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We evaluated the association between radiation therapy and severe capsular contracture or reoperation after 717 delayed breast implant reconstruction procedures (288 1- and 429 2-stage procedures) identified in the prospective database of the Danish Registry for Plastic Surgery of the Breast during the period between 1999 and 2006. A history of radiation therapy was associated with increased risk of severe capsular contracture for 1- and 2-stage procedures, with adjusted hazard ratios (HR) of 3.3 (95% confidence interval [CI]: 0.9-12.4) and 7.2 (95% CI: 2.4-21.4), respectively. Similarly, a history of radiation therapy was associated with a non-significantly increased risk of reoperation after both 1-stage (HR = 1.4; 95% CI: 0.7-2.5) and 2-stage (HR = 1.6; 95% CI: 0.9-3.1) procedures. Reconstruction failure was highest (13.2%) in the 2-stage procedures with a history of radiation therapy. Breast reconstruction approaches other than implants should be seriously considered among women who have received radiation therapy.

Studies of complications following reconstructive surgery with implants among women with breast cancer are needed. As the, to our knowledge, first prospective long-term study we evaluated the occurrence of complications following delayed breast reconstruction separately for one- and two-stage procedures. From the Danish Registry for Plastic Surgery of the Breast, which has prospectively registered data for women undergoing breast implantations since 1999, we identified 559 women without a history of radiation therapy undergoing 592 delayed breast reconstructions following breast cancer during the period 1999 to 2006; 239 one-stage procedures and 353 two-stage procedures. The postoperative course through November 2009 was evaluated by cumulative incidence adjusting for competing risks for the selected outcomes; hematoma, infection, seroma, implant rupture, severe capsular contracture (modified Baker III and IV), extrusion of the implant, asymmetry/displacement of the implant, any complication, and reoperation. These analyses were performed both overall and separately according to type of procedure (one- or two-stage). The overall 10-year risk estimates were 68.1% for any complication, 7.7% for severe capsular contracture, 32.3% for displacement/asymmetry of the implant and 38.6% for reoperation. When comparing one- and two-stage procedures, we observed significantly higher risk estimates for infection, seroma and extrusion of the implant following two-stage procedures, whereas the risk of reoperation was significantly higher following the one-stage procedure. For both procedures, the majority of reoperations were due to asymmetry or displacement of the implant. In conclusion, non-radiated one- and two-stage delayed breast implant reconstructions are associated with substantial risks of complications and reoperation which should be taken into consideration in the planning of breast reconstruction., (Copyright © 2011 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: The number of women suitable for breast conserving treatment as well as immediate reconstruction after breast cancer has been increasing, and studies of complications hereafter are needed., Material and Methods: The cohort was identified in the prospective database of the Danish Registry for Plastic Surgery of the Breast during the period 1999 to 2006; 167 women with 189 immediate breast reconstructions (40 one-stage and 149 two-stage procedures) after breast cancer without a history of radiation therapy. The women were followed for complications until November 2009. Cumulative incidence risks were computed for infection, hematoma, seroma, severe capsular contracture (modified Baker III and IV), extrusion of the implant, implant rupture, asymmetry/displacement of the implant, any complication, and reoperation. In addition, we compared the postoperative course of immediate two-stage procedures with delayed two-stage procedures., Results: The overall eight-year risk estimates for the immediate procedures were 76.4% for any complication, 5.3% for severe capsular contracture, 29.5% for displacement/asymmetry of the implant and 40.6% for reoperation. Significantly higher risk for reoperation was observed after immediate one-stage than after two-stage procedures. For immediate two-stage procedures acute complications such as infection, seroma and hematoma were higher in the expansion period than after the second planned surgery. Higher risks for acute complications were observed after immediate than after delayed two-stage procedures., Conclusion: Immediate breast implant reconstruction was found to have substantial risks of complications in non-radiated women, which should be considered in the guidance of breast cancer patients before choosing reconstructive procedure.

The association of silicone breast implants with connective tissue diseases (CTDs), including systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, and fibromyalgia, as well as a hypothesized new "atypical" disease, which does not meet established diagnostic criteria for any known CTD, has been extensively studied. We have reviewed the epidemiologic literature regarding an association between cosmetic breast implants and CTDs, with particular emphasis on results drawn from the most recent investigations, many of which are large cohort studies with long-term follow-up, as well as on those studies that address some of the misinformation and historically widespread claims regarding an association between breast implants and CTDs. These claims have been unequivocally refuted by the remarkably consistent evidence from published studies, as well as numerous independent meta-analyses and critical reviews, which have demonstrated that cosmetic breast implants are not associated with a subsequent increased occurrence of individual CTDs or all CTDs combined, including fibromyalgia. Moreover, there is no credible evidence for the conjectured excess of "atypical" CTD among women with cosmetic breast implants, or of a rheumatic symptom profile unique to these women. No increased risk of CTDs is evident in women with extracapsular ruptures in two studies, which evaluated risk by implant rupture status, and no consistent association has been observed between silicone breast implants and a variety of serologic markers or autoantibodies. Thus, any claims that remain regarding an association between cosmetic breast implants and CTDs are not supported by the scientific literature but rather are a residual byproduct of the unprecedented large-scale product liability litigation in the USA.

Background: Prospective long-term data on the occurrence of complications following breast augmentation are sparse and the reported frequencies differ substantially., Methods: The Danish Registry for Plastic Surgery of the Breast has prospectively registered preoperative, perioperative, and postoperative data for women undergoing breast augmentation in Denmark since 1999. From the Registry, the authors identified 5373 women with a primary cosmetic breast augmentation between 1999 and 2007. The authors calculated incidence proportions of adverse clinical outcomes within three time intervals (0 to 30 days, 0 to 3 years, and 0 to 5 years) after primary implantation. Outcomes of primary interest were capsular contracture, asymmetry/ displacement of the implant, hematoma, and infection., Results: During the entire follow-up period (mean, 3.8 years; range, 0.1 to 8.7 years), 16.7 percent of the women were registered with an adverse event and 4.8 percent of the women were registered with a surgery-requiring complication. The most common adverse events within 30 days were hematoma (1.1 percent) and infections (1.2 percent), whereas the most common adverse events within 5 years were change of tactile sense (8.7 percent) and asymmetry/ displacement of implant (5.2 percent). Within 5 years, 1.7 percent of the women had a record of severe capsular contracture. Displacement/asymmetry and capsular contracture were the most frequent indications for reoperation with removal or exchange of the implant., Conclusions: Population-based complication frequencies among women with cosmetic breast augmentation in a Danish nationwide implant registry were generally lower than those reported in other studies, although frequencies of complications increased with length of follow-up.

Five large epidemiologic mortality studies of women with cosmetic breast implants have consistently reported a two- to threefold higher rate of suicide compared with the general female population. Overall, 135 suicides have been observed, compared with 66.9 expected, yielding a significantly elevated standardized mortality ratio of 2.0 (95% CI, 1.5-2.6). In addition to suicides, excesses from other external causes of death related to drug and alcohol abuse/dependence, atypical motor vehicle accidents, and other self-harm causes have been consistently reported. These observations, together with limited but direct epidemiologic evidence of preimplant psychiatric hospitalization, as well as self-reports of preimplant psychiatric disorders, including depression, eating disorders, and body image dissatisfaction, among implant women raise the possibility of significant underlying psychiatric morbidity for a subgroup of implant patients. Research into the psychiatric profiles and history of the women who have committed suicide in the investigated cohorts appears warranted.

Background: Prospective long-term data on the occurrence of complications following breast augmentation are sparse and the reported frequencies differ substantially., Methods: The Danish Registry for Plastic Surgery of the Breast has prospectively registered preoperative, perioperative, and postoperative data for women undergoing breast augmentation in Denmark since 1999. From the Registry, the authors identified 5373 women with a primary cosmetic breast augmentation between 1999 and 2007. The authors calculated incidence proportions of adverse clinical outcomes within three time intervals (0 to 30 days, 0 to 3 years, and 0 to 5 years) after primary implantation. Outcomes of primary interest were capsular contracture, asymmetry/displacement of the implant, hematoma, and infection., Results: During the entire follow-up period (mean, 3.8 years; range, 0.1 to 8.7 years), 16.7 percent of the women were registered with an adverse event and 4.8 percent of the women were registered with a surgery-requiring complication. The most common adverse events within 30 days were hematoma (1.1 percent) and infections (1.2 percent), whereas the most common adverse events within 5 years were change of tactile sense (8.7 percent) and asymmetry/displacement of implant (5.2 percent). Within 5 years, 1.7 percent of the women had a record of severe capsular contracture. Displacement/asymmetry and capsular contracture were the most frequent indications for reoperation with removal or exchange of the implant., Conclusions: Population-based complication frequencies among women with cosmetic breast augmentation in a Danish nationwide implant registry were generally lower than those reported in other studies, although frequencies of complications increased with length of follow-up.

An excess of suicide among women with cosmetic breast implants compared with controls has consistently been reported in epidemiologic studies. We have evaluated psychological characteristics among 423 Danish women with cosmetic breast implants, compared with 414 controls. Odds ratios (OR) with 95% confidence intervals (CI) for self-reported psychological symptoms were calculated using multiple logistic regression. Substantial excesses of all studied symptoms before implant surgery were reported among women with breast implants compared with women with other cosmetic surgery, whereas ORs for virtually all symptoms occurring after surgery were close to or below 1.0. In particular, ORs for treatment for depression, cognitive/depressive symptoms, and depression/low spirit before surgery were 4.6 (95% CI = 2.1-10.0), 3.9 (95% CI = 1.9-7.8), and 2.5 (95% CI = 1.1-5.5), respectively. In contrast, the corresponding ORs for these 3 psychological symptoms after surgery were 0.9 (95% CI = 0.6-1.4), 1.0 (95% CI = 0.7-1.5), and 1.0 (95% CI = 0.6-1.5), respectively. In conclusion, women with cosmetic breast implants reported preoperative psychological symptoms indicative of depressive disorders substantially more frequently than women with other cosmetic surgery. Future studies using standardized, validated psychiatric assessment tools are needed to determine whether this can explain the higher risk for suicide among a subset of women seeking cosmetic breast implants.

Background: In the past, concerns about lymphoma among women with breast implants have been raised by anecdotal observations. A recent report of a case-control study from The Netherlands reported an association of breast implants with anaplastic large T-cell lymphoma, but limitations inherent in the study design and the restriction of the association to saline implants preclude any causal evaluation., Methods: To determine whether lymphoma risk is in fact elevated in women with breast implants, the authors have reviewed the evidence from five long-term follow-up studies comprising over 43,000 women with cosmetic breast implants followed for up to 37 years, which reported results specifically regarding the incidence of non-Hodgkin's lymphoma, among other cancers., Results: Overall, there were 48 observed incident cases of non-Hodgkin's lymphoma compared with 53.9 cases expected, yielding a summary standardized incidence ratio of 0.89 (95 percent confidence interval, 0.67 to 1.18). None of the epidemiologic cohort studies reported a primary lymphoma originating in the breast., 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.

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., (Copyright (c) 2008 Wiley-Liss, Inc.)

The purpose of this study is to compare women with cosmetic breast implants with population controls to examine health-related quality of life. A questionnaire including quality-of-life questions was mailed to 399 Finnish women who had had cosmetic breast implants during the years 1973-2002. The response rate of the study was 85. Results were compared with average Finnish women from a representative population sample. There were no differences in total score of health-related quality of life between women with breast implants and controls. Women with breast implants had lower health-related quality of life in dimensions of distress and sexual activity and partly also in dimensions of sleeping and mental function when compared with controls. On the other hand, operated women reported significantly less discomfort and symptoms than controls. Differences in health-related quality of life between women with breast implants and controls were largest in dimensions of distress, sexual activity, sleeping, and symptoms.

Background: To assess whether maternal cosmetic breast implants are associated with adverse health outcomes among offspring, the authors examined published findings of epidemiologic studies that addressed this hypothesis., Methods: Four epidemiologic studies, all from Scandinavia, were identified. Women with breast implants were identified from existing public and private registers of patients, and their offspring were traced through nationwide population and birth registers. The studies included a total of 11,445 women with breast implants and 3248 children born after the mothers' implantation procedures. Comparison was made with children born to mothers who had undergone other cosmetic surgery or general population controls. Outcomes under study were congenital malformations, hospitalization for esophageal and rheumatic disorders, and perinatal mortality., Results: Overall, the studied outcomes were similar between children born to mothers with breast implants and children of controls, and between children born before and after maternal breast implantation. In the Danish studies, significantly elevated rates of esophageal disorders were observed for children born before (observed-to-expected ratio, 2.0; 95 percent confidence interval, 1.3 to 2.8) but not after (observed-to-expected ratio, 1.3; 95 percent confidence interval, 0.5 to 2.9) the mother's breast implant surgery. Similar excesses were observed among control children born before and after maternal breast reduction. In the Swedish and Finnish studies, all risk estimates for malformations and perinatal health were close to unity., 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.

Background: Large-scale epidemiologic studies to date have not found any credible association between silicone breast implants and either well-defined connective tissue diseases or undefined or atypical connective tissue diseases. It has been hypothesized that implant rupture could prompt an immunologic reaction giving rise to autoimmune or related diseases. In this article, the authors review the available literature on implant ruptures and connective tissue disease., Methods: Articles were identified from PubMed and by cross-checking reference lists of retrieved articles., Results: Five publications were identified. In none of the studies were diseases or symptoms related to well-defined or ill-defined connective tissue diseases associated with rupture status., Conclusions: 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.

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.

An increased rate of suicide among women with cosmetic breast implants has been consistently reported in the epidemiologic literature. We extended by 8 years the follow-up of our earlier mortality study of a nationwide cohort of 3527 Swedish women with cosmetic breast implants to examine in greater detail suicide and other causes of death. The number of deaths observed among these women was compared with the number expected among the age- and calendar-period-matched general female population of Sweden. Women with breast implants were followed for over 65,000 person-years, with a mean follow-up of 18.7 years (range, 0.1-37.8 years). Overall, 175 deaths occurred among women with breast implants versus 133.4 expected (standardized mortality ratio (SMR) = 1.3; 95% confidence interval [CI], 1.1-1.5). Among women with implants, we observed statistically significant 3-fold excesses of suicide (SMR, 3.0; 95% CI, 1.9-4.5) and deaths from alcohol or drug dependence (SMR, 3.1; 95% CI, 1.0-7.3), as well as an excess of deaths from accidents and injuries consistent with substance abuse or dependence. The increased risk of suicide was not apparent until 10 years after implantation. Deaths from cancer overall were close to expectation (SMR, 1.1; 95% CI, 0.8-1.4). Women with cosmetic implants had elevated SMRs for lung cancer and chronic respiratory disease. There was no excess of breast cancer mortality. The excess of deaths from suicides, drug and alcohol abuse and dependence, and other related causes suggests significant underlying psychiatric morbidity among these women. Thus, screening for pre-implant psychiatric morbidity and post-implant monitoring among women seeking cosmetic breast implants may be warranted.

Purpose: Numerous epidemiologic studies have demonstrated that breast implants are not associated with connective tissue diseases (CTDs). However, many CTDs are rare, and continued follow-up of women with breast implants is warranted., Methods: We extended by 5 years the follow-up of our earlier population-based cohort study of Danish women with cosmetic breast implants (n = 2761) and comparison groups of women with other types of cosmetic surgery (n = 8807). All women were followed from January 1977 through December 2001. Hospitalization and outpatient data for CTD and ill-defined and other rheumatic conditions in the implant and comparison groups were compared with those in the general Danish population. Additionally, CTDs and fibromyalgia were confirmed through medical chart review, and direct comparisons of the breast implant cohort with the comparison cohort were performed., Results: When compared with general population rates, CTDs were not statistically significantly elevated in either the implant or the comparison cohorts. However, unspecified rheumatism was similarly increased in the implant (standardized rate ratio = 1.9; 95% confidence interval = 1.6 to 2.2) and comparison (standardized rate ratio = 1.5; 95% confidence interval = 1.4 to 1.7) cohorts. In analyses of diagnoses validated by chart review, women with cosmetic breast implants compared with those having other types of plastic surgery or consultation for plastic surgery had no statistically significant excess for any specific confirmed CTD or combined CTDs (hazard ratio = 1.3; 95% CI = 0.9 to 1.9). In addition, there was no relation between breast implants and confirmed fibromyalgia (hazard ratio = 1.2; 95% CI = 0.6 to 2.1)., Conclusions: This extension of our earlier cohort study further supports the consensus of epidemiologic research that breast implants are unrelated to the development of CTD.

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.

Concerns regarding potential health effects of silicone breast implants have recently shifted from long-term illnesses to postoperative local complications. In this study, occurrence of local complications and treatment procedures were evaluated in a population of 685 Finnish women who received cosmetic silicone breast implants between 1968 and 2002. Patient records were abstracted, and additional information was gathered using a structured questionnaire that was mailed to 470 of the women in the cohort. Overall, 36% of the women had 1 or more diagnoses of postoperative complications in their medical records. The most common complication was capsular contracture, occurring in 17.7% of women and 15.4% of implantations. Other complications were more rare. The majority of women (74%) needed no postoperative treatment. However, 22% of women required 1 or more surgical procedures after the primary implantation. Most of the women were satisfied with the implantation, but only 40% considered the preoperative information on possible risks related to implantation as sufficient. With respect to the occurrence of local complications following cosmetic breast implantation, the findings of this study are consistent with previous studies. Frequencies of complications were remarkably similar in medical records and self-reports.

Four epidemiologic studies have examined mortality among women with cosmetic silicone gel-filled breast implants and have found that risk of death from suicide is two- to threefold higher in this group than among women of comparable age in the general population. The authors review the literature on the psychological and psychiatric hypotheses concerning women undergoing plastic surgery, although these hypotheses do not specifically address the association with suicide. Epidemiologic research is urgently needed to evaluate whether this association is an artifact of a higher prevalence of underlying and unreported psychopathology and other risk factors for suicide among women receiving breast implants or whether implants have an actual causal role in the risk of suicide. Until such studies are completed, psychiatric consultation should be considered before breast augmentation, especially for patients perceived to be at high risk by the plastic surgeon.

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.

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.

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.

Background: No epidemiological evidence of an association between silicone breast implants and connective tissue disease has been found. Based on case reports, it has been hypothesized that silicone breast implants may be associated with a unique rheumatic symptom cluster termed "atypical connective tissue disease.", Material and Methods: We have evaluated self-reported rheumatic symptoms among women who received breast implants between 1977 and 1997 at 2 private plastic surgery clinics in Denmark. Women with other cosmetic surgery, including breast reduction, as well as women from the general population, were identified as controls., Results: No statistically significant differences in mild (odds ratio [OR] = 0.9; 95% confidence interval [CI] = 0.6-1.3), moderate (OR = 0.7; 95% CI = 0.4-1.2), or severe (OR = 1.1; 95% CI = 0.6-2.1) musculoskeletal symptoms were observed when women with breast implants were compared with women with other cosmetic surgery. Compared with women from the general population, women with breast implants were statistically significantly less likely to have mild or moderate musculoskeletal symptoms (OR = 0.5; 95% CI = 0.3-0.7 and OR = 0.3; 95% CI = 0.2-0.5, respectively); for severe symptoms the deficit was not statistically significant (OR = 0.7; 95% CI = 0.3-1.3). For individual symptom groups, there was no consistent pattern of reporting among women with implants., 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.

To assess whether maternal breast implants are related to adverse health outcomes in offspring, the authors conducted a retrospective cohort study of esophageal disorders, rheumatic disease, and congenital malformations among 2,854 children born to women with breast implants and among 5,805 children born to a comparison group of women who underwent breast reduction or other plastic surgery. Rates were calculated using both hospitalization and outpatient data. Significantly higher rates of esophageal disorders were observed (O) than were expected (E) for children born before (O/E, 2.0; 95% CI, 1.3-2.8) but not after (O/E, 1.3; 95% CI, 0.5-2.9) maternal breast implant surgery. Risk of rheumatic disease was similar among children born before (O/E, 1.4; 95% CI, 0.7-2.6) and after (O/E, 1.4; 95% CI, 0.2-5.0) maternal breast implant surgery. A marginally significant excess of congenital malformations of the digestive organs was observed among children born after maternal implant surgery (O/E, 1.8; 95% CI, 1.0-3.1), with a similar finding among children born to women in the comparison group (O/E, 1.9; 95% CI, 1.4-2.4). The risk of malformations overall was not statistically significantly higher than expected among children born after maternal breast implant surgery. The elevated risks of adverse health outcomes appear unrelated to breast implants per se, because similar findings were observed among children born both before and after the mother's implant surgery, as well as among children born to mothers in the comparison cohort.

Concern has been raised recently regarding the absence of information on the occurrence and severity of local complications after cosmetic breast implantation. The authors evaluated the occurrence of local complications in a large epidemiological retrospective cohort study of women with cosmetic breast implants in Denmark. All women with breast implants were identified from the files of two private clinics of plastic surgery in Denmark. Information on implant characteristics, surgical procedure, as well as short- and long-term complications was obtained through medical record review. Patient characteristics were obtained through a self-administered questionnaire. A total of 754 women (1,572 implants) had at least one cosmetic implantation performed at the study clinics. Average age at implantation was 32 years. Implant types included silicone double lumen with textured surface, 31.2%; silicone single lumen with textured surface, 27.8%; silicone single lumen with smooth surface, 24.5%; silicone double lumen with smooth surface, 0.8%; and other or missing information, 15.7%. Average implant size was 247 ml (range, 110-630 ml). Placement was submuscular for 91.3% of implants, subglandular for 2.6%, and 6.1% had no available information. Overall, 77.8% of implantations were not followed by complications, 17.8% were followed by one complication, 3.6% were followed by two complications, and 0.8% were followed by three or more complications. In 94.6% of implantations, no additional hospitalizations were recorded as a result of complications. Forty-seven of 57 explantations/reimplantations were secondary to postoperative complications. General complications such as hematoma and infection were rare, occurring in 2.3% and 2.0% of implantations respectively. Capsular contracture remains the most common complication, occurring in 11.4% of implantations. In this investigation, among the first epidemiological studies of local complications, the authors found cosmetic breast implant surgery to be associated with a low frequency of normal surgical complications such as infection, hematoma, and wound dehiscence. Most complications were mild and did not lead to additional hospitalization. The complication that led most frequently to the need for additional surgery/hospitalization was capsular contracture. Kjøller K, Hölmich LR, Jacobsen PH, Friis S, Fryzek J, McLaughlin JK, Lipworth L, Henriksen TF, Jørgensen S, Bittmann S, Olsen JH. Epidemiological investigation of local complications after cosmetic breast implant surgery in Denmark.

The authors investigated the association between the occurrence of capsular contracture and implant and patient characteristics. All women with breast implants from 1977 to 1997 were identified from the files of two private plastic surgery clinics in Denmark. Information on implant and patient characteristics, surgical procedure, and complications was obtained through medical records and self-administered questionnaires. Of 754 women (1,572 implants), average age at implantation was 32 years. Implant types were silicone double lumen, textured, 31.2%; silicone single lumen, textured, 27.8%; silicone single lumen, smooth, 24.5%; silicone double lumen, smooth, 0.8%; and other or missing, 15.7%. Placement was submuscular for more than 90% of implants. Capsular contracture occurred in 7.9% of implanted breasts, on an average of 621 days postoperatively, with 51.6% being bilateral. Overall, 66.1% of capsular contractures were recorded within the first 12 months postoperatively, and 79.0% were recorded within 24 months. Double-lumen implants were associated with a significantly (p < 0.01) reduced occurrence of capsular contracture. In summary, capsular contracture typically occurs within the first 2 years of implantation. Host factors may be important because more than half the capsular contractures in the current study were bilateral. Occurrence of capsular contracture did not appear to be associated with implant surface or placement, occurrence of local complications, or patient characteristics, although these findings should be interpreted cautiously.

Objective: To examine the occurrence of connective tissue diseases (CTDs) as well as ill-defined and other rheumatic conditions among Danish women with cosmetic silicone breast implants., Patients and Methods: A total of 2761 women with breast implants and 8807 control subjects were identified from plastic surgery private clinics and from public hospital plastic surgery departments. Women operated on at plastic surgery private clinics were identified through the files of each clinic, while women operated on at public hospitals were identified using the nationwide Danish National Registry of Patients. The control group consisted of women who underwent cosmetic surgery other than breast implantation or who only had a consultation. All women were followed up from January 1, 1977, through December 31, 1996, through the Danish National Registry of Patients for the occurrence of CTD as well as ill-defined and other rheumatic conditions. For the study period January 1, 1977, through December 31, 1994, the Danish National Registry of Patients contains information on hospitalization only, whereas data on outpatient visits are included from 1995 on, thus improving the sensitivity of the data. The implant and control groups were compared with the Danish population rates for CTD and ill-defined and other rheumatic conditions, and a direct comparison between the implant and control groups was also performed., Results: When compared with rates from the general population, no excess of definite CTD was observed in the implant cohorts. For ill-defined and other rheumatic conditions, statistically significant excesses of unspecified rheumatism were observed in both the implant and control cohorts when compared with national rates. A direct comparison between the implant and control cohorts found no material differences between the groups., 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.

Objectives: To investigate the risk of neurological disease among women with cosmetic breast implants., Material and Methods: We identified 1,653 women who had undergone breast implant surgery at private clinics in Denmark and a comparison cohort of 1,736 women who underwent other types of cosmetic surgery at the same clinics. Ratios of observed-to-expected numbers of hospitalizations for neurological disease in the private implant and comparison cohorts were calculated, separately and combined with data from updated public hospital cohorts., Results: The occurrence of neurological disease in the private clinic implant cohort was comparable to that in the general population. A similar risk pattern was observed in the private clinic comparison cohort. When data for these private clinic cohorts were combined with updated data for public hospital cohorts, excess risks for neurological disorders were seen in both implant and comparison cohorts, reaching statistical significance only in the comparison cohort., Conclusion: Our findings indicate no causal association between silicone breast implants and neurological disease.

The aim of this study was to investigate whether women with silicone breast implants (SBI) present with a unique rheumatic symptomatology. We assessed the profile of rheumatic disease in six groups of women identified through Danish hospital and population registers, three groups of women with a prior hospital diagnosis of muscular rheumatism (a non-specific 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 sugery (n = 56). All women in the study population (n = 188) underwent a thorough clinical examination, blood tests and a personal interview. In all study groups soft-tissue rheumatism and degenerative diseases were the most frequent diagnoses. Women with a prior diagnosis of muscular rheumatism but no prior breast surgery had a significantly higher prevalence of soft-tissue rheumatism than those with breast implant or reduction surgery. No significant differences in the frequencies of rheumatic diseases were observed among the three groups of women without previous muscular rheumatism. No specific pattern of inflammatory rheumatic disorders or soft-tissue complaints was identified among the women with SBI, and blood tests for autoimmunity revealed no unique pattern. Overall, women with earlier rheumatism had significantly increased frequencies of rheumatic conditions than did those without. We found no evidence of a rheumatic symptomatology unique to women with silicone breast implants. Our study emphasises the need for consideration of prior rheumatic disease when evaluating rheumatic manifestations in women with SBI.

Epidemiologic studies have found no association between breast implants and cancer or well-defined connective tissue diseases. However, women with cosmetic breast implants continue to report specific as well as nonspecific physical and psychological symptoms after receiving their implants. In an attempt to determine whether local complications of implantation may contribute to this excess of symptom reporting, the authors studied a large cohort of women in Sweden with cosmetic breast implants (n = 1280) and a comparison cohort of women who had cosmetic breast reduction surgery (n = 2211). Both groups of women had operations between 1969 and 1996. Medical record reviews of local complications revealed that approximately 31 percent of the women with cosmetic breast implants had an implant change, implant leakage, or a capsulotomy. Capsulotomies occurred more often in women who were age 35 or older at the time of the operation, had ever smoked, and had implants with a smooth surface. On self-administered questionnaires, symptoms were reported more often by the women who had implants regardless of whether they had local complications. Twenty of the 28 symptoms occurred more frequently among women with local complications and breast implants, compared with the women in the breast reduction comparison group or the women with breast implants but no local complications. This study suggests that local complications, particularly capsular contractures as indicated by capsulotomy, may be an important factor to consider when studying symptom reporting among women with breast implants.

The article reports a study that aimed to find out frequency rates of local complications in a population of cosmetic breast implant patients in Finland. Researchers of the study stated that from the patient record of 685 women, 36% of the women had at least one complication diagnosed in patient records. Capsular contracture was the most common complication, diagnosed in 17% of the women. Other complications were found to be quite rare. Capsular contracture was the main indication for additional surgery. Most of the women were satisfied with their decision to undergo the implantation operation.