Anticipated reconstructive courses with the use of prostheses.
Henriksen TF, Fryzek JP, Hölmich LR, McLaughlin JK, Krag C, Karlsen R, Kjøller K, Olsen JH, Friis S. Reconstructive Breast Implantation After Mastectomy for Breast CancerClinical Outcomes in a Nationwide Prospective Cohort Study. Arch Surg. 2005;140(12):1152-1159. doi:10.1001/archsurg.140.12.1152
Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005
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.
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.
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.
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.
Breast cancer is the most common malignancy among women in Europe, North America, Australia, New Zealand, and some parts of South America, with age-standardized incidence rates (IRs) exceeding 90 cases per 100 000 woman-years.1 Patient care includes optimal cancer treatment, but care providers must also consider quality of life. The choice between mastectomy and breast-conserving therapy is based on several factors, including feasibility of surgery, tolerance for postoperative radiotherapy, and patient preference. Definite indications for mastectomy include a multifocal disease and the inability to obtain clear margins. Other indications for mastectomy include a large tumor-breast ratio or other factors suggestive of a poor cosmetic outcome of tumor resection. The patient group seeking postmastectomy breast reconstruction is heterogeneous with respect to age and sequelae from cancer treatment. A decision on the timing and type of postmastectomy breast reconstruction must accommodate these factors, as well as stage of breast cancer at diagnosis, concomitant diseases, and patient preferences regarding quality of life.2- 9
Breast reconstruction may be performed with a prosthesis, autologous tissue, or a combination of these. Implantation of a prosthesis is the most frequent reconstructive procedure. Advantages of breast reconstruction with implants compared with reconstruction with pedicled or free flaps include the simple technique, short operation time, minimal scarring, native skin color, and, possibly, preservation of some sensitivity. Based on individual evaluation of the patient, including skin quality, mastectomy scar, radiation damage, muscle bulk and function, the contralateral breast, and the patient’s request, breast reconstruction with a prosthesis may be planned as a 1- or 2-stage procedure (Figure). In most cases, breast reconstruction with implants is planned as a 2-stage procedure, initiated with a temporary tissue expander, which is an implant with a filler port used for successive isotonic sodium chloride infusion to gain tissue cover for a breast mound. The tissue expander is implanted submuscularly. After the expansion phase, the tissue expander is exchanged with a permanent prosthesis at a second procedure. In other cases, a combined prosthesis (ie, an expandable permanent prosthesis) is used. Depending on the type of tissue expander, the filler port may be left in situ or removed surgically through a small separate incision after sufficient expansion. In a few cases, such as among slim patients with a small contralateral breast, it may be possible to perform the reconstruction as a 1-stage procedure, with implantation of a permanent prosthesis without prior tissue expansion. All patients must anticipate potential subsequent surgical interventions for reconstruction of the nipple-mammilla complex, optimization of the desired contour, and possible correction of the contralateral breast to achieve symmetry.
Breast implantation following mastectomy is associated with local complications, which may result in medical or surgical intervention.10- 21 The results of a previous prospective study22 of cosmetic breast implantation demonstrated a higher incidence of adverse events after reimplantation compared with initial implantation. When implantation surgery is part of a reconstructive course after mastectomy, the sequelae of mastectomy and possible adjuvant treatment must be considered, and the risk of complications may be high. Although local complications, including capsular contracture, implant displacement, infection, and hematoma, are clinically well-known complications after reconstructive surgery, systematic surveys of short-term and long-term complications are few, are mostly retrospective, and report results that are difficult to compare. To provide further knowledge about the clinical course following reconstructive breast implantation and to describe the incidence and severity of short-term complications, we prospectively examined data for women with postmastectomy breast reconstruction registered in the Danish Registry for Plastic Surgery of the Breast (DPB).
The DPB collects baseline and follow-up data for women undergoing cosmetic and corrective breast augmentation or reconstructive breast implantation at public and private clinics of plastic surgery nationwide. By July 2003, registration had been initiated at 31 private and public clinics of plastic surgery, of which 9 public and 9 private clinics perform implantation for reconstructive purposes. After providing informed consent, the patient submits a preoperative, self-administered questionnaire to the DPB on health issues and demographic and lifestyle factors. Immediately after implantation, the surgeon registers the date of the implantation procedure, details of the surgery, and characteristics of the implants on a standardized operation form and forwards this to the DPB. At each follow-up visit, planned consultation, or extra visit because of complications, the surgeon completes a follow-up form with information on the follow-up date, objective findings, and any treatment required. Information is registered centrally in accord with rules specified by the Danish Data Protection Agency. Details of the structure and operation of the DPB and a description of the patients’ and surgeons’ participation have been described in detail elsewhere.23
The study population included all 574 women included in the DPB with postmastectomy breast implantation (the reconstructive cohort) between June 1, 1999, and July 24, 2003. Follow-up ended on September 15, 2003. Women who had undergone reconstruction with implants alone or with implants combined with autologous tissue reconstruction were included, while women with pure autologous tissue reconstruction were excluded.
Baseline characteristics at each operation during the reconstructive course were obtained through the DPB. These include the patient name, personal identification number (assigned to all Danish citizens at birth), operation date, indication, type of current operation (primary implantation, implantation after prior removal, revision with removal, implant exchange, or implant left in situ), surgical route, location of the implant, use of antibiotics or other prophylactic medical treatment, drainage of the implant cavity, type of anesthesia, and implant characteristics (type, surface, size, and manufacturer).
Outcome information was ascertained by means of the DPB standardized follow-up forms completed by the surgeons during postoperative visits. For an uncomplicated course, the plastic surgeon reported the date of follow-up and indicated that there were no adverse events. In case of a complication, the surgeon noted the date, type of complication, and treatment required (indication for surgery or other treatment vs no treatment). For a capsular contracture, the modified Baker grade of contracture24 was also recorded. In the present study, all unintended postoperative events registered at clinical follow-up were considered an outcome of interest and were defined as an adverse event, including wound infection, periprosthetic infection, wound rupture, skin perforation, implant folds, asymmetry, displacement of the implant, necrosis, prolonged pain in the breast (>3 months), and others.
To obtain further details on cancer diagnosis, linkage of the cohort to the Danish Cancer Registry25 was performed by means of the personal identification number. This was accomplished for all 487 women in the reconstructive cohort who were diagnosed as having breast cancer on or before December 31, 2002 (the latest update of the Danish Cancer Registry at the time of the study). Information was retrieved on the month and year of cancer diagnosis, laterality, tumor stage, and histologic findings.
Frequencies of tumor characteristics were calculated for those 487 women who had data recorded in the Danish Cancer Registry. Further descriptive analyses of surgical and implant characteristics, as well as complications, were conducted for all 574 women in the reconstructive cohort. Analyses were stratified according to initial implantation procedures and subsequent implantation procedures to evaluate differences in IRs of complications following these. Stratified analyses of tissue expanders or expandable prostheses vs permanent prostheses were also performed to evaluate the effect of complications during the expansion course. Incidence rates for short-term adverse events were calculated as the number of events per 1000 person-months for the first 2 years after implantation. The follow-up period for specific clinical outcomes began on the date of the initial reconstructive implantation procedure recorded in the DPB and ended 2 years later, or on the date of last residence in Denmark, death, implant exchange (censoring was performed at the implant level only, with follow-up at the patient level continuing to the end of the study [September 15, 2003]), or the outcome of interest, whichever came first. Similarly, in the analyses of adverse events after subsequent implantation, the follow-up period started on the date of implant exchange or implant insertion after prior removal and ended 2 years later, or on the date of last residence in Denmark, death, implant reexchange, September 15, 2003, or the outcome of interest, whichever came first. Furthermore, to evaluate the incidence of selected complications by various periods after implantation, cumulative rates were calculated for 0 to 90 days, 91 to 120 days, 121 to 365 days, and 366 to 730 days after implantation. The severity of complications as defined by the treatment (surgery, other treatment, or no treatment) was also described.
The 574 women constituting the reconstructive cohort of the DPB underwent 901 implantation procedures during the study period (June 1, 1999, through July 24, 2003). Four hundred seven women were enrolled at the time of initial implantation, 135 of whom subsequently underwent reimplantation, while an additional 167 women underwent an initial reconstructive implantation before study start and were enrolled at the time of a subsequent implantation. At the implant level, 484 initial implantation procedures among 407 women were recorded, as well as 417 reimplantation procedures (implant exchange or implant insertion after prior removal) among 302 women. One hundred thirty-five women in the DPB were registered with both an initial implantation and a subsequent implantation, while 167 had their initial implantation before the establishment of the DPB. The mean age at the time of initial implantation was 50 years (age range, 21-78 years). For subsequent implantation, the mean age was 51 years (age range, 24-78 years). Women in the study population were followed up for a mean of 23 months (range, 3-56 months) after initial implantation and 24 months (range, 4-52 months) after subsequent implantation. There were 15 deaths among the study population during the follow-up period.
Table 1 gives the characteristics of the 502 breast tumors among 487 women with data recorded in the Danish Cancer Registry on or before December 31, 2002. Most of the breast cancers were unilateral, with 49% in the left breast and 43% in the right breast. Sixty-five percent of the tumors were localized, but some tumors had regional (27%) or distant (1%) metastases at the time of diagnosis. Sixty-seven percent of the breast tumors were infiltrating ductal carcinoma, and 14% were lobular carcinoma.
Seven percent of the reconstruction procedures were performed at the time of mastectomy, while the others were delayed procedures with implantation alone (88%), combined implantation and autologous tissue reconstruction (3%), and implantation with other surgical procedures (eg, liposuction) (2%) (data not shown). Seventy-three percent of the 484 initial postmastectomy breast reconstruction procedures were begun with tissue expansion and 27% without. Among implants used for initial procedures, 48% were temporary tissue expanders and 25% were expandable prostheses (silicone and isotonic sodium chloride), while the remaining 27% were permanent prostheses. Table 2 gives surgical and implant characteristics for the reconstructive cohort stratified by initial implantation and subsequent implantation.
Forty-nine percent of the subsequent implantation procedures were planned second-stage events (Figure). Tissue expander exchange to a permanent prosthesis was performed a mean of 6 months (range, 2-16 months) after initial implantation. Unplanned second procedures were performed for different reasons, and patients often had more than 1 indication for surgery. Other reimplantation procedures were at patient request (for a larger implant [9%], a smaller implant [5%], or an unspecified request [6%]) or for clinical indications, most frequently capsular contracture (23% of 417 subsequent implantation procedures), asymmetry (20%), displacement of the implant (16%), and suspicion of implant rupture (5%) (data not shown). Among implants used for subsequent implantation procedures, 17% contained silicone gel, 68% contained cohesive silicone, and 6% contained isotonic sodium chloride. The most commonly used implant size for permanent prostheses was 355 mL (range, 100-650 mL) (Table 2).
Table 3 gives the frequencies and IRs for all reported unintended postoperative events occurring within 2 years after postmastectomy implantation, stratified by initial and subsequent implantation, at the implant and patient levels. Thirty-one percent of the women undergoing an initial implantation experienced at least 1 adverse event, ranging from minor adverse events (eg, delayed wound healing) to complications requiring surgical intervention (eg, severe capsular contracture or periprosthetic infection). Sixteen percent developed at least 2 adverse events, and 8% developed at least 3 adverse events. Wound infection was the most frequent immediate adverse event (7%; IR, 4.8 cases per 1000 person-months), whereas periprosthetic infection, hematoma, seroma, and skin perforation each were recorded among 3% of the women.
Baker grade II-IV capsular contracture was reported among 52 patients after initial implantation. Seventeen of these patients developed moderate to severe contracture, resulting in a firm and distorted breast, graded as Baker III-IV (IR, 2.7 cases per 1000 person-months). Asymmetry or displacement of the implant was reported as a complication among 7% of the women (IR, 4.9 cases per 1000 person-months). Three cases of implant rupture were registered during the follow-up period (IR, 0.4 cases per 1000 implant-months).
Besides the local adverse events, there were 7 cases of locoregional cancer recurrence among the women who underwent initial implantation. Three cases were diagnosed within 2 months after implantation, while the remaining 4 cases were diagnosed 217, 258, 326, and 352 days after surgery.
Compared with initial implantation, there was a somewhat different pattern of adverse events after subsequent implantation (Table 3). Hematoma was more common (4%) after subsequent implantation, corresponding to the less frequent use of drainage of the implant cavity, but other immediate adverse events during the early postoperative course were less frequent compared with initial implantation. In total, 36% of 302 women developed at least 1 adverse event, 19% developed at least 2 adverse events, and 8% developed 3 or more adverse events. Asymmetry or displacement of the implant was the most frequently reported adverse event, occurring in more than 19% of the women. Capsular contracture was recorded less frequently following subsequent implantation (12%) compared with initial implantation (13%). However, the proportion of patients with capsular contracture grade III-IV was higher (7% vs 4%; IR, 4.3 cases per 1000 person-months). Prolonged pain in the breast, wrinkles, and scar indentation were each recorded among 3% of the women. One woman had recurrence of the cancer 82 days after subsequent implantation.
Surgical intervention was required after initial implantation among 21% of the women (corresponding to 21% of the implants), most frequently because of capsular contracture, asymmetry, or displacement of the implant (Table 4). Virtually all cases of periprosthetic infection, skin perforation, and capsular contracture led to surgical intervention. Another 3% of the women developed complications requiring other treatment. Although the frequency of adverse events was higher after subsequent implantation, the frequency of adverse events requiring surgical intervention (21%) or other treatment (3%) was similar to the frequency after initial implantation. Besides treatment for definitive complications, surgical corrections to optimize the cosmetic result (correction of scar indentation, skin excess, asymmetry, or contour deficits) contributed to the total number of surgical procedures.
Incidence rates for specific complications varied during the 2-year follow-up period. Wound infection, periprosthetic infection, wound rupture, skin perforation, hematoma, and seroma were mostly diagnosed within the first 3 months, while capsular contracture and displacement were diagnosed later, with the highest IRs between 6 and 12 months of follow-up. Overall, 49% of the 235 complications were recorded within the first 3 months of follow-up, 67% within the first 6 months, and 91% within the first year (data not shown).
Clinical outcomes were also stratified by tissue expanders (389 tissue expanders or expandable prostheses among 320 women) vs permanent prostheses (512 permanent prostheses among 506 women) regardless of type of surgery (initial vs subsequent implantation) (data not shown). During tissue expansion, 30% of 320 women developed 1 complication, and 14% developed 2 or more complications during the expansion course. Specific adverse events were recorded more frequently with tissue expanders compared with permanent prostheses as follows: wound infection (IR, 4.2 vs 2.4 cases per 1000 implant-months), wound rupture (IR, 0.8 vs 0.2 cases per 1000 implant-months), seroma (IR, 2.4 vs 1.2 cases per 1000 implant-months), skin perforation (IR, 1.5 vs 1.0 cases per 1000 implant-months), and minor capsular contracture (IR, 5.7 vs 3.0 cases per 1000 implant-months). In total, 156 tissue expansion procedures among 111 women were completed during the study period. Fifteen percent of the tissue expansions were terminated or interrupted because of complications.
Breast reconstruction is often an important part of the rehabilitation process for mastectomy patients,26- 30 and the prospect of breast reconstruction may better prepare women psychologically to cope with the distress of mastectomy.13 Breast reconstruction with implants is one option available for patients with breast cancer, but implantation may be associated with complications and may result in discomfort, impaired cosmetic result, pain, or other morbidities. Local complications are considered the primary safety issue with breast implantation for cosmetic purposes.11 To our knowledge, this is the first prospective epidemiological study to provide quantitative data on short-term local complications among women receiving implants for breast reconstruction.
Based on prospective data collected in the nationwide DPB, adverse events in general and surgical treatment for these adverse events were common following postmastectomy breast implantation. After initial implantation, 31% of the women developed at least 1 adverse event, most frequently capsular contracture, asymmetry, displacement of the implant, and wound infection. Surgical intervention because of adverse events was required among 21% of the women, while another 3% of the women received treatment other than surgery. The frequency of surgical and medical intervention after subsequent implantation was similar to the frequency after initial implantation, but the type of adverse events differed from first-time implantations owing to lower frequencies of many immediate complications vs more frequent occurrence of skin excess, scar indentation, and wrinkles, which led to surgery for improvement of the cosmetic result. The latter complications required minor surgical correction but did not result in implant loss and have limited safety implications.
The high incidence of short-term complications supports previous findings that short-term complications occur in up to 30% to 40% of breast reconstruction procedures with implants.10 Other study populations have differed with respect to type and frequency of specific complications and requirement for surgical intervention. Among 185 women followed up retrospectively for a mean of 26 months, Noone et al4 documented skin necrosis (15%), fluid collection (12%), symptomatic capsular contracture (Baker grade III-IV) (11%), prosthesis exposure or loss (4%), and skin infection (2%). Based on a prospective evaluation of 360 patients receiving postmastectomy implant reconstruction between 1989 and 1997, Clough et al16 reported an early complication rate (<2 months) of 9.2%, an explantation rate of 1.7%, a late complication rate (≥2 months) of 23%, and a symptomatic capsular contracture rate of 11% at 2 years after surgery. In our study, we included a wider range of adverse events, from minor clinically insignificant complications to complications requiring major surgery.
Capsular contracture is considered a major problem after cosmetic and reconstructive breast implantation. In our study population, frequencies of varying degrees of capsular contracture were lower than those reported in most previous studies.18- 21 In a prospective randomized controlled clinical trial, Hammerstad et al20 evaluated 43 patients with breast cancer at 32 months after surgery and found that, among patients with textured implants, 9% (4/47) of implants had capsular contracture graded as moderate or severe vs 24% (11/46) of double-lumen implants with a smooth surface.
The high incidence of short-term complications following implant reconstruction may be explained by various factors, including the more challenging surgical procedure compared with simple initial cosmetic breast augmentation and the older mean age of the patients. In a prospective study22 of 1946 healthy women enrolled in the cosmetic cohort of the DPB, 19% of the women developed adverse postoperative events, ranging from minor events to complications requiring surgical intervention in 6%. Slightly higher incidences were seen after subsequent implantation compared with initial implantation. Therefore, during a 2-year period after implantation, the percentage of patients with complications requiring surgery after reconstruction (20.3% after initial and 22.1% after subsequent implantation) was almost 4-fold higher than after cosmetic implantation (5.5% after initial and 7.4% after subsequent implantation) found in the previous study.22 This difference in complication profiles in cosmetic and reconstructive surgery has been reported in other studies.14,31
Furthermore, the patient group seeking reconstructive surgery after mastectomy is heterogeneous with regard to cancer stage, type of cancer, and postoperative adjuvant treatment. Local conditions such as lack of skin tissue and impaired skin quality due to postmastectomy radiotherapy pose challenges for reconstruction and affect the expected outcome. Radiotherapy-induced fibrosis and skin changes can markedly affect cosmesis.32 Radiotherapy is often considered a contraindication for implant reconstruction because of lack of skin elasticity; however, for some patients, this method may be the preferred option. Our study population comprised all women who underwent reconstructive implantation, including irradiated patients. Unfortunately, we had no information on adjuvant treatment in our study. Krueger et al15 prospectively evaluated complications according to adjuvant treatment with radiotherapy in a sample of 81 patients. With a mean follow-up of 31 months, complications occurred in 68% (13/19) of patients in the radiotherapy group compared with 31% (19/62) in the nonirradiated group (P = .005). Other authors have also found that irradiated patients have higher rates of tissue expander failure, implant reconstruction failure, and complications than do nonirradiated patients.33,34 In addition, chemotherapy and treatment with tamoxifen citrate have been shown to affect the occurrence of complications.10,12
The major strength of this study is the prospective study design based on a nationwide implantation registry. To our knowledge, the DPB provides the first systematic collection of preoperative, perioperative, and postoperative data in relation to mammoplasty procedures. The prospective retrieval of specific data permits a comprehensive evaluation of outcomes based on unselected patients, with a minimum of bias. The fact that all public departments of plastic surgery, which account for most of the reconstructive implantation procedures after mastectomy for breast cancer, contribute to the DPB strengthens outcome assessment. The use of a personal identification number allows merging of clinical data at the implant and patient levels within the DPB and permits access to complete follow-up information on vital status and emigration as registered in the Central Population Register. The DPB comprises surgical and clinical follow-up data on numerous outcomes, including requirement of medical or surgical intervention, which allows a comprehensive evaluation of patients with postmastectomy reconstruction. The heterogeneity of our patient group, with different surgical procedures and clinical applications, is also a strength because it mirrors clinical reality and allows for the generalizability of our results.
The follow-up period is the main shortcoming of the study. Women were enrolled during a 4-year period; therefore, follow-up was brief for those who enrolled late in the study. Although most of the recorded adverse events occurred during the first year after initial breast reconstruction, we were not able to fully explore the outcomes of subsequent implantation. In addition, information bias may exist. Despite the use of standardized follow-up forms, some underreporting of complications, as well as qualitative and quantitative variations in the reported data, cannot be excluded. However, in our validation of the follow-up data, we found a high level of concordance between data from the returned forms and those in the medical files. Patient enrollment varied among the departments of plastic surgery. Most of the clinics and departments have established a routine to invite their patients to participate in the DPB and successfully register complete data; however, patient registration has been less consistent at a few departments.
Women who undergo postmastectomy reconstructive breast implantation frequently experience short-term local complications. Surgical or medical intervention is commonly required during the reconstructive course. One in 5 women needed surgical intervention because of complications within the first 2-year period, but permanent loss of implants occurred infrequently. When evaluating benefits and risks associated with breast reconstruction, the surgeon and patient should consider that the reconstructive process often requires additional surgical interventions to treat local complications or to achieve the desired cosmetic result. Detailed information on the likelihood of local complications associated with the given indication (cosmetic vs reconstructive) should be an essential part of adequate informed consent for women seeking breast implantation.
Correspondence: Joseph K. McLaughlin, PhD, International Epidemiology Institute, Suite 550, Rockville, MD 20850 (email@example.com).
Accepted for Publication: January 31, 2005.
Funding/Support: This study was funded by the International Epidemiology Institute, which received unrestricted funding for the DPB from the Dow Corning Corporation, Midland, Mich.
Acknowledgment: We thank the following clinics and hospitals for their cooperation: University Hospital H:S Rigshospitalet and Cosmeticon, Copenhagen; University Hospital Herlev; University Hospital Odense, Private Hospital HC Andersen, and Private Hospital Mariahjemmet, Odense; University Hospital Århus, Center of Plastic Surgery, and Grymers Clinic for Plastic Surgery, Århus; Vejle Hospital and Private Hospital Mølholm A/S, Vejle; Odder Hospital, Odder; Roskilde Hospital, Roskilde; Esbjerg Hospital and Surgical Clinic by Nis Alstrup, Esbjerg; Aabenraa Hospital, Aabenraa; Viborg-Kjellerup Hospital, Viborg; Grindsted Hospital, Grindsted; Stege Hospital, Stege; The Private Hospital Erichsens Clinic, Charlottenlund; Annet Aasted A/S and Frederiksborg Clinic, Hørsholm; Holte Clinic for Plastic Surgery, Holte; Private Hospital Hamlet, Frederiksberg; and Private Hospital Søllerød, Virum.