RIVM has conducted a laboratory study into six mesh implants from different manufacturers used in the Netherlands in 2018. The study revealed no indication that these products are unsafe for patients.
In order to treat patients with pelvic organ prolapse, mesh implants can be implanted into the body.
Various types of tests
The laboratory study into these products consisted of various types of tests. One of the tests focused on the identity of the materials they consist of. Another assessed the structure and dimensions of various components of the mesh implants. The results of these tests were in line with the descriptions of the manufacturers in the technical documentation of their products.
No damaged cells
An additional test analyzed whether the mesh implants were harmful to laboratory-grown cells. The results of this test also confirmed the descriptions of the manufacturers in the technical documentation. Five of the six products triggered no response in the cells used in the test. One product triggered a mild cellular response. This particular product is designed to be partially absorbed in the body. In comparison, the other tested mesh products are non-absorbable. This difference might play a role in the observed mild cellular response with this product. The manufacturer tested this product more extensively before it was allowed onto the market. The results of all these laboratory tests combined gave no indication of harmful effects.
RIVM recommends taking the results of this study into consideration in the periodic review of the international document that describes the cell test method.
RIVM carried out this study on behalf of the Health and Youth Care Inspectorate (IGJ).