Vanessa Hartmann

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.

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.

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.

Decrease of reported adverse events to injectable polylactic acid after recommending an increased dilution: 8‐year results from the Injectable Filler Safety study

Background  Injectable fillers are widely used in aesthetic medicine. Polylactic acid (PLA) is a semipermanent filler that needs to be diluted with sterile water before injection. PLA has been associated with an increased risk of adverse reactions, specifically nodule formation.

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.

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.

Expert guideline on the use of porcine collagen in aesthetic medicine

JDDG | 3 ̇2010 (Band 8)

Methodological standards in medical reporting

Published research findings are the basis for health care decisions or further medical research. However, reporting of research methods and findings is often incomplete and of insufficient quality. Poor reporting hampers the assessment of reliability and validity of study results. Strengths and weaknesses of the investigation cannot be completely evaluated and subsequently it can mislead decision making in health care or in further clinical research.

The impact of adverse reactions to injectable filler substances on quality of life: results from the Berlin Injectable Filler Safety (IFS) - study.

Injectable filler substances are commonly used in aesthetic medicine. Adverse reactions are rare, but may cause severe impact on quality of life (QoL). To the best of our knowledge, data on the impact of adverse reactions caused by injectable filler substances on QoL is missing.

Methodische Standards in der medizinischen Berichterstattung

Forschungsergebnisse werden in vielfältiger Form publiziert und dadurch für andere nutzbar gemacht. Jedoch kann aufgrund unpräziser Beschreibung der Studie bezüglich der zugrundeliegenden Fragestellung, Durchführung und statistischen Auswertung sowie der Schlussfolgerungen der Autoren eine umfassende Evaluation der Studienergebnisse durch den Leser erschwert werden. Potenzielle Schwächen der Studien und die daraus resultierenden Verzerrungen im Ergebnis werden nicht erkannt und führen unter Umständen zu Fehlentscheidungen in der Planung weiterer Forschungsvorhaben oder bei Therapieentscheidungen. Eine transparente Berichterstattung kann dazu beitragen, Fehlinterpretationen von Publikationen zu minimieren. Seit einigen Jahren existieren für die Berichterstattung verschiedener Studientypen Leitlinien, die anhand von tabellarischen Checklisten Hilfestellungen geben, welche Informationen in den Publikationen aufgeführt werden sollen. Ziel dieser Leitlinien ist es, die Qualität wissenschaftlicher Artikel zu verbessern, damit Forschungsergebnisse unverzerrt zur Verfügung stehen. In diesem CME–Artikel werden Leitlinien vorgestellt, die Standards für die Berichterstattung von randomisierten kontrollierte Studien (CONSORT), Beobachtungsstudien (STROBE) sowie von systematischen Übersichtsarbeiten und Meta-Analysen (PRISMA, MOOSE) definieren und deren Anwendung bei Veröffentlichungen zunehmend von internationalen Fachzeitschriften gefordert wird.