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

Volumizing effects of a smooth, highly cohesive, viscous 20-mg/mL hyaluronic acid volumizing filler: prospective European study

<p>Abstract</p> <p>Background</p> <p>Facial volume loss contributes significantly to facial aging. The 20-mg/mL hyaluronic acid (HA) formulation used in this study is a smooth, highly cohesive, viscous, fully reversible, volumizing filler indicated to restore facial volume. This first prospective study evaluated use in current aesthetic clinical practice.</p> <p>Methods</p> <p>A pan-European evaluation conducted under guidelines of the World Association of Opinion and Marketing Research, the trial comprised a baseline visit (visit 1) and a follow-up (visit 2) at 14 ± 7 days posttreatment. Physicians photographed patients at each visit. Each patient was treated with the 20-mg/mL HA volumizing filler as supplied in standard packaging. Procedural details, aesthetic outcomes, safety, and physician and patient ratings of their experience were recorded.</p> <p>Results</p> <p>Fifteen physicians and 70 patients (91% female; mean age: 50 years) participated. Mean volume loss at baseline was 3.7 (moderate) on the Facial Volume Loss Scale. Local anesthesia was used in 64.3% of cases. Most injections (85%) were administered with needles rather than cannulas. Of the 208 injections, 59% were in the malar region, primarily above the periosteum. Subcutaneous injections were most common for other sites. The mean total injection volume per patient was 4.6 mL. The mean volume loss score declined significantly (<it>P </it>< .001) to 2.1 at visit 2. On the Global Aesthetic Improvement Scale, 88% and 76% of the treatments were rated very much improved or much improved by physicians and patients, respectively. Of the physicians, 95.6% rated this HA filler as very or fairly easy to use. Similarly, 92% of patients were very likely or quite likely to return for treatment; nearly all (98%) would recommend this treatment to friends. Transient (mean duration: 5.5 days) injection-site adverse events (AEs) occurred in 24 patients. Bruising was the most common AE.</p> <p>Conclusion</p> <p>The 20-mg/mL smooth, highly cohesive, viscous, volumizing HA filler was effective, well tolerated, and easy to use in current clinical practice. Participants were very likely to recommend this product to colleagues and friends, and patients would be very or quite likely to request this product for future treatments.</p

Surgical treatment of zygomatic bone fracture using two points fixation versus three point fixation-a randomised prospective clinical trial

<p>Abstract</p> <p>Background</p> <p>The zygoma plays an important role in the facial contour for both cosmetic and functional reasons; therefore zygomatic bone injuries should be properly diagnosed and adequately treated. Comparison of various surgical approaches and their complications can only be done objectively using outcome measurements which in turn require protocol management and long-term follow up. The preference for open reduction and internal fixation of zygomatic fractures at three points has continued to grow in response to observations of inadequate results from two point and one point fixation techniques.</p> <p>The objectives of this study were to compare the efficacy of zygomatic bone after treatment with ORIF using 2 point fixation and ORIF using 3 point fixation and compare the outcome of two procedures.</p> <p>Methods</p> <p>100 patients were randomly divided equally into two groups. In group A, 50 patients were treated by ORIF using two point fixation by miniplates and in group B, 50 patients were treated by ORIF using three point fixation by miniplates. They were evaluated for their complications during and after surgery with their advantages and disadvantages and the difference between the two groups was observed.</p> <p>Results</p> <p>A total of 100 fractures were sustained. We found that postoperative complication like decreased malar height and vertical dystopia was more common in those patients who were treated by two point fixation than those who were treated with three point fixation.</p> <p>Conclusions</p> <p>Based on this study open reduction and internal fixation using three point fixation by miniplates is the best available method for the treatment zygomatic bone fractures.</p

A New Approach for Adipose Tissue Treatment and Body Contouring Using Radiofrequency-Assisted Liposuction

A new liposuction technology for adipocyte lipolysis and uniform three-dimensional tissue heating and contraction is presented. The technology is based on bipolar radiofrequency energy applied to the subcutaneous adipose tissue and subdermal skin surface. Preliminary clinical results, thermal monitoring, and histologic biopsies of the treated tissue demonstrate rapid preaspiration liquefaction of adipose tissue, coagulation of subcutaneous blood vessels, and uniform sustained heating of tissue

Individual and ethnic aspects of preoperative planning for posttraumatic rhinoplasty

The aim of this study was to compare the aesthetic results of post traumatic rhinoplasty among Europeans with populations of healthy Caucasians described in earlier reports, and to collate correct parameters of nasal shape in healthy representatives of both sexes and various races for improvement in aesthetic results of surgery. 3-D scanning of the face was performed in 54 patients after posttraumatic septorhinoplasty. Analysis of 3D model was based on two indices of the nasal proportions and four angles of the region from 18 anthropological points. Parameters of the nasal shape in addition to gender were compared to average values of healthy Caucasian population, described before. Normal characteristics of the nose among individuals of three races from previous studies were also compared to one another. In females, mean height and width of the nose as well as length of both nostrils was smaller. Neither were there any significant differences in width of the nostrils and length of the nasal pyramid nor nasal prominence. Nasal proportions were similar in both sexes. Some of the nasal angles differed in addition to gender. Posttraumatic rhinoplasty resulted in correct shape of the nose similar to the healthy Caucasian population. The aesthetic nose differ among healthy individuals of the three races analysed. While preoperative planning is important, knowledge of the normal values of parameters characterising shape in both genders is equally important as the individual differences in relation to the whole face

High-density hyaluronic acid for the treatment of HIV-related facial lipoatrophy

Facial lipoatrophy is a stigmatizing hallmark of HIV. The injection of facial fillers has an essential role in the treatment of this condition. The objective of our study was to verify the safety and efficacy of a new formulation of high-density hyaluronic acid for the injectable treatment of HIV-related facial lipoatrophy.We treated with high-density hyaluronic acid injections HIV patients affected by moderate to severe facial lipoatrophy and evaluated them at last follow-up, at a minimum of 36 weeks. Physician-related outcomes included pre-and post-treatment ultrasound measurement of the soft-tissue thickness of the cheeks and qualitative assessment of aesthetic results by means of the Global Aesthetic Improvement Scale using pre- and post-treatment photos of the patients. Patient satisfaction outcomes were evaluated with the VAS-face scale and Freiburg test.Fifty-four patients were studied. The median number of treatment sessions was 3 and the median length of treatment was 5.5 months. The thickness of the soft tissues of the cheek increased significantly from 9.45 to 13.12 mm (p&lt;0.0001). On the basis of the Global Aesthetic Improvement Scale, 87.5% of the patients were judged as "much improved" or "improved." Patient satisfaction at 1 year from the end of treatment was proven (VAS-face: 77.9; Freiburg questionnaire: 93.6% of patients were satisfied or very satisfied). Complications were limited to mild redness and swelling in the early postoperative period.Long-term improvement of facial contour and excellent patient satisfaction, in the absence of severe side effects, were obtained by the injection of high-density hyaluronic acid (STYLAGE\uae XL) in HIV patients with facial lipoatrophy