National Institute for Public Health and the Environment
Ministry of Health, Welfare and Sport
By order of the Dutch Health and Youth Care Inspectorate (hereafter inspectorate), RIVM is currently assessing the technical files of mesh implants intended to treat pelvic organ prolapse (POP). There are two surgical routes to treat POP using mesh products: transvaginal and transabdominal.
The RIVM has finished the technical file assessment of two transvaginal mesh implants used to treat POP that were still on the Dutch market on November 1st 2019. RIVM identified major shortcomings in both these technical files. Therefore, RIVM decided to report the results to the inspectorate ahead of the full analysis of the technical files of all the selected products. This document provides a summary of the identified shortcomings.
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.