Breast Implants and the Risk of Squamous Cell Carcinoma of the Breast: A Systematic Literature Review and Epidemiologic Study.

Squamous cell carcinoma may arise primarily from the breast parenchyma (PSCCB) or from the periprosthetic capsule in patients with breast implants (BIA-SCC). A systematic literature review was performed to identify all PSCCB and BIA-SCC cases, and estimate prevalence, incidence rate (IR) and risk. Using predefined keywords, studies since no time limit up to November 2023 were searched on PubMed, Web of Science, Google Scholar, and Cochrane Library. As the numerator for PSCCB and BIA-SCC we used the cases obtained from literature, while as the denominator for PSCCB the female population aged from 18 to 99, and for BIA-SCC the population with breast implants. Overall 219 papers were included, featuring 2,250 PSCCB and 30 BIA-SCC cases. PSCCB prevalence was 2.0 per 100,000 (95%CI 0.2:100,000 to 7.2:100,000) individuals with a lifetime risk of 1:49,509 (95%CI 0.2:10,000 to 5,6:10,000); and BIA-SCC prevalence was 0.61 per 100,000 (95%CI 0.2:100,000 to 1.3:100,000), with a lifetime risk of 1:164,884 (95%CI 0.2:100,000 to 5.6:100,000). BIA-SCC prevalence is 3.33-times lower than PSCCB, while BIA-ALCL prevalence is 3,84-times higher than Primary Breast ALCL. When comparing, BIA-SCC prevalence of 1:164,910 individuals with breast implants regardless of texture, to the BIA-ALCL prevalence of 1:914 patients with textured implants, the BIA-SCC risk is 180-times lower than BIA-ALCL. BIA-SCC occurs less frequently than PSCCB and considerably less than BIA-ALCL. The association between textured implants and BIA-SCC cases is relevant for patient education regarding uncommon and rare risks associated with breast implants, and ongoing vigilance, research, and strengthened reporting systems remain imperative.

DIEP flap perfusion assessment using microdialysis versus Doppler ultrasonography: A comparative study.

BACKGROUND: The increasing number of buried free-tissue transfer procedures and the need for an objective method to evaluate vascular complications of free flaps has led to the development of new technologies. Microdialysis has been used to monitor free flaps using interstitial biological markers. Previous uses mainly focused on muscular flaps. Our aim is to compare external Doppler ultrasonography (EDU) evaluation versus microdialysis in the early follow-up of adipocutaneous flaps, and propose an efficient postoperative monitoring protocol. METHODS: We retrospectively assessed 68 consecutive DIEP flaps (50 patients) performed between January 2019 and March 2021. All flaps received standardized post-operative monitoring using clinical signs, EDU and microdialysis. Glucose and lactate concentrations were assessed using glucose <1 mmol/L and lactate >6 mmol/L as ischemic trend thresholds. We calculated Glucose/Lactate ratio as a new parameter for the assessment of flap viability. RESULTS: Among all the 68 flaps, two flaps returned to the operative theater when a combination of unsatisfactory microdialysis values and clinical/EDU signs identified vascular impairment; only one developed total flap necrosis. Reoperation rate was 2.94% with an overall flap success rate of 98.53%. External Doppler ultrasonography had 100% sensitivity and 82% specificity, while microdialysis had 100% sensitivity and 100% specificity. CONCLUSIONS: Microdialysis values proved flap viability sooner than external Doppler ultrasonography, making it an excellent tool for post-operative monitoring. With the appropriate thresholds for glucose and lactate concentrations, and glucose/lactate ratio used as a new parameter, it can help potentially avoiding unnecessary re-explorations, and reducing flap ischemia times.

Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in the United States: A Systematic Review.

BACKGROUND: Although textured implants represent fewer than 10% of implants used in the United States, the country reports the highest incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). OBJECTIVES: The aim of this study was to perform a systematic literature review on US-based epidemiology to update knowledge on BIA-ALCL in the United States. METHODS: Publications on US BIA-ALCL epidemiology were searched between September 2022 and March 2023 on MEDLINE (National Institutes of Health; Bethesda, MD), Embase (Elsevier, Amsterdam, the Netherlands), Web of Science (Clarivate, London, UK), and SCOPUS (Elsevier, Amsterdam, the Netherlands). The US numerator was obtained by averaging the FDA MAUDE database and the PSF PROFILE registry, while the denominator was estimated from chest X-rays, and included female transgender individuals. Prevalence and risk were assessed accordingly, but the incidence rate (IR) could not be updated due to the lack of available follow-up data. RESULTS: Out of 987 identified manuscripts, 10 were included. The US prevalence of BIA-ALCL in the literature ranged from 1:300 to 1:500,000 and the IR from 4.5 per 10,000 to 31.1 per 100 million persons per year. A mean value of 453.5 BIA-ALCL cases was calculated. From a denominator of 4,264,618 individuals, which includes all breast implant surfaces, we calculated 414,521 individuals with textured implants, indicating a textured prevalence of 109.4 cases per 100,000 individuals and a risk of 1:913. CONCLUSIONS: BIA-ALCL IR, prevalence, and risk has increased when calculated exclusively for patients with textured devices. Although US macrotextured implants were recalled by the FDA, these findings may influence the surveillance of existing patients and the use of macrotextured implants in other parts of the world where they remain widespread.

BIA-ALCL Epidemiology in an Aesthetic Breast Surgery Cohort of 1501 Patients.

BACKGROUND: Epidemiologic studies on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) currently estimate the risk between 1:300 and 1:30,000, assessed mainly in large breast reconstruction populations. OBJECTIVES: The aim of the study was to assess BIA-ALCL epidemiology in a cohort of patients who have received textured implants for cosmetic indications. METHODS: In a prospective cohort observational study, 1501 patients who received a cosmetic breast augmentation between 2006 and 2016 were monitored, recording any implant-related complications, including BIA-ALCL. Cross-checking of clinical, pathology, and external records data identified cases. Prevalence, implant-specific prevalence (I-SP), incidence rate (IR), event-free time (EFT), and the Kaplan-Meier survival estimate were calculated. RESULTS: All but 2 patients received macrotextured or microtextured devices bilaterally. Mean follow-up was 3.2 years (1 months to 16.4 years). Five BIA-ALCL cases were investigated. Prevalence was 1:300 patients; I-SP was 6.9 cases/1000 individuals/Allergan BIOCELL devices and 1.3 cases/1000 individuals/Mentor Siltex devices; and IR was 1.07 cases/1000 females/year. Mean (SD) EFT was 9.2 years. CONCLUSIONS: When using a denominator based on a cohort of cosmetic patients, BIA-ALCL occurrence is higher than previously reported, particularly with macrotextured devices. Given the similar IRs in reconstructive and cosmetic cohorts, their even distribution could be consequent to underreporting due to poorer follow-up and lower awareness in the latter group. The genetic predisposition in the oncologic cohort reasonably affects the early onset more than the IR. The importance of accurate follow-up is confirmed. Stratification risks analysis can guide surgeons during patient counseling regarding the decision for prophylactic explantation.

Effects of DIEP flap-based breast reconstruction on respiratory function.

BACKGROUND: Breast reconstruction (BR) is an essential part of breast cancer treatment, and the DIEP flap is considered the gold standard reconstruction technique, which uses a free abdominal flap. Concerns have been raised regarding the effects of abdominoplasty on respiratory functions. This topic has not been addressed regarding donor-site closure of DIEP flaps. Our aim is to prospectively compare preoperative and postoperative spirometry in patients undergoing DIEP flap-based BR, investigating its impact on respiratory function. MATERIALS AND METHODS: We enrolled 21 patients who received BR with DIEP flap in our institution, who underwent pulmonary function assessment by spirometry 1 month preoperatively and 1 year postoperatively. We assessed Forced Expiratory Volume in the first second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC ratio, and Peak Expiratory Flow (PEF). Statistical analysis was performed using the paired samples test. RESULTS: An improvement in the mean values of all 4 variables was found at 1 year from surgery. Namely, FEV1 improved by 0.1 L with a standard deviation (SD) of 0.39 L, FVC by 0.04 L with SD of 0.627, FEV1/FVC by 2.11 L with SD of 7.85 L, and PEF by 1.2 L with SD of 1.45 L. Only PEF was statistically significant [P = 0.001]. CONCLUSION: Our results suggest that DIEP flap BR does not negatively impact respiratory function. Although further knowledge is required, we confirm the possibility of considering the indication for abdominoplasty and DIEP flap reconstruction in patients with altered and reduced pulmonary function.

Immediate prepectoral breast reconstruction using an ADM with smooth round implants: A prospective observational cohort study.

Prepectoral breast reconstruction using acellular dermal matrices (ADMs) is well established and used in candidates for nipple/skin-sparing mastectomies; it is based on many different matrices and a great variability in breast implant selection. We describe our experience and clinical outcomes using Braxon® ADMs and smooth round breast implants. Females aged 18-80 years who underwent mastectomies with immediate prepectoral reconstruction between April 2019 and April 2021 were prospectively included. Complications were classified as mastectomy-related (hematoma, necrosis) or reconstruction-related (seroma, infection, red breast syndrome). Binary logistic regression analysis was performed to assess correlation between complication rate and selected variables, which were analyzed per breast with Kruskal-Wallis H test. Fifty-eight patients (102 breasts) received 45 bilateral and 12 unilateral procedures. Drains collected 485.9 cc [range: 100-1260] and were removed 15.7 days [range: 6-29] postoperatively. We report 41 complications (40.2%): 33 mastectomy-related, 8 reconstruction-related. Reoperation occurred in 14 patients: 7 wound debridement and revisions under local anesthesia; and 7 explantation. Implant loss rate was 6.8%. Mastectomy and reconstruction complications were not correlated with any variable. In conclusion, we found prepectoral reconstruction with Braxon® ADMs and smooth round implants to be associated with acceptable complication rates that are not influenced by any patient- or surgery-related factors. Drainage volume is comparable to other breast implant reconstructive techniques, but drains are left in place for longer.

Free-style technique versus computed tomographic angiography-guided perforator selection in deep inferior epigastric perforator flap harvest: A prospective clinical study.

BACKGROUND: Computed tomographic angiography (CTA) is the preferred diagnostic tool in preoperative deep inferior epigastric perforator (DIEP) flap assessment, though some surgeons prefer approaching perforator selection with intraoperative findings alone. METHODS: This prospective observational study conducted between 2015 and 2020 assessed our intraoperative decision-making "free-style" technique for DIEP flap harvest. Any patient with indication for immediate or delayed breast reconstruction using abdominally based flaps and who received preoperative CTA was enrolled. Only unilateral cases performed by the same surgeon were considered. Allergy to iodine-based contrast media, renal impairment and claustrophobia were other exclusion criteria. Primary endpoint consisted in comparing operative times and complication rates between free-style technique and CTA-guided approach. Secondary endpoints included evaluation of agreement rate between intraoperative findings and CTA, and identification of variables affecting operative time and complication rate. Demographics, surgical information, agreement versus non-agreement and complications were collected. RESULTS: Starting from 206 patients, 100 were enrolled. Fifty were assigned to Group A, receiving DIEP flap with free-style technique. The other 50 were assigned to Group B, receiving DIEP flap with CTA-guided perforators selection. Study groups' demographics were homogenous. Operative time was statistically lower (p = .036) in free-style group (252.4 ± 44.77 min vs. 265.6 ± 31.67 min). Complication rates were higher in CTA-guided group (10% vs. 2%) though this was not significant (p = .092). Overall agreement rate in dominant perforator selection between intraoperatively and CTA-based assessment was 81%. Multiple regression analysis showed no variable increased complication rate, though CTA-guided approach, BMI > 30 and harvesting more than one perforator were respectively associated with B-coefficient of 17.391 (2.430-32.351, 95% CI) [p = .023], 3.50 (0.640-6.379, 95% CI) [p = .017] and 18.887 (6.232-31.542, 95% CI) [p = .004], predicting increased operative time. CONCLUSIONS: The free-style technique proved to be a useful tool for guiding DIEP flap harvest with good sensibility in detecting the dominant perforator suggested by CTA without statistically increasing surgery duration and complications.

Determining Breast Implant Prevalence: A Population Study of Italian Chest Radiographs.

BACKGROUND: Current breast implant prevalence within the general population remains elusive. An accurate prevalence is critical to serve as the denominator for any assessment of breast implant-related complication. The purpose of this manuscript is to assess this prevalence in women aged 20-70 years in Italy. MATERIALS AND METHODS: Eight reviewers, demonstrating a mean sensitivity of 87.0% and specificity of 97.0%, were recruited for retrospective identification of implants on chest radiographs from a tertiary academic hospital in a major urban setting. Three final reviewers were selected, and they assessed all eligible chest radiographs collected between January and December 2019. The hospital-based population was compared to epidemiological data at a local, regional and national level to demonstrate homogeneity of age structures using the phi correlation coefficient. RESULTS: We identified 3,448 chest X-rays which yielded 140 implants, with an overall prevalence of 4.1% for women aged 20-70. Implants were bilateral in 76% of cases and unilateral in 24%. They were placed cosmetically in 47.1% cases and used for reconstruction in 52.9% cases. Phi correlation coefficient found no differences across hospital-based, local, regional and national populations. CONCLUSION: A validated method was performed to estimate implant prevalence from an academic hospital in a major urban setting at 4.1% and was used to estimate national prevalence in Italy. The implications of this epidemiologic study may reach across national borders for improved understanding of breast implant epidemiology and in predicting the total number of patients within a given population that may be affected by device complications. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Comment on the Invited Discussion on "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants".

We here present a few comments on the invited discussion of Dr. van Heijningen on the paper "Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants". Dr. van Heijningen made some reservations regarding paper conclusions due to the high dropout rate, the adopted exclusion criteria and the location and mechanism of implant rupture. First of all, a high dropout rate is not unbeknown to researchers in surveys-based studies and may be expected when recalling in 6 months a population observed during last 20 years. In our study data are missing at random not affecting the risk of bias, while the population accurately depicts the people we care, mainly but not only reconstructive. Patients who did not respond to the questionnaire could not participate to the survey, while those who did not hold recent imaging were excluded because of the risk of false negative due to possible silent rupture, accounting to 10% in some reports. MRI imaging often shows that implants fold back on their selves when capsular contracture reduces implant pocket. As the use of the underwire bra prevents implant inferior displacement, repeated muscular contraction may worsen implant folds and the chronic wear-and-tear mechanism may be responsible for the rupture. Finally, folding is presumably easier to occur at the upper quadrants where anatomical implant shell is thinnest and gel concentration reduced than the opposite, therefore is not surprising that the higher percentage of ruptures is located in the upper implant quadrants.Level of evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Study of the Effect of Different Breast Implant Surfaces on Capsule Formation and Host Inflammatory Response in an Animal Model.

BACKGROUND: Breast implants are biomaterials eliciting a physiological and mandatory foreign body response. OBJECTIVES: The authors designed an animal study to investigate the impact of different implant surfaces on the formation of the periprosthetic capsule, the inflammatory response, and the cellular composition. METHODS: The authors implanted 1 scaled-down version of breast implants by different manufactures on 70 female Sprague Dawley rats. Animals were divided into 5 groups of 14 animals. Group A received a smooth implant (Ra ≈ 0.5 µm) according to the ISO 14607-2018 classification, Group B a smooth implant (Ra ≈ 3.2 µm), Group C a smooth implant (Ra ≈ 5 µm), Group D a macrotextured implant (Ra ≈ 62 µm), and Group E a macrotextured implant (Ra ≈ 75 µm). At 60 days, all animals received a magnetic resonance imaging (MRI), and 35 animals were killed and their capsules sent for histology (capsule thickness, inflammatory infiltrate) and immunohistochemistry analysis (cellular characterization). The remaining animals repeated the MRI at 120 days and were killed following the same protocol. RESULTS: MRI showed a thinner capsule in the smooth implants (Groups A-C) at 60 days (P < .001) but not at 120 days (P = .039), confirmed with histology both at 60 days (P = .005) and 120 days (P < .001). Smooth implants (Groups A-C) presented a mild inflammatory response at 60 days that was maintained at 120 days and a high M2-Macrophage concentration (anti-inflammatory). CONCLUSIONS: Our study confirms that smooth implants form a thinner capsule, inferior inflammatory infiltrate, and a cellular composition that indicates a mild host inflammatory response. A new host inflammatory response classification is elaborated classifying breast implants into mild, moderate, and high.

BIA-ALCL Epidemiological Findings From a Retrospective Study of 248 Cases Extracted From Relevant Case Reports and Series: A Systematic Review.

BACKGROUND: The epidemiologic picture of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is unclear, with no high-level evidence, because only case reports and series are available. OBJECTIVES: The aim of this study was to update knowledge on BIA-ALCL epidemiology by utilizing all available data through a systematic review of scientific literature. METHODS: A search on PubMed, Scopus, and Web of Science was conducted between October 2021 and April 2022. Out of the 2799 available records, 114 pertinent articles were selected, featuring 248 BIA-ALCL cases which were retrospectively analyzed by means of descriptive statistics, incidence rate (IR), Kaplan-Meier survival curves, and Pearson correlation coefficients. RESULTS: The United States, the Netherlands, Italy, and Australia were the countries reporting the most cases. The mean age at first implantation was 42 years, and the mean age at diagnosis was 53 years. Aesthetic indications were the reason for 52% of cases, and reconstruction for 48%; macrotextured surface was linked to 73.8% of cases, and seroma to 83%. Total follow-up was 492 months, and mean event-free time (EFT) to BIA-ALCL development was 129 months. The IR was 96 new cases/1,000 women per year after first implantation, and was directly correlated to the number of replacements. EFT was directly correlated to the number of replacements, implant rupture, and capsule contracture, and was inversely associated with patients' age at first implantation and to BRACA1/2 and TP53 mutations. CONCLUSIONS: Macrotextured implant use in older patients and in patients with BRCA1/2 and TP53 mutations should be reconsidered, because this is associated with earlier disease onset. Implant replacement of asymptomatic, risk-stratified patients can be indicated due to its protective role against BIA-ALCL, reducing IR and risk, while increasing the EFT.

Assessment of Risk Factors for Rupture in Breast Reconstruction Patients with Macrotextured Breast Implants.

BACKGROUND: Breast implants (BI) are widely used in plastic surgery, though they are not lifetime devices. Average life before rupture is reported to be around 10-15 years. No consensus exists regarding which factors are involved. OBJECTIVES: Following FDA recommendations, this study aims at identifying potential risk factors by evaluating their effect on BI rupture cases. METHODS: In this observational study, 763 BI patients were operated between 2003 and 2019, with a mean implant indwelling of 12.2 years. Patients that returned for follow-up were administered a questionnaire regarding postoperative lifestyle and habits. Implant rupture rate was 15.1%, while BI lifespan was 10.1 years. We obtained complete data from 191 breast implant patients (288 implants). Twenty-three potential risk factors were evaluated and divided in four categories: patient-related, surgery-related, postoperative complications/symptoms, and postoperative care/lifestyle habits. Odds Ratio (OR) for each factor was calculated. Linear regression analysis was calculated for those with a significant OR. RESULTS: We report 120 patients (195 implants) with intact and 71 (93 implants) with ruptured devices. BIs were macrotextured in 95.1% of cases (86.8% Allergan BIOCELL). OR was significant for underwire bra use (OR: 2.708), car seat belts (OR: 3.066), mammographic imaging (OR: 2.196), weightlifting (OR: 0.407) and carry-on heavy purses and backpacks (OR: 0.347). CONCLUSION: Wearing underwire bras, seat belts and undergoing mammography increases the risk of rupture. Weightlifting and carry heavy bags do not increase that risk. Implant rupture is directly linked with time of indwelling. Postoperative recommendations in BI patients should consider findings from our study, though larger multicenter studies should be encouraged. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

BACKGROUND: Because of poor knowledge of risks and benefits, prophylactic explantation of high BIA-ALCL risk breast implant (BI) is not indicated. Several surgical risks have been associated with BI surgery, with mortality being the most frightening. Primary aim of this study is to assess mortality rate in patients undergoing breast implant surgery for aesthetic or reconstructive indication. MATERIALS AND METHODS: In this retrospective observational cohort study, Breast Implant Surgery Mortality rate (BISM) was calculated as the perioperative mortality rate among 99,690 patients who underwent BI surgery for oncologic and non-oncologic indications. Mean age at first implant placement (A1P), implant lifespan (IL), and women's life expectancy (WLE) were obtained from a literature review and population database. RESULTS: BISM rate was 0, and mean A1P was 34 years for breast augmentation, and 50 years for breast reconstruction. Regardless of indication, overall mean A1P can be presumed to be 39 years, while mean BIL was estimated as 9 years and WLE as 85 years. CONCLUSION: This study first showed that the BISM risk is 0. This information, and the knowledge that BI patients will undergo one or more revisional procedures if not explantation during their lifetime, may help surgeons in the decision-making process of a pre-emptive substitution or explant in patients at high risk of BIA-ALCL. Our recommendation is that patients with existing macrotextured implants do have a relative indication for explantation and total capsulectomy. The final decision should be shared between patient and surgeon following an evaluation of benefits, surgical risks and comorbidities. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The use of Fat-Augmented Latissimus Dorsi (FALD) flap for male Poland Syndrome correction: a case report.

We present a 23-year-old male patient with severe PS, characterized by marked left thoracic wall deformity. Reconstruction was performed using the Fat-Augmented Latissimus Dorsi flap, which was fixed to the chest wall hollowing corresponding to where the pectoralis major muscle was missing. Patient was satisfied with final aesthetic and functional result.

Oncologic Outcome of 1000 Postmastectomy Breast Reconstructions with Fat Transfer: A Single-Center, Matched Case-Control Study.

BACKGROUND: Autologous fat transfer has an important role in breast reconstructive surgery. Nevertheless, some concerns remain with regard to its oncologic safety. The authors present a single-center, case-matching study analyzing the impact of autologous fat transfer in the cumulative incidence of local recurrences. METHODS: From a prospectively maintained database, the authors identified 902 patients who underwent 1025 breast reconstructions from 2005 to 2017. Data regarding demographics, tumor characteristics, surgery details, and follow-up were collected. Exclusion criteria were patients with distant metastases at diagnosis, recurrent tumor, or incomplete data regarding primary tumor; and patients who underwent prophylactic mastectomies and breast-conserving operations. Statistical analysis was conducted to evaluate the impact of the variables on the incidence of local recurrence. A value of p < 0.05 was considered statistically significant. RESULTS: After 1: n case-matching, we selected 919 breasts, of which 425 patients (46.2 percent) received at least one autologous fat transfer session versus 494 control cases (53.8 percent). Local recurrences had an overall rate of 6.8 percent, and we found local recurrences in 14 autologous fat transfer cases (3.0 percent) and 54 controls (9.6 percent). Statistical analysis showed that autologous fat transfer did not increase the risk of local recurrences (hazard ratio, 0.337; CI, 0.173 to 0.658; p = 0.00007). Multivariate analysis identified invasive ductal carcinoma subtype and lymph node metastases to have an increased risk of local recurrences (hazard ratio >1). Conversely, positive hormonal receptor status was associated with a reduced risk of events (hazard ratio <1). CONCLUSIONS: Autologous fat transfer was not associated with a higher probability of locoregional recurrence in patients undergoing breast reconstruction; therefore, it can be safely used for total breast reconstruction or aesthetic refinements. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Total breast reconstruction with the fat-augmented latissimus dorsi (FALD) flap: High safety in a single-center uncontrolled case series.

According to ASPS, 107,238 breast reconstructions (BR) have been performed in the United States this year. The latissimus dorsi (LD) flap is used for breast reconstruction (BR), either with an implant or an extended flap harvest. Implant-enhanced LD is associated with 50% reoperation rates. To avoid implant-related complications, we introduced the Fat-Augmented LD (FALD) flap. Several authors report 92% patient satisfaction and 36% complication rates (CR). The aim of our study is to present a single-center uncontrolled case series with long follow-up assessing CR and esthetic results. Women with small-to-moderate breasts requiring immediate or delayed BR were included, whereas athletic and paraplegic women or patients with contraindication for free flap BR were excluded. Clinical and surgical data were analyzed. Esthetic analysis was performed using a panel of independent observers. Between December 2010 and November 2019, 100 patients underwent 148 FALD-based BR. Average operative time was 193.5 min for unilateral procedure and 290.6 min for bilateral procedure. Mean immediate AFT volume was 105.3 cc (range 60-170) per breast. Major complication (total or partial flap necrosis > 30%) rate was 0%, and minor complication (partial flap necrosis < 30%, fat necrosis hematoma, seroma, donor site dehiscence, and chronic pain) rate was 6.76%. Esthetic analysis garnered satisfactory results for all types of mastectomies. For variables regarding skin texture (p = 0.001), scar location (p = 0.005), and total score (p = 0.001), patients undergoing Modified Radical Mastectomy scored lower than Skin-Sparing Mastectomy and Nipple-Sparing Mastectomy. We were able to confirm that the FALD flap is a safe with a low complication rate and high patient satisfaction. Level of Evidence IV.