Litigation in gender affirming surgery: Reviewing five decades of the medical malpractice landscape.

The present study sought to analyze malpractice cases related to gender affirming surgery to provide information to physicians as it may serve to minimize the risk of malpractice suits. The Westlaw and Lexis Nexis databases were queried for jury verdicts and settlements related to gender affirming surgery malpractice lawsuits. A total of 26 cases were identified between 1970 and 2020, five of which were determined relevant on further review. Motives included adverse surgical and medical outcomes, and failure to treat. All cases were decided in favor of the defendant and resulted in $0 compensatory damages.

Out-of-Pocket Costs and Payments in Autologous and Implant-Based Breast Reconstruction: A Nationwide Analysis.

BACKGROUND: Many factors influence a patient's decision to undergo autologous versus implant-based breast reconstruction, including medical, social, and financial considerations. This study aims to investigate differences in out-of-pocket and total spending for patients undergoing autologous and implant-based breast reconstruction. METHODS: The IBM MarketScan Commercial Databases were queried to extract all patients who underwent inpatient autologous or implant-based breast reconstruction from 2017 to 2021. Financial variables included gross payments to the provider (facility and/or physician) and out-of-pocket costs (total of coinsurance, deductible, and copayments). Univariate regressions assessed differences between autologous and implant-based reconstruction procedures. Mixed-effects linear regression was used to analyze parametric contributions to total gross and out-of-pocket costs. RESULTS: The sample identified 2079 autologous breast reconstruction and 1475 implant-based breast reconstruction episodes. Median out-of-pocket costs were significantly higher for autologous reconstruction than implant-based reconstruction ($597 vs $250, P < 0.001) as were total payments ($63,667 vs $31,472, P < 0.001). Type of insurance plan and region contributed to variable out-of-pocket costs (P < 0.001). Regression analysis revealed that autologous reconstruction contributes significantly to increasing out-of-pocket costs (B = $597, P = 0.025) and increasing total costs (B = $74,507, P = 0.006). CONCLUSION: The US national data demonstrate that autologous breast reconstruction has higher out-of-pocket costs and higher gross payments than implant-based reconstruction. More study is needed to determine the extent to which these financial differences affect patient decision-making.

An Analysis of Medical Malpractice Litigation Involving Orbital Fractures.

BACKGROUND: Orbital fractures frequently require operative management by a plastic and reconstructive surgeon. Due to the proximity to the globe and complexity of the reconstruction, orbital fractures, and related procedures have the potential to be a source of medical litigation. The aim of the present study was to review orbital fracture malpractice litigation, including case outcomes and compensatory damages. METHODS: The Westlaw and Lexis Nexis databases were queried for jury verdicts and settlements related to orbital fracture malpractice lawsuits. The Boolean terms included "orbit! /10 fracture," "orbit! & fracture," and "ocular & fracture" for both databases. Cases were included if they were state or federal cases related to both orbital fracture and medical malpractice involving surgical or medical mismanagement or misdiagnosis of orbital fracture. RESULTS: A total of 49 cases from 1994 to 2018 met inclusion criteria between the databases. The most common legal complaint was the defendant's failure to make a diagnosis either by not ordering the proper radiological tests or by not interpreting radiological tests correctly, seen in 35% of cases. In 57% of the cases, the defendant was a surgeon, 46% of which involved a plastic surgeon specifically. Cases were resolved in favor of the defendant 49% of the time. Most cases (57%) resulted in a monetary outcome of $0. However, cases that were decided in favor of the plaintiff had significant compensatory damages with the majority being over $100,000, and 1 case as high as $8 million. CONCLUSION: Although almost half of the orbital fracture malpractice cases resulted in an outcome favoring the defendant, significant monetary consequences against the defendant were possible in cases when the plaintiff prevailed.

Statistical fragility of outcomes in acellular dermal matrix literature: A systematic review of randomized controlled trials.

BACKGROUND: Acellular dermal matrix (ADM) is commonly used in plastic and reconstructive surgery. With the abundance of randomized controlled trials (RCTs) reporting P-values for ADM outcomes, this study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of the outcomes in ADM RCTs. METHODS: PubMed, Embase, SCOPUS, Medline, and Cochrane databases were reviewed for ADM RCTs (2003-present) reporting a dichotomous, categorical outcome. FI and rFI (event reversals influencing outcome significance) and FQ (standardized fragility) were calculated and reported as median. Subgroup analysis was performed based on intervention types. RESULTS: Among the 127 studies screened, 56 RCTs with 579 outcomes were included. The median FI stood at 4 (3-5) and FQ was 0.04 (0.03-0.07). Only 101 outcomes were statistically significant with a median FI of 3 (1-6) and FQ of 0.04 (0.02-0.08). The nonsignificant outcomes had a median FI of 4 (3-5) and FQ of 0.04 (0.03-0.07). Notably, 26% of the outcomes had several patients lost to follow up equal to or surpassing the FI. Based on the intervention type, the median FIs showed minor fluctuations but remained low. CONCLUSIONS: Outcomes from ADM-related RCTs were statistically fragile. Slight outcome reversals or maintenance of patient follow-up can alter the significance of results. Therefore, future researchers are recommended to jointly report FI, FQ, and P-values to offer a comprehensive view of the robustness in ADM literature.

Never events in plastic surgery: An analysis of surgical burns and medical malpractice litigation.

INTRODUCTION: Burns and fires in the operating room are a known risk and their prevention has contributed to many additional safety measures. Despite these safeguards, burn injuries contribute significantly to the medical malpractice landscape. The aim of the present study is to analyze malpractice litigation related to burn and fire injuries in plastic and reconstructive surgery, identify mechanisms of injury, and develop strategies for prevention. METHODS: The Westlaw and LexisNexis databases were queried for jury verdicts and settlements in malpractice lawsuits related to burn and fire injuries that occurred during plastic surgery procedures. The Boolean terms included "burn & injury & plastic", "fire & injury & "plastic surg!"" in Westlaw, and "burn & injury & "plastic surg!"", "fire & injury & "plastic surg!"" in LexisNexis. RESULTS: A total of 46 cases met the inclusion criteria for this study. Overheated surgical instruments and cautery devices were the most common mechanisms for litigation. Plastic surgeons were defendants in 40 (87%) cases. Of the included cases, 43% were ruled in favor of the defendant, while 33% were ruled in favor of the plaintiff. Mishandling of cautery devices 6 (13%), heated surgical instruments 6 (13%), and topical acids 2 (4%) were the most common types of errors encountered. CONCLUSION: Never events causing burn injury in plastic and reconstructive surgery are ultimately caused by human error or neglect. The misuse of overheated surgical instruments and cauterizing devices should be the focus for improving patient safety and reducing the risk of medical malpractice. Forcing functions and additional safeguards should be considered to minimize the risk of costly litigation and unnecessary severe harm to patients.

Surgery or Not? A Systematic Review of Facial Congenital Melanocytic Nevi Treatment Patterns and Outcomes.

BACKGROUND: Treatment management for congenital melanocytic nevi (CMN) on the face (FCMN) is highly variable and requires a thorough assessment of multiple factors. To date, a systematic review of FCMN treatment is lacking. The purpose of the present study was to elucidate the frequency, variety, and outcomes of treatment modalities for FCMN with different levels of complexity. METHODS: A comprehensive review of Pubmed, Embase, and Google Scholar databases from 1950 to 2022 was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Articles reporting on FCMN treatment approaches, outcomes, and associated complications were screened and data were extracted according to inclusion criteria. Data were tabulated for thematic analysis of FCMN treatment types, anatomic locations, outcomes, and complications. RESULTS: Of the 561 studies retrieved, 34 met inclusion criteria including 19 surgical treatments, 14 nonsurgical treatments, and one combined surgical and nonsurgical treatment study, totaling 356 patients. The majority of treated FCMN were small-to-medium-sized (56%). Facial CMN treated conservatively were mostly located on the cheek (27%) and/or perinasal region (21%), whereas FCMN treated with surgery were primarily located in the periorbital region (44%) and/or the cheek (17%). Across all treatment cohorts, 22% of patients experienced at least one complication, with 12% of complications experienced by patients treated by surgery. CONCLUSIONS: There is a greater need for standardized FCMN nomenclature that encompasses nevi pattern, dimensions, anatomical coverage, and quantitative measurements of treatment outcome. Future studies should focus on identifying anatomic locations of FCMN that are more prone to complications and determine which treatment approach optimizes outcomes.

Contextualizing the Impact of Pop Culture on Breast Implant Illness and its Medical Relevance.

INTRODUCTION: Despite a lack of data demonstrating causation, there is growing concern over breast implants and systemic illness. This study examines the impact of rising public interest in breast implant illness (BII) and its implications on breast implant removals (BIR). METHODS: A Google Trends (GT) analysis of each year between 2010 and 2022 was performed globally, and then separately for the United States alone (US), using the search terms "capsular contracture," "breast implant illness," and "breast implant(s) removal". Linear regression was performed to determine significant correlations. Data on BII-related Facebook advocacy groups, relevant pop culture events, numbers of BIR surgeries, and number of BII-related publications were collected and analyzed alongside GT data to determine relevance. RESULTS: For global GT, there was a significant relationship between "breast implant illness" and "breast implant(s) removal" in 2016 (R2=0.62, ß =0.33, p<0.01), 2020 (R2=0.53, ß =0.23, p=0.01), and 2022 (R2=0.60, ß =0.44, p=0.01). In the US, 2016 (R2=0.53, ß =1.75, p=0.01) 2018 (R2=0.61, ß =1.93, p<0.01) and 2020 (R2=0.72, ß=0.91, p<0.01) were significant. In 2020, "capsular contracture" and "breast implant(s) removal" was significant in the US (R2=0.58, ß=0.4, p=0.01). In 2016, Facebook was the platform for the largest BII advocacy group and in 2020 YouTube was the platform for the first BII documentary and TEDx talk. From 2010 to 2020, PubMed publications containing "ASIA" and "BII" increased 24-fold and ASPS reports on BIR rose 70%. CONCLUSION: This study suggests that BII is a topic of global concern and has implications on both academic medicine and clinical practice. 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 .

Are Gender-Affirming Plastic Surgeons Adequately Compensated? An Analysis of Relative Value Units.

BACKGROUND: Gender-affirming surgery (GAS) has a complicated history within US health care. As GAS procedures and reimbursement availability continue to uptrend, the present study aims to investigate whether compensation is equitable between GAS procedures and general plastic surgery procedures. METHODS: The National Surgical Quality Improvement Program database was queried for all surgeries performed by plastic surgeons from 2016 to 2020. Cases were assigned to the GAS or non-GAS cohort using ICD-10 codes. Duplicate Current Procedural Terminology (CPT) codes were removed for analysis. Operative time, total wRVUs, wRVUs per hour (wRVU/h), reoperation/readmission rate, and number of concurrent procedures were compared between the cohorts. RESULTS: A total of 132,319 non-GAS and 3,583 GAS were identified. After duplicate CPT removal, 299 cases (21 unique CPTs) remained in the GAS cohort and 20,022 (37 unique CPTs) in the non-GAS cohort. Operative time was higher in the GAS cohort (262.9 vs 120.7 min, P < 0.001), as were total wRVUs (59.4 vs 21.6, P < 0.001). Reoperation/readmission rate (7.0% vs 6.0%) and wRVU/h (15.8 vs 15.1) were not significantly different (all P > 0.05). There was a positive correlation between total operative time and total wRVUs (P < 0.001) and a negative correlation between total operative time and wRVU/h (P < 0.001). CONCLUSIONS: Proportional wRVUs are allocated to gender affirming plastic procedures. However, the RVU scale does not allocate proportional wRVUs to longer operative times for both GAS and general plastic surgeries. Compensation for gender affirming plastic surgeries is higher than that of general plastic surgeries; however, there is no difference in wRVUs per hour on comparison.

Diversity of Leadership and Its Influence on Diversity of Integrated Plastic Surgery Residency Cohorts: A Study in the Virtual Era.

Background: In the aftermath of COVID-19, the residency application process has largely remained in the virtual space, introducing a new challenge to prospective integrated plastic surgery residents. Many programs enhanced their online presence to address this challenge, but both programs and applicants are still limited to a virtual snapshot when determining "fit." An important influence of fit is the ability to racially, ethnically, and/or culturally identify with the program. The aims of this study are to: (1) better understand the online information that residency programs are making available to prospective applicants, (2) characterize the racial diversity of programs, and (3) investigate the effect of program leadership on racial diversity. Methods: A cross-sectional study of US integrated plastic surgery residency programs was performed in August 2022. Data on race were collected for residency program directors and resident cohorts and compared with self-reported data from the Association of American Medical Colleges (AAMC). Relationships between these groups were analyzed. Results: Racial data were collected on 82 program directors and their corresponding residency cohorts, representing a total of 1174 individuals. These data closely matched the AAMC data on race/ethnicity in plastic surgery programs. By race, the smallest percentage of resident groups are Black/African American (3.4%) and Hispanic (4.2%). Though not statistically significant, more residents of a given race are in programs with a director of the same race. Conclusions: Online information about residency programs and their cohorts is robust. The racial diversity of a residency cohort is positively associated with racial diversity of program directors.

Complications from Fat Grafting and Gluteal Augmentation in Outpatient Plastic Surgery: An Analysis of American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF, QUAD A) Data.

BACKGROUND: Gluteal augmentation with autologous fat grafting, colloquially referred to as Brazilian butt lift (BBL), is an increasingly common procedure with a highly reported complication profile. OBJECTIVES: This study aims to analyze the prevalence and characteristics of complications that accompany these surgeries in ambulatory surgery facilities. METHODS: Adults patients who experienced fat grafting complications from 2019-2021 were identified in formerly QUAD A, formerly known as the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), database. Patients and complications were analyzed based on sociodemographic, surgery and facility-specific variables using descriptive statistics and logistic regression. RESULTS: Overall, 436 fat grafting procedures with complications were reported to QUAD A, with an overall complication rate of 0.93%. Of these complications, 153 (37.6%) were confirmed to be from gluteal augmentation procedures. Notably, the number of gluteal augmentation with fat grafting complications decreased from the year 2019 (48) to 2020 (36), then nearly doubled from 2020 to 2021 (69). The majority of patients were female (96.7%) with a mean age of 42.0 years and a mean BMI of 28.3 kg/m2. Wound infection was the most commonly documented complication (22.3%). Of the patients who experienced complications, 35.9% presented to a hospital for their complications and 12.6% required reoperation. Four deaths were described. There was no association between sociodemographic or surgical variables and increased odds of readmission or reoperation (p>0.05). CONCLUSIONS: Gluteal augmentation accounts for a large proportion of complications from fat grafting procedures. Increased reporting requirements may aid in future determination of incidences of complications and improve patient safety.

Application of Field Sterility to Safely Reduce Cost and Waste in Cleft Surgery.

BACKGROUND: Healthcare spending in the United States remains a major concern, requiring reforms to control spending and curtail costs. Medical supply is one of the largest expenses for hospitals and strategies should be utilized to reduce nonbeneficial service delivery, which increases cost without concomitant increase in value. Introduction of field sterility is one of the potential strategies that has been applied in several surgical disciplines to improve cost-efficiency by reducing overuse of resources and decreasing enormous medical waste. Of course, this must be applied without a diminution in safety. METHODS: The PubMed, Medline, and Cochrane databases from 1980 to 2022 were used to review literature. Key words included "cleft surgery and field sterility," "sterile gloves and oral surgery," "oral surgery and field sterility," "sterile techniques and cleft palate surgery," "sterile versus nonsterile gloves," "sterile and non-sterile gloves and minor surgery," "skin laceration repair and sterile techniques," "sterile gloves and wound suture," "surgical site infection and field sterility," "operating room versus clinical setting," "operating rooms economics and hand surgery," and "main operating room versus ambulatory." RESULTS: The literature search yielded 827 articles. Following evaluation of titles, abstracts, and manuscript contents, 23 articles were ultimately included, of which 10 discussed field sterility and cost-efficiency for cutaneous procedures, 9 hand surgery, and 4 oral surgery. There was no study evaluating field sterility application in cleft surgery. In the reviewed studies, no statistical significance was observed in surgical site infection (SSI) with substantial cost savings and medical waste reduction when hand procedures were performed in ambulatory settings with field sterility compared to the main operating room (OR). Furthermore, no difference was observed for SSI in wound closure, excision of skin lesions, or Mohs micrographic surgery when nonsterile gloves were used. CONCLUSION: The incidence of infection following most cleft-related procedures remains low. As such, the application of field sterility may be ideal for this setting. The cost and waste associated with standard operating protocols are not warranted for many cleft procedures.

Vaginal Reconstruction in the Pediatric Population: An Analysis of a National Database.

OBJECTIVE: In the pediatric population, vaginoplasties can be performed in patients with either congenital malformations or acquired conditions. To our knowledge, there has been no study to date investigating the outcomes of vaginoplasty in the pediatric population using a nationwide database. Here, we present a national cohort study of perioperative characteristics and 30-day complications of vaginoplasty in pediatric patients. METHODS: A level II retrospective, prognosis cohort study was performed using the Pediatric National Surgical Quality Improvement Program (NSQIP-P) database from 2012 to 2020. Data from patients age 0 to 18 who underwent vaginoplasty was queried using CPT code 57,335. Descriptive analysis was performed to elucidate patterns in patient demographics, perioperative characteristics, and 30-day postoperative outcomes. RESULTS: A total of 183 patients were identified. Median age was 2.41 years (IQR 0.9 to 12.1). In this population, 58.5% of patients had ASA class 2, and 33.3% ASA class 3. Congenital malformation was present in 75.9%. Average total length of stay was 2.7 days (SD = 3.8) and readmission rate was 7.86%. Complications included urinary tract infection (3.3%), bleeding/transfusions (2.2%), organ/space surgical site infection (1.1%), and superficial incisional surgical site infection (0.6%). The most common procedures performed simultaneously with vaginoplasty included cystourethroscopy (n = 66), clitoroplasty for intersex state (n = 58), and plastic repair of introitus (n = 22). CONCLUSION: Vaginoplasties in the pediatric population were found to have low rates of 30-day readmission and low incidence of 30-day postoperative complications. Further studies focusing on prospective clinical data related to pediatric vaginoplasty can help identify factors to improve long-term outcomes in this population.