Abstract: We investigated if delayed breast implant reconstruction after breast cancer impairs prognosis. Using data from the Danish Breast Cancer Cooperative Group register, we identified all women <70 years who underwent breast reconstruction with implants after mastectomy after invasive breast cancer during 1978 to 1992, on average 2.2 years (range, 3 days-9.4 years) after mastectomy. The reconstructed women were closely matched to breast cancer patients without reconstruction on age and calendar time of diagnosis, tumor size, regional lymph node involvement, and adjuvant radiation therapy. Overall, 580 reconstructed women and 1158 individually matched controls were followed-up for disease-free survival within the first 10 years and for overall survival for an average of 20.1 year (range, 12.8-27.5 years). Disease-free survival was significantly improved hazard ratio 0.78; 95% confidence interval 0.64-0.95 and overall survival was nonsignificantly improved (hazard ratio, 0.90; 95% confidence interval 0.76-1.06) among the breast reconstructed women. This is likely because of differences in socioeconomic and health factors.

Abstract: All women who underwent breast augmentation at 1 public and 1 private clinic in Denmark from 1973 to 1988, and available for follow-up, were invited to participate in a clinical study including a self-administered questionnaire, medical record abstraction, and a clinical examination. One hundred ninety (52%) out of 368 eligible women participated.Mean time with implants in situ was 19 years (range, 5-35). Sixty-one percent of the women had 1 implantation, 23% had 2 implantations, 16% had 3 or more implantations. Nineteen women (10%) had no implants at the time of examination. A large proportion of the women (62%) had clinically significant capsular contracture, and only half of the study women were found to have satisfactory overall breast appearance at examination. In contrast, the majority of women reported satisfaction with their implant surgery (60%). The women tended to grade themselves more positively than the examining physicians.

Abstract: 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.

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.

Abstract: BACKGROUND: Malignant degeneration of chronic ulcers such as nonhealed burn wounds has been described in the literature, but this phenomenon has never been quantified in an epidemiologic study. We investigated the risks for skin and other cancers among patients with a prior burn. METHODS: We identified 16,903 patients from the Danish Hospital Discharge Register who had been admitted to a hospital with a thermal or chemical burn during 1978 to 1993. The cohort was followed for cancer in the Danish Cancer Registry through 2002, and the cancer incidence in the cohort was compared with that in the general population of Denmark. RESULTS: Patients with burn had 139 skin cancers, with 189 expected, yielding a standardized incidence ratio of 0.7 (95% confidence interval = 0.6-0.9). This reduced risk was due mainly to deficits of basal cell carcinoma and malignant melanoma, whereas the number of squamous cell carcinomas observed was close to expected. We saw no consistent increases in risk for skin cancer in the subgroups of patients with the most severe injuries or with the longest periods of follow up. CONCLUSIONS: The tendency to malignant degeneration of burn scars, described in previous reports of case series, did not result in an excess of squamous cell carcinoma of the skin or of any other type of skin cancer during up to 25 years' follow up of a large unselected cohort of patients hospitalized for burn injuries.

Abstract: STUDY OBJECTIVE: The aim of this study was to evaluate the accuracy of Magnetic Resonance Imaging (MRI) as performed according to a strict study protocol in diagnosing rupture of silicone breast implants. MATERIAL AND METHODS: The study population consisted of 64 women with 118 implants, who had participated in either one or two study MRI examinations, aiming at determining the prevalence and incidence of silent implant rupture, respectively, and who subsequently underwent explantation. Implant rupture status was determined by four independent readers and a consensus diagnosis of either rupture (intracapsular or extracapsular), possible rupture or intact implant was then obtained. Strict predetermined rupture criteria were applied as described in this report and findings at surgery were abstracted in a standardised manner and results compared. RESULTS: At MRI, 66 implants were diagnosed as ruptured, nine as possibly ruptured and 43 as intact. Among the ruptured implants, 27 were categorized as extracapsular. At surgery, on average 297 days after the MRI, 65 of the 66 rupture diagnoses were confirmed, as were 20 of the cases with extracapsular silicone. Eight of the nine possibly ruptured implants were in fact ruptured at surgery. Thirty-four of the 43 intact implants were described as intact at surgery. When categorising possible ruptures as ruptures, there were one false positive and nine false negative rupture diagnoses at MRI yielding an accuracy of 92%, a sensitivity of 89%, and a specificity of 97%. Correspondingly, the predictive value of a positive MRI examination was 99% and the predictive value of a negative MRI examination was 79%. CONCLUSIONS: We conclude that MRI is highly accurate for identification of silicone breast implant rupture, with a high sensitivity and specificity when evaluation of images are based on presence of well-defined rupture criteria.

Abstract: Cosmetic breast implants have become increasingly popular throughout the world. However, there is insufficient knowledge about the frequency and severity of local complications such as rupture and capsular contracture. A pilot study of 25 Finnish women with 50 cosmetic breast implants was organized to determine the feasibility of conducting a magnetic resonance imaging (MRI)-based study of rupture incidence. The pilot investigation included a clinical examination by a plastic surgeon, MRI scan, and self-administered questionnaire. The participation rate was 100%. Implants in our study represented a cross-section of the different generations of implants in Finland, with implant ages varying from 4 months to 20 years. The average implant size was 215 mL, typical in Finnish cosmetic surgery. MR images were evaluated by two independent readers. The first reader diagnosed six implants with intracapsular rupture, while the other diagnosed all implants as intact. The procedures of the feasibility study proved successful, and the results demonstrate the importance of a rigid image evaluation protocol with employment of well-defined rupture criteria, as well as the benefits of several image readers.

Abstract: Epidemiologic data on local complications after breast augmentation are scarce. In particular, few prospectively collected data are available on modern breast implants on this issue. Using data from the Danish Registry for Plastic Surgery of the Breast, the authors examined determinants of surgery-requiring complications and capsular contracture grades III to IV among 2277 women who underwent cosmetic breast implantation from June 1999 through April 2003. During an average follow-up period of 1.6 years after implantation, 4.3% of these women (3% of implants) required secondary surgery as a result of short-term complications. The most frequent clinical indications for surgery were displacement of the implant (38%), capsular contracture grades III to IV (16%), ptosis (13%), and hematoma (11%). Overall, the authors found that inframammary incision and subglandular placement were associated with decreased risks of developing complications requiring surgical intervention, whereas implants larger than 350 mL increased the risk of such complications (relative risk [RR], 2.3; 95% confidence interval [CI], 1.3-4.0). Thirty-nine Baker III to IV capsular contractures were identified, of which 22 were treated surgically within the study period. Submuscular placement of the implant decreased the risk of capsular contracture grades III to IV (RR, 0.3; 95% CI, 0.2-0.8), whereas surgical routes other than inframammary and drainage of implant cavity were associated with increased risk of capsular contracture. Current surgical practices and modern implants used for breast augmentation produce fewer short-term complications than procedures and devices of the past. This prospective study indicates that surgical procedures are more important predictors for local (short-term) complications than implant or patient characteristics.

Abstract: BACKGROUND: Clinical reports have raised concern about local complications following breast implantation used in reconstructive or cosmetic surgery, but there is a shortage of epidemiological studies in this area. OBJECTIVE: To assess in a prospective epidemiological manner the occurrence of short-term local complications in a nationwide implantation registry. DESIGN, SETTING, AND PARTICIPANTS: The Danish Registry for Plastic Surgery of the Breast prospectively collects preoperative, perioperative, and postoperative information on Danish women undergoing breast augmentation. Through the registry, we collected data on short-term local complications among 574 women who underwent postmastectomy reconstruction with breast implants from June 1, 1999, through July 24, 2003. MAIN OUTCOME MEASURES: Complication incidence rates. RESULTS: Thirty-one percent of the women who underwent initial implantation developed at least 1 adverse event. Forty-nine percent of the adverse events occurred within 3 months after implantation and 67% within 6 months. Surgical intervention was required after initial implantation among 21% of women, most frequently because of capsular contracture, asymmetry, or displacement of the implant. Thirty-six percent of women who underwent subsequent implantation experienced at least 1 adverse event, and 21% underwent surgical intervention to treat definitive complications or to optimize cosmetic result. CONCLUSIONS: Women who undergo postmastectomy breast implantation frequently experience short-term local complications. Surgical or medical intervention is commonly required during the reconstructive course, but reconstruction failure (loss of implant) is rare. However, when weighing benefits and risks associated with reconstruction, the patient should consider that breast reconstruction is a process involving planned and unplanned supplementary surgical correction to achieve the desired result.

Abstract: The objective was to evaluate the usefulness of clinical examination in the evaluation of breast-implant integrity, using the diagnosis at magnetic resonance imaging (MRI) as the "gold standard." Fifty-five women with 109 implants underwent a breast examination either just before or shortly after an MRI examination. Twenty-four of 109 implants were clinically diagnosed with possible rupture or rupture. Eighteen of the 24 implants were ruptured according to the MRI examination (75%). Eighty-five implants were clinically classified as intact, and 43 of these were actually ruptured at MRI (51%). The sensitivity of the clinical examination for diagnosing rupture was thus 30% and the specificity 88%. The positive predictive value of a clinical diagnosis of rupture was 75%, and the negative predictive value was 49%. In this study, we found that when a clinical examination is used as the sole diagnostic tool to identify implant rupture, neither the sensitivity nor the specificity is acceptable.

Abstract: Long-term safety data are important in the evaluation of possible adverse health outcomes related to silicone breast implants. The authors evaluated long-term symptoms and conditions and medication use among 190 Danish women with cosmetic silicone breast implants compared with 186 women who had undergone breast reduction surgery and with 149 women from the general population. Breast implant and reduction surgeries were performed from 1973 to 1988 at one public hospital and one private plastic surgery clinic. Among women with breast implants, the average implantation time was 19 years, 60 percent (n = 114) had only one implantation, and 10 percent (n = 19) had undergone explantation before the time of study (1997 to 1998). The authors found no material differences in self-reported diseases or symptoms among study groups, except for breast pain, which was reported nearly three times as often by women with implants than by women with breast reduction (odds ratio, 2.8; 95 percent confidence interval, 1.4 to 5.3). Approximately 80 percent of women in each study group reported at least one symptom. No consistent differences were observed in the seroprevalences of antinuclear antibodies or other autoantibodies. Self-reported use of psychotropic drugs was higher among women with breast implants than among either control group. The authors conclude that long-term cosmetic breast implantation may cause capsular contracture and breast pain but does not appear to be associated with other symptoms, diseases, or autoimmune reactivity. The authors' finding of excess use of drugs for treatment of depression and anxiety among women with breast implants may warrant further investigation.

Abstract: 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.

Abstract: Implant rupture is a well-known complication of breast implant surgery that can pass unnoticed by both patient and physician. To date, no prospective study has addressed the possible health implications of silicone breast implant rupture. The aim of the present study was to evaluate whether untreated ruptures are associated with changes over time in magnetic resonance imaging findings, serologic markers, or self-reported breast symptoms. A baseline magnetic resonance imaging examination was performed in 1999 on 271 women who were randomly chosen from a larger cohort of women having cosmetic breast implants for a median period of 12 years (range, 3 to 25 years). A follow-up magnetic resonance imaging examination was carried out in 2001, excluding women who underwent explantation in the period between the two magnetic resonance imaging examinations (n = 44). On the basis of these examinations, the authors identified 64 women who had at least one ruptured implant at the first magnetic resonance imaging examination and, for comparison, all women who had intact implants at both examinations (n = 98). Magnetic resonance images from the two examinations were compared and changes in rupture configuration were evaluated. Comparisons were also made for self-reported breast symptoms occurring during the study period and for changes in serum values of antinuclear antibodies, rheumatoid factor, and cardiolipin antibodies immunoglobulin G and immunoglobulin M. The majority of the women with implant rupture had no visible magnetic resonance imaging changes of their ruptured implants. For 11 implants (11 percent) in 10 women, the authors observed progression of silicone seepage, either as a conversion from intracapsular into extracapsular rupture (n = 7), as progression of extra-capsular silicone (n = 3), or as increasing herniation of the silicone within the fibrous capsule (n = 1); however, in most cases, these changes were minor. Some changes could be ascribed to trauma, but others seemed spontaneous. There was no increase in levels of autoantibodies during the study period in either study group. Women with untreated implant ruptures reported a significant increase in nonspecific breast changes (odds ratio, 2.1; 95 percent confidence interval, 1.2 to 3.8) compared with women without ruptures. On the basis of this first study of women with untreated silicone breast implant rupture, the authors conclude that implant rupture is a relatively harmless condition, which only rarely progresses and gives rise to notable symptoms. Even so, because of a small risk of silicone spread, the authors suggest that women with implant ruptures be followed clinically, if not operated on. Because implant ruptures often occur asymptomatically, any woman with silicone implants, regardless of rupture status, should be evaluated at regular intervals.

Abstract: BACKGROUND: Groin pain is a diagnostic and therapeutic challenge to sports medicine. The literature provides no consensus on definitions of or diagnostic criteria for groin pain in athletes. To compare the results of research and treatments, the methods used to diagnose and evaluate the degree of groin pain must be clearly defined and reproducible. OBJECTIVES: To describe clinical examination techniques for groin pain in athletes and evaluate the intraobserver and interobserver reliability of these. METHODS: Eighteen athletes, nine with sports related groin pain and nine without groin pain, were examined by two doctors and two physiotherapists. The examiners were trained in the examination techniques before the study. The examiners were blinded to the symptoms and identity of the subjects. The subjects were examined twice by each examiner in random order. The examinations included evaluation of adductor muscle related pain and strength, iliopsoas muscle related pain, strength, and flexibility, abdominal muscle related pain, and strength and pain at the symphysis joint. Kappa statistics and percentage of agreement were used to evaluate the data. RESULTS: Overall, the kappa values and percentage of agreement were in accordance and showed good reliability of the examinations. The kappa values for the intraobserver agreement were above 0.60 in 11 of 14 tests, and those for the interobserver agreement of the pain tests were above 0.60 in eight of 10 tests. The only test without acceptable interobserver reliability was the strength test for iliopsoas muscle. CONCLUSION: All but one of the tests investigated were reproducible and subject only to limited intraobserver and interobserver variation.

Abstract: BACKGROUND: Epidemiologic studies indicate that women with cosmetic breast implants have a significantly increased risk of suicide. Our objectives were to examine mortality among Danish women who underwent cosmetic breast implant surgery and to evaluate the baseline prevalence of psychopathological disorders as measured by admission to a psychiatric hospital among women seeking cosmetic surgery. METHODS: Cohort study of 2761 women who underwent cosmetic breast implant surgery at private clinics of plastic surgery or public hospitals, 7071 women who underwent breast reduction surgery at public hospitals, and 1736 women who attended private clinics for cosmetic surgery other than breast implantation, between 1973 and 1995. Causes of death through 1999 were identified through the Danish Mortality Files. Information on admission to psychiatric hospitals prior to cosmetic surgery was obtained from the Danish Psychiatric Central Register. RESULTS: Women with cosmetic breast implants had significantly elevated standardized mortality ratios (SMRs) for death overall (SMR, 1.4; 95% confidence interval [CI], 1.1-1.7), nonmalignant lung disease (3.4; 95% CI, 1.4-6.9), and suicide (SMR, 3.1; 95% CI, 1.7-5.2). Women who underwent breast reduction exhibited low SMRs for death overall (0.7; 95% CI, 0.7-0.8) and several specific causes, including breast cancer (0.4; 95% CI, 0.2-0.6), whereas death from suicide was moderately above expectation (SMR, 1.6; 95% CI, 1.0-2.5). The prevalence of psychiatric admission prior to cosmetic surgery was higher among women who underwent cosmetic breast implant surgery (8.0%; 95% CI, 7.0%-9.0%) than among women who underwent breast reduction (4.7%; 95% CI, 4.2%-5.2%) or other cosmetic procedures (5.5%; 95% CI, 4.5%-6.7%). When compared with all control groups, women with cosmetic implants had an odds ratio for prior psychiatric admission of 1.7 (95% CI, 1.4-2.0). CONCLUSIONS: Danish women with cosmetic breast implants experienced higher overall mortality compared with women in the general population owing in part to a 3-fold increase in suicide. Women with breast reduction had a low total and cause-specific mortality but a moderate excess risk of suicide. For the first time, to our knowledge, we found evidence of an increased prevalence of mental illness as measured by admission to a psychiatric hospital prior to implant surgery among women receiving cosmetic breast implants. Studies are needed to clarify the underlying reasons for the consistently reported 2- to 3-fold excess of suicide among women with cosmetic breast implants.

Abstract: 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.

Abstract: Herein the authors describe characteristics of women with breast implants compared with women with other types of cosmetic surgery as well as population controls. All women who acquired breast implants from 1977 to 1997 were identified from the files of two private plastic surgery clinics in Denmark. Patient characteristics were obtained through a self-administered questionnaire. The magnitude of differences between patient and control groups was estimated using odds ratios and 95% confidence intervals. Women with breast implants had a significantly lower body mass index and reported a two-fold greater incidence of current smoking compared with women from the general population and compared with women with other cosmetic surgery. Women with implants reported a greater number of full-term pregnancies and were less likely than controls to have had their first birth at age 30 years or older. Women with implants were not more likely than women in either control group to report a history of diseases, including connective tissue diseases, cancer, or depression before their implant surgery. Women with cosmetic breast implants differ from women with other forms of cosmetic surgery and from general population controls with respect to characteristics that may importantly influence health outcomes and that need to be addressed in future breast implant studies.

Abstract: Concern has been raised about the potential delay in breast cancer diagnosis in the augmented breast. We linked a cohort of 2955 women, who received cosmetic breast implants in Denmark during the period 1973-1997 with the Danish Cancer Registry and the Danish Breast Cancer Cooperative Group register. We identified 23 incident cases of invasive breast cancer diagnosed subsequent to breast implantation. We randomly selected 11 controls for each case from the Danish Breast Cancer Cooperative Group's register, and obtained detailed information on all study subjects about surgery, histopathology and stage of breast cancer at diagnosis, intended adjuvant treatment according to trial protocols and overall survival. We found that women with breast implants on average were diagnosed with breast cancer at the same stage as controls. Significantly more women with breast implants had tumour cells in the surgical margins according to the Danish Breast Cancer Cooperative Group's data. There was no significant difference in overall survival between the two groups after an average of 6.4 years of follow-up. Based on this limited number of women with breast cancer subsequent to breast augmentation, breast implants do not appear to delay the diagnosis of breast cancer, and no evidence of impaired survival after breast cancer diagnosis in augmented women was found.

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.

Abstract: Although numerous epidemiologic studies have examined the long-term safety of silicone breast implants during the past decade, there is a relative lack of surveillance data on short-term health effects and complications following cosmetic surgery of the breast. The Danish Registry for Plastic Surgery of the Breast, established in May of 1999, provides plastic surgeons with a nationwide system for the collection of preoperative, perioperative, and postoperative data on women undergoing breast implantation, breast reduction, or mastopexy. The purpose of the Registry is to examine short-term and, eventually, long-term local complications and possible health effects, and to contribute to an ongoing evaluation of surgical results and surveillance of the products. Furthermore, the Registry will allow the identification of new areas for research into cosmetic and reconstructive breast surgery. Women accepting registration in the Danish Registry for Plastic Surgery of the Breast complete a self-administered questionnaire focusing on medical history and demographic and behavioral factors. Preoperative blood samples are drawn for storage. Surgical data, postoperative results, and complications are registered following surgery and at postoperative visits. Currently, registration has been initiated at 24 private and public clinics, representing more than 80 percent of the plastic surgery clinics in Denmark. As of November of 2001, a total of 1472 women with breast implants and 560 women with breast reduction were included in the Registry. These figures are expected to increase annually by 1000 women undergoing breast implantation and 500 women undergoing breast reduction or mastopexy. The authors present their experience of establishing the first nationwide comprehensive clinical-epidemiologic database and biological bank for cosmetic and reconstructive surgery procedures.

Abstract: The frequency and severity of local complications remain the primary safety issues with silicone breast implants. The Danish Registry for Plastic Surgery of the Breast (DPB), established in 1999, prospectively collects pre-, peri- and postoperative information regarding Danish women undergoing breast augmentation. Through DPB, we conducted a prospective follow-up study of short-term local complications among 1090 women who underwent cosmetic breast implantation from June 1999 through October 2002. Nineteen percent of women who underwent initial implantation developed at least 1 adverse effect. Forty percent of the adverse effects occurred within 3 months of implantation; 79%, within 6 months. Capsular contracture grade II-IV was observed among 4.1% of women in the 2-year follow-up period. Overall, 97 (29%) of the 344 adverse effects among 55 (6%) of the 971 women required surgical intervention. A higher incidence of adverse effects typically occurred after subsequent implantations. According to the DPB experience, we conclude that most short-term postoperative adverse effects following cosmetic implantation are clinically insignificant and do not require treatment and that short-term complications requiring adjuvant treatment are rare.

Abstract: HYPOTHESIS: The incidence of silicone breast implant rupture varies with implantation time and type of implant. OBJECTIVE: To measure the incidence of implant rupture by repeated magnetic resonance imaging (MRI) among women with silicone breast implants. DESIGN, SETTING, AND PARTICIPANTS: In 1999, 271 women who had received breast implants at least 3 years before, and who were randomly chosen from a larger cohort of women with cosmetic breast implants, underwent a baseline MRI. A second MRI was performed in 2001; 317 silicone implants (in 186 women) that were intact at the baseline MRI (n = 280) or were intact at baseline but removed before the second MRI (n = 37) were included in the rupture incidence analyses. MAIN OUTCOME MEASURES: Implants were diagnosed with definite or possible rupture. Crude and implant age-adjusted incidence rates were calculated, and implant survival was estimated based on the observed rupture rates. RESULTS: We found 33 definite ruptures (10%) and 23 possible ruptures (7%) during the 2-year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 implants per year (95% confidence interval, 4.0-7.0). The rupture rate increased significantly with increasing implant age. Double-lumen implants were associated with substantially lower rupture risk than single-lumen implants. For modern implants intact 3 years after implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years. CONCLUSIONS: The risk of implant rupture increases with implant age. A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation.

Abstract: 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.

Abstract: We compared two different treatments for displaced distal radius Colles' type fractures (Older type 3 and 4), at two hospitals. We found bridging external fixation superior to reduction and fixation in a dorsal plaster cast regarding both the end-anatomic results at 3 months and the functional scores at 3 and 9 months (modified Gartland and Werley).

Abstract: 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.

Abstract: The durability of silicone gel-filled breast implants is of concern, but there are few epidemiological studies on this issue. To date, most of the relevant findings are derived from studies of explantation, which suffer from bias by including women with symptoms or concerns about their implants. As part of a long-term magnetic resonance imaging study of the incidence of rupture, this study involved 271 women with 533 cosmetic breast implants who were randomly selected from among women who underwent cosmetic breast implantation from 1973 through 1997 at one public and three private plastic-surgery clinics in Denmark. The prevalence of rupture was determined from the first magnetic resonance screening. The images were evaluated by four independent readers, using a standardized, validated form. The outcomes under study were rupture, possible rupture, and intact implant. Ruptures were categorized as intracapsular or extracapsular. Overall, 26 percent of implants in 36 percent of the women examined were found to be ruptured, and an additional 6 percent were possibly ruptured. Of the ruptured implants, 22 percent were extracapsular. In multiple regression analyses, age of implant was significantly associated with rupture among second- and third-generation implants, with a 12-fold increased prevalence odds ratio for rupture of implants that were between 16 and 20 years of age, compared with implants between 3 and 5 years of age. Surgitek implants (Medical Engineering Corporation, Racine, Wis.) had a significantly increased prevalence odds ratio of 2.6 for rupture, compared with the reference implants. No significant association was found with the position (subglandular or submuscular) or the type of implant (single- or double-lumen). Extracapsular ruptures were significantly associated with a history of closed capsulotomy (p = 0.001). In the future, the authors plan to examine the women in their cohort with a second magnetic resonance imaging scan to establish the incidence of rupture, a parameter unknown to date in the literature, and to further characterize those factors associated with the actual risk of rupture.

Abstract: In 34 rabbits, both tibiae were inoculated with Staphylococcus aureus. 14 legs received no treatment and served as controls. In 12 legs, the wound was treated with pure collagen and in 18 legs, collagen with gentamicin (Gentacoll) in a dose of 10 mg/kg body weight was applied to the wound before closure. Postoperatively 12 received 10 mg/kg body weight gentamicin intravenously and no local treatment. The animals were killed 7 days after inoculation and evaluated macroscopically and microbiologically for infection. 6 rabbits (12 legs) were used for pharmacokinetic studies only and they were killed after 2, 4, and 18 hours, respectively. 11/14 untreated legs developed a macroscopically acute osteomyelitis. No infection was found in the 18 legs treated with Gentacoll and 1/12 treated with gentamicin systemically had growth of the inoculated bacteria in tissue biopsies. The concentrations of gentamicin in the serum as well as locally reached peak values were well above the MIC value in all groups, with a maximum after 1-2 hours. No gentamicin could be detected after 18 hours, independently of the mode of administration.

Abstract: Data from the EU-project EHLASS (European Home and Leisure Accident Surveillance System) collected from five Danish hospitals during the period 1989-1991 contained 185,551 accidents occurring at home and during leisure time. The population in the catchment area is approximately 700,000. Of these accidents, 9900 involved eye-injury, 2940 of these occurred during hobby-activities, and 1460 of these while the subject was using either drilling-, welding- or grinding-equipment. The incidence of eye-injuries occurring during the use of these machines has risen from 0.6/1000/year in 1989 to 0.7/1000/year in 1990 and to 0.8/1000/year in 1991. In 98% of the cases the patients were men, 30% were between 20 and 29 years of age. A common activity at the time of the accident was "car-repairing". Foreign-body-lesions were seen in 60% of the cases, and actinic conjunctivitis in 30%. None of the injuries were serious, but they were often very painful and demanding of resources. All the injuries could have been avoided by the use of proper eye protection.

Abstract: We report a case of familial congenital paresis of ramus marginalis nervus facialis in 5 generations. The paresis varied in location, i.e., 2 right-sided and 3 left-sided, 1 side unknown. The primary patient, a 33-year-old female, presented with a complete right-sided congenital lower lip palsy. Electromyographic examination showed absent voluntary activity of the right depressor labii inferior muscle. There was no evidence of denervation of the paretic muscle. These findings may suggest either absence of the depressor labii inferior muscle or possibly absent voluntary activation due to a defect at brainstem level.