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.

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.

Altered Foreign Body Response at the Posterior Surface Compared to the Anterior Surface of Human Silicone Breast Implants.

Soft implantable devices are crucial to optimizing form and function for many patients. However, periprosthetic capsule fibrosis is one of the major challenges limiting the use of implants. Currently, little is understood about how spatial and temporal factors influence capsule physiology and how the local capsule environment affects the implant structure. In this work, we analyzed breast implant capsule specimens with staining, immunohistochemistry, and real-time polymerase chain reaction to investigate spatiotemporal differences in inflammation and fibrosis. We demonstrated that in comparison to the anterior capsule against the convex surface of breast implants, the posterior capsule against the flat surface of the breast implant displays several features of a dysregulated foreign body reaction including increased capsule thickness, abnormal extracellular remodeling, and infiltration of macrophages. Furthermore, the expression of pro-inflammatory cytokines increased in the posterior capsule across the lifespan of the device, but not in the anterior capsule. We also analyzed the surface oxidation of breast explant samples with XPS analysis. No significant differences in surface oxidation were identified either spatially or temporally. Collectively, our results support spatiotemporal heterogeneity in inflammation and fibrosis within the breast implant capsule. These findings presented here provide a more detailed picture of the complexity of the foreign body reaction surrounding implants destined for human use and could lead to key research avenues and clinical applications to treat periprosthetic fibrosis and improve device longevity.

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.

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.

Textured versus Smooth Tissue Expanders: A Comparison of Complications in 3526 Breast Reconstructions.

BACKGROUND: Increased understanding of breast implant-associated anaplastic large-cell lymphoma has led to a shift away from textured breast devices. A few small studies have compared the complication rates of textured and smooth tissue expanders (TEs). The aim of this study was to compare complication profiles in patients undergoing two-stage postmastectomy breast reconstruction with either textured or smooth TEs. METHODS: The authors performed a retrospective review of female patients who underwent immediate breast reconstruction with textured or smooth TEs from 2018 to 2020 at their institution. Rates of seroma, infection/cellulitis, malposition/rotation, exposure, and TE loss were analyzed in the overall cohort and subgroups undergoing prepectoral and subpectoral TE placement. A propensity score-matched analysis was used to decrease the effects of confounders comparing textured and smooth TEs. RESULTS: The authors analyzed 3526 TEs (1456 textured and 2070 smooth). More frequent use of acellular dermal matrix, SPY angiography, and prepectoral TE placement was noted in the smooth TE cohort ( P < 0.001). Univariate analysis suggested higher rates of infection/cellulitis, malposition/rotation, and exposure in smooth TEs (all P < 0.01). Rates of TE loss did not differ. After propensity matching, no differences were noted in infection or TE loss. Prepectoral smooth expanders had increased rates of malposition/rotation. CONCLUSIONS: TE surface type did not affect rates of TE loss, although increased rates of expander malposition were noted in the smooth prepectoral cohort. Further research is needed to examine breast implant-associated anaplastic large-cell lymphoma risk with temporary textured TE exposure to improve decision-making. CLINICAL QUESTION/LEVEL OF EVIDENCW: Therapeutic, III.

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.

Implant-based breast surgery and capsular formation: when, how and why?-a narrative review.

Background and Objective: Implant-based breast surgery is a common procedure for both reconstructive and aesthetic purposes. Breast implants, like any foreign object, trigger the formation of a capsule around them. While generally harmless, the capsule can undergo fibrotic changes leading to capsular contracture, which can negatively impact surgical outcomes and patient well-being. Additionally, rare but serious complications, such as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and capsule-associated squamous cell carcinoma, have been reported. This paper aims to review the physiology of capsular formation, identify factors contributing to capsule-related pathologies, and discuss their clinical implications. Methods: A review of relevant literature was conducted by searching databases for articles published between inception and September 2022. The search included but not limited to terms such as "capsular formation" and "capsular contracture". Selected articles were critically analyzed to address the objectives of this review. Key Content and Findings: Capsular formation involves interactions between the implant surface, surrounding tissues, and the immune system. Factors influencing pathological changes in the capsule include genetic predisposition, bacterial contamination, implant characteristics, and surgical techniques. Capsular contracture, characterized by tissue hardening, pain, and implant distortion, remains the most common complication. Rare but life-threatening conditions, such as BIA-ALCL and capsule-associated squamous cell carcinoma, necessitate vigilant monitoring and early detection. Conclusions: Understanding the physiology of capsular formation and its associated pathologies is crucial for healthcare providers involved in implant-based breast surgery. Efforts should focus on minimizing the risk of capsular contracture through improved implant materials, surgical techniques, and infection prevention. The emergence of BIA-ALCL and capsule-associated squamous cell carcinoma underscores the importance of long-term surveillance and prompt diagnosis. Further research is needed to uncover underlying mechanisms and develop preventive measures and treatments for these complications. Enhancing our knowledge and clinical management of capsular formation will lead to safer and more successful outcomes in implant-based breast surgery.

Topical Tranexamic Acid in Breast Reconstruction: A Double-Blind Randomized Controlled Trial.

BACKGROUND: Excess fluid accumulation (seroma/hematoma) around the breast implant after reconstruction can lead to significant complications. Topical administration of tranexamic acid (TXA) may reduce fluid accumulation and reduce postoperative complications. This trial aims to investigate whether TXA-treated mastectomy pockets will exhibit less postoperative fluid production and complications. METHODS: This paired, double-blind, randomized, controlled trial enrolled patients undergoing bilateral mastectomies with immediate direct-to-implant reconstruction. In each patient, one breast was randomized to receive 3 g of TXA (100 cc), and the other received 100 cc of normal saline. The blinded solutions were soaked in the mastectomy pocket for 5 minutes before implant placement. Postoperatively, daily drain outputs, complications, and baseline demographics were recorded. RESULTS: Fifty-three eligible patients, representing 106 breasts, were enrolled. All patients underwent bilateral nipple-sparing mastectomies. After randomization, TXA was placed in the right breast in 30 patients (56.6%). The use of topical TXA resulted in a mean drain output reduction of 30.5% (range, -83.6% to 26.6%). Drains on the TXA-treated breast were eligible for removal 1.4 days (range, 0 to 4 days) sooner than the control side. The TXA-treated group had three complications (5.67%) versus 15 (28.3%) in the control group (OR, 0.1920; P = 0.0129). Specifically, for operative hematomas, the TXA group had none (0%), versus three in the control group (5.7%) (OR, 0.1348; P = 0.18). CONCLUSIONS: Soaking the mastectomy bed with 3% topical TXA before implant insertion leads to a decrease in drain output and a decrease in complications. Topical administration of TXA represents an option to decrease complications in alloplastic breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Making the Case for Virtual Surgical Planning: Bilateral Sequential Fibula Flaps with Immediate Dental Implants for Maxillectomy.

SUMMARY: Oncologic maxillectomy defects requiring bony reconstruction are among the most challenging head and neck cases because of the complex three-dimensional geometry of the midface. Virtual surgical planning technology is advantageous in these cases because it provides superior positional precision and accuracy compared with traditional techniques and facilitates prosthodontic rehabilitation. Maxillary cancer recurrence after an initial fibula flap reconstruction presents a unique challenge. The authors report the first two cases of sequential fibula flaps after second or recurrent cancer of the maxilla. Virtual surgical planning facilitated resection with adequate tumor margins, optimized anatomic positioning of the fibula construct with three-dimensional printed plates, and enabled immediate functional dental implant placement.

Direct-to-Implant, Prepectoral Breast Reconstruction: Geometric Breast Measurements and Changes at 2-Year Follow-Up.

BACKGROUND: Prepectoral breast reconstruction has recently experienced a resurgence in popularity. However, in direct-to-implant (DTI) reconstruction, there is no opportunity for capsular modifications before final implant insertion. Implant pocket and breast shape are thus maintained, initially, solely by the mastectomy skin flaps, and eventually, by attachments of the periprosthetic capsule. The present study aims to quantify changes in breast geometric measurements over time following DTI prepectoral breast reconstruction. METHODS: A retrospective chart review was performed for patients who underwent bilateral prepectoral DTI reconstruction performed by a single surgeon from June of 2016 to January of 2018. Patients followed for more than 2 years were included. Yearly standardized frontal photographs were analyzed, and nipple-to-midline, sternal notch-to-nipple, and midclavicle-to-lower pole measurements were obtained. Patient demographics, operative details, and complications were documented. RESULTS: A total of 72 breasts (38 women) undergoing direct-to-implant, prepectoral breast reconstruction were included in the final analysis. Acellular dermal matrix was used in 56 breasts only (78.9%) for anterior coverage. The average change in nipple-to-midline distance after 2 years decreased by 0.41 cm (range, -2.00 to 2.97 cm), sternal notch-to-nipple distance decreased by 0.62 cm (range, -4.98 to 5.4 cm), and midclavicle-to-lower pole distance decreased 0.10 cm superiorly (range, -6.07 to 3.6 cm). In breasts that underwent postmastectomy radiation therapy, the average changes were -0.08, -0.43, and -0.56 cm, respectively. No patient in this cohort had severe malposition requiring further surgery. CONCLUSIONS: The present study provides insight into geometric breast measurements following prepectoral breast reconstruction at 2-year follow-up. The minimal breast shape changes observed demonstrate the feasibility of prepectoral DTI reconstruction with or without the use of acellular dermal matrix. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Effective Strategies to Patent Plastic Surgery Ideas and Intellectual Property.

SUMMARY: Patents are of great importance to plastic surgery, a field fueled by constant innovation. Familiarity with the patent process could promote further innovation by plastic surgeons. By granting proprietary rights to inventors in exchange for publication of their inventions, patents incentivize creativity and innovation while promoting diffusion and transfer of technology. The task of securing patent protection, however, is complex, and begins well before the patent application. Inventors must familiarize themselves with regulations to ensure that their inventions satisfy the criteria for patentability, which can differ among countries. Patents regarding surgical methods should undergo additional ethical deliberation given their potential interference with medical altruism. The patent application must be devised and written thoroughly, as it needs to withstand meticulous examination by patent offices and potential third-party opposition, and professional assistance in doing so should be sought. Filing of the application calls for intricate procedural and timing requirements that bear major benefits if well understood and respected by applicants. Given that patent rights only cover the issuing country's territorial scope, further endeavors must be pursued when seeking patent protection in additional countries. In this regard, two options exist, and the ultimate decision should be tailored to each inventor's personal needs. At every step of the patenting process, financial readiness is key because costs can be unpredictable and escalate quickly. In this article, the authors propose effective strategies directed at plastic surgeons to facilitate patenting of their ideas and protection of their intellectual property.

Current Surgical Outcomes of Nasal Tip Grafts in Rhinoplasty: A Systematic Review.

BACKGROUND: Refinement of the nasal tip plays an important role in rhinoplasty surgery outcomes and may be considered the most technically challenging aspect of the procedure. Numerous techniques have been described for nasal tip augmentation utilizing grafts. The aim of this study was to systematically review the existing literature on nasal tip grafts and appraise it critically. METHODS: A PubMed search was performed to identify journal articles related to nasal tip grafts from the past decade. A total of 44 studies met inclusion criteria. The Newcastle-Ottawa Quality Assessment Scale and Jadad scale were used to appraise 38 observational studies and six randomized trials, respectively, to determine the quality of the studies. RESULTS: Critical assessment revealed that the studies were highly variable in focus and encompassed autologous, homologous, and alloplastic grafts. The quality of the data included an average Newcastle-Ottawa Quality Assessment Scale score of 6.5 (out of 9) and Jadad score of 2.5 (out of 5). A majority of studies (86.4%) included objective outcomes using anthropometric measurements and a portion of studies (27.3%) also included patient-reported outcomes. CONCLUSIONS: The results of this systematic review suggest that more than one type of nasal tip graft may result in satisfactory outcomes. This review provides an expansive collection of studies on nasal tip grafts, which can serve as an invaluable tool for the plastic surgeon engaging in rhinoplasty.