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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.

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.

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.

While it has been demonstrated that prophylactic mastectomy reduces breast cancer incidence among women at high risk, many women often consider this disfiguring surgery unacceptable. One alternative approach may be breast reduction surgery. In order to evaluate the long-term incidence of breast cancer following surgical removal of breast tissue, we have extended by 9 years the follow-up period of our earlier retrospective cohort study of Swedish women electing cosmetic breast reduction surgery (n=30,444) between 1965 and 1993, yielding an average of nearly 16 years of follow-up. Cancer incidence through 2002 was ascertained via the Swedish Cancer Registry. Standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were calculated comparing women who underwent breast reduction surgery with women in the general Swedish population. Breast cancer was observed in 443 women versus 624 expected for a statistically significant reduced SIR of 0.71 (95% CI=0.65-0.78). Analyses by age at surgery, time since surgery or calendar year of surgery revealed similar reductions in risk. Our study of over 30,000 women with long-term follow-up offers further evidence that women undergoing breast reduction surgery have reduced breast cancer risk. As the evidence from large-scale cohort studies accumulates, direct testing of this reduction in risk through clinical trials should be considered.

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.

Prophylactic bilateral mastectomy has been demonstrated to reduce breast cancer incidence in women with a high inherited susceptibility to breast cancer. For the majority of high-risk women, however, bilateral prophylactic mastectomy is not an acceptable option for primary prevention of breast cancer. Several epidemiological follow-up studies have indicated that there may be a substantial reduction in breast cancer risk among women who have undergone breast reduction surgery. The authors reviewed the evidence from these studies, with emphasis on the problems inherent in interpreting the results of nonexperimental studies of elective medical procedures. Although such observational studies cannot demonstrate definitively that reduction mammaplasty reduces the risk of breast cancer, the evidence from these studies is sufficiently strong to warrant the evaluation of breast reduction surgery as an option for primary prevention in clinical studies of women at increased risk of breast cancer. The availability of a more acceptable surgical option for primary prevention of breast cancer could increase the number of women willing to choose risk reduction surgery and thus may result in an overall reduction in breast cancer mortality among high-risk women.

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.

To determine whether women with cosmetic breast implants have distinct demographic, lifestyle, and reproductive characteristics that put them at increased risk for subsequent morbidity, the authors compared 1,369 such women to 2,211 women who had undergone breast reduction surgery, and to a random sample of 49,262 women from the general population of Sweden. Information was collected through self-administered questionnaires, and comparisons were made using the prevalence odds ratio. Women with cosmetic breast implants were significantly (p <0.05) more likely to be current smokers, have a lower body mass index, have had a prematurely terminated pregnancy (induced abortion or miscarriage), and have had fewer live births than either women who underwent breast reduction or women from the general population. Type of implant (silicone gel or saline) did not modify the associations. Regardless of the comparison group used, studies of the health effects of breast implants need to consider that women who undergo cosmetic breast implantation have certain distinct characteristics.

Comments on a study that evaluated the association of decreased breast cancer incidence in women who have undergone breast reduction mammoplasty. Contribution of prophylactic bilateral mastectomy to the decrease in the risk of breast cancer in women who have genetic predisposition to the disease; Importance of breast reduction surgery to patients with breast cancer; Efficacy of the surgery in treating aged patients.