A Comprehensive Analysis of the Safety of a New Range of Injectable Hyaluronic Acid Products for Aesthetic Indications
David E. Bank, MD, Derek H. Jones, MD, Cindy Wong, MD, Jay Mashburn
It is known that less common adverse events may not be detected in clinical studies because of the number of subjects studied. For injectable hyaluronic acid soft tissue fillers, while the safety and effect are studied in pre-approval registration studies; certain less common adverse events such as late onset nodules have been reported for some products only after the products have been put on the market. Therefore post-market safety experience from a larger patient population may provide important new information.
The new hyaluronic acid (HAOBT) range of products consists of five hyaluronic acid (HA) soft tissue fillers formulated through a unique process called XpresHAn TechnologyTM, known as Optimal Balance TechnologyTM (OBT) outside the US. These products have an HA concentration of 20 mg/mL and their distinctive physical properties are obtained by varying the cross-linking degree and particle size. The HAOBT injectable gel products are intended for facial tissue augmentation and to add volume to the tissue. They have been available for use in Europe since 2010. An analysis of the post market experience is intended to provide further insight into the safety of these products.
The authors will present a comprehensive assessment on the available data on the safety of these products obtained after product launch, based on a review of published literature and analysis of post-market adverse events reported to the manufacturer since launch. The manufacturer of HAOBT has made available the post-market adverse events data base for review. An analysis of the types of adverse events with focus on adverse events with onset more than one month after treatment will be presented.
All safety data collected from all sources world-wide during 2011 to 2015 was reviewed. Published and unpublished post market studies on over 2000 patients did not identify any safety concerns. The post-market reporting frequency for potentially related cases was estimated to be 0.033% and cases of nodules were reported at 0.004%. The majority of the cases of nodules had onset within 3 months of treatment and there were very few cases reported with onset after 6 months.
In parallel, a review of the adverse events data in the FDA Maude database was conducted specifically looking at late onset events reported for other HA products as background information.
Based on this comprehensive review, it can be concluded that products produced by OBT technology have a good and accepted safety profile.