Analysis reveals safety profile dominated by CSF leak and infection risks with hydrogel dural sealants, highlighting the need for cautious use.
PEG hydrogel dural sealants show post-market safety patterns dominated by CSF leak, suspected infection, and swelling-related neurologic events. Exclusive reliance on structured MAUDE codes underestimates key complications. Integrating structured fields with negation-aware narrative review yields a more complete safety profile and supports cautious use in constrained intracranial spaces.
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Porwal et al. (2026) studied this question.
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