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, FACSKarol@DrGutowski.com

Available at DrGutowski.com

[FOR PHYSICIANS]