DuraSeal: Where Is The Safety Data?

The Federal Drug Administration (FDA) in 2009 approved a synthetic nontoxic bioabsorbable hydrogel sealant (DuraSeal) via the Pre-Market Approval (PMA) process that is used in the case of accidentally caused CSF leaks that occur with spinal surgeries.  DuraSeal when applied over a tear in the dura mater (durotomy), that will cause a CSF leak, will seal the defect shut within seconds of application.

Previously DuraSeal had been approved by the FDA’s PMA process in 2005 for the use in achieving watertight closure for dura mater repair required for intracranial surgery.  The manufacturer then applied to have it approved to augment sutured repair of a spinal durotomy.  As part of the PMA of DuraSeal in 2009, the FDA ordered a Post-Approval Study by the manufacturer to ensure that it is safe for its use in spinal procedures.

News Source: http://www.WiredPRNews.com