Surgical Management and Long-Term Outcomes of BIA-ALCL: A Multidisciplinary Approach.

BACKGROUND: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a subtype of ALCL that arises as a seroma or a mass in the capsule surrounding textured breast implants. However, collections of cases usually come from large groups of institutions or countries, with different approaches regarding surgery and treatment. Here we describe a cohort of 18 cases undergoing implant removal and capsulectomy followed at Memorial Sloan Kettering Cancer Center (MSKCC). PATIENTS AND METHODS: We retrospectively analyzed all the cases of women with breast implants undergoing implant removal and capsulectomy for BIA-ALCL at MSKCC from January 2011 to June 2020. RESULTS: Median age at diagnosis was 57 (range 35-77) years following a median implant exposure of 11 (range 7-33) years. All known implants were macrotextured with the proprietary Biocell macrotexturing pattern from salt-loss technique. A total of 16 patients (89%) had implants placed for breast cancer reconstruction. Patients presented with clinically evident effusion in 78% of cases and a mass in 17% of cases, and 83% of patients presented with stage 1 BIA-ALCL. Patients were followed for a median of 43.4 months (SD 45 months) after diagnosis. There were no cases of recurrent ALCL. All patients remain disease free and no patients died of ALCL. CONCLUSIONS: In this cohort of patients with BIA-ALCL surgically treated and followed at a single institution, we confirm the importance of adequate surgery (bilateral implant removal and complete capsulectomy) in patients presenting with seroma-confined disease. This dataset reinforces high rates of progression-free and overall survival when diagnosis is identified and treatment performed in those with limited-stage disease.

Immediate Prepectoral Tissue Expander Breast Reconstruction Without Acellular Dermal Matrix Is Equally Safe Following Skin-Sparing and Nipple-Sparing Mastectomy.

BACKGROUND: Prepectoral breast reconstruction has become increasingly popular over the last decade. There is a paucity of data surrounding the impact of mastectomy type on clinical outcomes when comparing prepectoral immediate breast reconstruction without acellular dermal matrix (ADM) using tissue expansion. The purpose of this study was to compare 90-day reconstructive surgical outcomes in immediate prepectoral tissue expander reconstruction between patients with nipple-sparing mastectomy (NSM) and skin-sparing mastectomy (SSM). METHODS: A retrospective review of patient records was carried out on all patients undergoing NSM or SSM with immediate prepectoral tissue expander reconstruction without ADM, in a single institution, from June 2020 to December 2021. All complications were recorded, categorized, and statistically analyzed for significance. RESULTS: Seventy-nine patients (97 breasts) were studied. The mean age was 51 years old (range, 31-77). Twenty-two patients suffered complications recorded in 22 breasts (22.7%). There was no statistically significant difference in the total complications between the NSM (25.7%) and SSM (21.0%) groups or in the incidence of all major and minor complications. CONCLUSIONS: Breast reconstruction using tissue expanders without ADM has similar reconstructive outcomes in both NSM and SSM. There were no significant differences in complication rates between either groups. Breast reconstruction without ADM can confer institutional cost savings without compromising safety.

Complications of Aesthetic and Reconstructive Breast Implant Capsulectomy: An Analysis of 7486 Patients Using Nationwide Outcomes Data.

BACKGROUND: Despite increasing demand for breast capsular surgery to treat various benign and malignant implant-related pathologies, high-quality evidence elucidating complication profiles of capsulectomy and capsulotomy is lacking. OBJECTIVES: We provide the largest-scale analysis of associated outcomes and complications using the Tracking Operations and Outcomes for Plastic Surgeons (TOPS) database, and investigate clinical scenarios that may subject patients to increased risks for complications, most notably, extent of capsular surgery (complete vs partial), and index indication of implantation (aesthetic vs reconstructive). METHODS: An analysis of the TOPS database from 2008-2019 was performed. CPT codes were used to identify complete capsulectomy and partial capsulectomy/capsulotomy cases. Breast implant exchange procedures constituted procedural controls. RESULTS: In total, 7,486 patients (10,703 breasts) undergoing capsulectomy or capsulotomy were assessed. Relative to controls, capsulectomy (4.40% vs 5.79%; p = 0.0154), but not capsulotomy (4.40% vs 4.50%; p = 0.8876), demonstrated higher overall complication rates. Both capsulectomies (0.83% vs 0.23%; p < 0.0001) and capsulotomies (0.56% vs 0.23%; p = 0.0307) also had greater rates of seroma relative to controls. Subgroup analyses demonstrated that reconstructive patients, relative to aesthetic patients, experienced greater overall complications (6.76% vs 4.34%; p < 0.0001), and increased risks for seroma (1.06% vs 0.47%; p = 0.0016), dehiscence (0.46% vs 0.14%; p = 0.0059), surgical site infections (1.03% vs 0.23%; p < 0.0001), and implant loss (0.52% vs 0.23%; p = 0.0401). A detailed synthesis of 30-day outcomes, including all patient- and breast-specific complications, for both capsulectomy and capsulotomy, stratified according to all potential confounders, is presented herein. CONCLUSIONS: Surgeries on the breast capsule are overall safe, though complete capsulectomies and reconstructive patients were associated with significantly increased operative risks. Present findings will enhance patient selection, counselling, and informed consent.

Breast Implant Safety: an Overview of Current Regulations and Screening Guidelines.

Breast implant surgery for cosmetic or reconstructive purposes is becoming increasingly common. While the devices used are regulated and approved by the US Food and Drug Administration, all patients with breast implants require continued follow-up. Many patients will seek this care from their primary care providers, especially when follow-up with their plastic surgeon is difficult. It is vital that treating clinicians are knowledgeable about the history of breast implants, routine screening guidelines, and the recent breast implant "hot topics"-breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), connective tissue disease, and breast implant illness. This paper will provide the necessary information for primary care providers to appropriately counsel patients with breast implants to maintain not only their trust, but also their health.

Breast Implant-Related Adverse Events During Mammography: An Assessment of the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BACKGROUND: Adverse events arising in patients with breast implants during mammography reported by the Food and Drug Administration include implant rupture, pain, and impaired visualization. However, data supporting these claims were collected in 2004, and since, newer implant generations have been developed with overall rate of implantation increasing by 48%. OBJECTIVES: This article aims to determine the current incidence of implant-related adverse events arising during mammography. METHODS: We analyzed reports regarding silicone and saline breast implants published in the Food and Drug Administration Manufacturer and User Facility Device Experience database between 2008 and November 2018. Search terms included "mammogram," "mammography," "radiograph," "breast cancer screening," "breast cancer test," and "x-ray." RESULTS: Of the 20 539 implant-related adverse events available in the Manufacturer and User Facility Device Experience database, 427 were retrieved using our search strategy and 41 were related to mammography. Thirty-five of identified cases (85.4%) reported implant rupture, of which 19 (54.3%) were confirmed by a healthcare professional, 9 (25.7%) were clinically confirmed by saline implant deflation, and 7 (20.0%) were unverified reports by patients. Sixteen ruptures (45.7%) occurred with silicone implants, whereas 19 ruptures (54.3%) occurred with saline. Other adverse events included pain (29.3%), change in implant appearance (14.6%), and swelling (7.3%). CONCLUSIONS: Although implant rupture, pain, change in implant appearance, and swelling may occur, minimal implant-related adverse events arise during mammography. Given the extremely low reported risk of implant rupture, this should neither prevent patients from adhering to breast cancer screening programs nor deter patients from seeking breast implants. Patients should be aware of these reported risks and discuss screening options with their breast cancer screening team.

Axilla versus Wrist as the Recipient Site in Vascularized Lymph Node Transfer for Breast Cancer-Related Lymphedema: A Systematic Review and Meta-Analysis.

BACKGROUND: Vascularized lymph node transfers (VLNT) are being used with increasing frequency for the treatment of breast cancer-related lymphedema (BCRL). However, there is a lack of consensus in the surgical field as to which recipient site should be utilized. We, therefore, aim to assess the evidence comparing the wrist and axilla as recipient sites for VLNT in BCRL. METHODS: We conducted a systematic literature review to compare the wrist and axilla as recipient sites for VLNT in BCRL. Demographic data, as well as circumference reduction rate (CRR), excess volume reduction (EVR), postoperative decrease in infections per year, postoperative discontinuation of compression garments, and overall pooled complication rate were extracted from included studies. These were compared through a meta-analysis. RESULTS: A total of 37 studies met the inclusion criteria for a total of 689 patients. VLNTs to the wrist and axilla resulted in a decrease in CRR of 42.1 and 51.5%, and a decrease in EVR of 35.6 and 48.8%, respectively. However, our meta-analysis showed no significant differences between CRR or EVR and between wrist and axilla as recipient sites. Similarly, we found no differences in postoperative decrease in infections per year, postoperative discontinuation of compression garments, and overall pooled complication rate. CONCLUSION: These data suggest noninferiority between the wrist and axilla as recipient sites for VLNT in the context of BCRL. In the absence of randomized, prospective data, we hope these results can be used as an evidence-based reference and facilitate future studies.

Patents for the Plastic Surgeon: A Primer.

ABSTRACT: Although innovation and entrepreneurship are complementary in the process of creating new products, plastic surgeons are frequently discouraged by the challenges associated with the regulatory and administrative environments in patent filing. The following primer provides a step-by-step guide for understanding patents and outlines the steps and costs involved in patent filing. To improve opportunities for successful patent filing, we elaborate on some of the common pitfalls in the process, including the timing of public disclosure, conducting a private art search, selecting a patent attorney or agent, determining the level of inventor involvement, and navigating academic and employment contracts. The innovative drive in plastic surgery provides a strong impetus for strengthening knowledge about patents and patent filing in order to support efforts for providing high-value patient care.

Correlation of Prediction and Actual Outcome of Three-Dimensional Simulation in Breast Augmentation Using a Cloud-Based Program.

BACKGROUND: Breast augmentation is among the most frequently performed cosmetic plastic surgeries. Providing patients with "realistic" 3D simulations of breast augmentation outcomes is becoming increasingly common. Until recently, such programs were costly and required significant equipment, training, and office space. New simple user-friendly cloud-based programs have been developed, but to date there remains a paucity of objective evidence comparing these 3D simulations with the post-operative outcomes. OBJECTIVES: To determine the aesthetic similarity between pre-operative 3D simulation generated by Crisalix and real post-operative outcomes. METHODS: A retrospective review of 20 patients receiving bilateral breast augmentation was conducted comparing 6-month post-operative outcomes with 3D simulation using Crisalix software. Similarities between post-operative and simulated images were measured by three attending plastic surgeons and ten plastic surgery residents using a series of parameters. RESULTS: Assessment reveals similarity between the 3D simulation and 6-month post-operative images for overall appearance, breast height, breast width, breast volume, breast projection, and nipple correction. Crisalix software generated more representative simulations for symmetric breasts than for tuberous or ptotic breasts. Comparison of overall aesthetic outcome to simulation showed that the post-operative outcome was more appealing for the symmetric and tuberous breasts and less appealing for the ptotic breasts. CONCLUSIONS: Our data suggest that Crisalix offers a good overall 3D simulated image of post-operative breast augmentation outcomes. Improvements to the simulation of the post-operative outcomes for ptotic and tuberous breasts would result in greater predictive capabilities of Crisalix. Collectively, Crisalix offers good predictive simulations for symmetric breasts. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

CD109, a novel TGF-ß antagonist, decreases fibrotic responses in a hypoxic wound model.

Excessive extracellular matrix deposition that occurs in many fibrotic skin disorders such as hypertrophic scarring and scleroderma is often associated with hypoxia. CD109 is a novel TGF-ß co-receptor and TGF-ß antagonist shown to inhibit TGF-ß-induced extracellular matrix protein production in vitro. We examined whether CD109 is able to regulate extracellular matrix deposition under low oxygen tension in vivo using transgenic mice overexpressing CD109 in the epidermis. By creating dorsal bipedicle skin flaps with centrally located excisional wounds in these mice and their wild-type littermates, we generated a novel murine hypoxic wound model. Mice were sacrificed on 7 or 14 days post-wounding, and tissues were harvested for histological and biochemical analysis. Hypoxic wounds in both transgenic and wild-type mice showed increased levels of HIF-1α and delayed wound closure, validating this model in mice. Hypoxic wounds in CD109 transgenic mice demonstrated decreased collagen type 1 and fibronectin expression, and reduced dermal thickness on day 7 post-wounding as compared to those in wild-type mice and to non-hypoxic control wounds. These results suggest that CD109 decreases extracellular matrix production and fibrotic responses during hypoxic wound healing. Manipulating CD109 levels may have potential therapeutic value for the treatment of fibrotic skin disorders associated with poor oxygen delivery.

CD109 overexpression ameliorates skin fibrosis in a mouse model of bleomycin-induced scleroderma.

OBJECTIVE: Transforming growth factor ß (TGFß) is a profibrotic cytokine, and its aberrant function is implicated in several types of fibrotic pathologies including scleroderma (systemic sclerosis [SSc]). Multiple lines of evidence show that increased TGFß signaling contributes to progressive fibrosis in SSc by promoting fibroblast activation, excessive extracellular matrix (ECM) deposition, and dermal thickening. We have previously identified CD109 as a TGFß coreceptor and have shown that it antagonizes TGFß signaling and TGFß-induced ECM expression in vitro in human keratinocytes and fibroblasts. The aim of the present study was to examine the ability of CD109 to prevent skin fibrosis in a mouse model of bleomycin-induced SSc. METHODS: Transgenic mice overexpressing CD109 in the epidermis and their wild-type (WT) littermates were injected with bleomycin in phosphate buffered saline (PBS) or with PBS alone every other day for 21 days or 28 days. Dermal thickness and collagen deposition were determined histologically using Masson's trichrome and picrosirius red staining. In addition, collagen and fibronectin content was analyzed using Western blotting, and activation of TGFß signaling was examined by determining phospho-Smad2 and phospho-Smad3 levels using Western blotting and immunohistochemistry. RESULTS: Transgenic mice overexpressing CD109 in the epidermis showed resistance to bleomycin-induced skin fibrosis, as evidenced by a significant decrease in dermal thickness, collagen crosslinking, collagen and fibronectin content, and phospho-Smad2/3 levels, as compared to their WT littermates. CONCLUSION: Our findings suggest that CD109 inhibits TGFß signaling and fibrotic responses in experimental murine scleroderma. They also suggest that CD109 regulates dermal-epidermal interactions to decrease extracellular matrix synthesis in the dermis. Thus, CD109 is a potential molecular target for therapeutic intervention in scleroderma.

Population preferences of undergoing brachioplasty for arm laxity.

BACKGROUND: The number of patients requesting surgical procedures performed for brachioplasty and massive weight loss is increasing. The authors set out to quantify the health state utility outcome assessment of living with arm deformity requiring brachioplasty. METHODS: Utility assessments using the visual analog scale (VAS), time trade-off (TTO), and standard gamble (SG) were used to obtain utilities scores for arm deformity, monocular blindness, and binocular blindness from a sample of the general population and medical students. Linear regression and Student t test were used for statistical analysis. A P value less than 0.05 was deemed statistically significant. RESULTS: All the measures for arm deformity of the 107 volunteers (VAS, 0.80 ± 0.14; TTO, 0.91 ± 0.12; SG, 0.94 ± 0.10) were significantly different (P < 0.001) from the corresponding measures for monocular blindness and binocular blindness. When compared to the sample of the general population, having a medical education demonstrated a statistical significance of being less likely to trade years of life and less likely to gamble risk of death for a procedure such as a brachioplasty. Race and sex were not statistically significant independent predictors of risk acceptance. CONCLUSIONS: We have objectified the health state of living with upper arm deformity requiring brachioplasty. Utility outcome scores (VAS, 0.80 ± 0.14; TTO, 0.91 ± 0.12; SG, 0.94 ± 0.10) were comparable to living with health states such as aging neck needing rejuvenation, excess skin in the thighs necessitating thigh lift, and massive weight loss requiring panniculectomy based on previously reported studies.

Heparin-induced thrombocytopenia and thrombosis as an under-diagnosed cause of flap failure in heparin-naive patients: a case report and systematic review of the literature.

BACKGROUND: Heparin-induced thrombocytopenia and thrombosis (HITT) is an immune complex mediated and potentially devastating cause of flap loss in microvascular surgery. HITT may be an under-reported cause of early-flap failure due to subclinical manifestations at the time of flap loss. A case report of a patient presenting with HITT-related flap failure and the results of a systematic literature review of the clinical presentation of HITT in microsurgery are presented here. CASE REPORT: A patient suffering from a chronic wound on the right medial malleolus was treated with an ALT flap, which was compromised by thrombosis. Multiple attempts to rescue the flap including thrombolysis, popliteal AV loop, and a second free flap were all unsuccessful. Six days following the initial procedure, a diagnosis of HITT was made following a positive HITT-antibody test as the cause of flap failure. METHODS: PubMed, MEDLINE, and EMBASE searches yielded 113 results, of which 6 met our criteria for manuscripts describing HITT in microsurgical procedures. RESULTS: Evaluation of the peer-reviewed literature describing HITT in microsurgery suggests that HITT-related flap failure occurs rapidly, more frequently in heparin-naïve patients, and in advance of systemic thrombosis and thrombocytopenia. CONCLUSIONS: Due to the rapid and unpredictable onset of HITT during microsurgery, we recommend maintaining an index of suspicion for HITT in flaps with otherwise unexplained early thrombosis. We also encourage hematology consultation, discontinuing heparin use and initiating alternate thromboprophylaxis in order to inhibit the potential for subsequent life-threatening systemic complications as well as improving the potential for delayed reconstructive success.

Living with a unilateral mastectomy defect: a utility assessment and outcomes study.

BACKGROUND: The gold standard for the treatment of breast cancer includes mastectomy surgery. Our goal was to quantify the health state utility assessment of living with unilateral mastectomy. METHODS: The visual analogue scale (VAS), time trade-off (TTO), and standard gamble (SG) were used to obtain utilities for unilateral mastectomy, monocular blindness and binocular blindness from a prospective sample of the general population and medical students. RESULTS: All measures (VAS, TTO, SG) for unilateral mastectomy (0.75 SD 0.17, 0.87 SD 0.14, and 0.86 SD 0.18, respectively) of the 140 volunteers were significantly different from the corresponding scores for monocular (0.61 SD 0.18, 0.84 SD 0.17, and 0.84 SD 0.18, respectively) and binocular blindness (0.38 SD 0.17, 0.67 SD 0.24, and 0.69 SD 0.23, respectively). Age, gender, race, education, and income were not statistically significant independent predictors of utility scores. CONCLUSION: In a sample of the general population and medical students, utility assessments for living with unilateral mastectomy were comparable with those of living with bilateral mastectomy and severe breast hypertrophy. Our sample population, if faced living with unilateral mastectomy was willing to gamble a theoretical 14% chance of death and willing to trade 4.2 years of existing life-years.

Demystifying vascularized lymph node transfers and lymphatico-venous anastomoses.

Lymphedema continues to be a widely prevalent condition with no definitive cure. It affects a wide range of patients across different ages and backgrounds. The significant burden of this chronic and debilitating condition necessitates more research and comprehensive healthcare coverage for affected patients. In developed countries, cancer survivors are disproportionality affected by this condition. Risk factors including lymph node dissections and radiation render many cancer patients more susceptible to the development of lymphedema. Part of the challenge with lymphedema care, is that it exits on a broad spectrum with significant variability of symptoms. Advances and broader availability of various imaging modalities continue to foster progress in lymphedema surgery. The conservative management of lymphedema remains the primary initial management option. However, lymphedema surgeries can provide significant hope and may pave the way for significant improvements in the quality-of-life for many patients afflicted by this progressive and enfeebling condition. Reductive and physiologic procedures are becoming an important part of the armamentarium of the modern plastic and reconstructive surgeon. Recent advances in physiologic lymphedema surgeries are accelerating their transition from experimental surgeries to broadly adopted and widely accepted procedures that can lead to major successes in the fight against this condition. Prophylactic lymphedema surgery also presents a promising choice for many patients and can help prevent lymphedema development in high-risk patients.

The cellular and molecular properties of capsule surrounding silicone implants in humans vary uniquely according to the tissue type adjacent to the implant.

The foreign body reaction (FBR) to biomaterials results in fibrous encapsulation. Excessive capsule fibrosis (capsular contracture) is a major challenge to the long-term stability of implants. Clinical data suggests that the tissue type in contact with silicone breast implants alters susceptibility to developing capsular contracture; however, the tissue-specific inflammatory and fibrotic characteristics of capsule have not been well characterized at the cellular and molecular level. In this study, 60 breast implant capsule samples are collected from patients and stratified by the adjacent tissue type including subcutaneous tissue, glandular breast tissue, or muscle tissue. Capsule thickness, collagen organization, immune and fibrotic cellular populations, and expression of inflammatory and fibrotic markers is quantified with histological staining, immunohistochemistry, and real-time PCR. The findings suggest there are significant differences in M1-like macrophages, CD4+ T cells, CD26+ fibroblasts, and expression of IL-1ß, IL-6, TGF-ß, and collagen type 1 depending on the tissue type abutting the implant. Subglandular breast implant capsule displays a significant increase in inflammatory and fibrotic markers. These findings suggest that the tissue microenvironment contributes uniquely to the FBR. This data could provide new avenues for research and clinical applications to improve the site-specific biocompatibility and longevity of implantable devices.