Navigating Food and Drug Administration Mandated Breast Implant Patient Literature: A Call to Increase Equitable Healthcare Access Within Plastic Surgery.

OBJECTIVES: In October 2021, the US Food and Drug Administration mandated patient decision checklists and new labeling for breast implants with the goal of improving the informed decision-making process for patients considering breast implantation. Given growing concerns over breast implant-associated anaplastic large cell lymphoma, breast implant-associated squamous cell carcinoma, and breast implant illness, patients should be able to easily review these resources to make a fully informed decision when considering surgery. This study seeks to elucidate the accessibility, and therefore the utility of the newly mandated literature for the average breast implant patient. METHODS: Patient decision checklists and breast implant boxed warnings were obtained from the most used breast implant manufacturers in the United States-Allergan, Mentor, and Sientra. Readability analysis of all Food and Drug Administration required documents was performed using the Flesch Reading Ease Score, Flesch Kincaid Grade Level, Gunning-Fog Index, Coleman-Liau Index, Simplified Measure of Gobbledygook, and Automated Readability Index. RESULTS: The overall readability of all Allergan, Mentor, and Sientra patient materials correlates with a college reading level. Documents from all 3 implant manufacturers were of a statistically significantly higher reading level than that recommended by the American Medical Association and US Department of Health and Human Services. No materials were found to be at or below the recommended sixth-grade level. CONCLUSIONS: The newly mandated breast implant patient decision guides are written at a college reading level. These materials should be simplified to improve health literacy shared decision making.

The Insurance Landscape for Implant- and Autologous-based Breast Reconstruction in the United States.

Insurance coverage of postmastectomy breast reconstruction is mandated in America, regardless of reconstructive modality. Despite enhanced patient-reported outcomes, autologous reconstruction is utilized less than nonautologous reconstruction nationally. Lower reimbursement from Medicare and Medicaid may disincentivize autologous-based reconstruction. This study examines the impact of insurance and sociodemographic factors on breast reconstruction. Methods: A retrospective analysis of the Healthcare Cost and Utilization Project National Inpatient Sample Database from 2014 to 2017 was performed. International Classification of Diseases Clinical Modification and Procedure Coding System codes were used to identify patients for inclusion. De-identified sociodemographic and insurance data were analyzed using χ 2, least absolute shrinkage and selection operator regression analysis, and classification trees. Results: In total, 31,468 patients were identified for analysis and stratified by reconstructive modality, sociodemographics, insurance, and hospital characteristics. Most patients underwent nonautologous reconstruction (63.2%). Deep inferior epigastric perforator flaps were the most common autologous modality (46.7%). Least absolute shrinkage and selection operator regression identified Black race, urban-teaching hospitals, nonsmoking status, and obesity to be associated with autologous reconstruction. Publicly-insured patients were less likely to undergo autologous reconstruction than privately-insured patients. Within autologous reconstruction, publicly-insured patients were 1.97 (P < 0.001) times as likely to obtain pedicled flaps than free flaps. Black patients were 33% (P < 0.001) less likely to obtain free flaps than White patients. Conclusions: Breast reconstruction is influenced by insurance, hospital demographics, and sociodemographic factors. Action to mitigate this health disparity should be undertaken so that surgical decision-making is solely dependent upon medical and anatomic factors.

Pediatric Dog Bites: A Review of 1422 Cases Treated at a Level One Regional Pediatric Trauma Center.

BACKGROUND: Children under the age of 14 account for over 40% of the almost 900,000 annual hospital visits associated with dog bites. Care for dog bites ranges from simple wound irrigation to complex surgical reconstruction. Due to a number of factors, children frequently sustain dog bites to highly vulnerable regions, often necessitating intervention by plastic surgeons. METHODS: This retrospective study analyzed data from the 1422 pediatric patients who sustained dog bites and presented to the Le Bonheur Children's Hospital Emergency Room from January 2011 to May 2017. RESULTS: The typical pediatric dog bite case was male (63.5%), African-American (57.4%), and less than 10 years old (69.4%). The head and neck were the most commonly affected areas (64.7%). Of the head and neck regions, the cheeks and lips were the most frequently injured structures (34.5%). Hospital admission was required for 188 patients (13.2%) and operative repair was deemed necessary in 16.9% of all cases. Of the patients requiring inpatient operative repair, most (78.3%) were discharged in less than 24 hours. Operative complications occurred in 5.8% of all cases, with infections accounting for the majority (92.9%). No fatal dog bites occurred in this study. CONCLUSIONS: Age, bite location, and number of bites sustained are several factors of significance, which may aid the novice plastic surgeon in identifying, which pediatric dog bite cases will require surgical intervention.

Management of Asymptomatic Patients With Textured Breast Implants: A Survey Analysis of Members of The Aesthetic Society.

BACKGROUND: The management of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has been well established. However, there is minimal data and significant variability in the management of asymptomatic textured implant (ATI) patients. OBJECTIVES: The purpose of this study was to survey members of The Aesthetic Society on management of ATI patients in order to understand trends in practice patterns. METHODS: Members of The Aesthetic Society were queried via an electronic survey regarding management of ATI patients. Anonymous responses were collected by QualtricsXM (SAP, Walldorf, Germany) survey software. Descriptive statistics were used to examine the data, reported as frequencies. All analyses were performed with IBM SPSS Statistics 26. RESULTS: The survey was sent to 2149 active and candidate members of The Aesthetic Society with a total of 470 responses (21.87% response rate). For ATI patients presenting with concerns regarding BIA-ALCL risk, 88.8% of respondents educate the patient with clinical follow-up and/or imaging. The other 11.2% of surgeons recommend implant removal with variability in capsulectomy technique. For ATI patients requesting surgery, 42.5% of respondents educate the patient with clinical follow-up and/or imaging. The majority of surgeons (57.6%) recommend removal of the implant, with 30% recommending total capsulectomies. CONCLUSIONS: There is considerable variability in how members of The Aesthetic Society manage ATI patients who request surgery. Future regulatory agency and professional society collaborative efforts should continue to aim for generation of high-level scientific data to aid in the counseling and management of ATI patients.

An Updated Overview of Gender Dysphoria and Gender Affirmation Surgery: What Every Plastic Surgeon Should Know.

Gender dysphoria refers to the medical condition experienced by individuals whose physical anatomy is not consistent with their gender identity. Surgery is a safe and effective treatment for many individuals, yet the current demand for surgery exceeds the number of trained surgeons. This article reviews gender-affirming surgical procedures and emphasizes an individualized approach within the context of a multidisciplinary team. We review pre-, intra-, and postoperative care including the preoperative requirements for surgery.

Neurological manifestations of Erdheim-Chester Disease.

OBJECTIVE: To characterize the spectrum of neurologic involvement in Erdheim-Chester Disease (ECD), a treatable inflammatory neoplasm of histiocytes. METHODS: Sixty-two patients with ECD were prospectively enrolled in a natural history study that facilitated collection of clinical, imaging, laboratory, neurophysiologic, and pathologic data. RESULTS: Ninety-four percent of the patients had neurologic abnormalities on examination or imaging, and 22% had neurologic symptoms as the initial presentation of ECD. The most common neurologic findings were cognitive impairment, peripheral neuropathy, pyramidal tract signs, cranial nerve involvement, and cerebellar ataxia. Imaging revealed atrophy and demyelination along with focal lesions that were located throughout the nervous system, dura, and extra-axial structures. The BRAF V600E variant correlated with cerebral atrophy. Brain pathology revealed lipid-laden, phagocytic macrophages (histiocytes) accompanied by demyelination and axonal degeneration. INTERPRETATION: In patients with ECD, neurologic morbidity is common and contributes significantly to disability. Since neurologic symptoms can be the presenting feature of ECD and, given the mean delay in ECD diagnosis is 4.2 years, it is critical that neurologists consider of ECD and other histiocytosis in patients with inflammatory, infectious, or neoplastic-appearing white matter. Furthermore, given the broad spectrum of neurologic involvement, neurologists have an important role in a team of specialists treating ECD patients.

Sensory neurotization of muscle: past, present and future considerations.

Research has shown that temporary innervation by a sensory neuron can provide trophic support to a denervated muscle and stave off muscular atrophy until motor neuron transfer is viable. This so called 'sensory protection' allows for improved outcomes when motor reinnervation able to occur. The theoretical benefit of sensory neurotization is hypothesized to maintain tissue architecture of the end organ due to tropic effects of stimulation. While the literature supports direct motor neurotization from 2 to 4 months post-injury, patient factors including the location of the injury and loss of nerve can preclude this therapeutic window. When direct neurotization is not possible, or there is a long distance to traverse for reinnervation, sensory neurotization may be beneficial. The theorized trophic stimulation enabling end organ architectural maintenance provided by sensory neurotization has been shown to allow for delayed direct motor neurotization without the irreversible sequelae of prolonged denervation. This is a review of the pathogenesis of nerve injury and a literature review of sensory neurotization. An analytical search of the literature in PubMed was performed in order to find articles pertinent to the topic of sensory neurotization, including experimental data from both animal models and case reports in humans.

Clinical and Histopathologic Features of Interstitial Lung Disease in Erdheim⁻Chester Disease.

Limited information is available regarding interstitial lung disease (ILD) in Erdheim⁻Chester disease (ECD), a rare multisystemic non-Langerhans cell histiocytosis. Sixty-two biopsy-confirmed ECD patients were divided into those with no ILD (19.5%), minimal ILD (32%), mild ILD (29%), and moderate/severe ILD (19.5%), based on computed tomography (CT) findings. Dyspnea affected at least half of the patients with mild or moderate/severe ILD. Diffusion capacity was significantly reduced in ECD patients with minimal ILD. Disease severity was inversely correlated with pulmonary function measurements; no correlation with BRAF V600E mutation status was seen. Reticulations and ground-glass opacities were the predominant findings on CT images. Automated CT scores were significantly higher in patients with moderate/severe ILD, compared to those in other groups. Immunostaining of lung biopsies was consistent with ECD. Histopathology findings included subpleural and septal fibrosis, with areas of interspersed normal lung, diffuse interstitial fibrosis, histiocytes with foamy cytoplasm embedded in fibrosis, lymphoid aggregates, and focal type II alveolar cell hyperplasia. In conclusion, ILD of varying severity may affect a high proportion of ECD patients. Histopathology features of ILD in ECD can mimic interstitial fibrosis patterns observed in idiopathic ILD.

The clinical spectrum of Erdheim-Chester disease: an observational cohort study.

Erdheim-Chester Disease (ECD) is a rare, potentially fatal, multi-organ myeloid neoplasm occurring mainly in adults. The diagnosis is established by clinical, radiologic, and histologic findings; ECD tumors contain foamy macrophages that are CD68+, CD163+, CD1a-, and frequently S100-. The purpose of this report is to describe the clinical and molecular variability of ECD. Sixty consecutive ECD patients (45 males, 15 females) were prospectively evaluated at the NIH Clinical Center between 2011 and 2015. Comprehensive imaging and laboratory studies were performed, and tissues were examined for BRAF V600E and MAPK pathway mutations. Mean age at first manifestations of ECD was 46 years; a diagnosis was established, on average, 4.2 years after initial presentation. Bone was the most common tissue affected, with osteosclerosis in 95% of patients. Other manifestations observed in one-third to two-thirds of patients include cardiac mass and periaortic involvement, diabetes insipidus, retro-orbital infiltration, retroperitoneal, lung, CNS, skin and xanthelasma, usually in combination. Methods of detection included imaging studies of various modalities. Mutation in BRAF V600E was detected in 51% of 57 biopsies. One patient had an ARAF D228V mutation, and one had an activating ALK fusion. Treatments included interferon alpha, imatinib, anakinra, cladribine, vemurafenib and dabrafenib with trametinib; eleven patients received no therapy. The diagnosis of ECD is elusive because of the rarity and varied presentations of the disorder. Identification of BRAF and other MAPK pathway mutations in biopsies improves ECD diagnosis, allows for development of targeted treatments, and demonstrates that ECD is a neoplastic disorder.