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.

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.

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.

Scalding saline injuries: Preventing a rare but serious event in medical litigation.

This study aimed to investigate the causes, outcomes, and compensation amounts of saline-induced perioperative burns, a rare but entirely preventable event. Saline-induced burns pose a significant risk to patients, and understanding the factors associated with such incidents is crucial for improving patient safety. Previous studies highlighted the use of hot saline bags and solution during medical procedures as a potential cause of these burns. A retrospective analysis of cases involving perioperative saline-induced burns was conducted using the Westlaw and Lexis Nexis legal databases. Eight relevant cases were identified and analyzed to determine the causes, outcomes, and compensation amounts. Hot saline bags used for positioning and hot saline solution were identified as the primary causes of saline-induced burns. Out of the eight cases analyzed, four resulted in a favorable verdict for the plaintiff, three cases were settled, and one case was in favor of the defense. Compensation amounts ranged from no monetary compensation to over one million dollars. This study highlights the need for increased awareness among medical professionals regarding the risks associated with saline-induced burns, and the importance of implementing guidelines for the safe use of hot saline bags and solution. Together these measures can hopefully mitigate the occurrence of these preventable incidents, improve patient safety, and reduce medicolegal exposure.

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 .

Complication Rates Following Cerebral and Coronary Angiography: Nationwide Analysis 2008-2014.

Catheter-based angiography is an essential procedure for the diagnosis and treatment of vascular complications in patients. Since cerebral and coronary angiography are similar techniques that utilize the same access sites and general principles, the associated risks overlap and should be identified to help direct patient care. The purpose of this study was to determine complication rates in a combined cohort of cerebral and coronary angiography patients, as well as conduct a comparative analysis of coronary and cerebral angiography complications. The National Inpatient Sample was queried from 2008 to 2014 to identify patients who underwent coronary or cerebral angiography. After assessment of baseline characteristics, complication rates, and disposition in the combined cohort, propensity matching was utilized to create sub-cohorts of coronary and cerebral angiography patients based on demographics and comorbidities. Comparative analysis of procedural complications and disposition was then performed. A total of 3,763,651 hospitalizations were included in our study cohort (3,505,715 coronary angiographies and 257,936 cerebral angiographies). The median age was 62.9 years, with females being 46.42%. The most prevalent comorbidities in the overall cohort were hypertension (69.92%), coronary artery disease (69.48%), smoking (35.64%), and diabetes mellitus (35.13%). Propensity matching demonstrated that the cerebral angiography cohort had lower rates of acute and unspecified renal failure (5.4% vs 9.2%, OR 0.57, 95% CI, 0.53-0.61, P < 0.001), hemorrhage/hematoma formation (0.8% vs 1.3%, OR 0.63, 95% CI, 0.54-0.73, P < 0.001), and equivalent rates of retroperitoneum hematoma formation (0.03% vs 0.04%, OR 1.49, 95% CI, 0.76-2.90, P = 0.247) and arterial embolism/ thrombus formation (0.3% vs 0.3%, OR 1.01, 95% CI, 0.81-1.27, P = 0.900). Our study showed both cerebral and coronary angiography have generally low rates of procedural complications. Matched cohort analysis demonstrated that cerebral angiography patients are at no greater risk for complications than coronary angiography patients.

FX knockout CHO hosts can express desired ratios of fucosylated or afucosylated antibodies with high titers and comparable product quality.

During antibody dependent cell cytotoxicity (ADCC) the target cells are killed by monocytes and natural killer cells. ADCC is enhanced when the antibody heavy chain's core N-linked glycan lacks the fucose molecule(s). Several strategies have been utilized to generate fully afucosylated antibodies. A commonly used and efficient approach has been knocking out the FUT8 gene of the Chinese hamster ovary (CHO) host cells, which results in expression of antibody molecules with fully afucosylated glycans. However, a major drawback of the FUT8-KO host is the requirement for undertaking two separate cell line development (CLD) efforts in order to obtain both primarily fucosylated and fully afucosylated antibody species for comparative studies in vitro and in vivo. Even more challenging is obtaining primarily fucosylated and FUT8-KO clones with similar enough product quality attributes to ensure that any observed ADCC advantage(s) can be strictly attributed to afucosylation. Here, we report generation and use of a FX knockout (FXKO) CHO host cell line that is capable of expressing antibody molecules with either primarily fucosylated or fully afucosylated glycan profiles with otherwise similar product quality attributes, depending on addition of fucose to the cell culture media. Hence, the FXKO host not only obviates the requirement for undertaking two separate CLD efforts, but it also averts the need for screening many colonies to identify clones with comparable product qualities. Finally, FXKO clones can express antibodies with the desired ratio of primarily fucosylated to afucosylated glycans when fucose is titrated into the production media, to allow achieving intended levels of FcγRIII-binding and ADCC for an antibody. Biotechnol. Bioeng. 2017;114: 632-644. © 2016 Wiley Periodicals, Inc.

Microfluidic validation of diagnostic protein markers for spontaneous cerebrospinal fluid rhinorrhea.

Cerebrospinal fluid (CSF) rhinorrhea is a potentially dangerous condition identified by CSF leakage into the nasal cavity. This malady stands to benefit from rapid and noninvasive screening diagnostics to complement low-throughput imaging based methods currently in use. To address this gap, we demonstrate on-chip immunosubtraction to accelerate biomarker validation and immunoassay development for a putative CSF rhinorrhea diagnostic marker, transthyretin, by combining high-specificity immunoaffinity capture with subsequent polyacrylamide gel electrophoresis (PAGE). We demonstrate the on-chip assay using photopatterned polyacrylamide immunofilters. The filter consists of polymer with controlled pore-sizes to size-exclude (i.e., "subtract") large antibody-target immune complexes from downstream PAGE separation. A control PAGE separation is also performed for comparison without immunoaffinity capture (i.e., no antibody present). We compare on-chip immunosubtraction to Western blotting and ELISA to validate CSF rhinorrhea biomarkers from nasal surgery samples. For samples representative of spontaneous rhinorrhea, the 5 min on-chip assay achieved clinical specificity of 100%, compared to 50% for ELISA which required 6 h. On-chip immunosubtraction also generated results for clinical samples not assayable via ELISA due to matrix protein spurious signals. The pilot study suggests the capability of a rapid on-chip validation tool to expedite scrutiny of putative protein markers for new clinical assays.