ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation

Maxima Medical Center50 enrolled

Overview

In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics.

Worldwide there is a lot of commotion about the effects and complications of various implants. In analogy to patients with silicone breast implants, some patients report various systemic complaints following inguinal polypropylene (PP) mesh implantation, suggesting 'Autoinflammatory/Autoimmunity Syndrome Induced by Adjuvants' (ASIA; Shoenfeld's syndrome) or some other suspected systemic auto-immune/inflammatory response. Although an evidence-based and causal relationship is lacking, patients report serious complaints. Therefore, the investigators recently started seeing these patients at the outpatient clinic and developed a diagnostic workup, including an elaborate anamnesis, conventional immunologic analyses and mesh allergy testing (MAT). Further, in case the implant is removed as part of the treatment due to a persistent wish of the patient, the PP explant will be histologically examined to find additional cues for an auto-immune/inflammatory response (and thus ASIA). So far, evidence on the optimal diagnostic workup for patients with suspected ASIA syndrome is lacking completely.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Autoimmunity Inguinal Hernia Stress Urinary Incontinence

Interventions

mesh allergy testDIAGNOSTIC_TEST

a 5 mm\^2 part of polypropylene mesh will be dissolved in 1 mL Methyl ethyl ketone (MEK), 25 microliters of this solution will be topically applied in a Finn chamber, and a reaction to the topical applicant will be assessed within 48 hours after application.

blood testsDIAGNOSTIC_TEST

Blood tests for diagnosis of autoimmune diseases will be performed

Mesh removalPROCEDURE

If wish for mesh removal persists, this procedure can be performed after separate informed consent (within the study), as standard practice of care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients \>18 years of age and written informed consent obtained; * Suspected ASIA syndrome after elective hernia, pelvic organ prolapse (POP) surgery, or stress urinary incontinence (SUI) repair, defined as three major ASIA criteria (Table 1), of which the exposure to an external stimulus (PP mesh) is one; * ASIA complaints evolved after the implantation of PP mesh and were not present before the surgical repair. Exclusion Criteria: * Known auto-immune disorders; * Known malignancies; * (Low grade) infections or other inflammatory diseases at time of surgery; * Cognitively impaired individuals.

Locations (3)

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

ACTIVE_NOT_RECRUITING

Maxima Medical Centre

Veldhoven, North Brabant, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, Netherlands

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Positive diagnostic tests

Rate of positive diagnostic tests of either blood draws or MAT as an indication for presence of an autoimmune disease.

Time frame: At inclusion. There is no need to repeat this test after first result.

Secondary Outcomes

Autoimmune complaints and objective findings in immunologic blood test

Association between subjective outcomes of autoimmune/inflammatory symptoms and objective findings in blood tests that indicate presence of inflammation or autoimmunity.

Time frame: At inclusion, questionnaires repeated after 6 and 12 months. Blood tests will not be repeated after tests at inclusion.

Autoimmune complaints and objective findings in mesh allergy test (MAT)

Association between subjective outcomes of autoimmune/inflammatory symptoms and objective findings of the mesh allergy test (MAT) that either indicate presence of intolerance to mesh, or indicate no dermal/allergic reaction to the material of the mesh.

Time frame: At inclusion, questionnaires repeated after 6 and 12 months. MAT will not be repeated after test at inclusion due to either a positive test (and therefore emergence of immune memory cells) or negative test (and therefore no immune response to mesh at t0)

Mesh removal and subjective complaints

Success rate of mesh removal for the resolution of subjective complaints using Tissue Connective Disease Screening Questionnaire (CSQ) and Patient Global Impression of Improvement (PGI-I) questionnaire and ASIA symptoms.

Time frame: Follow-up 1 year after surgery. At inclusion, questionnaires repeated after 6 and 12 months.

Mesh histopathology

All explanted meshes will be examined histopathologically to check for granulomatous inflammatory or acute inflammatory reactions surrounding the explant.

Time frame: Directly after surgery if surgical mesh removal is deemed safe by the surgeon and preferred by the patient. As attempts will be made to completely remove the mesh, mesh histopathology will only be performed once.

Patient demographics

Baseline patient demographics will be collected for all included patients, as well as for patients undergoing surgical mesh removal. Descriptive analysis will be performed.

Time frame: At the start of the inclusion period demographics will be recorded. Demographics will also be recorded for the population undergoing surgery, in combination with Outcome measure 3 of subjective complaints.