Kim Kjøller

Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors.

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.

Epidemiological investigation of local complications after cosmetic breast implant surgery in Denmark.

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 diagnosis of silicone breast-implant rupture : Clinical findings compared with findings at magnetic resonance imaging

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.

Incidence and severity of short-term complications after breast augmentation: results from a nationwide breast implant registry.

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.

Untreated Silicone Breast Implant Rupture

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.

Breast implants and cancer risk in Denmark

Although millions of women worldwide have received breast implants for cosmetic or medical reasons, possible late effects (in particular cancer) have not been well studied. To provide quantitative information on cancer occurrence among women undergoing breast implant surgery, 1,135 women treated for cosmetic reasons in Denmark were evaluated. Patients were identified using the nationwide Hospital Discharge Registry with linkage to the nationwide Danish Cancer Registry to determine subsequent cancer incidence. The average age of the women at implant surgery was 31 years, and the average follow‐up was 8.4 years, up to a maximum of 17 years. Overall, 27 cancers developed after implant surgery compared with 24.7 expected based on incidence rates from the general population (standardized incidence ratio [SIR]= 1.1; 95% CI: 0.7‐1.6). Eight breast cancers were observed vs. 7.8 expected (SIR = 1.0; 95% CI: 0.4‐2.0). No evidence was found to link breast implants with increased cancer risk in the decade after surgery. While the results are encouraging, longer follow‐up into later life will be necessary to assess fully any possible adverse effects. Int. J. Cancer 71: 956‐958, 1997.

Prevalence of silicone breast implant rupture among Danish women.

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 doublelumen). 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. (Plast. Reconstr. Surg. 108: 848, 2001.)

Cancer risk among Danish women with cosmetic breast implants

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.

Capsular contracture 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.Kjøller K, Hölmich LR, Jacobsen PH, et al. Capsular contracture after cosmetic breast implant surgery in Denmark. Ann Plast Surg 2001;47:359–366

Cancer occurrence after cosmetic breast implantation in Denmark

Most studies on cancer incidence after breast implantation have focused on breast cancer, while the risk of cancers at other sites has been less well investigated. We examined cancer incidence among 1,653 women who underwent cosmetic breast implant surgery at private clinics of plastic surgery in Denmark and 1,736 women attending the same clinics for other reasons during the period 1973–1995. Furthermore, we updated previously reported results among 1,114 women who received implants for cosmetic indications at public hospitals. All women were followed for cancer through the Danish Cancer Registry. In comparison with the general female population, the overall standardized incidence ratio (SIR) for cancer among women who received implants in private clinics was 1.65 [95% confidence interval (CI) = 1.17–2.27]. This elevated SIR reflected increased incidence ratios for almost all major cancer sites; however, only for non‐melanoma skin cancer was there an excess of more than 2 cases. No significant excess of cancer was observed among women who received implants in public hospitals (SIR = 1.10, 95% CI = 0.76–1.52) or among women attending the private clinics for other problems (SIR = 1.10, 95% CI = 0.78–1.52). The SIRs for breast cancer after breast implantation were 1.1 (95% CI = 0.5–2.2) among private clinic patients and 0.9 (95% CI = 0.4–1.7) among public hospital patients. The overall findings of these 2 implant cohorts and results from other investigations suggest that cancer risk is probably not increased among women receiving cosmetic breast implants. The inconsistent results for private clinics and public hospitals are likely related to selection bias and confounding among the private clinic patients, but our data did not permit exploration of these possibilities. Further research into the determinants of these inconsistencies is warranted. Int. J. Cancer 88:301–306, 2000.