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.

Incision Location Predicts 30-Day Major Adverse Events after Cosmetic Breast Augmentation: An Analysis of the Tracking Outcomes and Operations for Plastic Surgeons Database.

BACKGROUND: Enhanced understanding of early postoperative adverse events will improve patient counseling and preoperative risk modification to decrease complications in implant-based breast augmentation. This study seeks to evaluate the early major adverse events following cosmetic breast augmentation. METHODS: A retrospective cohort analysis of the Tracking Outcomes and Operations for Plastic Surgeons database was performed to identify any women undergoing augmentation mammaplasty with an implant between 2008 and 2016. RESULTS: A total of 84,296 patients were studied. Major adverse events were identified in 0.37 percent. Seroma requiring drainage was observed in 0.08 percent, hematoma requiring drainage was observed in 0.15 percent, deep wound disruption was observed in 0.09 percent, and implant loss was observed in 0.11 percent. The authors identified multiple independent predictors of major adverse events, including body mass index greater than 30 kg/m2 (relative risk, 2.05; p < 0.001), tobacco use (relative risk, 2.25; p < 0.001), and diabetes mellitus (relative risk, 1.8; p < 0.05). Use of a periareolar incision significantly increased the risk of developing an early postoperative complication (relative risk, 1.77; p < 0.001). CONCLUSIONS: The findings of this study indicate an early major adverse event rate following cosmetic breast augmentation with implants of 0.37 percent. The authors identified multiple independent predictors of major adverse events, including body mass index greater than 30 kg/m2, tobacco use, and diabetes mellitus. In addition, when controlling for other factors, periareolar incision significantly increased the risk for major adverse events, when compared to an inframammary incision. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Delay in Cleft Lip and Palate Surgical Repair: An Institutional Review on Cleft Health Disparities in an Urban Population.

Access to specialized medical care is critical to decrease complications and minimize long-term morbidity, yet racial disparities in cleft surgery persist as time to initial reconstruction remains delayed among minority patients. Research has demonstrated an average 3-week delay in surgery for minority patients nationally. A retrospective chart review of patient demographics, visit timing, and surgical history was performed for patients who underwent primary cleft lip with or without palate (CL + P) reconstruction between 2002 and 2016 at an urban craniofacial center. Of the 89 children who underwent surgery, 87% were ethnic minorities (58% Hispanic, 25% African-American, 4% Asian/Other). Caucasian children were the earliest to receive CL (3.5 months) and CP (13-months) repair. Minority children trended toward a delay in CL repair, with surgery for African-Americans at 5-months (P = 0.06) and Hispanics at 4.8-months (P = 0.07). Time from first visit to CL surgery showed significant delays for minority, non-English speaking, and public insurance patients; however, for CP repair, male children were delayed from first visit to surgery compared to females (P = 0.03). While there was no statistical difference in age at CL or CP surgical repair among our racial/ethnic cohorts, there were significant racial/ethnic differences in timing spent in the preoperative period for CL. However, racial/ethnic differences decreased as the patients spent more time within the healthcare system. Thus, established, interdisciplinary cleft/craniofacial centers well versed in minority patients can minimize the complex social and cultural factors that contribute to delays in cleft care.

Trends in Breast Reconstruction by Ethnicity: An Institutional Review Centered on the Treatment of an Urban Population.

Previous studies have investigated reconstructive decisions after mastectomy and such studies document a preference among African American women for autologous tissue-based procedures and among Latin American women for implant-based reconstructions, however, there is a paucity of studies evaluating the current relationship between ethnicity and reconstructive preferences. This institutional review provides a unique, up-to-date evaluation of an understudied urban population composed of majority ethnic minority patients and explores reconstructive trends. Consecutive breast reconstruction patients were entered into a prospectively maintained database at the University of Illinois at Chicago and affiliate hospitals between July 2010 and October 2013. Demographics and oncologic characteristics including tumor stage, pathology, BRCA status, and adjuvant treatment were reviewed, and reconstructive trends were assessed by racial group with a focus on reconstructive procedure, mastectomy volume, and implant characteristics. Statistical analysis was performed using SAS (version 9.2). One-hundred and sixty breast reconstructions were performed in 105 women; of which 50 per cent were African American, 26 per cent Hispanic, 22 per cent Caucasian, and 2 per cent Asian. Age, tumor stage, prevalence of triple negative disease, chemotherapy, and radiation treatment was comparable between groups. Rates of obesity, hypertension, and diabetes mellitus were slightly higher in African American and Hispanic cohorts, with more African American patients having one or more of these comorbidities as compared with the Caucasian and Hispanic cohorts (P = 0.047). Despite comparable positive BRCA testing rates, significant differences were seen in the percentage of bilateral mastectomy; 68 per cent African American, 48 per cent Caucasian, and 30 per cent Hispanic (P = 0.004). Hispanics predominantly underwent flap-based reconstruction (56%), while African American (74%) and Caucasian (60%) patients had a preference toward tissue expander reconstruction (P = 0.04 across all groups). African American and Hispanic presented with increased mastectomy weights and thus required higher implant volumes as compared with Caucasians that approached significance (P = 0.06 and P = 0.06). Implant size utilization followed a unimodal distribution for Caucasians, peaking at 500 cc; while African American and Hispanic demonstrated a bimodal distribution, peaking once at 550 cc and again at the max implant volume of 800 cc. This study of a large proportion of minority patients in an urban geographic setting offers an evolving understanding of breast reconstruction patterns. The data demonstrated unique findings of increased rates of bilateral implant-based reconstruction in African American women and unilateral flap-based reconstructions in Hispanic patients. Reconstructive decision-making seems to be greatly influenced by cultural and geographically driven preferences.

Age-dependent Characteristics in Women with Breast Cancer: Mastectomy and Reconstructive Trends at an Urban Academic Institution.

Breast reconstruction is an important aspect of treatment after breast cancer. Postmastectomy reconstruction bears a significant impact on a woman's postsurgical confidence, sexuality, and overall well-being. Previous studies have inferred that women under age 40 years have unique characteristics that distinguish them from an older cohort. Identifying age-dependent trends will assist with counseling women on mastectomy and reconstruction. To identify age-dependent trends, 100 consecutive women were sampled from a prospectively maintained breast reconstruction database at an urban academic institution from June 2010 through June 2013. Women were placed into two cohorts <40 and ≥40 as well cohorts by decade (20s, 30s, 40s, 50s, and 60s). Statistical trends were reported as odds of risk per year of increasing age using logistic regression; linear regression, χ(2), and Fischer's exact were used to compare <40 and ≥40 and split cohorts for comparison. Comorbidities, tumor staging, oncologic treatment including chemotherapy and radiation, disease characteristics and genetics, and mastectomy, reconstructive and symmetry procedures were evaluated. Statistical analysis was performed using SAS software. In 100 patients of the sample study cohort, 151 reconstructions were performed. Increasing age was associated with one or more comorbidities [odds ratio (OR) = 1.07, P = 0.005], whereas younger age was associated with metastatic disease (OR = 0.88, P = 0.006), chemotherapy (OR = 0.94, P = 0.01), and radiation (OR = 0.94, P = 0.006); split cohorts demonstrated similar trends (P < 0.005). Mastectomy and reconstructive characteristics associated with younger age included bilateral mastectomy (OR = 0.94, P = 0.004), tissue expander (versus autologous flap) (OR = 0.94, P = 0.009), extra high implant type (OR = 0.94, P = 0.049), whereas increasing use of autologous flaps and contralateral mastopexy symmetry procedures (OR = 1.09, P = 0.02) were associated with an aging cohort. Increasing age was not associated with an increasing likelihood of complications (P = 0.75). Age-related factors play a role in the treatment of patients with breast cancer. Younger women typically present with more aggressive features requiring oncologic treatment including chemotherapy and radiation. Mastectomy and reconstructive choices also demonstrate age-dependent characteristics. Women in younger age groups are more likely to pursue risk-reduction procedures and implant-based strategies, whereas older women had a higher propensity for abdominal-based autologous reconstruction. In addition, preferential reconstructive strategies correlate with age-dependent archetypical features of the breast (higher profile implants in younger patients; autologous reconstruction on affected side mimicking natural ptosis, and contralateral mastopexy in older patients). These trends seem to be consistent with each increasing year of age. Age-related preferences and expectations, age-dependent body habitus and breast shape, and lifetime risk play a role in the choices pursued for mastectomy and reconstruction.

Recalcitrant Hidradenitis Suppurativa: An Investigation of Demographics, Surgical Management, Bacterial Isolates, Pharmacologic Intervention, and Patient-reported Health Outcomes.

Hidradenitis suppurativa (HS) is characterized by chronic inflammation, recurrent abscesses, and scarring. Surgery is performed when medical management and antibiotic therapy fails. This study sought to evaluate the demographics, surgical procedures, bacteriology, pharmacologic intervention, and quality of life of patients with recalcitrant HS requiring surgical intervention. A retrospective chart review was performed of 76 recalcitrant HS patients at the University of Illinois Medical Center. Patient demographics, bacterial culture, and surgery data were reviewed. Quality of life was assessed using the 36-item short-form health survey. Patients were mostly female (73.7%) and African American (81.6%) with a mean duration of symptoms of 8.6 years before surgery. Patients underwent at least one surgical procedure, most often to the axillae (57.6%) and 73.7 per cent received antibiotics. The most common culture isolates were Corynebacterium species (14.0%), Staphylococcus epidermidis (13.1%), and Staphylococcus aureus (10.4%) with varying resistance patterns. Surveyed patients had depressed 36-item short-form health survey physical functioning and social functioning scores. Recalcitrant HS patients with progressive symptomology over approximately nine years before surgical intervention were more likely to be African American women with axillary HS. Quality of life was diminished. We recommend initial treatment of HS with clindamycin and trimethoprim-sulfamethoxazole in clindamycin refractory cases.

Evaluating Autologous Lipofilling for Parry-Romberg Syndrome-Associated Defects: A Systematic Literature Review and Case Report.

BACKGROUND: Parry-Romberg syndrome (PRS) is a rare craniofacial disease that causes progressive hemifacial atrophy of the soft tissue before spontaneously entering remission. Autologous fat grafting may provide a less invasive alternative, producing aesthetically pleasing results while avoiding the need for traditional microsurgical free flap coverage. METHODS: A systematic review of the literature was conducted. Inclusion and exclusion criteria were applied. The case report highlights the technique using two-dimensional and three-dimensional photography. RESULTS: Our review yielded 31 articles in addition to our case describing 147 cases of lipofilling to correct PRS soft-tissue defects. Patients underwent an average of 2.2 procedures, receiving on average 95 mL of grafted fat. Disease severity was classified into mild (41%), moderate (42%), and severe (17%) in the identified patients. Increasing disease severity correlated with an increasing number of procedures and fat-grafting volumes to achieve adequate aesthetic outcomes (mean, 1.5 and 38 mL; 2.3 and 81 mL; 3.7 and 129 mL, respectively). Reported benefits over flap-based reconstructions included reductions in cost (40%), operative time (50%), donor-site morbidity (52%), and rate of complications (33%). Aesthetic benefits cited included improved skin quality (65%), more natural contours (1%), and more natural facial expressions (10%). CONCLUSION: Fat grafting for correction of PRS-associated soft-tissue defects is receiving heightened acceptance for its ability to restore natural facial contours. While additional fat-grafting procedures may be required with increased disease severity, autologous fat grafting may be a beneficial option as a sole modality to correct PRS-associated soft-tissue atrophy.

Advances in oncologic head and neck reconstruction: systematic review and future considerations of virtual surgical planning and computer aided design/computer aided modeling.

BACKGROUND: Mastery of craniomaxillofacial reconstruction has been traditionally considered to be learning curve dependent, often with inconsistent results during the skill acquisition phase. Until recently, the overall success in bony oncologic reconstruction of the craniomaxillofacial skeleton has relied mainly on the use of 2D imaging modalities, as well as surgical trial-and-error. Virtual surgical planning (VSP) and computer aided design (CAD)/computer aided modeling (CAM) are gaining traction in oncologic applications and offers opportunity for increased accuracy, improved efficiency, and enhanced outcomes. Its role in oncologic head and neck reconstruction has not been formally evaluated. METHODS: A systematic review of the current literature was conducted by three independent reviewers. Three separate search schemes were utilized to identify cases incorporating VSP-CAD/CAM technology in head and neck reconstruction for an oncologic indication. Inclusion and exclusion criteria were applied; articles that met criteria were evaluated for cohort demographics, osteocutaneous flap type and usage, oncologic indication, recipient bone reconstructed, flap survival, follow up, VSP technology usage, specific reported benefits of the technology, and qualitative and quantitative outcome assessments. RESULTS: The systematic literature review yielded 87 articles; of these, 33 met inclusion criteria describing a total of 220 cases of oncologic head and neck reconstruction incorporating virtual planning technology. Numerous qualitative benefits of VSP were reported including increased accuracy of the reconstruction (93%), decreased intraoperative time (80%), and ease of use (24%) among others. However, quantitative results using survey data or preoperative/postoperative CT scan comparisons were given for only 33% (3%, 30% respectively) of cases. CONCLUSION: VSP represents an evolving technology that ushers oncological craniomaxillofacial reconstruction into a modern era that holds potential to advance the field with increased reconstructive accuracy, expedition of the surgical phase, and improved outcomes. While qualitative improvements from the technology are delineated, specific quantifiable benefits and cost-benefit analysis are limited and need to be further investigated.

Abdominoplasty with suction undermining and plication of the superficial fascia without drains: a report of 113 consecutive patients.

BACKGROUND: Postoperative abdominoplasty seromas are a problem. Although drains are still commonly used during the initial postoperative period, this article has demonstrated that the combination of an extended incision, suction undermining, and progressive tension sutures can produce superior results without the need for suction drains. METHODS: A retrospective review of 113 consecutive abdominoplasty patients operated on between April of 2004 and May of 2010 was carried out and complications were reviewed. RESULTS: There were 109 women and four men, with ages spanning 23 to 76 years (average, 50 years). Complications of the surgery included hematoma (2.7 percent), with one requiring drain placement (0.9 percent) and two treated with needle aspiration (1.8 percent); seroma (8.8 percent), with four requiring closed suction drainage (3.5 percent) and six minimally treated with needle aspiration (5.3 percent); infection (2.7 percent), with one requiring intravenous antibiotics (0.9 percent) and two with minimal local erythema (1.8 percent); and minimal marginal skin necrosis with spontaneous healing (3.5 percent). CONCLUSIONS: The technique of abdominoplasty with the addition of an extended incision, liposuction undermining of the deep fatty tissue between the superficial and abdominal muscle fascia, and the use of progressive tension sutures results in a better abdominal wall and waist contour. This decreases the need for dissection of the abdominal panniculus above the umbilicus except for a small tunnel to allow for the suturing of the rectus abdominis muscles. This allows for preservation of the arterial and lymphatic vessels, improving blood flow to the superior flap and decreasing seroma formation to the point where operative drains are not required. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Adult congenital pulmonary valve replacement: a simple, effective, and reproducible technique.

Pulmonary valve replacement is a relatively uncommon operation in adults, with the exception of those patients operated on previously for congenital heart disease. We present a technique for pulmonary valve replacement and right ventricular outflow tract augmentation. It has been utilized in over 50 consecutive patients. This technique is simple, effective, and easily reproducible. The postoperative hemodynamics, echocardiographic data, and outcomes have been excellent.