Frank Bachmann

Hyaluronidase in the correction of hyaluronic acid‐based fillers: a review and a recommendation for use

Background  Hyaluronic acid (HA) preparations are the most commonly used injectable fillers in esthetic medicine. In contrast to other injectable fillers with hyaluronidase, there is a tool available to reduce unwanted depots of this filler.

The Spectrum of Adverse Reactions After Treatment with Injectable Fillers in the Glabellar Region: Results from the Injectable Filler Safety Study

BACKGROUND For the glabellar region, severe partly vascular adverse events have been reported after treatment with injectable fillers. METHODS AND MATERIALS For this study, data from the Injectable Filler Safety Study, a German‐based registry for those reactions, was analyzed to characterize adverse events seen in the glabellar region. Patients were analyzed descriptively. RESULTS Forty of 139 registered patients reported adverse events in the glabellar region. All patients were female, with an average age of 52.3. Nineteen patients with adverse reactions to hydroxyethylmethacrylate (HEMA) and ethylmethacrylate (EMA) in a fixed combination with hyaluronic acid (HA) and 10 patients with adverse reactions to different hyaluronic acid products were reported; five patients reacted to poly‐l‐lactic acid (PLA). The most common adverse reactions to HEMA/EMA in HA and PLA were nodules and hardening. In HA‐treated patients, erythema and inflammation, swelling, and pain were most frequent. The adverse reactions to HEMA/EMA in HA were severe in 50% of the patients. Severe adverse reactions were found to a lesser extent in patients treated with HA and PLA. Potential vascular complications were documented in only two patients. CONCLUSION Adverse reactions seen in the glabella are overwhelmingly product associated and to a lesser extent location associated. Vascular complications with necrosis and ulceration were rare. Dr. Rzany is an advisor for Johnson & Johnson, Merz, Pharmaceuticals GmbH, Q‐Med, and Teoxane Laboratoires.

Safety and Efficacy of the Tumor Necrosis Factor Antagonists

Psoriasis is one of the most common systemic inflammatory diseases and affects the quality of life of the affected persons profoundly. Further knowledge of the pathogenesis and new biotechnological techniques have made it possible to develop new targeted therapies, such as antibodies against tumor necrosis factor (TNF)-alpha. Today, 3 TNF inhibitors, infliximab, adalimumab, and Etanercept, have been approved for the treatment of psoriasis arthritis, psoriasis, and other indications like Crohns disease, depending on the distinct substance by the European Medicines Agency. Golimumab was approved in September 2009 for the use in psoriasis arthritis, respectively. These substances have added new effective treatment options to the therapeutic armamentarium of psoriasis. To use these new treatments for the best of our patients, it is important to know the correct application, the advantages, as well as contraindications or possible adverse effects of the substances. This article provides an update on the TNF-alpha inhibitors with emphasis on practical daily use. Most data are on the basis of high-quality studies and official guidelines, but if necessary, data from recent publications or clinical expertise have been added. In summary, with TNF inhibitors we have gained effective new treatment options showing a favorable safety profile when paying attention to safety aspects before and during therapy (screening, monitoring).

Efficacy and Durability of Two Hyaluronic Acid–Based Fillers in the Correction of Nasolabial Folds: Results of a Prospective, Randomized, Double‐Blind, Actively Controlled Clinical Pilot Study

BACKGROUND This pilot study compared a monophasic hyaluronic acid dermal filler with a biphasic filler for the correction of nasolabial folds. METHODS Participant- and assessor-blinded, randomized clinical trial involving participants with moderate to severe nasolabial folds. Split-face design comparing a monophase hyaluronic acid (HA) filler (mono-HA) with a biphasic HA filler (bi-HA). Injection with touch-up after 1 month. Wrinkle improvement was measured before and after injection and after 1, 2, 4, and 7 months, using the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale as outcome criteria. An optional treatment was offered at the end of the study, with participants allowed to choose one of the products. OBJECTIVE Evaluation of efficacy and safety of both products. RESULTS Both products showed immediate, good results after injection and touch-up and demonstrated good durability over time. Participant preference for optional treatment at the end of the study favoured mono-HA. Both products were well tolerated, without serious adverse events. CONCLUSION The effect after injection of mono-HA and bi-HA is generally comparable, although there was a trend in favor of mono-HA. Materials and funding for this study were provided by Teoxane, Geneva, Switzerland.

Risk of Severe Adverse Reactions To an Injectable Filler Based on a Fixed Combination of Hydroxyethylmethacrylate and Ethylmethacrylate with Hyaluronic Acid

BACKGROUND Hydroxyethylmethacrylate and ethylmethacrylate in a fixed combination with hyaluronic acid has been used as an injectable filler for nearly a decade. Severe adverse reactions have been associated with this filler. OBJECTIVE To characterize the adverse reactions to this filler. METHODS Data from the Berlin registry for adverse reactions to injectable fillers were analyzed. The registry is a partially population‐based registry with the aim of collecting adverse reactions to injectable fillers. Patients were interviewed based on a standardized questionnaire. RESULTS Thirty‐four of 118 (28.8%) registered patients were treated with this filler. Of 95 treated areas, 87 responded with a reaction (91.6%). The most frequently observed adverse events were the development of nodules (n=85) in 87 affected areas, discoloration (n=39), erythema or inflammation (n=32), and swelling (n=24). Most nodular reactions were rated as severe. The mean time after the last treatment until appearance of an adverse reaction was 23.1±22.8 months. CONCLUSION Adverse reactions to this methacrylate filler are common. The mean latency period for these mostly severe rated reactions was nearly 2 years. Based on the frequency and severity of these reactions, the use of this filler does not seem to be advisable. The authors have indicated no significant interest with commercial supporters.

Adverse reactions caused by consecutive injections of different fillers in the same facial region: risk assessment based on the results from the Injectable Filler Safety study

Background  The combination of different injectable fillers in one area is considered to increase the risk of adverse reactions.

The Current State of Treatment of Adverse Reactions to Injectable Fillers

BACKGROUND Adverse reactions to injectable filler may be challenging to treat. The spectrum of treatment options ranges from immunomodulatory drugs (e.g., glucocorticosteroids) to antibiotics to laser therapy and surgery. OBJECTIVES To assess how adverse reactions were treated and how they processed over time. MATERIALS AND METHODS Participants from the Injectable Filler Safety (IFS) Study were reinterviewed to obtain data on the course of adverse reactions and the therapy. RESULTS Forty‐one participants from the IFS Study were reinterviewed; 35 (85%) received treatment, 17 (41%) with a combination of drug therapy and surgery, 14 (34%) with drug therapy only, and four (10%) with a surgical intervention. Six (15%) did not receive any treatment. Fifty‐one percent of all of the treated participants reported treatment‐related adverse reactions. Participants with more severe adverse reactions were more likely to be treated with a combination of drugs and surgery. In all participants, adverse reactions improved. CONCLUSION We certainly need more evidence. Reporting positive and negative treatment outcomes is important to improve our knowledge regarding these reactions. Therefore, registries focusing on adverse reactions to injectable fillers and their treatment should be encouraged. The authors have indicated no significant interest with commercial supporters.

Injizierbare Füllmaterialien@@@Injectable fillers: Nebenwirkungen und Management@@@Adverse reactions and their management

Injectable fillers are one of the corner stones of aesthetic medicine. In general they are safe to use. However, adverse reactions may occur. These reactions may be acute, subacute or delayed, e.g. after decades. It is important to know these reactions and to be prepared so that they can be adequately treated, in view of the clinical symptoms, the injected material and if applicable other diseases/treatments that might trigger these reactions. Last but not least, all reactions should be reported either to specialized registries or regulatory agencies. Only then we are able to learn more about these reactions and their best possible treatment.

Hand augmentation with stabilized hyaluronic acid (Macrolane VRF20 and Restylane Vital, Restylane Vital Light).

Volume augmentation of the back of the hand is a new technique which is not yet often employed. We describe the treatment of two patients who received hyaluronic acid products produced by Q‐Med (Macrolane™ VRF20, Restylane® Vital and Vital Light). The injections of Macrolane™ VRF 20 were done by feathering technique using a long and blunt 18 gauge canula while Restylane® was injected by tunneling or tenting technique with a 30 gauge needle. Significant adverse events did not occur. After injection of the hyaluronic acid fillers, the appearance of the back of the hands was improved. Both patients were very satisfied with the result.

Komplikationen auf injizierbare Füllmaterialien

Injectable fillers are an established component of aesthetic medicine. In general they are safe to use. However, adverse reactions are possible for the whole spectrum of products. These reactions can occur immediately, subacute or delayed, e.g. after years. Erythema, edema, abscesses, nodule formation or even ulcerations can be observed. A correct diagnoses of these reactions is important to allow an appropriate treatment, taking into consideration the clinic, the injected material and if applicable other diseases/treatments that might contribute to these reactions. All of these reactions should be reported either to specialized registries and/or to the appropriate national agencies. Only then will we be able to learn more about these reactions and the best possible treatment.