Dermal fillers in the Netherlands : A market surveillance study

Abstract

Dermal fillers, or just fillers, are products that are injected into or under the skin for medical or cosmetic purposes. This could be to restore the natural contours of the body after an operation for example, but also to mask the visible effects of ageing. The National Institute for Public Health and the Environment (RIVM) has compiled an overview of 26 so-called non-permanent fillers that were marketed in the Netherlands in 2014, and has analysed these products in a laboratory. The technical files of the 14 manufacturers of these products were also investigated. Following a request through professional associations, 67 treating professionals completed a questionnaire about the fillers that they use and about their potential side effects. All 26 products from 14 manufacturers proved to be harmless. In order to establish this, an internationally recognised laboratory test that measures harmful effects on cells was carried out. The composition of the products conforms with the description in the technical files. According to the treating professionals, the products from the 14 manufacturers cause very few side effects. The quality of key sections in the technical files of the 14 manufacturers varied. It is important that manufacturers ensure their technical files are kept in good order. By keeping complete and correct files, manufacturers underpin the safety of the product for the patient, although a limitation in the files does not lead directly to a substandard product. Two sets of files were incomplete, meaning that the safety of the product for the patient is not well substantiated. Most of the inadequacies in the files were of an administrative nature, and are not expected to have any influence on the safety of the product for the patient.