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The Pitanguy ligament is a crucial structure in nasal tip support and in maintaining the integrity of the soft tissue envelope of the nose. In this cadaveric study, we dissected out the Pitanguy ligament on a series of fresh human cadaver specimens to better elucidate the structure of the ligament and its fate in open rhinoplasty. The Pitanguy ligament can act as a tethering force to the nasal tip when reshaping the nasal tip. Release of the Pitanguy ligament alleviated downward tension on the nasal tip, and tip shaping to a more appropriate position demonstrated that this ligament was displaced from its ideal position. In patients seeking rhinoplasty, this structure may require release and reconstruction to successfully alter tip position and avoid supratip deformity., (Copyright © 2024 by the American Society of Plastic Surgeons.)

Summary: Alar base surgery is approached with hesitancy and is often avoided by many surgeons because of inexperience and a lack of understanding. However, with a thorough knowledge of the anatomy and dynamic nature of the lower third of the nose, alar base resection can achieve favorable and reproducible results. Beyond correcting alar flare, an appropriately diagnosed and performed alar base procedure serves to contour both the alar rim and the alar base. The following article presents a case series of 436 consecutive rhinoplasties from a single surgeon, 214 of which underwent alar base surgery. The outcomes demonstrate that the procedure is safe and yields desirable results without a single revision being required. As the third in a series of three articles on alar base surgery by the senior author (R.J.R.), this article unifies the management of the alar base. An intuitive approach to the classification and management of alar flare and the implications of alar base surgery on contouring of the alar base and alar rim is presented., Clinical Question/level of Evidence: Therapeutic, IV., (Copyright © 2023 by the American Society of Plastic Surgeons.)

Background: The field of plastic surgery has been at the forefront of ideation and innovation. Surgeon scientists today continue to develop novel products that fulfill the needs of the medical community and patients. Part of this process requires the approval from various regulatory agencies and offices, including the U.S. Food and Drug Administration. Unfortunately, medical training does not include regulatory knowledge, and many surgeon scientists find the regulatory pathway and U.S. Food and Drug Administration perplexing, overly complicated, and insurmountable. The authors aim to clearly outline the path of the regulatory process as it pertains to the U.S. Food and Drug Administration and its various jurisdictions that may relate to the plastic surgeon., Methods: The authors aim to demystify the classification system, 510(k), and Premarket Approval processes for devices; clarify the Investigational New Drug and New Drug Application requirements for drugs; and explain how human cells, tissues, and cellular or tissue-based products are classified and approvals obtained., Results: The structure of the U.S. Food and Drug Administration, its offices, and their roles are delineated, and the complex process of obtaining approval to market devices, drugs, biologics, and combination products is explained in a manner that is broadly useful to innovators whether new or experienced., Conclusion: The authors provide information for innovators and inventors developing promising technologies to be more knowledgeable and motivated to embrace the process in a fashion that will potentially save time and errors in U.S. Food and Drug Administration submissions.

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided.

Background: Body mass index does not allow accurate risk stratification for individuals undergoing component separation repair of ventral hernias. The authors hypothesized that tissue morphology measurements (morphomics) of preoperative computed tomography scans stratify the risk of surgical site infection in patients undergoing ventral hernia repair with a component separation technique., Methods: The authors identified 93 patients who underwent component release ventral hernia repair (2004 to 2012). The surgical technique involved release of the external oblique muscle lateral to the linea semilunaris. Using analytic morphomic techniques, the authors measured patients' morphology using routine preoperative computed tomography scans. Two-sample t test was used to evaluate the effect of morphomic and demographic factors on surgical-site infection. Separate logistic regression analyses were performed on these morphomic factors to evaluate their predictive value in assessing the risk of surgical site infection, controlling for demographic covariates., Results: Surgical site infections were observed in 31 percent (n = 29) of the population. Subcutaneous fat area, total body area, and total body circumference had increased odds ratios for surgical site infection (p = 0.004, 0.014, and 0.012, respectively), indicating that these measures are better associated with surgical site infection than body mass index. These calculations control for demographic covariates, confirming that these morphomic parameters are predictive of surgical site infection., Conclusion: Specific morphomic values serve as superior predictors of surgical site infection in patients undergoing component separation technique hernia repair than currently used values such as body mass index., Clinical Question/level of Evidence: Risk, III.

Background: Estimates of blood loss during craniosynostosis surgeries have ranged from 42 to 126 percent of infant's total blood volume. Currently, no risk model has been developed to determine the likelihood of needing a blood transfusion. The authors propose an objective model, based on patients' three-dimensional anatomical characteristics, to stratify the likelihood of needing perioperative packed red blood cells., Methods: High-throughput image analysis from already ordered preoperative computed tomographic scans was used to reconstruct the three-dimensional anatomy of the temporalis muscle and overlying temporal fat pad. Using these morphomic measurements, the authors created a risk assessment model of the amount of packed red blood cells infused based on morphomic variations in temporal soft tissue., Results: The authors evaluated 139 infants with nonsyndromic craniosynostosis from the University of Michigan Health System. Results show the need for blood transfusion ranged from 94.1 percent among patients in the smallest quartile for temporal fat pad volume compared with 65.7 percent among the group with the largest quartile for temporal fat pad volume (p = 0.0057). Using multivariable linear regression, temporal fat pad volume (p = 0.012) and fat pad thickness (p = 0.036) were independent predictors for amount of packed red blood cells required., Conclusions: The authors demonstrate that patients with diminished temporal fat pad volume are significantly more likely to need increased packed red blood cell transfusions. In addition, by use of multivariable linear regression, their data suggest that temporal fat pad volume and thickness were independent predictors for the amount of required transfusion of packed red blood cells.