Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: 3-Month Results.

BACKGROUND: Cellulite is an aesthetic condition affecting the appearance of skin in certain body regions and is associated with body dissatisfaction, psychosocial stress, and decreased quality of life. Previous studies established the safety and feasibility of a novel, minimally invasive device to identify and release septa responsible for cellulite depressions: targeted verifiable subcision (TVS). OBJECTIVES: The objective of this single-arm, open-label, multicenter study was to evaluate the safety and efficacy of TVS for reducing the appearance of moderate to severe cellulite in adult women. METHODS: Adult women aged 21 to 55 years and a BMI < 30 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were eligible to enroll at 9 sites. Endpoint data included results from 4 of the postprocedural follow-up visits at 24 hours, 7 days, 30 days, and 90 days. The primary endpoints were a mean ≥1 point reduction in the Cellulite Severity Scale at 90 days and no related serious adverse events at 30 days. RESULTS: Seventy-four female participants with a mean BMI of 24.8 ±â€…2.7 and age of 41.4 ±â€…7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ±â€…0.9 (P < 0.0001). There were no device-related serious adverse events at 30 days. CONCLUSIONS: TVS for selectively identifying and verifiably releasing septa responsible for cellulite depressions is an effective and safe means to improve the appearance of moderate to severe cellulite in adult women.

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months.

BACKGROUND: Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3 months postprocedure and have been published. Final, 12-month data describing durability of treatment effect and safety are presented here for the first time. OBJECTIVES: The authors sought to evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed employing the Avéli device (Revelle Aesthetics, Inc.; Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. METHODS: Effectiveness was determined by 3 independent physicians employing the Cellulite Severity Scale and Global Aesthetic Improvement Scale to assess improvement of baseline photographs when compared with 3-, 6- and 12-month posttreatment photographs. Blinded participant-reported outcomes and safety evaluations were also performed at all postprocedure time points. RESULTS: Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 (P < .0001) at 3 months, 1.54 points at 6 months, and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12-month visit. CONCLUSIONS: A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment.

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.

A Study of a Novel Controlled Focal Septa Release Method for Improving Cellulite.

Cellulite is a common and often emotionally distressing condition among affected individuals. The dimpled appearance is caused by fibrous connective tissue, or septa, which tether the dermis to underlying fascia. A novel, minimally invasive, controlled focal septa release method was developed to selectively identify, target and manually release the tethers in a precise manner from a single insertion point (Revelle Aesthetics). The following pilot study evaluated the safety and feasibility of this method for treating subjects with moderate-to-severe cellulite. Methods: Female subjects (N = 10), 21-55 years old underwent unilateral controlled, focal fibrous septa release on the buttocks and thighs. Local anesthesia was administered using standard techniques. Cellulite depressions were marked with the subject standing at rest. Target septa were identified in the marked areas by applying tension with the device to reproduce the dimple appearance on the skin. Once identified, the contributing septa were severed with the device. For eight subjects, access was achieved with one small incision in the gluteal crease. Study assessments occurred on posttreatment days 1, 3, 14, 30, and 90. Results: All procedures were successfully completed with no serious or unexpected adverse events and the procedure was well tolerated. Mild adverse events were transient bruising and soreness. Target septa can be visualized on the skin by applying tension with the device. Multiple depressions can be treated from a single entry point. Conclusion: These results confirm the safety and feasibility of the controlled focal fibrous septa release method to treat moderate and severe cellulite. Additional trials are ongoing.

Limited dilute lidocaine anesthesia: A useful technique with many practical applications.

BACKGROUND: Limited dilute lidocaine infiltration facilitates a comfortable procedure and a rapid recovery process following a novel intervention for reduction of cellulite. Infiltration of dilute lidocaine has many other practical applications in dermatologic surgery. OBJECTIVES: This article describes a safe, effective technique for local infiltration of limited volume dilute lidocaine anesthesia in a cellulite reduction procedure. METHODS: The limited dilute lidocaine technique was utilized in studies of a novel device designed to reduce the appearance of cellulite by focal release of fibrous septa in a minimally invasive procedure. No sedation was used. A small (27- to 30-gauge) needle was used to deliver anesthesia to the entry sites. Then, a 20-gauge spinal needle was tunneled under the skin in the superficial plane to manually deliver anesthetic along the advancement pathway of the device and marked cellulite targets. RESULTS: During the initial studies, the mean delivered anesthesia volume was 357.2 ml (range, 250-525 ml) or 18.7 mg/kg (range, 11.1-28.4 mg/kg). The mean anesthesia time was 16 min (range, 8-32 min). The mean number of cellulite depressions treated was 19.8 (range, 11-34). Adverse events were closely monitored, and there were no signs of toxicity in any study patients. There were very low levels of discomfort; all patients reported the procedure was tolerable. This technique facilitates a time-efficient procedure and minimizes weeping of excess fluid during recovery. CONCLUSIONS: When administered with care and skill, the limited dilute anesthesia technique is a safe, effective approach for local anesthesia with many practical applications in dermatologic surgery.

Assessment of patient-to-patient and intra-individual human abdominal skin immune cell variability.

Introduction: The objective of the study was to characterize the baseline intra-individual and inter-individual variability of immune cell subsets within abdominoplasty skin specimens. Methods: Abdominoplasty biopsies were taken from 5 patients and analysed using the Vectra 3 automated quantitative pathology imaging system with inForm software. Results: Adjacent skin regions demonstrated intra-patient variability in immune subset counts ranging from 1- to 5-fold. Inter-variability between patients was approximately 2- to 7-fold for most subsets, except for HLA-DR+ antigen presenting cells, which varied 19-fold. Conclusions: Our data highlight the importance of including multiple patients and multiple patient samples when designing dermatological studies that utilise abdominoplasty skin.

Augmentation Mastopexy:: Planning and Performance for Predictability: Management of Complications.

Augmentation mastopexy is generally considered to be one of the most difficult operations in breast surgery. It has an undeserved reputation for high complication rates and unhappy patients. Through careful planning, surgical techniques involving manipulation of the breast while maintaining blood supply and implant cover, and good augmentation technique, the operation can achieve predictable results in most cases with a low complication rate. Techniques to assess and manage the 2 main complications of waterfall deformity and bottoming out are discussed.

A Novel Classification of the Inframammary Fold for Use in Primary Breast Augmentation.

BACKGROUND: Previous aesthetic breast surgery algorithms have not addressed the importance of evaluating the native inframammary fold before primary breast augmentation. In the authors' experience, assessment of native inframammary fold anatomy significantly impacts surgical planning and technique. Failure to adequately evaluate and manage the inframammary fold leads to many of the common problems of the lower pole, including double-bubble deformity. METHODS: The authors assessed the inframammary fold preoperatively in 2192 consecutive patients undergoing primary breast augmentation between June of 2014 and December of 2018. A novel classification of inframammary fold morphology was devised based on review of standardized preoperative photographs. Outcome assessment was performed postoperatively at 3-month intervals. RESULTS: The authors identified four clear inframammary fold subtypes based on their clinical appearance, ranging from the nonexistent type F0 to the well-formed and fixed type F3. The key outcome measure examined was the presence of double-bubble deformity postoperatively. There were three total cases of double-bubble deformity identified in our cohort (<1 percent of patients). All cases of double-bubble deformity occurred in patients with a type 3 fold. CONCLUSIONS: The inframammary fold defines the inferior boundary of the lower pole of the breast and is a critical landmark to the aesthetic breast surgeon. The authors describe a unique and simple inframammary fold classification system that assists in selection of the appropriate approach to the inframammary fold in addition to implant dimensional planning. The authors have found that this system-in particular, the identification of the type F3 inframammary fold-has minimized the risk of inframammary fold-associated complications in over 2000 cases. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Breast Implant Selection: Consensus Recommendations Using a Modified Delphi Method.

BACKGROUND: Geographical differences in breast implant selection approaches exist, and clinical data to guide the process are limited. Developing knowledge of implant-related risk factors further complicates the process. This analysis aimed to establish expert consensus on considerations for breast implant selection in Australia and New Zealand based on practice patterns in those countries. METHODS: A modified Delphi method was used to gain consensus from experts in breast augmentation surgery in Australia and New Zealand. Panelists anonymously completed an initial questionnaire on current considerations in implant selection, discussed a summary of their responses in a live meeting, and completed a final consensus survey based on their live recommendations. RESULTS: Seven panelists completed the final consensus survey. Consensus recommendations included ensuring consideration of proper surgical technique (pocket formation, positioning of implant) and patient tissue and anatomical characteristics, weighing relative expected results of various surface textures, sizes, and degrees of cohesivity, and careful contemplation of the migration risk. CONCLUSIONS: This modified Delphi exercise provided consensus recommendations on the key factors involved in implant selection from the perspective of plastic surgeons with practices in Australia and New Zealand. A primary recommendation was that the choice of implant for each patient should be individualized to patient tissue and anatomical characteristics.

Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination around the Device: Experience in 42,000 Implants.

BACKGROUND: Bacteria/biofilm on breast implant surfaces has been implicated in capsular contracture and breast implant-associated anaplastic large-cell lymphoma (ALCL). Macrotextured breast implants have been shown to harbor more bacteria than smooth or microtextured implants. Recent reports also suggest that macrotextured implants are associated with a significantly higher incidence of breast implant-associated ALCL. Using techniques to reduce the number of bacteria around implants, specifically, the 14-point plan, has successfully minimized the occurrence of capsular contracture. The authors hypothesize that a similar effect may be seen in reducing the risk of breast implant-associated ALCL. METHODS: Pooled data from eight plastic surgeons assessed the use of macrotextured breast implants (Biocell and polyurethane) and known cases of breast implant-associated ALCL. Surgeon adherence to the 14-point plan was also analyzed. RESULTS: A total of 42,035 Biocell implants were placed in 21,650 patients; mean follow-up was 11.7 years (range, 1 to 14 years). A total of 704 polyurethane implants were used, with a mean follow-up of 8.0 years (range, 1 to 20 years). The overall capsular contracture rate was 2.2 percent. There were no cases of implant-associated ALCL. All surgeons routinely performed all 13 perioperative components of the 14-point plan; two surgeons do not routinely prescribe prophylaxis for subsequent unrelated procedures. CONCLUSIONS: Mounting evidence implicates the role of a sustained T-cell response to implant bacteria/biofilm in the development of breast implant-associated ALCL. Using the principles of the 14-point plan to minimize bacterial load at the time of surgery, the development and subsequent sequelae of capsular contracture and breast implant-associated ALCL may be reduced, especially with higher-risk macrotextured implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.