information available.
Wolfe, F., Silicone Breast Implants
and the Risk of Fibromyalgia and Rheumatoid Arthritis. Arthritis
and Rheumatism 1995; 38: Suppl:S265.
Number of cases: 1,270 Number
of controls: 1,134
Disease studied: Compared women with rheumatoid
arthritis and fibromyalgia (though fibromyalgia data not included
in meta-analysis) to women with osteoarthritis and healthy women.
Additional notes: Only fourteen women reported
having breast implants in the study. The information on whether
the women had implants was self-reported and unverified. This study
was a non-peer-reviewed abstract from a meeting. It compared 533
patients with fibromyalgia and 637 with rheumatoid arthritis to
a control group that included 479 women with osteoarthritis. Women
with fibromyalgia or rheumatoid arthritis were no more likely to
report having silicone breast implants than controls. Patients were
asked to fill out questionnaires and controls (healthy women) were
questioned on the telephone.
