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.

Tension Reduction With Force Modulating Tissue Bridges Reduces Wounds in Breast Surgery.

BACKGROUND: Tension on healing wounds increases the risk of dehiscence and poor or pathologic scar formation. Force modulating tissue bridges (FMTBs) represent a new class of wound closure and support devices designed to offload tension on healing wounds to improve wound healing and scar outcomes. OBJECTIVES: The study was undertaken to assess the efficacy of FMTBs to reduce the risk of wound healing complications in elective breast surgery. METHODS: One hundred twenty-two consecutive patients undergoing bilateral aesthetic breast surgery underwent intraoperative placement of FMTBs on the vertical limb closure site. A matched case-control cohort of 121 consecutive patients was established for comparison. Wounds were considered significant if larger than 3 mm in diameter. The primary outcome of breast wounds >3 mm was reported with a relative risk, and all outcomes were framed with number needed to treat. RESULTS: The control and intervention cohorts had similar demographics, comorbidities, type of operation, and incision pattern utilized. Within the FMTB group, 96.7% (n = 118) patients completed treatment per protocol. Significant wounds occurred in 1.7% (n = 2) of patients in the tissue bridge vs 15.2% (n = 19) in controls on a per patient/per protocol basis (89% reduction, P < .001). Statistically significant improvements were maintained on sensitivity analyses with intention to treat, even when minor wounds were included. There were no complications noted related to FMTBs. CONCLUSIONS: FMTBs are safe and highly effective at reducing the risk of wound formation in elective breast surgery. Results are consistent with sensitivity analyses based on clinical and methodological factors. Further research will assess long-term scar outcomes.

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.

Preserving the Legitimacy of Board Certification.

OBJECTIVES: The aims of this discussion were to inform the medical community about the American Board of Cosmetic Surgery's ongoing attempts in Louisiana to achieve equivalency to American Board of Medical Specialties (ABMS) member boards so that its diplomates may use the term "board certified" in advertising and to ensure public safety by upholding the standards for medical board certification. BACKGROUND: In 2011, Louisiana passed a truth in medical advertising law, which was intended to protect the public by prohibiting the use of the term "board certified" by improperly credentialed physicians. An American Board of Cosmetic Surgery diplomate petitioned the Louisiana State Board of Medical Examiners to approve a rule that would establish a pathway to equivalency for non-ABMS member boards, whose diplomates have not completed training approved by the Accreditation Council for Graduate Medical Education (ACGME) in the specialty they are certifying. Physicians and physician organizations representing multiple specialties (facial plastic and reconstructive surgery, otolaryngology [head and neck surgery], orthopedic spine surgery, pediatric neurosurgery, dermatology, and plastic surgery) urged the Louisiana State Board of Medical Examiners to clarify its advertising policy, limiting the use of the term "board certified" to physicians who have completed ACGME-approved training in the specialty or subspecialty named in the certificate. DISCUSSION: The public equates the term "board certified" with the highest level of expertise in a medical specialty. When a certifying board does not require completion of ACGME or American Osteopathic Association (AOA)-accredited training in the specialty it certifies, the result is an unacceptable degree of variability in the education and training standards applied to its diplomates. Independent, third-party oversight of certifying boards and training programs is necessary to ensure quality standards are upheld. Any system that assesses a non-ABMS member or non-AOA-certified board for equivalency approval must ensure that the training and qualifications required by the non-ABMS or AOA board are equivalent in scope, content, and duration to those required by the ABMS and AOA. This issue must not be misconstrued as a "turf battle" between physicians of 2 competing specialties. Preserving the legitimacy of board certification is incumbent upon all medical specialties and subspecialties. This argument is a truthful, principled defense of the legitimacy of board certification.

Superiorly Based Short-Scar Mastopexy Augmentation: A 10-Year Review of 1217 Consecutive Cases.

BACKGROUND: Mastopexy augmentation is a challenging procedure, and a technique to create desirable, consistent, predictable results with a low rate of problems has not been well standardized. The inherent difficulty lies in competing surgical maneuvers. This study sought to evaluate the authors' experience and describe the key concepts and steps that allow safe, efficient, predictable results with low complication and long-term reoperation rates. METHODS: A 10-year retrospective review of all aesthetic breast operations between 2005 and 2015 was performed. Two senior surgeons (S.H.W. and H.C.W.) performed 1217 one-stage, superiorly based, short-scar mastopexy augmentation procedures. The data were evaluated in the context of other published series in the literature. RESULTS: The overall revision rate was 4.8%. Patients who had undergone prior breast surgery were statistically more likely to require a revision compared with patients who had virgin breast tissue (10.4% versus 3.8%; P = 0.0005). Average follow-up was 39 months. Twenty-eight percent of revisions were performed more than 2 years after the original surgery; 16% were performed more than 6 years later. All revisions were included, regardless of procedure scope or timing. Of the 58 revision cases, 86% were purely implant or implant-pocket related; 7% were purely tissue related. There was one case of partial nipple necrosis. There were no cases of emergent reoperation, implant loss, implant exposure, or major wound dehiscence. CONCLUSIONS: The authors' approach has been refined to maximize aesthetics, longevity, consistency, and surgical efficiency, and to minimize complications. This study demonstrates that safe and predictable results can be attained in one stage with low complication and reoperation rates. . CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Impact of liposome bupivacaine on the adequacy of pain management and patient experiences following aesthetic surgery: Results from an observational study.

BACKGROUND: Despite the efficacy of opioid analgesics for postsurgical pain, they are associated with side effects that may complicate recovery. Liposome bupivacaine is a prolonged-release formulation of bupivacaine approved for intraoperative administration at the surgical site for postsurgical analgesia. OBJECTIVES: To evaluate the effect of a single intraoperative administration of liposome bupivacaine on postsurgical pain, opioid use and opioid-related side effects in subjects undergoing breast surgery and/or abdominoplasty. METHODS: In the present phase IV, multicentre, prospective observational study, subjects received a single intraoperative administration (266 mg) of liposome bupivacaine. Rescue analgesia was available to all subjects as needed. Outcome measures, assessed through postoperative day 3, included postsurgical pain intensity (11-point numerical rating scale), opioid consumption and overall benefit of analgesic score. Results were evaluated comparing investigators' previous experience with similar surgeries. RESULTS: Forty-nine subjects entered the study: 34 underwent breast surgery only and 15 underwent abdominoplasty with or without breast surgery (six underwent breast surgery in addition to abdominoplasty). Mean numerical rating scale pain scores remained ≤4.3 from discharge through postoperative day 3. Median daily oral opioid consumption was approximately 1.0 tablet postoperatively on the day of surgery and was approximately 2.0 tablets by postoperative day 3. Mean overall benefit of analgesic score ranged between 2.8 and 4.9 throughout the study. CONCLUSION: In this particular subject population, liposome bupivacaine was associated with low pain intensity scores and reduced opioid consumption compared with the investigators' previous experiences. Subjects' satisfaction with postsurgical analgesia was high, with a low burden of opioid-related side effects.

HISTORIQUE: Malgré l'efficacité des opioïdes pour soulager la douleur postchirurgicale, des effets secondaires peuvent compliquer le rétablissement. La bupivacaïne liposomique est une formulation à libération prolongée approuvée pour l'administration peropératoire d'une analgésie postchirurgicale au site opératoire. OBJECTIFS: Évaluer l'effet de l'administration peropératoire d'une seule dose de bupivacaïne liposomique sur la douleur postchirurgicale, ainsi que sur l'utilisation d'opioïdes et leurs effets secondaires chez des sujets subissant une chirurgie mammaire, une abdominoplastie ou les deux interventions. MÉTHODOLOGIE: Dans le cadre de la présente étude d'observation prospective et multicentrique de phase IV, les sujets se sont fait administrer une seule dose peropératoire de bupivacaïne liposomique (266 mg). Tous les sujets pouvaient recevoir une analgésie de secours, au besoin. Les mesures des résultats, évaluées jusqu'au troisième jour postopératoire, incluaient l'intensité de la douleur postchirurgicale (sur une échelle numérique de onze points), la consommation d'opioïdes et les bienfaits globaux du score analgésique. Les chercheurs ont évalué les résultats en les comparant à leur expérience de chirurgies similaires. RÉSULTATS: Quarante-neuf sujets ont participé à l'étude : 34 ont subi seulement une chirurgie mammaire et 15, une abdominoplastie accompagnée ou non d'une chirurgie mammaire (six ont subi une chirurgie mammaire en plus de l'abdominoplastie). Les scores de douleur moyens sur l'échelle numérique ne dépassaient pas 4,3 entre le congé et le troisième jour postopératoire. La consommation quotidienne médiane d'opioïdes par voie orale après l'opération était d'environ 1,0 comprimé le jour de la chirurgie et d'environ 2,0 comprimés le troisième jour postopératoire. Les avantages globaux moyens du score analgésique se situaient entre 2,8 et 4,9 tout au long de l'étude. CONCLUSION: Au sein de cette population de sujets, la bupivacaïne liposomique s'associait à de faibles scores d'intensité de la douleur et à une consommation réduite d'opioïdes par rapport aux expériences passées des chercheurs. Les sujets étaient très satisfaits de l'analgésie postchirurgicale et présentaient un faible fardeau d'effets secondaires liés aux opioïdes.

Brief report: Normal hematology values of Sykes monkeys (Cercopithecus mitis albogularis).

Hematologic values are presented for the Sykes monkey (Cercopithecus mitis albogularis). The values are, in general, similar to published findings for other primate species. Elevated hemoglobin, possibly caused by high altitude, was noted. Significant differences of several values between males and females are discussed.