Clinical data on injectable tissue fillers: a review

Abstract

Treatment with injectable tissue fillers for aesthetic purposes is increasingly popular. In parallel with this success, questions related to the safety of these treatments and the products involved are being raised more prominently. To gain insight in the safety aspects of injectable tissue fillers, we performed a literature review to collect studies reporting clinical data of injectable tissue fillers. We found several case reports where serious complications after more than three years are described. However, there are only a limited number of well-defined prospective clinical studies available with follow-up periods longer than three years. Furthermore, causes of complications, that is, treatment or product related, are often not specified in literature. Considering the intended functional period of fillers in combination with the known occurrence of long-term complications, there is a need for well-defined prospective clinical studies. In order to be able to discriminate between product failure (a product safety issue) or application methodology (a physician expertise or training issue), better identification of observed complications and whether they are product or treatment related, is needed. For the safe use of the fillers it is important that treatment with injectable tissue fillers is performed by a trained physician, who knows the product specifications and its applications.

Keywords::

• clinical data
• complications
• injectable tissue fillers
• long-term follow-up
• prospective clinical studies
• safety

Acknowledgement

The authors would like to thank WH de Jong for critically reviewing the manuscript.

Financial & competing interests disclosure

This investigation has been performed by order and for the account of the Health Care Inspectorate of The Netherlands, within the framework of project V/360050 Supporting the Health Care Inspectorate on Medical Technology. The author have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • All semi-permanent and permanent injectable tissue fillers may cause complications.

• • Complications can occur long after the first treatment. Complications can be product- or treatment-related.

• • Tissue filler products need to be thoroughly evaluated in clinical studies with sufficient long-term follow-up before and after they are placed on the market.

• • Only trained physicians with knowledge of products and the intended use, who have evaluated the risks and benefits with the consumer, should perform treatment with tissue fillers.