Clinical Evaluation of Safety and Efficacy of Radiofrequency-Assisted Lipolysis on Breast Envelope and Nipple-Areola Complex Position.

BACKGROUND: Breast ptosis as a result of pregnancy and/or breastfeeding, age, genetics, and weight loss is a common complaint among women visiting a plastic surgeon. This study sought to evaluate the utility, efficacy, and safety of radiofrequency-assisted lipolysis on the breast and nipple-areola complex position in women with breast ptosis. METHODS: This was a single-center (i.e., Maxwell Aesthetics) study of women desiring tightening of the breast envelope and elevation of the nipple-areola complex. Each patient underwent one treatment with radiofrequency-assisted lipolysis in the operating room. Radiofrequency-assisted lipolysis was applied to each breast with a BodyTite Pro handpiece. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3 months, 6 months, and 12 months by means of manual and three-dimensional computer-generated measurements (i.e., Vectra). RESULTS: Ten female patients were enrolled. Ages ranged from 23 to 54 years. Follow-up was 12 months. Data were captured for seven measurements from the nipple longitudinally at five time points. The sternal notch-to-nipple distance, the nipple-to-inframammary fold distance, and the nipple-to-nipple distance improved statistically at 6-week follow-up, which persisted through the 12-month follow-up ( p < 0.05). Patient questionnaires revealed moderate to excellent satisfaction. CONCLUSIONS: Radiofrequency-assisted lipolysis with a bipolar device to deliver radiofrequency energy to the breast is an effective modality to moderately improve breast ptosis. This study demonstrates that this treatment improves breast measurements across time, regardless of measurement type (manual versus Vectra). This modality affords a minimally invasive, effective method to improve mild to moderate breast ptosis with minimal scarring and high patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Evaluation of the Safety of a GalaFLEX-AlloDerm Construct in Prepectoral Breast Reconstruction.

BACKGROUND: Prepectoral implant-based breast reconstruction is gaining in popularity. Acellular dermal matrices are an integral part of prepectoral reconstruction. However, large quantities of acellular dermal matrix are required for total implant coverage, and the cost of acellular dermal matrices could be a deterrent to reconstruction. To minimize the cost, the authors have resorted to the use of a bioabsorbable mesh, GalaFLEX, as a partial replacement to acellular dermal matrices. This study evaluates the comparative safety of using a GalaFLEX-AlloDerm construct versus AlloDerm alone in prepectoral reconstruction. METHODS: Consecutive patients who underwent immediate, expander-implant, prepectoral breast reconstruction were included in this retrospective study. Patients were stratified into two groups: those who received the GalaFLEX-AlloDerm combination versus AlloDerm alone. In GalaFLEX-AlloDerm reconstructions, the lower third of the expander was covered by the AlloDerm, whereas the rest of the expander was covered by GalaFLEX. Complications following reconstruction were compared between the groups. RESULTS: AlloDerm alone was used in 128 patients (249 breasts) and GalaFLEX-AlloDerm was used in 135 patients (250 breasts). The rate of any complication was 7.6 percent in the AlloDerm-alone group and 6.4 percent in the GalaFLEX-AlloDerm group. The rate of infection, major skin necrosis, seroma, capsular contracture, prosthesis exposure/extrusion, and prosthesis loss were less than or equal to 3.0 percent in the GalaFLEX-AlloDerm group and did not differ significantly from those in the AlloDerm-only group. CONCLUSIONS: GalaFLEX bioabsorbable matrix is a less costly alternative to acellular dermal matrices in two-stage, prepectoral reconstruction with comparable safety outcomes. Further long-term data and clinical experience are needed to better understand the safety of this matrix for use in breast reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Prepectoral Breast Reconstruction in Morbidly Obese Patients.

Prosthetic breast reconstruction via the subpectoral approach in morbidly obese patients (body mass index: ≥40 kg/m2) has been reported to be associated with an increased risk of perioperative complications and poor outcomes. Further, immediate reconstruction appears to carry a higher risk of poor outcomes than delayed reconstruction in this population. The impact of morbid obesity on outcomes after prepectoral breast reconstruction has not yet been evaluated, and such was the purpose of this study. Methods: This retrospective study included all consecutive patients with morbid obesity who underwent prepectoral expander/implant reconstruction between July 2009 and April 2020 in the first author's practice. Patient records were reviewed, and data on demographics, comorbidities, radiotherapy use, type of mastectomy, mastectomy specimen weight, and postoperative complications following reconstruction were retrieved. Complications were stratified and compared by timing of reconstruction (immediate versus delayed). Results: Eighty-five breasts in 45 morbidly obese patients were reconstructed. Postoperative complications occurred in 11 breasts (12.9%) and included major skin necrosis (3.5%), seroma (4.7%), wound dehiscence (5.9%), and reconstructive failure (1.2%). Timing of reconstruction had little impact on postoperative complications other than major skin necrosis, which was significantly higher in the delayed group (11.1% versus 1.5%). Conclusions: Prosthetic breast reconstruction via the prepectoral approach can be successfully performed in morbidly obese patients, with outcomes approaching those seen in nonobese patients when performed by experienced surgeons. Patients with morbid obesity should not be denied this reconstructive approach because of their body mass index.

Applying Principles of Breast Revision to Managing Aesthetic Patients with Textured Implants.

SUMMARY: Textured breast implants have garnered increased attention recently because of their risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon and treatable type of T-cell lymphoma. Treatment involves bilateral en bloc capsulectomy, which is curative in the majority of cases. At present, there is no defined management approach for aesthetic patients asymptomatic for BIA-ALCL requesting the removal of their textured implants, particularly as it relates to the management of the capsule. It is unclear if en bloc capsulectomy is necessary in these patients as it is in patients with BIA-ALCL. In the absence of clear guidance on the management of the capsule in asymptomatic patients, the basic principles of breast revision surgery can be applied to these patients.

Povidone-iodine Does Not Affect Acellular Dermal Matrix Integration in Patients Undergoing 2-staged, Prepectoral, Breast Reconstructive Surgery.

BACKGROUND: Povidone-iodine has been traditionally used as an antimicrobial agent to irrigate the breast pocket and rinse the prosthesis before placement in the pocket. Use of povidone-iodine with breast implants was banned from 2000 to 2017. During this period, acellular dermal matrix (ADM) was introduced to breast surgery. In nonclinical studies, povidone-iodine can impair collagen synthesis and kill fibroblasts. Cellular repopulation was critical for ADM integration. Whether povidone-iodine impacts ADM integration was unknown. METHODS: Patients who underwent immediate, prepectoral, 2-staged breast reconstruction were included in this retrospective study. Study population was divided into povidone-iodine-treated patients and triple-antibiotic-treated patients. The breast pockets were rinsed with the antimicrobial agent, and the prostheses and ADMs were presoaked in the agent perioperatively. At implant exchange, the extent of ADM integration was clinically assessed. ADM integration was defined as >25% of matrix vascularization. ADM integration and postoperative complications were compared between the groups. RESULTS: A total of 111 patients (257 reconstructions) were included-58 patients (111 reconstructions) were exposed to povidone-iodine and 53 patients (97 reconstructions) to triple-antibiotic solution. ADM integration was noted in 97% of breasts in each group. Integrated matrices appeared healthy, had no signs of foreign body reaction, and demonstrated punctate bleeding. Complications did not differ between the groups, including the rate of infections, seroma, and expander loss. CONCLUSION: Irrigation of the breast pocket and presoaking of the prosthesis and ADM with povidone-iodine appear to have no adverse consequences on clinical outcomes and did not impede matrix integration.

Dual-Plane versus Prepectoral Breast Reconstruction in High-Body Mass Index Patients.

BACKGROUND: Breast reconstruction in patients with a high body mass index (BMI) (≥30 kg/m) is technically challenging and is associated with increased postoperative complications. The optimal reconstructive approach for these patients remains to be determined. This study compared outcomes of prepectoral and dual-plane reconstruction in high-BMI patients to determine whether there was an association between postoperative complications and the plane of reconstruction. METHODS: High-BMI patients who underwent immediate dual-plane or prepectoral expander/implant reconstruction were included in this retrospective study. Patients were stratified by reconstructive approach (dual-plane or prepectoral), and postoperative complications were compared between the groups. Multivariate logistic regression analysis was performed to determine whether the plane of reconstruction was an independent predictor of any complication after adjusting for potential confounding differences in patient variables between the groups. RESULTS: Of 133 patients, 65 (128 breasts) underwent dual-plane and 68 (129 breasts) underwent prepectoral reconstruction. Rates of seroma (13.3 percent versus 3.1 percent), surgical-site infection (9.4 percent versus 2.3 percent), capsular contracture (7.0 percent versus 0.8 percent), and any complication (25.8 percent versus 14.7 percent) were significantly higher in patients who had dual-plane versus prepectoral reconstruction (p < 0.05). Multivariate logistic regression identified dual-plane, diabetes, neoadjuvant radiotherapy, and adjuvant chemotherapy as significant, independent predictors of any complication (p < 0.05). Dual-plane reconstruction increased the odds of any complication by 3-fold compared with the prepectoral plane. CONCLUSION: Compared with the dual-plane approach, the prepectoral approach appears to be associated with a lower risk of postoperative complications following immediate expander/implant breast reconstruction and may be a better reconstructive option in high-BMI patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Why Do We Need Anatomical Implants? the Science and Rationale for Maintaining Their Availability and Use in Breast Surgery.

The choice between anatomical and round implants is an important decision in breast augmentation surgery; however, both have their place and the decision between them that should be made on a patient-by-patient basis, taking into account the patient's desires, anatomy, and surgical history. In some individuals, there are clear indications for using either anatomical or round devices, and there is good evidence that aesthetic outcomes are better with anatomical implants in some instances. When both types are an option, anatomical devices may offer increased flexibility and, despite a longer learning curve needed to properly manage them, they are associated with positive long-term outcomes and high levels of patient satisfaction. Concerns about implant rotation can be minimized with proper patient selection and surgical technique, and the overall complication rate may favor anatomical over round devices in appropriate patients. Breast implant-associated anaplastic large-cell lymphoma is an important issue, and while rare, it must be considered in the context of the entire patient risk profile. Both anatomical and round implants remain key elements of a complete surgical toolbox in breast augmentation. 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 www.springer.com/00266.

The Evolution of Breast Implants.

Breast augmentation remains one of the most commonly performed aesthetic procedures in the United States and worldwide. Throughout the last few decades, the implants used for this procedure have undergone significant advancements, which has allowed surgeons to provide safer and more aesthetically pleasing outcomes. This article discusses the history of breast implants since their invention in 1962. Particular emphasis is given to the evolution of silicone implants with its many challenges, which has resulted in the development of the currently used fourth- and fifth-generation devices. Knowledge of these advances will allow physicians to more critically evaluate their results, and also will encourage them to provide more up-to-date scientific data on these devices to further improve the clinical outcomes of their patients.

Reading between the Lines: A Plastic Surgeon's Guide to Evaluating the Quality of Evidence in Research Publications.

An important component of practicing evidence-based medicine (EBM) in plastic surgery is staying current with published research, an increasingly difficult task given the rapid growth of the literature. This article reviews the methodological aspects specific to the aesthetic surgery field that should be considered when evaluating the quality of evidence in research publications in the context of the level of evidence (LOE) grading scales that are currently used by plastic surgery journals. Reporting the LOE in a research publication can help to highlight the quality of the research and the potential for bias so that the reader may prioritize information accordingly. However, LOE classifications are not an absolute index of the quality of evidence and do not preclude careful evaluation of the study's methods and results in the context of the authors' conclusions. As the application of evidence-based medicine expands in the plastic surgery community, surgeons must be mindful of how to appropriately interpret research findings and assess the utility of applying results to their practice.

Effect of Body Mass Index on Outcomes after Prepectoral Breast Reconstruction.

BACKGROUND: Body mass index has been shown to be a predictor of outcomes after subpectoral expander/implant reconstruction, with every unit increase in body mass index increasing the risk of complications by approximately 6 percent. The effect of body mass index on complications after prepectoral reconstruction has not yet been evaluated and is the purpose of this study. METHODS: A total of 366 reconstructed breasts from 197 patients were stratified into five body mass index groups (normal; overweight; and class I, class II, and class III, obese) and postoperative complications were compared across the groups. Additional analyses were performed using broad classifications of body mass index into nonobese and obese in addition to normal, overweight, and obese. Body mass index as an independent predictor of complications was assessed using multivariate logistic regression analysis. RESULTS: Complication rates did not differ significantly across body mass index groups when using the broad classifications. With five-group stratification, significantly higher rates of return to operating room, expander/implant loss, skin necrosis, wound dehiscence, and overall complications were seen in class II and/or class III obese versus overweight patients. However, on multivariate logistic regression analyses, body mass index, as a continuous variable, did not independently predict any complication. Diabetes and smoking emerged as significant predictors of any complication, indicating that these factors, rather than body mass index, were driving the increased rates of complications seen in the high-body mass index groups. CONCLUSION: Body mass index alone is not a predictor of outcomes after prepectoral expander/implant breast reconstruction and should not be used to estimate risk of postoperative complications or exclude patients for prepectoral reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

The Science of Cohesivity and Elements of Form Stability.

Silicone gel implants vary in terms of gel cohesivity and form stability. Various degrees of gel cohesivity are obtained by varying the density of crosslinking between silicone polymers. Less cohesive gels are less crosslinked, are more elastic, and have a softer feel while more cohesive gels more crosslinked, are less elastic, and have a firmer feel. When a highly cohesive gel is able to maintain its intended distribution within an implant, the gel is referred to as being form stable. Thus, a form-stable implant is able to retain its designed shape and dimensions in any position. Gel cohesivity and form stability influence breast shape, softness/firmness, and in vivo implant performance and an understanding of these parameters is critical to implant selection.

Outcomes Utilizing Inspira Implants in Revisionary Reconstructive Surgery.

BACKGROUND: Inspira round implants have a higher fill ratio than standard round implants and the 3 available implant types have increasing gel cohesivity. Collectively, these features may help provide a fuller upper pole and help reduce the risk of rippling, visible implant edges, and palpability and may be particularly beneficial in patients undergoing prepectoral reconstruction. Patient outcomes after prepectoral revision reconstruction with these implants are reviewed in this study. METHODS: This retrospective study included consecutive patients who had previously undergone subpectoral (dual plane), implant-based, breast reconstruction and presented for revision reconstruction between June 2015 and January 2018. Reasons for revision included animation deformity, pain, asymmetry implant malposition, size change, capsular contracture, and rippling. Revision reconstruction involved implant removal, site change from subpectoral to prepectoral, and immediate implant replacement in all patients. Complications after revision reconstruction were obtained from patient records. RESULTS: A total of 64 patients (124 breasts) met the inclusion criteria. During a mean follow-up period of 18.9 months, complications occurred in 4 breasts (3.2%) and included implant loss (1.6%), seroma (1.6%), hematoma (0.8%), surgical site infection (0.8%), and skin necrosis (0.8%). There was no incidence of capsular contracture and presenting complaints were resolved in all cases. CONCLUSIONS: Prepectoral reconstruction, in conjunction with Inspira round implants, appears to be a safe and effective approach in suitable patients presenting for revision surgery, at least in the short term. Implant features facilitate prepectoral implant placement, resulting in pleasing aesthetic outcomes. Whether these outcomes will withstand the test of time remains to be seen.

Implant selection in the setting of prepectoral breast reconstruction.

Implants vary in width, height, projection, volume, fill consistency, shell surface, and shape. Given the wide variety of implants that are available, selecting an implant that best suits a patient can be challenging. This article reviews the principles governing implant selection. Based on the authors' clinical experience, an algorithm for implant selection is proposed.

Economic Analysis Based on the Use of Closed-Incision Negative-Pressure Therapy after Postoperative Breast Reconstruction.

BACKGROUND: Breast cancer accounts for 30% of all new cancer diagnoses in women. Although more options are now available regarding breast reconstruction, the risk of complications (eg, infection, dehiscence, and expander exposure) is also prevalent and must be considered when choosing a reconstruction option because the cost for complications can be substantial. METHODS: A hypothetical cost model was applied to clinical outcomes of a previous retrospective study comparing the use of closed-incision negative-pressure therapy (ciNPT) and standard of care (SOC) over breast incisions after immediate reconstruction. The adjusted complication cost for a mastectomy with reconstruction was a mean of $10,402 and was calculated using a database of inpatient, outpatient, and carrier claims. RESULTS: The previous retrospective study included data on 665 breasts (ciNPT = 331, SOC = 334) and 356 female patients (ciNPT = 177, SOC = 179) and reported on complication rates at the breast level: 8.5% (28/331) for the ciNPT breast group versus 15.9% (53/334) for the SOC group (P = 0.0092). In the ciNPT group, 24/177 patients (13.6%) had a complication, whereas in the SOC group, 38/179 patients (21.2%) had a complication. Based on the adjusted mean complication cost of $10,402, total complication cost for the ciNPT group was $250,000 versus $395,000 for the SOC group with a per-patient cost savings of $218.00 with ciNPT. CONCLUSION: The authors' preliminary findings show potential cost savings with the use of ciNPT over breast incisions and warrant further study regarding the cost-effectiveness of ciNPT compared with standard of care after immediate breast reconstruction.