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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.