Synthetic mesh are used to treat patients with pelvic organ prolapse. There are two surgical routes that can be used to implant mesh: transvaginal and transabdominal.
By order of the Dutch Health and Youth Care Inspectorate, RIVM is currently assessing the technical files of mesh implants intended to treat pelvic organ prolapse. These mesh implants were on the Dutch market in 2018. In addition, RIVM is examining mesh implants in the laboratory.
Technical file assessment
Serious complications can occur upon transvaginal mesh implantation to treat pelvic organ prolapse. Therefore RIVM prioritized the technical file assessment of two transvaginal mesh implants that were still on the market on November 1st 2019. For these two products, RIVM identified major shortcomings.
Complete and correct technical files are essential to substantiate the safety and performance of the product. Although a shortcoming in the technical file does not necessarily imply that something is wrong with the product, it means there are uncertainties about the risks. The manufacturers have been given the opportunity to check for factual inconsistencies and to respond by submitting additional documentation. After assessment of the additional information from the manufacturers, the RIVM still identified major shortcomings in the technical documentation. Therefore, RIVM decided to report the results to the inspectorate ahead of the full analysis of the technical files of all selected products.
The technical file assessment is part of a larger investigation, in which the technical files of 9 mesh products intended to treat POP are being analyzed. The results of this analysis and of the laboratory testing are expected later this year.
Long-term complications of transvaginal mesh implants: a literature review
In a previous literature review RIVM examined international scientific literature to determine complications that can occur one year or longer after transvaginal mesh implantation to treat pelvic organ prolapse. Complications that were observed in the literature were: pain, mesh exposure and erosion, incontinence and pain during intercourse. In this literature review, most identified products studied in the identified articles were not on the Dutch market anymore.