BD Secures FDA Approval for First-of-Its-Kind Phasix™ ST Mesh for Umbilical Hernia Repair

BD (Becton, Dickinson and Company), a global leader in medical technology, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and announced the commercial launch of the Phasix™ ST Umbilical Hernia Patch. 

This is made from Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, and incorporates a hydrogel barrier based on Sepra® Technology. It is designed to be used with the same technique that surgeons currently use for traditional permanent mesh patches, offering flexibility in material choice. 

Its structure includes a pocket and strap system to assist with placement, positioning, and lateral fixation. The design closely follows that of the Ventralex™ ST Hernia Patch, a widely used product with more than two million global implants.

Phasix™ ST Umbilical Hernia Patch offers an absorbable solution that aims to meet patient and surgeon preferences. Survey data suggests that 60% of patients would rather have a non-permanent mesh option for hernia repair, while over 70% of surgeons are open to aligning treatment plans with patient preferences.

This latest product extends BD’s portfolio of absorbable Phasix™ Mesh solutions, which already includes over 385,000 implants and is supported by more than 85 peer-reviewed clinical studies involving over 4,000 patients. Available in three sizes, the new patch is suitable for a wide range of umbilical soft tissue repairs and supports surgeons’ needs for appropriate overlap during procedures.