DuraSorb™ Monofilament Mesh (Polydioxanone, PDO)
for Tissue Support
Karol A Gutowski, MD, FACSPrivate Practice
Clinical Associate – University of Chicago
Clinical Associate Professor – University of Illinois
Disclosures
Merz – Trainer, Advisory Board
Will use brand names due to lack of distinguishing generic names
Product Information
• DuraSorb®
• Polydioxanone (PDO)
• Similar polymer to PDS suture
• FDA clearance 2018
– Reinforcement of soft tissue where weakness exists
Presentation Level of Evidence
Levels of Evidence and Qualifying Studies (Therapeutic Studies):I High-quality, multi-centered or single-centered, randomized controlled
trial with adequate power (N ≥ 100); or a systematic review of these studies
II Lesser-quality, randomized controlled trial; prospective cohort study; or systematic review of these studies
III Retrospective comparative study; case-control study; or a systematic review of these studies
IV Case series
V Expert opinion; case report or clinical example; or evidence based on physiology, bench research or "first principles“
Current Tissue Support Options
• Biologics– High cost
– Occasional non-integration
• Permanent synthetic mesh– Infection
– Extrusion
– Other complications with class action lawsuits
• Absorbable synthetic mesh– Next wave of products
– Variable duration in vivo
Absorbable Synthetic Mesh Options
Product/Brand Manufacturer Base Monomer MonofilamentTime to
Absorption
DuraSorb® SIA p-dioxanone ✔ <1 year
GalaFlex® Galatea 4-hydroxybutyric acid ✔ 2+ years
Phasix® Bard 4-hydroxybutyric acid ✔ 2+ years
Vicryl® Mesh Ethicon Lactide and Glycoside X 2 months
TIGR Matrix® NovusGlycolide, Lactide, and Trimethylene
CarbonateX 3+ years
Seri Scaffold® Sofragen Fibroin X 3+ years
Polydioxanone (PDO) Mesh
• Similar to PDS suture
• Swine model preperitoneal placement
– Favorable biocompatibility at 30, 91, and 365 days
– Mild inflammatory cell response
– Tissue ingrowth/collagen deposition “very evident”
~1.0 mm
~1.0 mm
DuraSorb (PDO) Mesh
H&E Stain 91 DayAsterisks: Mesh Fibers
Red Arrows: NeovascularizationBlack Arrows: Inflammatory Cells
Dashed Line: Fibrovascular Tissue
In Vivo Repair Strength
1 1 2
Repair Strength Comparison
In Vivo Repair Strength of DuraSorb (PDO) vs Multi-Year Absorbable Mesh1
PDO Mesh Inferior Sling Support
Secured with 0-PDO Suture
No Problems with Exposed Mesh
• POD 10: Left breast minor dehiscence at “T”
• Mesh visible at base of wound
• Conservative treatment
• Healed uneventfully
• Consider cutting out a small wedge of mesh in area of skin stress
Ongoing US Post-Market Clinical Trial
• 5 sites active + 5 sites pending
• IRB-approval up to 500 patients
• Uses
– Abdominoplasty
– Mastopexy
– Augmentation IMF reinforcement
– Secondary breast reconstruction
• Other uses – currently enrolling
Summary
• Monofilament– Less surface area and
– Less bacterial adhesion
• “Goldilocks” absorption profile – “There when you need it, gone when you don’t”
• Known, safe, widely-used PDO polymer family
• Early tissue integration
• Conservative exposure management
• Soft and drapeable for easy handling/tailoring
• Significant cost reduction* from biologics
DuraSorb™ Monofilament Mesh (Polydioxanone, PDO)
for Tissue Support
Karol A Gutowski, MD, [email protected]
Available at DrGutowski.com
[FOR PHYSICIANS]