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Abstract Purpose An increasingly vocal movement of patients with systemic complaints, supposedly linked to polypropylene mesh implants, is leading to growing numbers of patient-preferred non-mesh surgical repairs for inguinal hernia. However, current literature does not support any association between polypropylene implants and Autoimmune Syndrome Induced by Adjuvants (ASIA). This prospective pilot aims to examine autoimmunity in patients in whom ASIA is suspected, based on previously described criteria. We aim to demonstrate the effectiveness of Mesh Allergy Testing and to investigate the natural evolvement of ASIA symptoms and the effect of mesh removal on ASIA-complaints. Methods This multi-center, prospective pilot study will include patients with symptoms of the ASIA syndrome following Shoenfeld’s Criteria. Physical examination, immunologic blood tests, and Mesh Allergy Tests will be performed and assessed by an experienced immunologist/allergologist. Questionnaires on improvement of symptoms, psychological susceptibility, and connective tissue disease will be collected at predefined time points. When patients’ wish for mesh removal is persistent, despite repeated elaborate discussion on the risks, mesh implants will be removed surgically. All meshes will be assessed histopathologically. Follow-up is 12 months. Discussion Current evidence on a causal relation between polypropylene mesh and ASIA syndrome is lacking, as is a treatment algorithm. Objective diagnostic tests are absent, expensive and/or aspecific. In this study, Mesh Allergy Testing will be evaluated as a first screening test specific for polypropylene implants. This study will be performed to further clarify knowledge gaps on diagnosis and prognosis on ASIA with polypropylene adjuvants.
Gielen et al. (Wed,) studied this question.