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Safe implants

The safety and efficacy of medical devices and particularly implants have been in the limelight in recent years. This attention derives from problems arising from silicon breast implants, metal-on-metal hip joints, and pelvic floor mesh.

Safety and efficacy study

The Health Care Inspectorate and the Ministry of Health, Welfare and Sport commissioned RIVM to carry out a study on the safety and efficacy of implants. RIVM investigated three aspects: setting up a national implant register; developing laboratory tests to identify safe silicon breast implants; and assessing information on quality and safety provided by manufacturers in their product dossiers.

Image of a breast implant 

National implant register

In January 2015, a national implant register was set up to increase the traceability of medical implants. Preparatory research carried out by RIVM indicated that most internal registers maintained by hospitals and private clinics cannot be directly transferred to a national implant register, but some national registers maintained by scientific associations were suitable for this purpose. The goal is to register all implants placed so that in the event of problems, such as in the case of the PIP breast implants, patients can be traced and informed as quickly as possible, after care provided, and further damage prevented.

Identifying safe breast implants

Is a breast implant safe? Can it, for example, rupture, leak or bleed? To discover this, RIVM developed a method to determine the chemical properties and the chemical fingerprint of a breast implant. Thus, it is possible to determine the type of silicon used and the extent to which the shell is leak-proof.  Safe implants can be identified and the specifications in the product dossier can be checked.

Dossiers on medical devices

Manufacturers of medical devices are required to provide a dossier setting out the purpose of the medical device, its composition, how is works and how safe it is. RIVM contributes to the regulations and technical standards required to safeguard the quality, safety and performance of medical devices on the market. In addition, RIVM regularly assesses the dossiers of medical devices for the Health Care Inspectorate. In 2015, RIVM will assess the product dossiers of silicon breast implants.