The lot history and sterilization records were reviewed.All records were found to be complete and showed that the product was manufactured to specifications.The following testing was required, and performed for this product: analysis of fish oil, fourier-transform infrared spectrophotometry (ftir) testing for coated mesh panels, suture retention and ball burst testing of bare mesh panels, and stitch strength testing.The analysis of fish oil showed that all requirements for chemical composition met acceptance criteria.The manufacturing records, inspection records, and sterilization records showed no non conformances or deviations.Based on the lot history review, there are no indications that the product was responsible for the incident reported.Clinical opinion: refractory chronic pain is characterized by pain that persists despite treatment and for longer than expected.Causes are varied and pain can occur anywhere in the body.Complications may occur due to a technical error, inadequate fixation and/or inadequate overlap which will cause separation of the mesh from the abdominal wall thereby increasing the possibility of infection, perforation, seroma, adhesions and pain.The instructions for use state complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material and possible adhesions when placed in direct contact with the viscera (intestines).
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