Age Impacts Clinical and Patient Reported Outcomes following Post Mastectomy Breast Reconstruction.

BACKGROUND: While the current literature indicates that age should not be a deterring factor in postmastectomy breast reconstruction (PMBR), the true impact of increasing age on postoperative outcomes remains unknown. The purpose of this study is to understand the impact of age on complications and patient-reported outcomes (PROs) using BREAST-Q longitudinally 5-years after PMBR. METHODS: We conducted a retrospective analysis of patients who underwent autologous (ABR) or implant-based reconstruction (IBR). Age was studied as both a categorical and continuous variable. Outcome measures included complications and BREAST-Q scores at preoperative, 6-months, and 1-5 years postoperative. RESULTS: 4,730 patients were included, of which 1,536 (32.5%) underwent ABR while 3,194 (67.5%) had IBR. Older age was significantly associated with increased risk of developing mastectomy skin flap/nipple necrosis, infection, and seroma. Older age was negatively correlated with Satisfaction with Breasts (ß=-0.06 [-0.12, -0.01]; p=0.033) and positively correlated with Psychosocial Well-being (ß=0.14 [0.09, 0.20]; p<0.001). Older age was not correlated with Physical Well-being of the Chest (ß=-0.03 [-0.08, 0.02], p=0.2) and Sexual Well-being (ß=-0.04 [-0.12, 0.02]; p=0.2). Subgroup analyses of ABR and IBR patients demonstrated different complications and PRO profiles. CONCLUSIONS: Our analysis of the impact of age on surgical outcomes and PROs suggests that complication rates increase with age and older age is negatively correlated with Satisfaction with Breasts but positively correlated with Psychosocial Well-being. Overall, older patients should be informed about the potential associated risks and anticipated patient reported outcomes.

Textured versus Smooth Tissue Expanders: A Comparison of Complications in 3526 Breast Reconstructions.

BACKGROUND: Increased understanding of breast implant-associated anaplastic large-cell lymphoma has led to a shift away from textured breast devices. A few small studies have compared the complication rates of textured and smooth tissue expanders (TEs). The aim of this study was to compare complication profiles in patients undergoing two-stage postmastectomy breast reconstruction with either textured or smooth TEs. METHODS: The authors performed a retrospective review of female patients who underwent immediate breast reconstruction with textured or smooth TEs from 2018 to 2020 at their institution. Rates of seroma, infection/cellulitis, malposition/rotation, exposure, and TE loss were analyzed in the overall cohort and subgroups undergoing prepectoral and subpectoral TE placement. A propensity score-matched analysis was used to decrease the effects of confounders comparing textured and smooth TEs. RESULTS: The authors analyzed 3526 TEs (1456 textured and 2070 smooth). More frequent use of acellular dermal matrix, SPY angiography, and prepectoral TE placement was noted in the smooth TE cohort ( P < 0.001). Univariate analysis suggested higher rates of infection/cellulitis, malposition/rotation, and exposure in smooth TEs (all P < 0.01). Rates of TE loss did not differ. After propensity matching, no differences were noted in infection or TE loss. Prepectoral smooth expanders had increased rates of malposition/rotation. CONCLUSIONS: TE surface type did not affect rates of TE loss, although increased rates of expander malposition were noted in the smooth prepectoral cohort. Further research is needed to examine breast implant-associated anaplastic large-cell lymphoma risk with temporary textured TE exposure to improve decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCW: Therapeutic, III.

Biologic versus synthetic prosthesis for chest wall reconstruction: a matched analysis.

OBJECTIVES: The aim of this study was to compare postoperative outcomes between biologic and synthetic reconstructions after chest wall resection in a matched cohort. METHODS: All patients who underwent reconstruction after full-thickness chest wall resection from 2000 to 2022 were reviewed and stratified by prosthesis type (biologic or synthetic). Biologic prostheses were of biologic origin or were fully absorbable and incorporable. Integer matching was performed to reduce confounding. The study end point was surgical site complications requiring reoperation. Multivariable analysis was performed to identify associated risk factors. RESULTS: In total, 438 patients underwent prosthetic chest wall reconstruction (unmatched: biologic, n = 49; synthetic, n = 389; matched: biologic, n = 46; synthetic, n = 46). After matching, the median (interquartile range) defect size was 83 cm2 (50-142) for the biologic group and 90 cm2 (48-146) for the synthetic group (P = 0.97). Myocutaneous flaps were used in 33% of biologic reconstructions (n = 15) and 33% of synthetic reconstructions (n = 15) in the matched cohort (P = 0.99). The incidence of surgical site complications requiring reoperation was not significantly different between biologic and synthetic reconstructions in the unmatched (3 [6%] vs 29 [7%]; P = 0.99) and matched (2 [4%] vs 4 [9%]; P = 0.68) cohorts. On the multivariable analysis, operative time [adjusted odds ratio (aOR) = 1.01, 95% confidence interval (CI), 1.00-1.01; P = 0.006] and operative blood loss (aOR = 1.00, 95% CI, 1.00-1.00]; P = 0.012) were associated with higher rates of surgical site complications requiring reoperation; microvascular free flaps (aOR = 0.03, 95% CI, 0.00-0.42; P = 0.024) were associated with lower rates. CONCLUSIONS: The incidence of surgical site complications requiring reoperation was not significantly different between biologic and synthetic prostheses in chest wall reconstructions.

Replacement of Shaped Textured Implants with Round Smooth Implants in Breast Reconstruction: Long Term Patient- and Surgeon- Reported Outcomes.

BACKGROUND: The number of patients undergoing exchange of textured implants for smooth devices has greatly increased due to concern over BIA-ALCL. The authors examine long-term patient- and surgeon-reported outcomes in terms of aesthetics, comfort, and complications. METHODS: Patients who underwent reconstruction with shaped, textured implants replaced with round, smooth implants between 1994-2022 with a minimum follow-up of 1 year were included. Patient-reported outcomes were collected using the BREAST-Q Reconstruction Module as well as a survey evaluating aesthetics and comfort. Surgeon-reported outcomes included evaluation of aesthetics and capsular contracture. RESULTS: 530 patients were reviewed, and 307 patients were included. Pairwise comparison of BREAST-Q data demonstrated psychosocial well-being (72.68 to 76.45; p=0.0075) and physical well-being (78.79 to 81.88; p=0.0078) significantly increased. Overall breast satisfaction (61.94 to 67.27; p=0.0082) and sexual well-being (53.89 to 57.98; p=0.0002) were also significantly higher in parallel with a clinically meaningful increase in BREAST-Q score of 5.33 and 4.09 points, respectively. Most patients felt they looked better (56.4%) or similar (27.3%) and were more comfortable (54.4%) or similar (39.4%) after the exchange procedure. The senior surgeon rated 40.1% of patients as a better aesthetic grade after replacement and 50.3% as the same. 36.8% of patients were rated as having a decrease in Baker capsular contracture grade. 2.9% of patients experienced a peri-operative complication and there were no reconstructive failures. CONCLUSION: Exchange of textured to smooth implants is safe, does not sacrifice aesthetic outcome, and provides a more comfortable and satisfactory outcome for patients with minimal complications.

Reconstruction of oncologic upper extremity defects with fibula free flaps has high union rates and excellent functional outcomes.

BACKGROUND: Limb salvage has better functional outcomes than amputation in the upper extremity. This can however be challenging after bony tumor resections. METHODS: This is a retrospective case series of patients who underwent humerus, ulna, or radius reconstruction with a fibula free flap. Data were collected on demographics, oncologic history, surgical details, and complications. Functional outcome measures included the patient's ability to perform activities of daily living (ADL), presence of pain, and musculoskeletal tumor society (MSTS) score. RESULTS: Over a 25-year period, 38 reconstructions were performed. The flap success rate was 97.5%. Bony union was obtained in 19 of 19 (100%) forearm reconstructions and in 15 of 19 (79%) humerus reconstructions (p = 0.10). All 19 forearm reconstruction patients and 18/19 humerus reconstruction patients were able to perform ADLs with no pain or only occasional pain. The MSTS scores were not significantly different between the humerus and forearm cohorts (27.1 vs. 27.3, p = 0.68). Functional outcomes were significantly better in limbs that achieved union (p < 0.001). Recipient and donor site complications occurred in 10 (26.3%) and 5 (13%) patients, respectively. CONCLUSIONS: Oncologic upper-extremity reconstruction with fibula free flaps has excellent functional outcomes. Bone union is a predictor of superior limb function.

The contribution of microvascular free flaps and pedicled flaps to successful chest wall surgery.

OBJECTIVE: Pedicled flaps (PFs) have historically served as the preferred option for reconstruction of large chest wall defects. More recently, the indications for microvascular-free flaps (MVFFs) have increased, particularly for defects in which PFs are inadequate or unavailable. We sought to compare oncologic and surgical outcomes between MVFFs and PFs in reconstructions of full-thickness chest wall defects. METHODS: We retrospectively identified all patients who underwent chest wall resection at our institution from 2000 to 2022. Patients were stratified by flap reconstruction. End points were defect size, rate of complete resection, rate of local recurrence, and postoperative outcomes. Multivariable analysis was performed to identify factors associated with complications at 30 days. RESULTS: In total, 536 patients underwent chest wall resection, of whom 133 had flap reconstruction (MVFF, n = 28; PF, n = 105). The median (interquartile range) covered defect size was 172 cm2 (100-216 cm2) for patients receiving MVFF versus 109 cm2 (75-148 cm2) for patients receiving PF (P = .004). The rate of R0 resection was high in both groups (MVFF, 93% [n = 26]; PF, 86% [n = 90]; P = .5). The rate of local recurrence was 4% in MVFF patients (n = 1) versus 12% in PF patients (n = 13, P = .3). Postoperative complications were not statistically different between groups (odds ratio for PF, 1.37; 95% confidence interval, 0.39-5.14]; P = .6). Operative time >400 minutes was associated with 30-day complications (odds ratio, 3.22; 95% confidence interval, 1.10-9.93; P = .033). CONCLUSIONS: Patients with MVFFs had larger defects, a high rate of complete resection, and a low rate of local recurrence. MVFFs are a valid option for chest wall reconstructions.

Making the Case for Virtual Surgical Planning: Bilateral Sequential Fibula Flaps with Immediate Dental Implants for Maxillectomy.

SUMMARY: Oncologic maxillectomy defects requiring bony reconstruction are among the most challenging head and neck cases because of the complex three-dimensional geometry of the midface. Virtual surgical planning technology is advantageous in these cases because it provides superior positional precision and accuracy compared with traditional techniques and facilitates prosthodontic rehabilitation. Maxillary cancer recurrence after an initial fibula flap reconstruction presents a unique challenge. The authors report the first two cases of sequential fibula flaps after second or recurrent cancer of the maxilla. Virtual surgical planning facilitated resection with adequate tumor margins, optimized anatomic positioning of the fibula construct with three-dimensional printed plates, and enabled immediate functional dental implant placement.

Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Patients with Textured Tissue Expanders.

BACKGROUND: The association between textured implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is well established, but the risk of BIA-ALCL in patients with transient exposure to a textured tissue expander (TE) is not as well documented. The aim of this study was to assess the incidence and risk of BIA-ALCL in patients with temporary exposure to a textured TE with subsequent smooth implant placement. METHODS: This single-institution retrospective cohort study included all female patients who underwent two-stage breast reconstruction with placement of a textured TE from 1995 to 2016 with subsequent exchange to a smooth permanent implant. Primary outcome of interest was development of BIA-ALCL. Patients with exposure to textured implants were excluded. Follow-up was determined by last documented visit. The authors calculated summary statistics for exposure time and follow-up intervals. RESULTS: Overall, 3310 patients had temporary exposure to a textured TE with exchange to a smooth implant, totaling 5201 textured TEs. Average textured TE exposure time was 6.7 months (median, 5.8 months). Average follow-up was 6.8 years (median, 6.3 years), ranging from 3.7 months to 18 years. No cases of BIA-ALCL were identified. CONCLUSIONS: As no cases of BIA-ALCL were identified, the risk of BIA-ALCL with short exposure to textured TEs is likely lower than the risk from exposure to permanent textured implants. Although longer follow-up is needed, these results can help counsel patients with previous exposure to textured TEs who are concerned about their risk of BIA-ALCL and can contribute to discussions on potential continued utility of textured TEs. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, IV.

Outcomes and Perioperative Risk Factors after Oncologic Free-Flap Scalp Reconstruction.

BACKGROUND: Little is known about the risk factors associated with complications after free flap scalp reconstruction. The purpose of this study was to identify patient, scalp defect, and flap characteristics associated with increased risk of surgical complications. METHODS: A retrospective study was performed of free-flap scalp reconstruction in oncologic patients at Memorial Sloan Kettering Cancer Center from 2002 to 2017. Data collection included patient, defect, flap, and complication characteristics. Complications were classified into major, defined as complications requiring surgical intervention, and minor, defined as complications requiring conservative treatment. Risk factors and outcome variables were compared using chi-square with Fisher's exact test. RESULTS: A total of 63 free flaps to the scalp in 58 patients were performed; average follow-up was 3.5 years. Most flaps were muscle-only or musculocutaneous. One-third of patients with free flaps experienced complications (n = 21, 15 major and 6 minor). Examining risk factors for complications, patients with cardiovascular disease were nearly three times more likely to have suffered a major complication than patients without cardiovascular disease (36.7 vs. 12.1%, p = 0.04). This was the only significant risk factor noted. Perioperative radiotherapy, prior scalp surgery, flap type, and recipient vessel selection were found to be nonsignificant risk factors. CONCLUSION: Cardiovascular disease may be a significant marker of risk for major complications in patients undergoing free-flap reconstruction of the scalp. This information should be used to help guide perioperative counseling and decision making in this challenging patient population.

Nipple-Sparing Mastectomy and Immediate Reconstruction: A Propensity Score-Matched Analysis of Satisfaction and Quality of Life.

BACKGROUND: Although it is intuitive that nipple-sparing mastectomy in selected patients would result in excellent cosmetic outcomes and high patient satisfaction, studies of clinical outcomes and health-related quality of life are limited and show mixed results. This study aimed to use a propensity score-matching analysis to compare satisfaction and health-related quality-of-life outcomes in patients who underwent implant-based reconstruction following bilateral nipple-sparing mastectomy or skin-sparing mastectomy. METHODS: A propensity score-matching analysis (1:1 matching, no replacement) was performed comparing patients undergoing nipple-sparing or skin-sparing mastectomy with immediate bilateral implant-based breast reconstruction. Patients with a history of any radiation therapy were excluded. Matched covariates included age, body mass index, race, smoking history, neoadjuvant chemotherapy, bra size, and history of psychiatric diagnosis. Outcomes of interest included BREAST-Q scores and complications. RESULTS: The authors examined 1371 patients for matching and included 460 patients (nipple-sparing mastectomy, n = 230; skin-sparing mastectomy, n = 230) in the final analyses. The authors found no significant differences in baseline, cancer, and surgical characteristics between matched nipple-sparing and skin-sparing mastectomy patients, who also had similar profiles for surgical complications. Interestingly, the authors found that postoperative Satisfaction with Breasts scores and all other health-related quality-of-life domains were stable over a 3-year period and did not differ significantly between the two groups. CONCLUSIONS: Compared with skin-sparing mastectomy, bilateral nipple-sparing mastectomy did not improve patient-reported or clinical outcomes when combined with immediate implant-based reconstruction. The impact that nipple-sparing mastectomy may have on breast aesthetics and the ability of the BREAST-Q to gauge an aesthetic result following nipple-sparing mastectomy warrant further investigation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Long-term Growth, Functional, and Aesthetic Outcomes after Fibula Free Flap Reconstruction for Mandibulectomy Performed in Children.

Background: The long-term outcome of mandible reconstruction when performed in children has not been well documented. Methods: This is a retrospective case series of patients who underwent immediate oncologic mandible reconstruction with a fibula free flap at younger than 18 years of age over a 20-year period, by a single surgeon, who had long-term follow-up. Results: A total of 10 patients met inclusion criteria. Patient age ranged from 3 years and 8 months to 17 years and 9 months (mean 11 years). The etiology was malignant tumors in seven patients and benign locally aggressive tumors in three patients. All fibula flaps survived. All donor sites were closed primarily. The mean follow-up duration was 10 years and 5 months (range 3-20 years). The mean patient age at follow-up was 21 years and 10 months (range 8 years and 9 months to 30 years and 9 months). All patients achieved a regular diet and normal speech. Final occlusion was normal in seven of 10 patients. The aesthetic outcome, as evaluated by clinical examination, was a symmetric mandible in eight patients (in the other two the aesthetic asymmetry and malocclusion was minor and did not require operative intervention). Dental implants were ultimately placed in three patients. Leg function was normal in eight patients. Achilles lengthening and tendon transfer was required in one patient, and one patient developed ankle pain associated with running. Conclusion: Mandible reconstruction in children with the fibula free flap provides excellent aesthetic and functional outcomes that are durable over time.

Association of Radiation Timing with Long-Term Satisfaction and Health-Related Quality of Life in Prosthetic Breast Reconstruction.

BACKGROUND: Radiation therapy is increasingly used after breast cancer surgery, which may impact patients' postoperative quality of life. This study assessed differences in long-term patient satisfaction and health-related quality of life after radiation therapy administered at different stages of implant-based breast reconstruction or with no radiation after surgery. METHODS: In this observational study, long-term outcomes were evaluated for four cohorts of women who completed breast reconstruction and received (1) no radiation, (2) radiation before tissue expander placement, (3) radiation after tissue expander placement, or (4) radiation after permanent implant between 2010 and 2017 at Memorial Sloan Kettering. Satisfaction and health-related quality of life were assessed using the prospectively collected Satisfaction with Breasts and Physical Well-Being of Chest BREAST-Q subscales. Score distributions were examined by radiation exposure status for 3 years after surgery using nonparametric analyses and regression models. RESULTS: Of 2932 patients who met the inclusion criteria, 25.8 percent received radiation during breast cancer treatment, including before tissue expander placement ( n = 239; 8.2 percent), after tissue expander placement ( n = 290; 9.9 percent), and after implant placement ( n = 228; 7.8 percent). Radiotherapy patients had average scores 7 to 9 points lower at all postoperative time points for Satisfaction with Breasts and Physical Well-Being of Chest subscales ( p < 0.001). Although patient-reported outcomes did not differ by radiation timing, there were higher rates of severe capsular contracture with postimplant radiotherapy ( p < 0.001). CONCLUSIONS: Radiation therapy significantly affected patient satisfaction and health-related quality of life following implant breast reconstruction through 3 years postoperatively. Patient perception of outcome was unaffected by radiotherapy timing; however, capsular contracture was higher after postimplant radiotherapy, suggesting there may be an advantage to performing radiotherapy before placement of the final reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

2022 Practice Recommendation Updates From the World Consensus Conference on BIA-ALCL.

BACKGROUND: Laboratory and clinical research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is rapidly evolving. Changes in standard of care and insights into best practice were recently presented at the 3rd World Consensus Conference on BIA-ALCL. OBJECTIVES: The authors sought to provide practice recommendations from a consensus of experts, supplemented with a literature review regarding epidemiology, etiology, pathogenesis, diagnosis, treatment, socio-psychological aspects, and international authority guidance. METHODS: A literature search of all manuscripts between 1997 and August 2021 for the above areas of BIA-ALCL was conducted with the PubMed database. Manuscripts in different languages, on non-human subjects, and/or discussing conditions separate from BIA-ALCL were excluded. The study was conducted employing the Delphi process, gathering 18 experts panelists and utilizing email-based questionnaires to record the level of agreement with each statement by applying a 5-point Likert Scale. Median response, interquartile range, and comments were employed to accept, reject, or revise each statement. RESULTS: The literature search initially yielded 764 manuscripts, of which 405 were discarded. From the remaining 359, only 218 were included in the review and utilized to prepare 36 statements subdivided into 5 sections. After 1 round, panelists agreed on all criteria. CONCLUSIONS: BIA-ALCL is uncommon and still largely underreported. Mandatory implant registries and actions by regulatory authorities are needed to better understand disease epidemiology and address initial lymphomagenesis and progression. Deviation from current diagnosis and treatment protocols can lead to disease recurrence, and research on breast implant risk factors provide insight to etiology.

Management of postoperative microvascular compromise and ischemia reperfusion injury in breast reconstruction using autologous tissue transfer: Retrospective review of 2103 flaps.

BACKGROUND: Although rates of microvascular thrombosis following free-flap breast reconstruction are low, debate persists about the optimal methods to restore blood flow and prevent ensuing flap shrinkage or fibrosis. Here we evaluate our management of microvascular compromise, including both a review of our approach for restoring blood flow and addressing the ensuing inflammatory changes following ischemia reperfusion. METHODS: We conducted a retrospective review of autologous free tissue transfer breast reconstructions from 1/2010 to 1/2020. Patients who had flaps requiring take-back for salvage were identified. Management of microvascular compromise and ischemia reperfusion injury were recorded. RESULTS: Of 2103 flaps were used in the breast reconstructions, 47 flaps required take-back for microvascular compromise (2.2%). Most flaps were either completely salvaged (n = 29, 61.7%) or partially salvaged (n = 5, 10.6%). Thirteen (27.7%) were a total flap loss, for an overall rate of 0.8% (including 3 flaps with no salvage attempt). Management of microvascular compromise most often included revision of the anastomosis (n = 33, 70.2%), thrombectomy (n = 27, 57.4%), tissue plasminogen activator administration (n = 26, 55.3%), and vein grafts (n = 18, 38.3%). Management of ischemia reperfusion included intraoperative steroids (n = 33, 70.2%), postoperative steroids (n = 17, 38.6%), and postoperative therapeutic anticoagulation (n = 27, 61.3%). Of 34 salvaged flaps, 5 (14.7%) had partial flap loss and/or fat necrosis on clinical examination at an average follow-up of 2.7 ± 2.8 years. CONCLUSIONS: Salvage of microvascular compromise in autologous breast reconstruction should include restoration of blood flow and management of ischemia reperfusion injury. Attention to both is paramount for successful outcomes.

Stability of Long-Term Outcomes in Implant-Based Breast Reconstruction: An Evaluation of 12-Year Surgeon- and Patient-Reported Outcomes in 3489 Nonirradiated and Irradiated Implants.

BACKGROUND: Outcomes following prosthetic breast reconstruction have been well studied. However, the majority of studies are limited by short-term follow-up and a lack of aesthetic and patient-reported outcomes. This study objectively examines long-term surgeon- and patient-reported outcomes following two-stage prosthetic breast reconstruction. METHODS: Consecutive patients undergoing two-stage prosthetic breast reconstruction from 1994 to 2016 performed by the senior author (P.G.C.), with at least 1-year follow-up after implant exchange, were reviewed retrospectively. Long-term surgeon-reported outcomes, including aesthetic and capsular contracture scores, and patient-reported outcomes using the BREAST-Q, were recorded at each outpatient visit and analyzed over the 12-year follow-up period. RESULTS: Retrospective review revealed 2284 patients, or 3489 breasts, that fit the inclusion criteria. Aesthetic scores and capsular contracture rates remained stable over the entire follow-up period. Subset analysis demonstrated that bilateral and nonirradiated reconstructions consistently had the highest aesthetic scores, whereas unilateral irradiated breasts had the lowest. Irradiated breasts consistently had high rates of capsular contracture, although the extent of contracture improved over time in all patients. Patient-reported BREAST-Q scores showed either stability or improvement over time in all patients. Irradiated and nonirradiated patients demonstrated comparable long-term satisfaction with outcomes despite significant differences in satisfaction with their breasts. CONCLUSIONS: The authors' study, the largest of its kind, demonstrates that prosthetic breast reconstruction outcomes do not deteriorate over time. This stability is apparent in both long-term surgeon- and patient-reported outcomes data measured in the same patients. These results contradict the surgical dogma surrounding prosthetic breast reconstruction and therefore should be given significant consideration when counseling patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Breast Implant-associated Anaplastic Large Cell Lymphoma Incidence: Determining an Accurate Risk.

OBJECTIVE: This study sought to estimate the incidence and incidence rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) at a high-volume single institution, which enables vigorous long-term follow-up and implant tracking for more accurate estimates. SUMMARY BACKGROUND DATA: The reported incidence of BIA-ALCL is highly variable, ranging from 1 in 355 to 1 in 30,000 patients, demonstrating a need for more accurate estimates. METHODS: All patients who underwent implant-based breast reconstruction from 1991 to 2017 were retrospectively identified. The incidence and incidence rate of BIA-ALCL were estimated per patient and per implant. A time-to-event analysis was performed using the Kaplan-Meier estimator and life table. RESULTS: During the 26-year study period, 9373 patients underwent reconstruction with 16,065 implants, of which 9589 (59.7%) were textured. Eleven patients were diagnosed with BIA-ALCL, all of whom had a history of textured implants. The overall incidence of BIA-ALCL was 1.79 per 1000 patients (1 in 559) with textured implants and 1.15 per 1000 textured implants (1 in 871), with a median time to diagnosis of 10.3 years (range, 6.4-15.5 yrs). Time-to-event analysis demonstrated a BIA-ALCL cumulative incidence of 0 at up to 6 years, increasing to 4.4 per 1000 patients at 10 to 12 years and 9.4 per 1000 patients at 14 to 16 years, although a sensitivity analysis showed loss to follow-up may have skewed these estimates. CONCLUSIONS: BIA-ALCL incidence and incidence rates may be higher than previous epidemiological estimates, with incidence increasing over time, particularly in patients exposed to textured implants for longer than 10 years.

Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants.

BACKGROUND: The risk of BIA-ALCL for patients with textured breast implants has been estimated between 1/2832 and 1/30,000 women. Existing studies estimating the numbers exposed and at risk, may have under reported cases, and/or lacked comprehensive follow-up. Our objective is to determine the risk of BIA-ALCL in a defined cohort of patients reconstructed with macro-textured breast implants and consistently followed long-term. METHODS: A prospective cohort study was conducted in patients who underwent breast reconstruction by a single surgeon at Memorial Sloan Kettering Cancer Center (MSKCC) from December 1992 to December 2017. Major events related to implants were prospectively recorded. We identified cases of BIA-ALCL by cross-checking clinical, pathology and external records data. Patients were followed until lymphoma occurrence or last follow-up. The primary outcomes were incidence rate per person-years and cumulative incidence. RESULTS: From 1992 to 2017, 3546 patients underwent 6023 breast reconstructions, mainly after breast cancer removal, or contralateral prophylactic mastectomy, using macro-textured surface expanders and implants. All reconstructions were performed by a single surgeon (PGC). Median follow-up was 8.1 years (range, 3 months - 30.9 years). Ten women, 1/354, developed ALCL after a median exposure of 11.5 years (range, 7.4-15.8 years). Overall risk of BIA-ALCL in our cohort is 1/355 women or 0.311 cases per 1000 person-years (95% CI 0.118 to 0.503). DISCUSSION: This study, the first to evaluate the risk of macro-textured breast implants from a prospective database with long term follow-up, demonstrates that the incidence rate of BIA-ALCL may be higher than previously reported. These results can help inform implant choice for women undergoing breast reconstruction.

The Impact of Obesity on Patient-Reported Outcomes Following Autologous Breast Reconstruction.

BACKGROUND: Obesity is a significant public health concern and clear risk factor for complications following breast reconstruction. To date, few have assessed patient-reported outcomes (PROs) focused on this key determinant. OBJECTIVE: Our study aimed to investigate the impact of obesity (body mass index ≥ 30) on postoperative satisfaction and physical function utilizing the BREAST-Q in a cohort of autologous breast reconstruction patients. METHODS: An Institutional Review Board-approved prospective investigation was conducted to evaluate PROs in patients undergoing autologous breast reconstruction from 2009 to 2017 at a tertiary academic medical center. The BREAST-Q reconstruction module was used to assess outcomes between cohorts preoperatively and at 6 months, 1 year, 2 years, and 3 years after reconstruction. RESULTS: Overall, 404 patients underwent autologous breast reconstruction with abdominal free-tissue transfer (244 non-obese, 160 obese) and completed the BREAST-Q. Although obese patients demonstrated lower satisfaction with breasts preoperatively (p = 0.04), no significant differences were noted postoperatively (p = 0.58). However, physical well-being of the abdomen was lower in the obese cohort compared with their non-obese counterparts at long-term follow-up (3 years; p = 0.04). CONCLUSION: Obesity significantly impacts autologous breast reconstruction patients. Although obese patients are more likely to present with dissatisfaction with breasts preoperatively, they exhibit comparable PROs overall compared with their non-obese counterparts, despite increased complications.

Incidence of benign and malignant peri-implant fluid collections and masses on magnetic resonance imaging in women with silicone implants.

BACKGROUND: To assess the incidence of benign and malignant peri-implant fluid collections and/or masses on magnetic resonance imaging (MRI) in women with silicone implants who are being screened for silent implant rupture. METHODS: The institutional review board approved this HIPAA-compliant retrospective study and waived informed consent. Women who underwent silicone implant oncoplastic and/or cosmetic surgery and postoperative implant-protocol MRI from 2000 to 2014 were included. Peri-implant fluid collections and/or masses were measured volumetrically. A benign peri-implant fluid collection and/or mass was pathologically proven or defined as showing 2 years of imaging and/or clinical stability. A malignant peri-implant fluid collection was pathologically proven. Incidence of peri-implant fluid collections and/or masses and positive predictive value (PPV) were calculated on a per-patient level using proportions and exact 95% confidence intervals (CIs). Fisher's exact test was used in the analysis to test statistical significance pre-defined as P-value < 0.05. RESULTS: A total of 1070 women with silicone implants were included (mean age, 50.7 years; range, 40.4-53.8). Median time between reconstructive surgery and first MRI was 88.9 months (range, 0.8-1363.3). Eighteen women (1.7%) had a peri-implant fluid collection and/or mass: 15/18 (83.3%) had adequate follow-up; and only 1/15 was malignant implant associated anaplastic large cell lymphoma, with a PPV of 6.7% (95% CI: 0.003-0.0005). The median peri-implant fluid collection size was 89 mL (range, 18-450 mL). CONCLUSION: Peri-implant fluid collections and/or masses identified at silicone implant protocol breast MR imaging are rarely seen 24 months after reconstructive surgery. Image-guided fine-needle aspiration with flow cytometry may be warranted to evaluate for implant-associated lymphoma.