Plastic Surgeons' Perspective on the FDA Breast Implant Regulatory Mandates.

BACKGROUND: In 2021, the US Food and Drug Administration (FDA) issued a new checklist, labeling and rupture screening recommendations for breast implants to improve the decision-making process. OBJECTIVES: This study aims to understand the plastic surgeon's perspective on these changes and their perceived impact on clinical practice. METHODS: In September 2023, a 27 multiple-choice cross-sectional survey was distributed to 4,352 active members of the American Society of Plastic Surgeons to evaluate attitudes on the FDA's black box warning, informed decision checklist, and updated rupture screening recommendations. RESULTS: A total of 591 responses were collected (13.6%). The majority of respondents were between the ages of 45 to 64 (58%) and had been in practice for more than 20 years (52%). Surgeons felt like some additions were appropriate, however the majority (57%) stated that the informed decision checklist did not have a positive impact on workflow; 66% were also neutral or disagreed with the reported incidence rates related to complications and cancer. Nearly half of respondents (47%) did not feel the black box warning improved their patients' understanding of the risks and benefits. Additionally, 47% of respondents also believed these requirements, in combination, did not improve the overall patient experience with implants. CONCLUSIONS: Respondents had an overall positive response towards the addition of risk information provided by the FDA issued guidance and updates to rupture screening recommendations. However, they remain divided as to whether the black box warning and patient decision checklist had an overall positive impact on clinical practice patterns.

Reversal in Centers for Medicare & Medicaid Services Reimbursement for Deep Inferior Epigastric Perforator Flap Reconstruction-Empowering Plastic Surgeons in Sustaining Microsurgical Accessibility.

ABSTRACT: This Editorial discusses the recent overturning of a proposed Centers for Medicare & Medicaid Services policy that reduced reimbursement for deep inferior epigastric perforator flap breast reconstruction. The authors highlight the importance of advocacy efforts in sustaining access to complex microsurgical procedures, even those under investigation such as breast reinnervation and lymphatic reconstruction.

The Role of Antibiotic Prophylaxis in Primary and Secondary Implant-Based Breast Augmentation: A Systematic Review and Meta-Analysis.

BACKGROUND: The administration of antibiotic prophylaxis for implant-based breast augmentation (IBBA) is commonplace among many plastic surgeons. However, the current literature lacks evidence-based recommendations to support this practice. Although few studies have demonstrated a reduction in surgical site infection (SSI) and capsular contracture (CC) with antibiotics, these studies were underpowered and poorly designed. The aim of this study was to provide an updated comprehensive analysis of the literature to revisit the benefit of antibiotic prophylaxis. METHODS: A comprehensive literature search of PubMed, Embase, Web of Science, and Cochrane was performed from January 1989 to January 2022. Observational studies and randomized controlled trials (RCTs) involving primary and secondary IBBA and use of antibiotic prophylaxis were included. Primary outcomes included SSI and CC. Study quality and risk of bias were evaluated using standardized tools. A meta-analysis was performed for eligible studies. Trial Sequential Analysis was used to assess the need for future RCTs. RESULTS: A total of 5 studies (3 observational and 2 RCTs) with 2383 patients were included in this study. Rates of SSI ranged from 0% to 2.3%, whereas CC ranged from 0% to 53%. Antibiotic prophylaxis showed no benefit for both SSI (odds ratio, 1.77; 95% confidence interval, 0.76-4.13) and CC (odds ratio, 0.46; 95% confidence interval, 0.00-45.72). Trial Sequential Analysis demonstrated that further high-quality RCTs are needed. CONCLUSIONS: Antibiotic prophylaxis for IBBA failed to demonstrate improvements in SSI and CC in this comprehensive review. Current evidence was shown to be of low quality because of heterogeneity and high risk for bias. Further high-quality multicentered RCTs are warranted to fully evaluate the role of antibiotic prophylaxis for IBBA.

Novel Surgical and Radiologic Risk Factors for Progression or Recurrence of Pediatric Pilocytic Astrocytoma.

INTRODUCTION: Pilocytic astrocytomas (PA) are a common, benign childhood tumor known for their slow growth rates and excellent prognosis. The aim of our study was to characterize patient, tumor, and imaging-related risk factors for recurrence and progression of disease. METHODS: We identified 116 patients with PA who underwent surgery at our institution between 2000 and 2015. Data were collected retrospectively from the clinical charts. RESULTS: The mean age at resection was 7 ± 5 years (range 0.5-31) and mean follow-up was 6 ± 3 years. Initial resection was complete in 33 patients (29%), subtotal in 78 patients (67%), and biopsy in 5 patients (4%). A total of 45/116 (40%) patients experienced either recurrence or progression after initial resection with a mean time to recurrence or progression of 2.2 years. Bivariate analysis identified subtotal resection, tumor location, age at diagnosis, and imaging features (i.e., T2 invasion, exophytic component, hemorrhage, and solid tumors) as factors significantly associated with recurrence or progression (p < 0.05). Conversely, PAs that were completely resected, predominately cystic, and located in the cerebellum were significantly associated with no recurrence or progression (p < 0.05). Multivariate regression analysis narrowed down 4 robust risk factors: extent of resection, T2 invasion, predominantly solid lesions, and presence of an exophytic component (p < 0.05). CONCLUSION: Total surgical removal of PA has been the most important prognostic factor for the clinical course of PA. Our study reveals additional risk factors for the recurrence or progression of disease: tumor invasion, solid composition, and tumors with an exophytic component.

The macula densa prorenin receptor is essential in renin release and blood pressure control.

The prorenin receptor (PRR) was originally proposed to be a member of the renin-angiotensin system (RAS); however, recent work questioned their association. The present paper describes a functional link between the PRR and RAS in the renal juxtaglomerular apparatus (JGA), a classic anatomical site of the RAS. PRR expression was found in the sensory cells of the JGA, the macula densa (MD), and immunohistochemistry-localized PRR to the MD basolateral cell membrane in mouse, rat, and human kidneys. MD cell PRR activation led to MAP kinase ERK1/2 signaling and stimulation of PGE2 release, the classic pathway of MD-mediated renin release. Exogenous renin or prorenin added to the in vitro microperfused JGA-induced acute renin release, which was inhibited by removing the MD or by the administration of a PRR decoy peptide. To test the function of MD PRR in vivo, we established a new mouse model with inducible conditional knockout (cKO) of the PRR in MD cells based on neural nitric oxide synthase-driven Cre-lox recombination. Deletion of the MD PRR significantly reduced blood pressure and plasma renin. Challenging the RAS by low-salt diet + captopril treatment caused further significant reductions in blood pressure, renal renin, cyclooxygenase-2, and microsomal PGE synthase expression in cKO vs. wild-type mice. These results suggest that the MD PRR is essential in a novel JGA short-loop feedback mechanism, which is integrated within the classic MD mechanism to control renin synthesis and release and to maintain blood pressure.

Treatment of a chronically infected nasal silicone prosthesis with continuous antibiotic irrigation and gentamicin-impregnated polymethylmethacrylate beads.

Infected nasal alloplasts in revision rhinoplasty can be a complex problem, as timing between implant removal and reconstruction is the major limiting factor. Delaying reconstruction can result in loss of mechanical support, a constricted nose, and in severe cases, complete nasal airway collapse and respiratory compromise. In this case report, we describe a novel surgical approach for the management of a chronically infected nasal implant combining techniques used to treat biomaterial-associated infections: antibiotic-impregnated polymethymethacrylate beads and a continuous catheter-based antibiotic irrigation system. We report a case of a chronic alloplastic-associated infection following nasal reconstruction using a silicone implant. We utilized a two-staged approach. The involved nasal implant was removed and replaced temporarily with gentamicin-impregnated polymethymethacrylate beads and a continuous closed irrigation and drainage system with local and parenteral delivery of antibiotics. Both modalities allowed for complete eradication of the infection. In addition, the gentamicin beads provided sufficient mechanical support in order to minimize the risk of skin contracture. Twelve days after her initial surgery, nasal reconstruction was performed using a cadaver bone graft. The patient was followed for two years postoperatively and has shown good results with no evidence of skin contracture or recurrent infection. This technique may allow for shorter delay in revision surgery and reduce the risk of long-term complications without compromising functional and aesthetic outcomes.

P2Y12 Receptor Localizes in the Renal Collecting Duct and Its Blockade Augments Arginine Vasopressin Action and Alleviates Nephrogenic Diabetes Insipidus.

P2Y12 receptor (P2Y12-R) signaling is mediated through Gi, ultimately reducing cellular cAMP levels. Because cAMP is a central modulator of arginine vasopressin (AVP)-induced water transport in the renal collecting duct (CD), we hypothesized that if expressed in the CD, P2Y12-R may play a role in renal handling of water in health and in nephrogenic diabetes insipidus. We found P2Y12-R mRNA expression in rat kidney, and immunolocalized its protein and aquaporin-2 (AQP2) in CD principal cells. Administration of clopidogrel bisulfate, an irreversible inhibitor of P2Y12-R, significantly increased urine concentration and AQP2 protein in the kidneys of Sprague-Dawley rats. Notably, clopidogrel did not alter urine concentration in Brattleboro rats that lack AVP. Clopidogrel administration also significantly ameliorated lithium-induced polyuria, improved urine concentrating ability and AQP2 protein abundance, and reversed the lithium-induced increase in free-water excretion, without decreasing blood or kidney tissue lithium levels. Clopidogrel administration also augmented the lithium-induced increase in urinary AVP excretion and suppressed the lithium-induced increase in urinary nitrates/nitrites (nitric oxide production) and 8-isoprostane (oxidative stress). Furthermore, selective blockade of P2Y12-R by the reversible antagonist PSB-0739 in primary cultures of rat inner medullary CD cells potentiated the expression of AQP2 and AQP3 mRNA, and cAMP production induced by dDAVP (desmopressin). In conclusion, pharmacologic blockade of renal P2Y12-R increases urinary concentrating ability by augmenting the effect of AVP on the kidney and ameliorates lithium-induced NDI by potentiating the action of AVP on the CD. This strategy may offer a novel and effective therapy for lithium-induced NDI.

Intravital imaging of podocyte calcium in glomerular injury and disease.

Intracellular calcium ([Ca²âº]i) signaling mediates physiological and pathological processes in multiple organs, including the renal podocyte; however, in vivo podocyte [Ca²âº]i dynamics are not fully understood. Here we developed an imaging approach that uses multiphoton microscopy (MPM) to directly visualize podocyte [Ca²âº]i dynamics within the intact kidneys of live mice expressing a fluorescent calcium indicator only in these cells. [Ca²âº]i was at a low steady-state level in control podocytes, while Ang II infusion caused a minor elevation. Experimental focal podocyte injury triggered a robust and sustained elevation of podocyte [Ca²âº]i around the injury site and promoted cell-to-cell propagating podocyte [Ca²âº]i waves along capillary loops. [Ca²âº]i wave propagation was ameliorated by inhibitors of purinergic [Ca²âº]i signaling as well as in animals lacking the P2Y2 purinergic receptor. Increased podocyte [Ca²âº]i resulted in contraction of the glomerular tuft and increased capillary albumin permeability. In preclinical models of renal fibrosis and glomerulosclerosis, high podocyte [Ca²âº]i correlated with increased cell motility. Our findings provide a visual demonstration of the in vivo importance of podocyte [Ca²âº]i in glomerular pathology and suggest that purinergic [Ca²âº]i signaling is a robust and key pathogenic mechanism in podocyte injury. This in vivo imaging approach will allow future detailed investigation of the molecular and cellular mechanisms of glomerular disease in the intact living kidney.

Tracking the fate of glomerular epithelial cells in vivo using serial multiphoton imaging in new mouse models with fluorescent lineage tags.

Podocytes are critical in the maintenance of a healthy glomerular filter; however, they have been difficult to study in the intact kidney because of technical limitations. Here we report the development of serial multiphoton microscopy (MPM) of the same glomeruli over several days to visualize the motility of podocytes and parietal epithelial cells (PECs) in vivo. In podocin-GFP mice, podocytes formed sporadic multicellular clusters after unilateral ureteral ligation and migrated into the parietal Bowman's capsule. The tracking of single cells in podocin-confetti mice featuring cell-specific expression of CFP, GFP, YFP or RFP revealed the simultaneous migration of multiple podocytes. In phosphoenolpyruvate carboxykinase (PEPCK)-GFP mice, serial MPM found PEC-to-podocyte migration and nanotubule connections. Our data support a highly dynamic rather than a static nature of the glomerular environment and cellular composition. Future application of this new approach should advance our understanding of the mechanisms of glomerular injury and regeneration.