Significant increases in disease risk among implanted women

[Guest guest]

March, 2005

http://www.breastimplantinfo.org/news/iom2005.html

What Does the Institute of Medicine Report

Say About the Safety of Silicone Breast Implants?

By Zuckerman, PhD and 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, 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 sen 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., , 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.

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Friis, S., Mellemkjaer, L., McLaughlin, J.K., et al. Connective

Tissue Disease and other Rheumatic Conditions Following Breast

Implants in Denmark. ls 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.

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, 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.

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Giltay, E.J., Bernelot Moens, H.J., Riley, A.H., et al. Silicone

Breast Prostheses and Rheumatic Symptoms: a Retrospective Follow Up

Study. ls 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.

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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.

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Nyren, O., Yin, L., fsson, 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.

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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.

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-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.

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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. ls 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.

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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.

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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.

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Englert, H.J., , 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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.