Statements on the Safety of Permanent Soft Tissue Fillers in Europe

Increasing reported complications associated with permanent soft tissue fillers have led the national medical societies and governmental institutes in Europe to send out warnings regarding their use. Regulation and legislation for the introduction of new products and the use of existing products are necessary to guarantee patient safety

The PRS Rainbow Classification for Assessing Postbariatric Contour Deformities

Background: There is a need for a reliable classification system to grade contour deformities and to inform reimbursement of body contouring surgery after massive weight loss. We developed the PRS Rainbow Classification, which uses select photographs to provide standardized references for evaluating patient photographs, to classify contour deformities in postbariatric patients. To assess the reliability of the PRS Rainbow Classification to classify contour deformities in massive weight loss patients. Methods: Ten independent experienced plastic surgeons, 7 experienced medical advisors of the healthcare insurance company, and 10 laypersons evaluated 50 photographs per anatomical region (arms, breast, abdomen, and medial thighs). Each participant rated the patient photographs on a scale of 1-3 in an online survey. The inter-observer and the intra-observer reliabilities were determined using intra-class correlation coefficients (ICCs). The ICC analyses were performed for each anatomical region. Results: Inter-observer reliability was moderate to good in the body regions "arms," "abdomen," "medial thighs," with mean ICC values of 0.678 [95% confidence interval (CI), 0.591-0.768], 0.685 (95% CI, 0.599-0.773), and 0.658 (95% CI, 0.569-0.751), respectively. Inter-observer reliability was comparable within the 3 different professional groups. Intra-observer reliability (test-retest reliability) was moderate to good, with a mean overall ICC value of 0.723 (95% CI, 0.572-0.874) for all groups and all 4 body regions. Conclusions: The moderate to good reliability found in this study validates the use of the PRS Rainbow Classification as a reproducible and reliable classification system to assess contour deformities after massive weight loss. It holds promise as a key part of instruments to classify body contour deformities and to assess reimbursement of body contouring surgery

Tissue Stromal Vascular Fraction Improves Early Scar Healing:A Prospective Randomized Multicenter Clinical Trial

Background Wound healing and scar formation depends on a plethora of factors. Given the impact of abnormal scar formation, interventions aimed to improve scar formation would be most advantageous. The tissue stromal vascular fraction (tSVF) of adipose tissue is composed of a heterogenous mixture of cells embedded in extracellular matrix. It contains growth factors and cytokines involved in wound-healing processes, eg, parenchymal proliferation, inflammation, angiogenesis, and matrix remodeling.Objectives The aim of this study was to investigate the hypothesis that tSVF reduces postsurgical scar formation.Methods This prospective, double-blind, placebo-controlled, randomized trial was conducted between 2016 and 2020. Forty mammoplasty patients were enrolled and followed for 1 year. At the end of the mammoplasty procedure, all patients received tSVF in the lateral 5 cm of the horizontal scar of 1 breast and a placebo injection in the contralateral breast to serve as an intrapatient control. Primary outcome was scar quality measure by the Patient and Observer Scar Assessment Scale (POSAS). Secondary outcomes were obtained from photographic evaluation and histologic analysis of scar tissue samples.Results Thirty-four of 40 patients completed follow-up. At 6 months postoperation, injection of tSVF had significantly improved postoperative scar appearance as assessed by the POSAS questionnaire. No difference was observed at 12 months postoperation. No improvement was seen based on the evaluation of photographs and histologic analysis of postoperative scars between both groups.Conclusions Injection of tSVF resulted in improved wound healing and reduced scar formation at 6 months postoperation, without any noticeable advantageous effects seen at 12 months.</p

The Effect of Eyelid Cooling on Pain, Edema, Erythema, and Hematoma after Upper Blepharoplasty:A Randomized, Controlled, Observer-Blinded Evaluation Study

Background: The purpose of this study was to investigate the efficacy of eyelid cooling to reduce postoperative pain, edema, erythema, and hematoma after upper blepharoplasty. Methods: After bilateral upper blepharoplasty in 38 consecutive patients, one eyelid per patient was randomized for cooling with an ice pack, and the other eyelid was left uncooled. Pain was scored by the patients using a visual analogue scale (0 to 10) 1 hour and 1 day after surgery. Degree of edema, erythema, and hematoma were scored by the patients on a four-point rating scale (no, minimal, moderate, or severe) 1 hour, 1 day, 1 week, and 2 months after surgery. Light photography was obtained 1 week after surgery for scoring the degree of bruising on a four-point rating scale by a blinded observer. Results: Pain did not differ between cooled and uncooled eyelids on the day of surgery. However, pain in cooled eyelids was significantly lower 1 day after surgery (p = 0.046), yet absolute pain scores were low (median, 0 and 0.5, on a scale of 10). Edema, erythema, or hematoma did not differ between cooled and uncooled eyelids on any of the time points studied. Conclusions: Cooling of eyelids after upper blepharoplasty does not reduce edema, erythema, or hematoma of the eyelids, but reduces pain 1 day after surgery. However, because the degree of pain seems clinically irrelevant and because the majority of patients indicate that they have no preference for cooling over noncooling, eyelid cooling after upper blepharoplasty as a rule of thumb can be abandoned