National Institute for Public Health and the Environment
Ministry of Health, Welfare and Sport
As of April 5th 2019, as a precautionary measure, France has banned certain types of breast implants. The ban concerns macro-textured and polyurethane (PU) coated breast implants. These are breast implants with a rough surface. France made this decision because they see indications that breast implants with a rough surface present an increased risk of BIA-ALCL. The Dutch Health and Youth Care Inspectorate asked RIVM to assess the scientific substantiation of the French decision.
Medical devices are products which are covered by the Medical Devices Act. In practice, this comes down to all the equipment, software and consumables which are used in healthcare, with the exception of medicines. The National Institute for Public Health and the Environment (RIVM) performs laboratory and desk research (eg. literature research and reviews of manufacturers’ product files) for medical devices, with patient safety as the primary focus.