In 2018, the Health and Youth Care Inspectorate (IGJ) commissioned RIVM to carry out a scientific literature review into complications arising one year or more after transvaginal implantation of mesh implants.
Examples of complications that RIVM found in the scientific literature are pain, incontinence, pain during intercourse and the mesh implant becoming visible in the vagina. The literature review predominantly identified complications in patients who had products implanted that were no longer on the Dutch market in 2018.
Earlier literature reviews by RIVM (in 2011 and 2012) already examined complications that can arise after implantation of mesh implants. RIVM also assessed the technical documentation of a product about which the IGJ was receiving reports. In addition, RIVM analysed information about market data and reported complications involving mesh implants supplied to the IGJ by eight manufacturers. The results of these analyses were included in a report published by the IGJ (in Dutch).
Assessment of technical documentation
The IGJ commissioned RIVM to assess the technical documentation of mesh implants intended to treat patients with pelvic organ prolapse. These mesh implants were implanted by physicians in the Netherlands in 2018.
Manufacturers are obliged to compile technical documentation in order to show conformity with the regulatory requirements. Complete and correct files are essential to substantiate the safety and performance of the product. Manufacturers are obliged to compile complete and correct technical documentation to substantiate the safety and performance of their products. RIVM assessed the technical documentation of nine different mesh implants used by physicians in the Netherlands in 2018. Of these, four were implanted via the vagina (transvaginal) and five via the abdomen (transabdominal). The nine mesh implants were produced by six different manufacturers.
Interim report with initial results published in 2020
A literature review by RIVM showed that serious complications can occur after transvaginal implantation of mesh implants. Therefore, as a first step, RIVM completed its assessment of the technical documentation for the two transvaginal mesh implants that were still being used in the Netherlands in November 2019.
RIVM identified major shortcomings in the technical documentation. These major shortcomings were so serious that RIVM decided to share the results – provisional pending the full assessment of all selected mesh implants – directly with the IGJ. An interim report concerning the two transvaginal mesh implants was published in the first half of 2020.
In response to these initial results, the IGJ determined that transvaginal mesh implants should only be used within the parameters of strictly regulated medical research. The Dutch Society for Obstetrics and Gynaecology (NVOG), reacted to the interim report by issuing an opinion (in Dutch) on the use of transvaginal implants in the Netherlands.
Final report published in 2022
Then, RIVM assessed the technical documentation of the other mesh implants. RIVM identified shortcomings in the technical documentation of all nine mesh implants that were used in the Netherlands in 2018.
In both the interim report and the final report, RIVM concluded that the safety and performance of these products had not been properly substantiated. However, shortcomings in the technical documentation do not necessarily imply that something is wrong with the product itself.
Some of the manufacturers have indicated that the improved technical documentation passed audits by their notified bodies and stated that their technical documentation is now compliant with European regulatory requirements. These audits took place after the RIVM assessment was completed.
Laboratory study into mesh implants
RIVM conducted a laboratory study into six mesh implants used to treat patients with pelvic organ prolapse in the Netherlands in 2018. This study was commissioned by IGJ.
As part of this laboratory study, RIVM performed various types of analyses. The results of the various analyses were in line with the claims made by the manufacturers in the technical documentation for their products.
In this report (May 2023), RIVM concluded that the laboratory study had revealed no indication that these products were unsafe for patients.
The Dutch Society for Obstetrics and Gynaecology (NVOG) has taken a range of measures (in Dutch) to improve treatments with mesh implants used to treat patients with pelvic organ prolapse. Visit the IGJ website (in Dutch) for more information about complications that can arise after implantation of mesh implants and IGJ publications about this topic.
It is important that implants are safe. Reporting to MEBI (website in Dutch only) can help to make sure of this. Reporting possible side effects may help other patients. When many or unusual health problems are reported, MEBI will be able to detect potential connections between implants and problems at an early stage and inform healthcare professionals, patients and the government accordingly.