After a detailed assessment of the technical documentation of nine different mesh implants intended to treat pelvic organ prolapse that were used in the Netherlands in 2018, RIVM concludes that the safety and performance of these products were not properly substantiated. Shortcomings were found in the technical documentation of all nine mesh implants. This type of implants are used to treat patients with pelvic organ prolapse. The assessment was commissioned by the Dutch Health and Youth Care Inspectorate.
Mesh implants can be implanted via two surgical approaches: via the abdomen (transabdominal) and via the vagina (transvaginal). RIVM assessed the technical documentation of nine different mesh implants that were implanted by doctors in the Netherlands in 2018. Of these, four were implanted via the vagina and five via the abdomen. The nine mesh implants were produced by six different manufacturers.
Shortcomings
RIVM identified shortcomings in multiple parts of the technical documentation of all nine products. An example of a shortcoming is insufficient substantiation of safety and performance with data on the use of the product in humans. Another shortcoming is, for example, the lack of an adequate description of the surgical procedure in the instructions for use in cases where it is indicated that physicians have to be trained to perform this type of surgery.
Shortcomings in the technical documentation do not necessarily imply that something is wrong with the product itself or that the shortcomings would be harmful to the health of the patient. The regulatory system requires that manufacturers carefully examine and resolve shortcomings in their technical documentation. Several manufacturers indicate that they have improved the technical documentation. This took place after the RIVM assessment had been completed.
Some of the manufacturers exercised the right to object to the publication of the report. As a result, the publication of the report was delayed.