Breast implants, silicone

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Studies and Reports

  • Lipworth L et al., Breast implants and lymphoma risk: a review of the epidemiologic evidence through 2008, Plast Reconstr Surg. 2009 Mar;123(3):790-3.
    • Conclusions. "To date, there is no credible evidence of an increase of non-Hodgkin's lymphoma regardless of site or specifically originating in the breast among women with cosmetic breast implants."
  • Lipworth L et al., Cancer among Scandinavian women with cosmetic breast implants: a pooled long-term follow-up study, Int J Cancer. 2009 Jan 15;124(2):490-3.
    • Abstract. "No increased risks of specific types of cancer following breast implantation have been consistently reported, but data on risk beyond 15 years are limited. We have pooled the results of 2 nationwide cohort studies of 3,486 Swedish and 2,736 Danish women who underwent cosmetic breast implantation between 1965 and 1993. Cancer incidence through 2002 was ascertained through nationwide cancer registries. Standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were calculated to compare cancer incidence among women with implants with women in the general population. Mean duration of follow up was 16.6 years (range 0.1-37.8 years). Over 50% of women were followed for 15 years or more after breast implantation and 13.3% for at least 25 years. There was a reduced incidence of breast cancer (SIR=0.73; 95% CI 0.58-0.90), whereas lung cancer was above expectation (SIR=1.64; 95% CI 1.10-2.36). The increased risk of lung cancer is expected due to the high prevalence of smoking among the women with implants in our study. With respect to other site-specific cancers, no significantly increased or decreased SIR was observed. This study, which includes women followed for almost 4 decades, represents the longest follow up of women with cosmetic breast implants to date. The results provide no evidence of an association between breast implants and any type of cancer."
  • Kjoller K et al., Adverse health outcomes in offspring of mothers with cosmetic breast implants: a review, Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):129S-134S.
    • Conclusion. "Rates of esophageal and rheumatic disorders, congenital malformations, and perinatal mortality and hospitalization were comparable between children born to mothers with breast implants and children born to mothers who had undergone other cosmetic surgery."
  • Holmich L et al., Breast implant rupture and connective tissue disease: a review of the literature, Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):62S-69S.
    • Conclusion. "There appears to be little scientific basis for any association between implant rupture and well-defined connective tissue disease or undefined or atypical connective tissue diseases. The concept of silicone-related disease was developed by rheumatologists based on highly selected groups of symptomatic breast implant patients seen in their practices. It is likely that nonspecific complications or symptoms related perhaps to capsular contracture or implant rupture may be misinterpreted as representing a systemic disease."
  • McLaughlin J et al., The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence, Ann Plast Surg. 2007 Nov;59(5):569-80.
    • Abstract. "Few implantable medical devices have been studied for their safety more extensively than silicone gel-filled breast implants. We summarize the epidemiologic evidence on the safety of breast implants, most of which is drawn from large cohort studies with long-term follow-up. The topics addressed in this report include cancer, breast cancer detection, connective tissue disease, suicide, offspring effects, neurologic disease, implant rupture, and local perioperative complications and additional surgery. We conclude that the weight of the epidemiologic evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurologic disease. Women with breast implants do not present with more advanced stages of breast cancer or suffer impaired survival after breast cancer diagnosis. The only study to examine an actual incidence rate of breast implant rupture reported rupture-free survival of 98% at 5 years and 83%-85% at 10 years for newer "third-generation" implants. Future studies are needed to determine whether the consistently observed excess of suicide among women with implants reflects underlying psychiatric illness prior to breast augmentation surgery or other factors."
  • Fryzek J et al., A nationwide study of connective tissue disease and other rheumatic conditions among Danish women with long-term cosmetic breast implantation, Ann Epidemiol. 2007 May;17(5):374-9. Epub 2007 Feb 26.
    • Conclusion. This extension of our earlier cohort study further supports the consensus of epidemiologic research that breast implants are unrelated to the development of CTD.
  • McLaughlin J et al., Long-term cancer risk among Swedish women with cosmetic breast implants: an update of a nationwide study, J Natl Cancer Inst. 2006 Apr 19;98(8):557-60.
    • Abstract. "Epidemiologic evidence does not support a consistently increased cancer risk among women with cosmetic breast implants, but few studies have assessed risk beyond 15 years. Swedish women who underwent cosmetic breast implantation for the first time between January 1, 1965, and December 31, 1993 (N = 3486), were followed through December 31, 2002. Cancer incidence was ascertained through the nationwide Swedish Cancer Registry. Standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were calculated to compare cancer incidence of women with implants with women in the general population. Mean follow-up among women with breast implants was 18.4 years (range = 0.1-37.8 years). The incidence of breast cancer was below expectation (SIR = 0.7, 95% CI = 0.6 to 1.0), whereas lung cancer was above expectation (SIR = 2.2, 95% CI = 1.3 to 3.4). With respect to cancer overall and all other specific cancer sites, including brain cancer and sarcoma, non-Hodgkin lymphoma, and multiple myeloma, no statistically significantly increased or decreased SIRs were observed. Stratification by duration of follow-up revealed no statistically significantly increased or decreased SIR, with the exception of a two- to threefold excess of lung cancer among women followed for more than 15 years, which would be expected due to the high prevalence of smoking among the Swedish women with implants in our study."
  • Friis S et al., Cancer risk among Danish women with cosmetic breast implants, Int J Cancer. 2006 Feb 15;118(4):998-1003.
    • Abstract. "The available epidemiologic evidence does not support a carcinogenic effect of silicone breast implants on breast or other cancers. Data on cancer risk other than breast cancer are limited and few studies have assessed cancer risk beyond 10-15 years after breast implantation. We extended follow-up of our earlier cohort study of Danish women with cosmetic breast implants by 7 years, yielding 30 years of follow-up for women with longest implant duration. The study population consisted of women who underwent cosmetic breast implant surgery at private clinics of plastic surgery (n = 1,653) or public hospitals (n = 1,110), and a control group of women who attended private clinics for other plastic surgery (n = 1,736), between 1973-95. Cancer incidence through 2002 was ascertained using the Danish Cancer Registry. Risk evaluation was based on computation of standardized incidence ratios (SIR) and Cox proportional hazards models, adjusting for age, calendar period and reproductive history. We observed 163 cancers among women with breast implants compared to 136.7 expected based on general population rates (SIR = 1.2; 95% confidence interval [CI] = 1.0-1.4), during a mean follow-up period of 14.4 years (range = 0-30 years). Women with breast implants experienced a reduced risk of breast cancer (SIR = 0.7; 95% CI = 0.5-1.0), and an increased risk of non-melanoma skin cancer (SIR = 2.1; 95% CI = 1.5-2.7). Stratification by age at implantation, calendar year at implantation and time since implantation showed no clear trends, however, the statistical precision was limited in these analyses. When excluding non-melanoma skin cancer, the SIR for cancer overall was 1.0 (95% CI = 0.8-1.2). With respect to other site-specific cancers, no significantly increased or decreased SIR were observed. Similar results were found when directly comparing women who had implants at private clinics with women who attended private clinics for other plastic surgery, with rate ratios for cancer overall, breast cancer and non-melanoma skin cancer of 1.1 (95% CI = 0.8-1.6), 0.7 (95% CI = 0.4-1.3) and 1.5 (95% CI = 0.8-2.7), respectively. In conclusion, our study lends further support to the accumulating evidence that silicone breast implants are not carcinogenic. Reasons for the consistently reported deficit of breast cancer among women with breast implants remain unclear, whereas increased exposure to sunlight may explain the excess occurrence of non-melanoma skin cancer. We found no indication of delayed diagnosis of breast cancer due to the presence of breast implants."
  • Lipworth L et al., Silicone breast implants and connective tissue disease: an updated review of the epidemiologic evidence, Ann Plast Surg. 2004 Jun;52(6):598-601.
    • Abstract. "Numerous meta-analyses, weight-of-the-evidence, and critical reviews have summarized data from case-control and cohort studies, published through 1999, which have been conducted to evaluate the potential association between cosmetic silicone breast implants and the occurrence of well-defined connective tissue diseases, as well as a hypothesized new atypical disease, which does not fulfill established diagnostic criteria for any known connective tissue disease. These reviews have unanimously concluded that there is no evidence of an association between breast implants and any of the traditional connective tissue diseases evaluated individually or combined or atypical connective tissue disease. We have performed an updated review of the results of epidemiologic studies published since 1999. Two long-term follow-up studies of women with breast implants in Denmark and a retrospective cohort study in Australia found no excess of definite connective tissue disease, including rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus and Sjogren's syndrome, among women with cosmetic breast implants compared with breast reduction or other plastic surgery controls or women in the general population. No consistent evidence was observed of increased risk of definite connective tissue disease in women with extracapsular ruptures in 2 studies which evaluated risk by rupture status among women with cosmetic breast implants. The results of several studies provide no evidence of a higher frequency of undefined connective tissue disease among women with cosmetic breast implants or of a rheumatic symptom profile unique to these women and/or indicative of a specific atypical connective tissue disease. In conclusion, the most recent epidemiologic investigations have been remarkably consistent with earlier epidemiologic studies in finding no evidence of an excess of any individual connective tissue disease or all connective tissue diseases combined, including both established and atypical or undefined connective tissue disease, among women with cosmetic silicone breast implants. Thus, the conclusions reached in earlier independent reviews have not changed based on data published during the subsequent years."
  • Lipworth L et al., Breast implants and fibromyalgia: a review of the epidemiologic evidence, Ann Plast Surg. 2004 Mar;52(3):284-7.
    • Abstract. "Although the collective epidemiologic literature does not support an association between silicone breast implants and any well-defined or atypical connective tissue disease, a recent study raised concern regarding an increased risk for fibromyalgia among women with extracapsular ruptured implants. In this review, we examine the results of 6 epidemiologic studies which have evaluated the occurrence of fibromyalgia among women with breast implants. Two large nationwide follow-up studies of women with breast implants in Sweden and Denmark reported relative risks for fibromyalgia of 1.0 (95% confidence interval [CI] 0.3 to 3.0) and for unspecified rheumatism (including fibromyalgia and myalgia) of 1.2 (95% CI 0.9 to 1.5), respectively. Similarly, both a case-control and a cross-sectional study conducted within rheumatic disease clinics reported no association between silicone breast implants and the subsequent development of fibromyalgia. The single positive finding, that of a greater than 2-fold excess of self-reported fibromyalgia among women with magnetic resonance imaging-diagnosed extra-capsular ruptures in one study, can be explained by selection bias and the use of an inappropriate reference group in the analyses. In the most recent study of indefinite connective tissue disease (including fibromyalgia) by rupture status, no association was found among unselected Danish women with ruptured implants (relative risk 1.0; 95% CI 0.3 to 3.0), and none of the women with extracapsular rupture reported fibromyalgia. Thus, the weight of the epidemiologic evidence is remarkably consistent and reassuring in failing to support an association between breast implants and subsequent fibromyalgia."
  • McLaughlin J and Lipworth L, Brain cancer and cosmetic breast implants: a review of the epidemiologic evidence, Ann Plast Surg. 2004 Feb;52(2):115-7.
    • Abstract. "Recently, the findings of 1 mortality follow-up study have raised concern regarding the risk of brain cancer among women with cosmetic breast implants. In this review, the authors examine the results of 4 existing large-scale incidence follow-up studies comprising more than 10,000 women with cosmetic implants followed for as long as 29 years. Overall, there were 12 observed incident cases of brain cancer compared with 9.6 cases expected, yielding a nonstatistically significant summary standardized incidence ratio of 1.25 (95% confidence interval, 0.7-2.2). Based on the confidence interval alone, this result rules out the standardized mortality ratio of 2.45 reported in the 1 positive mortality study. Overall, the epidemiologic evidence does not support an association between breast implants and brain cancer incidence."
  • Kjoller K et al., http://www.ncbi.nlm.nih.gov/pubmed/14676691, Ann Plast Surg. 2004 Jan;52(1):1-7.
    • Conclusion. "We did not find an excess of rheumatic symptoms or symptom clusters among women with breast implants. In fact, the occurrence of mild, moderate, and severe musculoskeletal symptoms was generally lower among women with implants compared with women with other cosmetic surgery and women in the general population."
  • Pukkala E et al., Causes of death among Finnish women with cosmetic breast implants, 1971-2001, Ann Plast Surg. 51(4):339-42, October 2003.
    • Abstract. "Mortality patterns among women with cosmetic breast implants have not been well characterized. We examined cause-specific mortality among women who underwent cosmetic breast implantation at major public hospitals and private clinics in Finland from 1970 through 2000. Causes of death through 2001 were identified through the national mortality register. Expected numbers of deaths were calculated on the basis of mortality rates in the general female population, and standardized mortality ratios (SMR), i.e. ratios of observed to expected deaths, and 95% confidence intervals (CI) were calculated. Among the 2166 women with cosmetic breast implants, we observed 31 deaths versus 32.1 expected. Overall disease mortality was below expectation, mainly due to low mortality from diseases of the circulatory system (SMR, 0.28; 95% CI, 0.03-1.02). Mortality from cancer was close to expectation. There was a statistically significant excess of suicide, based on 10 deaths, which was most pronounced during the first 5 years of follow-up (SMR, 4.26; 95% CI, 1.56-9.26). In conclusion, although based on small numbers, women with cosmetic breast implants did not experience higher mortality overall than women in the general population. The high suicide risk supports other studies and warrants further detailed investigation."
  • Holmich L et al., Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants, Plast Reconstr Surg. 2003 Feb;111(2):723-32; discussion 733-4.
    • Abstract. "Epidemiologic evidence does not support an association between silicone breast implants and connective tissue or other rheumatic diseases. However, a recent study has suggested that women with ruptured implants may be at increased risk of developing fibromyalgia. An analysis of adverse health outcomes according to breast implant rupture status was conducted in 238 unselected Danish women with cosmetic silicone breast implants. Ninety-two of the women had definite implant rupture, and 146 had intact implants as determined by magnetic resonance imaging. Before undergoing imaging, the women provided blood samples and completed a self-administered questionnaire. Women with ruptured implants overall, and the subgroup with extracapsular ruptures (n = 23), were compared with women with intact implants regarding a number of self-reported diseases and symptoms and the presence of specific autoantibodies, such as antinuclear antibodies, rheumatoid factor, and cardiolipin immunoglobulin G and M antibodies. Overall, there were no differences in the occurrence of self-reported diseases or symptoms or in the presence of autoantibodies between women with intact implants and women with ruptured implants, including extracapsular rupture. The only exception was capsular contracture, which was reported six times more frequently by women with extracapsular ruptures than by women with intact implants (OR, 6.3; 95 percent CI, 1.7 to 23.5). In conclusion, this study of unselected women with silicone breast implants could establish no association between silicone implant rupture and specific diseases or symptoms related to connective tissue disease or other rheumatic conditions, except for an excess of capsular contracture among women with extracapsular rupture."
  • Jensen B et al., Self-reported symptoms among Danish women following cosmetic breast implant surgery, Clin Rheumatol. 2002 Feb;21(1):35-42.
    • Abstract. "The aim of this study was to examine self-reported symptomatology and to identify distinctive characteristics among women with silicone breast implants (SBI). Using the Danish hospital and population registers we identified three groups of women with a hospital diagnosis of muscular rheumatism (a nonspecific soft-tissue diagnostic code) who had previously undergone SBI surgery (n = 28), breast reduction surgery (n = 29) or no breast surgery (n = 27); and three groups of women without a diagnosis of muscular rheumatism who had undergone SBI surgery (n = 21), breast reduction surgery (n = 27) or no breast surgery (n = 56). All study subjects completed a self-administered questionnaire focusing on sociodemographic factors, lifestyle habits, somatic symptoms and psychological symptoms. Women with SBI and women with breast reduction with no previous diagnosis of muscular rheumatism had similar patterns of reporting for most symptoms and characteristics. They reported significantly more somatic symptoms and psychological distress, including somatisation, obsessive-compulsiveness and depression, than women with no breast surgery. No significant differences in self-reported symptomatology and characteristics were observed among the three groups of women with a previous diagnosis of muscular rheumatism. Overall, women with prior muscular rheumatism reported more symptoms than those without. We concluded that self-reported somatic symptoms among women with SBI were similar to those of controls. Women with cosmetic breast surgery appear to have distinctive psychological characteristics. Our study emphasises the importance of taking the psychological profile and previous history of rheumatic diseases into account when examining women with SBI."
  • Pukkala E et al., Incidence of breast and other cancers among Finnish women with cosmetic breast implants, 1970-1999, J Long Term Eff Med Implants. 12(4):271-9, 2002.
    • Abstract. "Epidemiologic evidence does not point to a carcinogenic effect of silicone implants on the breast, and evidence for or against a carcinogenic effect at sites other than the breast is limited. To examine subsequent cancer risk among women with cosmetic breast implants, we conducted a cohort study of 2171 women in Finland identified from operation diaries of major hospitals and private clinics, 1970-1999. The nationwide population and health outcome registries in Finland were used to trace these women for cancer incidence through 1999. Standard statistical techniques were used to compute expected values based on general population rates. The measure of risk was taken as the ratio of observed to expected cancers, that is, the standardized incidence ratio (SIR) and its 95% confidence interval (CI). Among the 2171 women with cosmetic breast implants, 30 developed cancer against 33.7 expected (SIR = 0.9,95% CI = 0.6-1.3). There was no evidence for an increase in breast cancer risk (SIR 0.5, 95% CI, 0.2-1.0), even among those followed for more than 10 years (2 observed, 4.6 expected). Stage at breast cancer diagnosis did not differ from that expected nor did incidence of any other cancer. Although hindered by small numbers, the consistency of our results with those of other Nordic studies leads us to conclude that cosmetic breast implants are not a cause of cancer and that they do not appear to delay the detection of breast cancers."
  • Kjoller K et al., Connective tissue disease and other rheumatic conditions following cosmetic breast implantation in Denmark, Arch Intern Med. 161(7):973-9, April 9, 2001.
    • Conclusions. "The findings of this study support previous investigations and independent review panel conclusions that an association between silicone breast implants and definite CTDs is unlikely. The observation of an excess of unspecified rheumatism among women with implants and among control women suggests that women undergoing cosmetic plastic surgery have hospitalization rates for this condition in excess of those from the general population."
  • Signorello L et al., Offspring health risk after cosmetic breast implantation in Sweden, Ann Plast Surg. 46(3):279-86, March 2001.
    • Abstract. "Case reports have suggested that children born to women with silicone breast implants may have an excess risk of rheumatic disease and/or esophageal disorders. In Sweden, the authors conducted a retrospective cohort study of 5,874 children born to women with cosmetic breast implants and 13,274 children born to women who had breast reduction surgery. Using national registers, they computed hospitalization rates for rheumatic and esophageal disorders, incidence rates for cancer, and prevalence rates for congenital malformations and perinatal death. Relative to children of women who had breast reduction surgery, children born to women who had cosmetic breast implants were not at excess risk of rheumatic disease (relative risk [RR] = 1.1; 95% confidence interval [95% CI], 0.2-5.3), esophageal disorders (RR = 1.0; 95% CI, 0.7-1.6), cancer (RR = 0.3; 95% CI, 0.0-2.5), congenital malformations in total (RR = 1.0; 95% CI, 0.6-1.5), or specifically involving the digestive organs (RR = 0.5; 95% CI, 0.2-1.3) or perinatal death (RR = 0.9; 95% CI, 0.5-1.8). The rates of these health outcomes among children born after a mother's implant surgery were also not significantly higher than among children born before a mother's implant surgery. This study provides no evidence that certain hypothesized health outcomes are more likely among the children of women with cosmetic breast implants"
  • Winther J et al., Neurological disease among women with silicone breast implants in Denmark, Acta Neurol Scand. 103(2):93-6, February 2001.
    • Conclusion. "Our findings indicate no causal association between silicone breast implants and neurological disease."
  • Fryzek J et al., Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery, Plast Reconstr Surg. 107(1):206-13, January 2001.
    • Abstract. "A retrospective cohort study was performed in Sweden to evaluate the possibility that an individual symptom or constellation of illness symptoms related to silicone occurs in women after breast implant surgery. A random sample (n = 2500) of all women in the Swedish national implant registry who underwent breast augmentation surgery with alloplastic breast implants during the years 1965 through 1993 was compared with a sample (n = 3500) of women who underwent breast reduction surgery during the same period, frequency matched to the implant patients for age and calendar year at the time of surgery. In total, 65 percent of the breast implant patients (n = 1546) and 72 percent of the breast reduction patients (n = 2496) completed a self-administered questionnaire covering 28 rheumatologic and other symptoms and lifestyle and demographic factors. Practically all of the 28 symptoms inquired about were reported more often by women in the breast implant cohort, with 16 (57 percent) significantly more common in breast implant recipients. In contrast, few significant differences or consistent patterns were observed in the length of time since the implant and in the type (silicone or saline) or volume of the implant. Although women with breast implants report a multitude of symptoms more often than women who have breast reduction surgery, the lack of specificity and absence of dose-response relationships suggest that the excess of reported symptoms is not causally related to cosmetic implants."
  • Mellemkjaer L et al., Cancer occurrence after cosmetic breast implantation in Denmark, Int J Cancer. 88(2):301-6, October 15, 2000.
    • Abstract. "Most studies on cancer incidence after breast implantation have focused on breast cancer, while the risk of cancers at other sites has been less well investigated. We examined cancer incidence among 1,653 women who underwent cosmetic breast implant surgery at private clinics of plastic surgery in Denmark and 1,736 women attending the same clinics for other reasons during the period 1973-1995. Furthermore, we updated previously reported results among 1,114 women who received implants for cosmetic indications at public hospitals. All women were followed for cancer through the Danish Cancer Registry. In comparison with the general female population, the overall standardized incidence ratio (SIR) for cancer among women who received implants in private clinics was 1.65 [95% confidence interval (CI) = 1.17-2.27]. This elevated SIR reflected increased incidence ratios for almost all major cancer sites; however, only for non-melanoma skin cancer was there an excess of more than 2 cases. No significant excess of cancer was observed among women who received implants in public hospitals (SIR = 1.10, 95% CI = 0.76-1.52) or among women attending the private clinics for other problems (SIR = 1.10, 95% CI = 0.78-1.52). The SIRs for breast cancer after breast implantation were 1.1 (95% CI = 0.5-2.2) among private clinic patients and 0.9 (95% CI = 0.4-1.7) among public hospital patients. The overall findings of these 2 implant cohorts and results from other investigations suggest that cancer risk is probably not increased among women receiving cosmetic breast implants. The inconsistent results for private clinics and public hospitals are likely related to selection bias and confounding among the private clinic patients, but our data did not permit exploration of these possibilities. Further research into the determinants of these inconsistencies is warranted."
  • Kjoller K et al., Health outcomes in offspring of mothers with breast implants, Pediatrics. 102(5):1112-5, November 1998.
    • Conclusion. "This first epidemiologic cohort study provides no evidence that silicone breast implants affect risks of esophageal or other disorders in children of the implantees. Rather, the observed risk pattern suggests that a lower threshold exists among both groups of women who have undergone cosmetic breast surgery in seeking professional medical care for problems normally solved outside the hospital."
  • Nyren O et al., Breast implants and risk of neurologic disease: a population-based cohort study in Sweden, Neurology. 50(4):956-61, April 1998.
    • Conclusion. "Our results provide no support for the conjecture that breast implants cause neurologic disease."
  • Winther J et al., Neurologic disease among women with breast implants, Neurology. 50(4):951-5, April 1998.
    • Conclusion. "Our findings do not support the hypothesis of silicone-induced neurologic disease. The reasons for the elevated rates of neurologic disease in both the exposed and comparison cohorts remain unclear, but may reflect selection processes associated with these women seeking medical care more often than the general population."
  • Nyren O et al., Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden, BMJ. 316(7129):417-22, February 7, 1998.
    • Conclusions. "This large nationwide cohort study shows no evidence of association between breast implants and connective tissue disease."
  • Friis S, Connective tissue disease and other rheumatic conditions following breast implants in Denmark, Ann Plast Surg. 39(1):1-8, July 1997.
    • Abstract. "To investigate the risks of connective tissue diseases (CTDs) following breast implants we used the nationwide Danish Hospital Discharge Register (HDR) to identify 2,570 women who received breast implants, either for cosmetic reasons (N = 1,135) or for breast reconstruction (N = 1,435), between 1977 and 1992. Two additional cohorts of women having either breast reduction surgery (N = 7,071) or breast cancer without implants (N = 3,952) were identified for comparison. Observed-to-expected (O/E) cases of CTDs and other rheumatic conditions were calculated based on national hospital discharge rates. The calculated O/E ratio for definite CTDs was 1.1 (95% confidence interval [CI], 0.2-3.4) among women with cosmetic breast implants, and 1.3 (95% CI, 0.5-2.6) among women receiving implants for breast reconstruction. No CTD excesses were seen in the breast reduction or breast-cancer-without-implant cohorts. Statistically significant risks for muscular rheumatism (a nonspecific discharge diagnosis) were observed in all four patient cohorts: cosmetic (O/E ratio, 2.5; 95% CI, 1.7-3.6), breast reconstruction (O/E ratio, 2.5; 95% CI, 1.7-3.4), breast reduction (O/E ratio, 2.0; 95% CI, 1.6-2.3), and breast cancer without implants (O/E ratio, 1.4; 95% CI, 1.0-1.9). In conclusion, breast implants showed little association with definite CTDs. Breast surgery per so, however, was associated with an apparent increase in muscular rheumatism."
  • Friis S et al., Breast implants and cancer risk in Denmark, Int J Cancer. 71(6):956-8, June 11, 1997.
    • Abstract. "Although millions of women worldwide have received breast implants for cosmetic or medical reasons, possible late effects (in particular cancer) have not been well studied. To provide quantitative information on cancer occurrence among women undergoing breast implant surgery, 1,135 women treated for cosmetic reasons in Denmark were evaluated. Patients were identified using the nationwide Hospital Discharge Registry with linkage to the nationwide Danish Cancer Registry to determine subsequent cancer incidence. The average age of the women at implant surgery was 31 years, and the average follow-up was 8.4 years, up to a maximum of 17 years. Overall, 27 cancers developed after implant surgery compared with 24.7 expected based on incidence rates from the general population (standardized incidence ratio [SIR] = 1.1; 95% CI: 0.7-1.6). Eight breast cancers were observed vs. 7.8 expected (SIR = 1.0; 95% CI: 0.4-2.0). No evidence was found to link breast implants with increased cancer risk in the decade after surgery. While the results are encouraging, longer follow-up into later life will be necessary to assess fully any possible adverse effects."
  • Burns C et al., The epidemiology of scleroderma among women: assessment of risk from exposure to silicone and silica, J Rheumatol. 1996 Nov;23(11):1904-11.
    • Conclusion. "Consistent with other studies, we found no increased risk of SSc among women with silicone breast implants, equivocal evidence of risk from other silicone exposures, and no evidence of risk from silica exposure."

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