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Medical devicesManufacturers of silicone breast implants must improve their technical files

News item | 09-06-2016

Laboratory investigation on the breast implants did not identify anomalies that may compromise health of patients. However, the technical files of the implants, which should guarantee the safety and quality of the implants, are below standard. This is the result of a study on silicone breast implants available on the Dutch market. The study was performed by the National Institute of Public Health and the Environment (RIVM) as commissioned by the Dutch Health Care Inspectorate (Inspectorate). The reason for this study was the ongoing public debate about the safety of breast implants. The Inspectorate considers the results to be reason for concern and will take action accordingly.

The RIVM study focused on 10 manufacturers active on the Dutch market at the start of the investigation in 2014. RIVM studied the composition of the silicone breast implants and the corresponding technical files. Manufacturers are legally obliged to compose these technical files. Notified bodies use the files as part of their assessment for market authorization of the devices. Complete and accurate files are essential. They are the foundation for guaranteeing the quality and safety of devices for the patient.

Quality of technical files is insufficient

According to the Inspectorate the results of the study illustrate that the technical documentation is below standard. Consequently, the quality and safety of the products are insufficiently guaranteed.

Actions Inspectorate

The Inspectorate considers the outcome of the study to be reason for concern and will therefore take the following actions: 

  • inform all manufacturers of their individual results and urge them to improve the technical documentation and inform their notified body; 
  • inform all notified bodies involved about the results in general and request them to contact their manufacturer. The Inspectorate also urges the notified bodies to take appropriate actions to improve the technical documentation and quality assurance; 
  • contact involved Member States with a manufacturer and/or notified body on their territory, allowing them to monitor the improvements made by manufacturers and/or notified bodies and take appropriate action when necessary; 
  • will establish a taskforce with their European partners for joint surveillance to make sure that necessary improvements are carried out.

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