U.S. and International Epidemiology Studies of Breast Implants and Connective Tissue Disease
The following is a summary of the epidemiology studies of connective tissue disease (CTD) and breast implants conducted by prominent researchers at prestigious institutions. Unlike the reports of individual women (often called case reports or case series), the following studies were designed to make comparisons between groups of women with and without implants. In contrast to case reports, these more rigorous epidemiology studies provide the opportunity to determine whether CTD among women with implants is occurring more frequently than might be expected.
University of Michigan, School of Public Health, Lacey, MPH; Laing, MD; Gillespie, PhD; et al.; Ann Arbor, MI. 1997
Breast Implants, Environmental Exposures/Scleroderma
This large-scale, population-based study looked at all women in the state of Ohio diagnosed with scleroderma between 1985 and 1992. The analyses compared the 189 women diagnosed with scleroderma to the 1,043 women in a control group who did not have scleroderma. The authors stated, “There was no association between SSc and silicone gel breast implants [adjusted odds ratio (aOR) 1.01, 95% confidence interval (CI) 0.13 to 8.15], any breast implants (aOR 1.48, 95% CI 0.34 to 6.39), or all silicone breast and facial implants (aOR 1.44, 95% CI 0.33 to 6.22).”
These investigators conducted a comparable study in Michigan and found similar results (see Burns et al. 1994 in this summary).
Directly funded by Dow Corning Corporation.
University of Maryland, School of Medicine; University of Pittsburgh, School of Medicine; University of California San Diego, School of Medicine, Hochberg, MD; Perlmutter, MS; Medsger MD; et al.; Baltimore, MD. 1996
Breast Implants/Scleroderma
This multicenter study compared the frequency of augmentation mammaplasty among 837 women with scleroderma to 2,507 women without scleroderma. The authors concluded, “These results fail to demonstrate a significant association between augmentation mammaplasty and SSc, and are consistent with those reported from other epidemiologic studies.”
Funded in part by the Plastic Surgery Educational Foundation. Dow Corning has contributed money to this foundation but has no control over what research the foundation chooses to fund.
Brigham & Women’s Hospital, The Women’s Health Cohort Study, Harvard Medical School, Hennekens, MD, DrPH; Lee, MBBS, ScD; Cook, ScD; et al.; Boston, MA. 1996
Breast Implants/Reports of Connective Tissue Disease This study of female health professionals assessed self-reported data on six connective tissue diseases and breast implants. It included 10,830 women with breast implants and 384,713 women without breast implants. The authors concluded that, based on the self-reported data, the study’s major contribution was to exclude large risks of connective tissue disease following breast implant surgery. Although the research raised the possibility of a small increased risk for women with implants, the investigators said the study could not reliably distinguish between this possibility and no risk. The study also found no difference in risk according to how long an implant was in place. According to Dr. Charles Hennekens, the lead investigator, “Considering all available evidence, women with breast implants should be reassured that there is no large risk of connective tissue disease.” The authors stated that the next phase of this study will attempt to validate the self-reported diagnoses of connective tissue diseases by independent medical record review.
Funded by the National Institutes of Health and Dow Corning Corporation.
University of Michigan, School of Public Health, Laing, MD; Gillespie, PhD; Lacey; et al.; Ann Arbor, MI. 1996
Breast Implants, Medical Devices/UCTD
This study identified 206 women in Michigan and Ohio with undifferentiated connective tissue disease (UCTD) and compared them with 2,239 women without the condition. No association was found with silicone breast implants. When considering medical devices in general (both those containing silicone and those not containing silicone, including breast implants), however, the authors found a statistically significant association with this condition. UCTD is a condition with signs and symptoms that may evolve over time to a recognizable connective tissue disease, may never progress, or may disappear.
Directly funded by Dow Corning Corporation.
Brigham and Women’s Hospital, Nurses’ Health Study, Harvard Medical School, Sanchez-Guerrero, MD; Colditz, DrPH; Karlson, MD; et al.; Boston, MA. 1995
Breast Implants/Connective Tissue Disease, Signs, Symptoms, and Laboratory Tests
This study examined the incidence of connective tissue disease and 41 signs, symptoms, or laboratory findings of connective tissue disease among registered nurses followed from 1976 to 1990. Funded by the National Institutes of Health, the study compared the findings in 1,183 women with implants to the findings in 86,318 women without implants. The authors concluded, “In a large cohort study, we did not find an association between silicone breast implants and connective-tissue diseases, defined according to a variety of standardized criteria, or signs and symptoms of these diseases.”
Directly funded by Dow Corning Corporation.
Emory University, Goldman, MD; Greenblatt, MD; Joines, MD; et al.; Atlanta, GA. 1995
Silicone Breast Implants/Connective Tissue Disease
A study of 4,229 women with and without breast implants from a rheumatology clinic found “no evidence that women with breast implants are at an increased risk for having rheumatoid arthritis or other diffuse connective tissue disease.”
University of Kansas, Arthritis Center, Wolfe, MD; Wichita, KS. 1995
Silicone Breast Implants/Rheumatoid Arthritis
This study compared 637 women with rheumatoid arthritis to 1,134 controls (479 women with osteoarthritis and 655 women selected at random from the general population). The author stated, “No associations between SBI [silicone breast implants] and RA [rheumatoid arthritis] were identified.”
Mayo Clinic, Gabriel, MD; O’Fallon, PhD; Kurland, MD; et al.; Rochester, MN. 1994
Breast Implants/Connective Tissue Diseases and Other Disorders
This study looked at medical records for all women in Olmsted County, Minnesota, who received breast implants between l964 and 1991, identified 749 women who had received breast implants and compared them with 1,498 women who had not received implants. The investigators stated, “We found no association between breast implants and the connective-tissue diseases and other disorders that were studied.”
Funded in part by the Plastic Surgery Educational Foundation. Dow Corning has contributed money to this foundation but has no control over what research the foundation chooses to fund.
Mayo Clinic, Duffy, MD; Woods, MD; Rochester, MN. 1994
Breast Implants/Connective Tissue Diseases and Other Disorders
This study looked at the medical records for 200 women who had 681 implants replaced or removed between 1970 and 1992. These women may be included in the Gabriel Mayo Clinic study noted previously. They found 85 percent of the implants were intact. The investigators stated, “In our 30-year experience with silicone-gel breast implants for augmentation mammaplasty or breast reconstruction, the data from this study suggest that no clinically evident adverse health problems were incurred by those women who subsequently experienced a silicone gel-implant failure.”
University of Michigan, School of Public Health, Burns, PhD; Schottenfeld, MD; et al.; Ann Arbor, MI. 1994
Breast Implants, Environmental Exposures, and Family History/ Scleroderma
This large-scale, population-based study looked at all women in the state of Michigan diagnosed with scleroderma between 1980 and 1991. Most of the analyses compared the 274 women diagnosed with scleroderma between 1985 and 1991 with the 1,184 women in a control group who did not have scleroderma. The 1994 dissertation by Burns stated, “‘There was no association between any contact with silicone and scleroderma.’ Their subsequent 1996 publication of this work concluded, ‘Consistent with other studies, we found no increased risk of [scleroderma] among women with silicone breast implants.’”
Directly funded by Dow Corning Corporation.
University of South Florida, College of Medicine and College of Public Health, Wells, MD; Cruse, MD; Baker, MD; et al.; Tampa, FL. 1994
Breast Implants/Symptoms and Diseases
The authors examined the incidence of 23 symptoms and four connective tissue diseases among 222 women with breast implant surgery compared to 80 women with other cosmetic surgery procedures. While the symptoms of tender and swollen glands under the arms were more frequent among the women with breast implants, the symptom of change in skin color was more frequent among those with non-breast implant cosmetic surgery. The study reported, “No cases of scleroderma or lupus were found, and the incidence of arthritis was not significantly different between the implant and control groups.”
University of Pennsylvania, School of Medicine, Strom, MD; Reidenberg, MD; Freundlich, MD; et al.; Philadelphia, PA. 1994
Breast Implants/Systemic Lupus Erythematosus
The researchers interviewed 133 women with systemic lupus erythematosus (SLE) and 100 age-matchReidenberg, MD; Freundlich, MD; et al.; Philadelphia, PA. 1994 Breast Implants/Systemic Lupus Erythematosus The researchers interviewed 133 women with systemic lupus erythematosus (SLE) and 100 age-matched friend controls who did not have SLE. From this study, the authors concluded, “No association was seen between silicone breast implants and the subsequent development of SLE.”
University of Texas M. D. Anderson Cancer Center, Schusterman, MD; Kroll, MD; Reece, MD; et al.; Houston, TX. 1993
Breast Implants/Autoimmune Disease
Results from this study of 603 patients (250 with breast implants and 353 with reconstruction from their own tissue) showed, “The incidence of autoimmune disease in mastectomy patients receiving silicone-gel implants is not different than in patients who had reconstruction with autogenous tissue.”
The Johns Hopkins Medical Institutions, Wigley, MD; Miller; Hochberg, MD; et al.; Baltimore, MD. 1992
Breast Implants/Scleroderma
This is part of the Hochberg study conducted at the University of Maryland School of Medicine noted previously. Among 210 Baltimore respondents and 531 from Pittsburgh with scleroderma (SSc), the frequent quency of breast implants was about the same as that estimated for the U.S. adult female population. The investigators concluded, “These data fail to support the hypothesis that augmentation mammaplasty with silicone-gel-filled prostheses is a risk factor for the development of SSc.”
University of Washington, Fred Hutchinson Cancer Research Center, Dugowson, MD; Daling, PhD; Koepsell, MD; et al.; Seattle, WA. 1992
Silicone Breast Implants/Rheumatoid Arthritis
A population-based study of 300 women with rheumatoid arthritis and 1,456 similarly aged control women showed, “These data do not support an increased risk for rheumatoid arthritis among women with silicone breast implants.”
University of California, Weisman, MD; Vecchione, MD; Albert, MD; et al.; San Diego, CA. 1988
Breast Implants/Connective Tissue Disease
The authors followed a group of 125 women from a plastic and cosmetic surgical practice in San Diego and stated, “Our survey did not reveal a single subject with an inflammatory rheumatic disease or condition following breast augmentation.” They added, “It does not appear likely that augmentation mammaplasty is a significant or major inducer of inflammatory connective-tissue diseases in general.”