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US FDA Patient Decision Checklist for Breast Implants Results of a Survey to Members of The Aesthetic Society, April 2022

Karp, Nolan; McGuire, Patricia; Adams, William P; Jewell, Mark L
The US FDA in response to concerns that patients undergoing breast implant surgery were not adequately informed about the risks of receiving an implanted medical device mandated a patient decision checklist (PDC) in October 2021. Breast implant manufactures communicated with plastic surgeons in 2022 regarding the use of the PDC as a condition for the sale of breast implants. Plastic surgeons voiced concerns over the accuracy of content in the PDC and its confusing statements about risk of adverse events associated with breast surgery. In April 2022, the Aesthetic Society developed a survey that was sent to its members regarding their experiences with the PDC. This was a 5-question survey and one additional place for comments. The purpose for this survey was to develop data on the six-month experience of plastic surgeons using the PDC. A total of 206 Aesthetic Society members (9%) participated in the survey (1849 total active members in the United States). Patients deserve appropriate information prior to breast implant surgery to make an informed decision after reviewing the potential risks and benefits. The authors believe that there is still more work to be done on an ideal PDC will make it fair and balanced and that it scientifically describes risk incidence in a way that patients understand and can be updated.
PMID: 36073650
ISSN: 1527-330x
CID: 5337072

Revisiting Reduction Mammaplasty: Complications of Oncoplastic and Symptomatic Macromastia Reductions

Morrison, Kerry A; Frey, Jordan D; Karp, Nolan; Choi, Mihye
BACKGROUND:Oncoplastic breast reduction has been shown to be an effective and safe approach to breast conservation surgery in women with macromastia. However, there remains a paucity of data investigating the comparative outcomes. This study seeks to delineate the complication profiles for oncoplastic and symmetrizing breast reductions versus mammaplasty for benign macromastia. METHODS:A retrospective review was conducted of all consecutively performed reduction mammaplasty cases at a single institution by two plastic surgeons over a 2-year period. RESULTS:A total of 632 breasts were analyzed: 502 reduction mammaplasties, 85 symmetrizing reductions, and 45 oncoplastic reductions in 342 patients. Mean age was 43.9 ± 15.93 years, mean body mass index was 29.15 ± 5.66 kg/m2, and mean reduction weight was 610.03 ± 313.13 g. Regarding surgical technique, a medial pedicle was used in 86% of cases. There were similar postoperative complication outcomes for nipple necrosis, wound healing, scar revision, fat necrosis, seroma, hematoma, and overall complication rates for all procedures. However, the rate of postoperative revision among reduction mammaplasty (2%), oncoplastic reduction (6.7%), and symmetrizing reduction (5.9%) was significantly different (P = 0.027). In univariate analysis, diabetes (P = 0.011), smoking (P = 0.007), higher body mass index (P = 0.003), larger reduction weight (P = 0.011), longer nipple-to-inframammary fold measurement (P = 0.014), and longer sternal notch-to-nipple measurement (P = 0.039) were all significant risk factors for a surgical complication in reductions performed for any indication. Using a multivariate logistic regression model, diabetes (P = 0.047), smoking (P = 0.025), and higher body mass index (P = 0.002) were all retained as statistically significant risk factors. CONCLUSION/CONCLUSIONS:The complication profiles for both oncoplastic breast reductions and breast reductions for symptomatic macromastia are similar and acceptably low. CLINICAL QUESTION/LEVEL OF EVIDENCE/METHODS:Therapeutic, III.
PMID: 36696305
ISSN: 1529-4242
CID: 5419602

Aesthetic Characteristics of the Ideal Female Breast

Bekisz, Jonathan M.; Boyd, Carter J.; Salibian, Ara A.; Choi, Mihye; Karp, Nolan S.
Background: The female breast is a subject of significant focus within plastic surgery. Little work to date has examined public perceptions of attractiveness with respect to breast anatomy and morphology. This study provides a comprehensive assessment of anatomic and aesthetic breast characteristics valued by the general population. Methods: A single-institution retrospective review was conducted of patients presenting for aesthetic or reconstructive breast surgery between 2009 and 2019. A cohort of 25 patients were included in a nationwide survey designed to assess subjective impressions of overall "breast attractiveness." Survey responses were assessed, and the five patients with the highest mean scores were identified. An in-depth analysis of this subgroup was performed, evaluating anatomic metrics on both two-dimensional photographs and three-dimensional imaging. Statistical analysis examined correlations between objective breast characteristics and subjective perceptions of "attractiveness." Results: There were 1021 survey responses. Across the entire patient cohort, the mean age was 47.4 years and mean BMI was 24.9 kg/m2. On a five-point Likert scale, the mean "breast attractiveness" score for the highest-scoring subgroup patients (n = 5) was 3.1 ± 0.1. Within this group, all patients had minimal ptosis and a projected contour. Average breast size was moderate, with mean volume of 299.4 ± 115.8 cm3. Conclusions: This study reverse engineers the aesthetically appealing female breast, beginning with overall impressions of attractiveness and subsequently analyzing the influence of objective anatomic parameters on subjective perceptions. In surveying a large and diverse population, moderately sized, projected breasts with upper pole fullness were found to be associated with increased "attractiveness" scores.
SCOPUS:85147591481
ISSN: 2169-7574
CID: 5424932

Catch-22: ADM and FDA Pre-Market Approval: How Can We Construct Studies?

Boyd, Carter J; Bekisz, Jonathan M; Choi, Mihye; Karp, Nolan S
As a biologic product derived from human tissue, acellular dermal matrices (ADMs) did not require pre-market approval for their initial use as a soft tissue support product. Since their first utilization in breast surgery, ADMs have allowed for numerous advances in breast reconstruction. ADMs quickly gained popularity in breast surgery and are frequently utilized in various applications. During an investigation into potential factors leading to breast implant-associated anaplastic large cell lymphoma, the United States Food and Drug Administration (FDA) made an official statement that ADMs were not approved for use in breast reconstruction and that using ADMs in breast surgery was considered off-label. This special topic article details the history of ADMs in breast surgery and describes the ongoing evolution of the relationship between the FDA and ADMs.
PMID: 36161788
ISSN: 1529-4242
CID: 5334032

Discussion: The Impact of Combined Oral Contraceptives on Adolescents with Macromastia

Karp, Nolan S
PMID: 36170439
ISSN: 1529-4242
CID: 5334342

Picking the Right Plane: A Comparison of Total Submuscular, Dual-Plane, and Prepectoral Implant-based Breast Reconstruction

Bekisz, Jonathan M; Salibian, Ara A; Frey, Jordan D; Choi, Mihye; Karp, Nolan S
BACKGROUND:Implant-based breast reconstruction has evolved, with a recent resurgence of prepectoral techniques. Comparative reconstructive outcomes and complications have not been fully elucidated among the total submuscular (TSM), dual-plane (DP), and prepectoral planes of implant placement. METHODS:All immediate implant-based breast reconstructions from March 2017 through August 2019 were retrospectively reviewed. Cases were divided into TSM, DP, and prepectoral cohorts. Demographics, operative techniques, and reconstructive outcomes and complications were compared among groups. RESULTS:826 cases (510 patients) were identified and divided into TSM (n=392), DP (n=358), and prepectoral (n=76) cohorts. Average follow-up for all patients was 27 months. The prepectoral cohort had a higher average BMI and rate of prior reduction/mastopexy. Overall complications were lowest in the TSM group, though this difference was not statistically significant. Major infection occurred more frequently in the DP group compared to the TSM cohort. The prepectoral cohort had a significantly increased incidence of wound dehiscence than the TSM group, while both the dual-plane and prepectoral groups had higher rates of seroma formation and explantation compared to TSM. CONCLUSIONS:Overall reconstructive complication rates were comparable among the cohorts. Compared to those undergoing TSM reconstruction, the DP cohort was more likely to develop a major infection or require explantation, while the prepectoral group had significantly higher rates of isolated dehiscence, seroma formation, and explantation. This suggest that the absence of overlying vascularized muscle may lead to an inherent inability to tolerate wound healing complications, though further research is needed to clarify these observations.
PMID: 35862095
ISSN: 1529-4242
CID: 5279302

Long-Term Cancer Recurrence Rates Following Nipple-Sparing Mastectomy: A 10-year Follow-up Study

Boyd, Carter J; Salibian, Ara A; Bekisz, Jonathan M; Axelrod, Deborah M; Guth, Amber A; Shapiro, Richard L; Schnabel, Freya R; Karp, Nolan S; Choi, Mihye
BACKGROUND:Despite the increased utilization of nipple-sparing mastectomies (NSM), there is limited data examining long-term cancer recurrence rates in these patients. The objective of this study was to analyze breast cancer recurrence in patients who received therapeutic NSM with a median of 10 years of follow-up. METHODS:All patients undergoing NSM at a single institution were retrospectively reviewed temporally to obtain a median of 10-years of follow up. Patient demographic factors, mastectomy specimen pathology, and oncologic outcomes were analyzed. Univariate analysis was performed to identify independent risk factors for locoregional recurrence. RESULTS:126 therapeutic NSM were performed on 120 patients. The most frequently observed tumor histology included invasive ductal carcinoma (48.4%) and ductal carcinoma in situ (38.1%). Mean tumor size was 1.62 cm. Multifocal or multicentric disease and lymphovascular invasion were present in 31.0% and 10.3% of NSM specimens, respectively. Sentinel lymph node biopsy was performed in 84.9% of NSM and 17.8% were positive. The rate of positive frozen subareolar biopsy was 7.3% (n=82) and permanent subareolar pathology was 9.5% (n=126). The most frequently observed pathologic tumor stages was stage I (44.6%) and stage 0 (33.9%). Incidence of recurrent disease was 3.17% per mastectomy and 3.33% per patient. Upon univariate analysis, no demographic, operative, or tumor-specific variables were independent risk factors for locoregional recurrence. CONCLUSIONS:Overall recurrence rates are low in patients undergoing NSM at a median follow-up of 10-years. Close surveillance should remain a goal for patients and their providers to promptly identify potential recurrence.
PMID: 35943969
ISSN: 1529-4242
CID: 5286852

Cryptocurrency as an Alternative Payment for Plastic Surgery

Boyd, Carter J; Bekisz, Jonathan M; Salibian, Ara A; Choi, Mihye; Karp, Nolan S
PMID: 35852331
ISSN: 1529-4242
CID: 5278922

Research Promotion is Associated with Broader Influence and Higher Impact of Plastic Surgery Publications

Boyd, Carter J; Bekisz, Jonathan M; Salibian, Ara A; Karp, Nolan S; Choi, Mihye
BACKGROUND:Social media has altered the mechanisms by which published research is disseminated and accessed. The objective of this study was to measure the effect of promotion on research article dissemination, influence, and impact in Plastic and Reconstructive Surgery. METHODS:All articles published in Plastic and Reconstructive Surgery from January 1, 2016-December 31, 2018 were obtained and reviewed to determine inclusion/exclusion and for the Altmetric Attention Score (AAS), citations, relative citation rate (RCR), and 16 unique promotional tags (journal club, editor's pick, press release, patient safety, etc.) as indexed on the Plastic and Reconstructive Surgery website. 1,502 articles were included in the analysis. Statistical analysis was completed using descriptive statistics, Pearson's correlations, and Student t-tests where appropriate with a predetermined level of significance of p≤0.05. RESULTS:A total of 637 articles (42.4%) had a promotional tag, while 252 (16.8%) had multiple tags. Articles with promotional tags had higher AAS (30.35 vs 8.22; p<0.001), more citations (11.96 vs 8.47; p<0.001), and a higher RCR (2.97 vs 2.06; p<0.001) compared to articles without a tag. Articles with multiple tags had higher AAS (50.17 vs 17.39; p<0.001), more citations (15.78 vs 9.47; p<0.001), and a higher RCR (3.67 vs 2.51; p<0.001) compared to articles with only one tag. As the number of tags increased for an article, AAS (p<0.001), citation count (p<0.001), and RCR (p<0.001) likewise increased. CONCLUSIONS:This analysis strongly suggests that promotion of research articles is associated with significantly wider dissemination, broader visibility, and more subsequent citations in the literature.
PMID: 35687416
ISSN: 1529-4242
CID: 5248542

Breast reconstruction during the COVID-19 pandemic: Single institution experience from the pandemic's epicenter in the United States

Boyd, Carter J; Hemal, Kshipra; Ramesh, Sruthi; Bekisz, Jonathan M; Salibian, Ara A; Thanik, Vishal; Levine, Jamie P; Choi, Mihye; Karp, Nolan S
INTRODUCTION/BACKGROUND:The coronavirus disease-19 (COVID-19) pandemic dramatically changed the delivery of breast cancer care. The objective of this study was to quantify the effect of the pandemic on breast cancer screening, treatment, and reconstruction at a single institution in New York City. METHODS:A retrospective chart review was conducted to determine the number of mammograms, lumpectomies, mastectomies, and breast reconstruction operations performed between January 1, 2019 and June 30, 2021. Outcomes analyzed included changes in mammography, oncologic surgery, and breast reconstruction surgery volume before, during and after the start of the pandemic. RESULTS:Mammography volume declined by 11% in March-May of 2020. Oncologic breast surgeries and reconstructive surgeries similarly declined by 6.8% and 11%, respectively, in 2020 compared with 2019, reaching their lowest levels in April 2020. The volume of all procedures increased during the summer of 2020. Mammography volumes in June and July 2020 were found to be at pre-COVID levels, and in October-December 2020 were 15% higher than in 2019. Oncologic breast surgeries saw a similar rebound in May 2020, with 24.6% more cases performed compared with May 2019. Breast reconstruction volumes increased, though changes in the types of reconstruction were noted. Oncoplastic closures were more common during the pandemic, while two-stage implant reconstruction and immediate autologous reconstruction decreased by 27% and 43%, respectively. All procedures are on track to increase in volume in 2021 compared to that in 2020. CONCLUSION/CONCLUSIONS:The COVID-19 pandemic reduced the volume of breast cancer surveillance, surgical treatment, and reconstruction procedures. While it is reassuring that volumes have rebounded in 2021, efforts must be made to emphasize screening and treatment procedures in the face of subsequent surges, such as that recently attributable to the Delta and Omicron variants.
PMCID:8866163
PMID: 35317981
ISSN: 1878-0539
CID: 5200492