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Phasix™ Mesh

Fully Absorbable Mesh for Ventral Hernia Repair and Soft Tissue Reconstruction

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Overview

Designed to enable constructive and functional tissue remodeling1

Phasix™ Mesh provides a fully resorbable monofilament scaffold for rapid tissue incorporation that has been designed to allow for the repair strength of a synthetic mesh along with the remodeling characteristics of a biologic graft.With rapid tissue ingrowth and long-lasting strength, Phasix™Mesh provides a strong, reliable repair when patients need it most.

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Features and Benefits

THE NEXT PHASE IN HERNIA REPAIR

High repair strength through the critical healing phase

 Composed of biologically-derived material, Poly-4-hydroxybutyrate (P4HB), Phasix™ Mesh provides critical strength during the initial healing phase with rapid tissue ingrowth and vascularization through its open-pore monofilament structure. The open monofilament mesh scaffold also provides early integration and repair strength*

ORGANIZED AND FUNCTIONAL COLLAGEN AT HERNIA REPAIR SITE

Preclinical testing confirms vascular integration and incorporation, with abundant mature collagen at 52 weeks. Gradually transfers load to native tissue over time*

Rapid tissue incorporation

As Phasix™ Mesh is remodeled, it is replaced with functional tissue, ultimately resulting in a strong repair at one year*

Predictable strength for the long run

Phasix™ Mesh gradually and predictably degrades within 12 to 18 months via hydrolysis leaving behind a durable, functional repair with over 3x the strength of the native abdominal wall.

WHAT IS PHASIX™ MESH?

  • Phasix™ Mesh is a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived, fully resorbable material.
  • Monomer form (4HB) is a naturally occurring human metabolite found in the brain, heart, liver, kidney, and muscle
  • Predictably resorbs through hydrolysis, as P4HB metabolizes into biocompatible byproducts (COand H2O)4

PROMISING RESULTS IN THE PRESENCE OF BACTERIA

  • Phasix™  Mesh has not been shown to break down in the presence of bacteria—maintaining 100% of its strength at 56 days —unlike biologic grafts which demonstrate accelerated degradation in the presence of bacteria.
  • As shown in the graphic below, there was no presence of bacterial colonization observed in Phasix Mesh™ or Phasix™ ST Mesh 7 days post-inoculation in preclinical testing. The other side of this graph shows the Presence of abscess (white material) observed SurgiMend®, Strattice™, Bio - A ®, and OviTex™. Other observed indications of bacterial colonization included swelling, the presence of fluids, and thickened capsule tissue.

 

MATERIAL STRUCTURE1

  • Material structure can impact host response.5 Consider these features of monofilament versus multifilament structures:
  • Monofilament mesh design allows for a prompt fibroblastic response through the open interstices of the mesh1
  • Material designs with complex architecture can have greater surface area and niches that bacteria can use as a haven from tissue ingrowth, neovascularization, antibiotic treatment, and host inflammatory response6
  • It has been reported that the surface area of multifilament material is 157% higher than monofilament materials6

TISSUE INCORPORATION1

  • Study objective: Evaluate material strength and histopathology of Phasix™ Mesh.
  • Study design: A 3-centimeter round defect was created in the ventral abdominal wall of 25 Yucatan mini-pigs (average weight 38 kg). Phasix™ Mesh was fixated directly over the defect with SorbaFix™ resorbable tacks. Ball burst testing and histopathology were conducted at 6, 12, 26, and 52 weeks.

RESULTS

  • Early tissue ingrowth, vascular integration, and incorporation of Phasix™ Mesh into the ventral abdominal wall, plus abundant mature collagen formed around the remaining fibers at 52 weeks.

CLINICAL

Prospective Multi-institutional Evaluation of Phasix™ Mesh in High Risk Ventral and Incisional Hernia Repairs: 18 month follow up. (Click on image to expand).

PROVEN PERFORMANCE FROM A RELIABLE PARTNER

With over 143,000 implants across the Phasix™ Mesh family,11 BD is proud to be the category leader for hernia repair and bioresorbable mesh. BD is committed to providing an innovative hernia portfolio that focuses on improving clinical outcomes for better patient care. 

The Phasix™ Mesh family is reliable and used around the globe:

  •  Over 143,000 implants
  • More than 10 clinical studies
  • More than 950 patients studied
  • Proven clinical outcomes at 3 years

 

The Phasix™ Mesh family also offers the following benefits

  •  Low recurrence
  •  Low surgical site infection (SSI)
  • Low seroma rates
  • Associated with improved quality of life
Reference

1. Preclinical data on file. Results may not correlate to clinical performance in humans.

2. Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.” Surgical Endoscopy 25.5 (2010): 1541-552.

3. Estimated from Standard Curve in (Martin DP, et al. “Characterizationof poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research. 2013; (184): 766-773

4. Martin, DP. et al. “ Medical applications of poly-4-hydroxybutyrate:a strong flexible absorbable biomaterial. Biochemical Engineering Journal. 2002; December 9

5. Amid PK, Shulman AG, Lichtenstein IL, Hakaha M. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archive Chir. 1994; 379(3): 168-71.

6. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus aureus Infection Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques. J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.

Indications

Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Contraindications

Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Phasix™ Mesh must not be put in direct contact with bowel or viscera. The safety and product use for patients with hypersensitivities to tetracycline hydrochloride or kanamycin sulfate is unknown. Use of this device in patients with known allergies to these antibiotics should be avoided. The safety and effectiveness of Phasix™ Mesh in pediatric use has not been evaluated or established. If an infection develops, treat the infection aggressively. An unresolved infection may require removal of the device.

Adverse Reactions

Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

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BD-16443

Products & Accessories
  • product-image

    Phasix™ Mesh, Rectangle, 4 in x 8 in (10 cm x 20 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 6 in x 12 in (15 cm x 30 cm)

  • product-image

    Phasix™ Mesh, Square, 19.5 in x 19.5 in (50 cm x 50 cm)

  • product-image

    Phasix™ Mesh, Square, 16 in x 16 in (40 cm x 40 cm)

  • product-image

    Phasix™ Mesh, Square, 3 in x 3 in (8 cm x 8 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 4 in x 10 in (10 cm x 25 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 8 in x 16 in (20 cm x 40 cm)

  • product-image

    Phasix™ Mesh, Square, 14 in x 14 in (35 cm x 35 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 12 in x 18 in (30 cm x 45 cm)

  • product-image

    Phasix™ Mesh, Square, 18 in x 18 in (45 cm x 45 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 4 in x 6 in (10.2 cm x 15.2 cm)

  • product-image

    Phasix™ Mesh, Round, 3 in (7.6 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 10 in x 16 in (25 cm x 40 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 2.4 in x 6.3 in (6 cm x 16 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 6 in x 8 in (15.2 cm x 20.3 cm)

  • product-image

    Phasix™ Mesh, Square, 12 in x 12 in (30 cm x 30 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 3 in x 6.3 in (8 cm x 16 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 3 in x 8 in (8 cm x 20 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 6 in x 10 in (15 cm x 25 cm)

  • product-image

    Phasix™ Mesh, Round, 4.5 in (11 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 8 in x 12 in (20 cm x 30 cm)

  • product-image

    Phasix™ Mesh, Square, 8 in x 8 in (20 cm x 20 cm)

  • product-image

    Phasix™ Mesh, Square, 4 in x 4 in (10 cm x 10 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 10 in x 12 in (25.4 cm x 30.5 cm)

  • product-image

    Phasix™ Mesh, Rectangle, 8 in x 10 in (20.3 cm x 25.4 cm)

Related Products

References

1. Preclinical data on file. Results may not correlate to clinical performance in humans.

2. Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.” Surgical Endoscopy 25.5 (2010): 1541-552.

3. Estimated from Standard Curve in (Martin DP, et al. “Characterizationof poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research. 2013; (184): 766-773

4. Martin, DP. et al. “ Medical applications of poly-4-hydroxybutyrate:a strong flexible absorbable biomaterial. Biochemical Engineering Journal. 2002; December 9

5. Amid PK, Shulman AG, Lichtenstein IL, Hakaha M. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archive Chir. 1994; 379(3): 168-71.

6. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus aureus Infection Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques. J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.

Indications

Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Contraindications

Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Phasix™ Mesh must not be put in direct contact with bowel or viscera. The safety and product use for patients with hypersensitivities to tetracycline hydrochloride or kanamycin sulfate is unknown. Use of this device in patients with known allergies to these antibiotics should be avoided. The safety and effectiveness of Phasix™ Mesh in pediatric use has not been evaluated or established. If an infection develops, treat the infection aggressively. An unresolved infection may require removal of the device.

Adverse Reactions

Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

true

BD-16443

Resources
References

1. Preclinical data on file. Results may not correlate to clinical performance in humans.

2. Deeken CR, Abdo MS, Frisella MM, Matthews BD. “Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.” Surgical Endoscopy 25.5 (2010): 1541-552.

3. Estimated from Standard Curve in (Martin DP, et al. “Characterizationof poly-4-hydroxybutyrate mesh for hernia repair applications.” Journal of Surgical Research. 2013; (184): 766-773

4. Martin, DP. et al. “ Medical applications of poly-4-hydroxybutyrate:a strong flexible absorbable biomaterial. Biochemical Engineering Journal. 2002; December 9

5. Amid PK, Shulman AG, Lichtenstein IL, Hakaha M. Biomaterials for Abdominal Wall Hernia Surgery and Principles of their Applications. Langenbecks Archive Chir. 1994; 379(3): 168-71.

6. Halaweish I, Harth K, Broome AM, Voskerician G, Jacobs MR, Rosen M. Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus aureus Infection Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques. J Surg Infect (Larchmt). 2010; Oct1(5): 449-54.

Indications

Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Contraindications

Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent wound or organ support from the mesh is required.

Warnings

Phasix™ Mesh must not be put in direct contact with bowel or viscera. The safety and product use for patients with hypersensitivities to tetracycline hydrochloride or kanamycin sulfate is unknown. Use of this device in patients with known allergies to these antibiotics should be avoided. The safety and effectiveness of Phasix™ Mesh in pediatric use has not been evaluated or established. If an infection develops, treat the infection aggressively. An unresolved infection may require removal of the device.

Adverse Reactions

Possible complications include infection, seroma, pain, mesh migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, allergic reaction, extrusion, erosion, fistula formation and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

true

BD-16443

The Basics of Phasix™ Mesh

Phasix™ Mesh provides a fully resorbable monofilament scaffold for rapid tissue incorporation that has been designed to allow for the repair strength of a synthetic mesh along with the remodeling characteristics of a biologic graft.

Composed of biologically-derived material, Poly-4-hydroxybutyrate (P4HB), Phasix™ Mesh provides critical strength during the initial healing phase with rapid tissue ingrowth and vascularization through its open-pore monofilament structure. Monomer form (4HB) is a naturally occurring human metabolite found in the brain, heart, liver, kidney, and muscle and P4HB scaffold has been used clinically for hernia repair for more than 5 years.

Phasix™ Mesh gradually and predictably degrades within 12 to 18 months via hydrolysis leaving behind a durable, functional repair with over 3x the strength of the native abdominal wall.

Phasix™ Mesh has not been shown to break down in the presence of bacteria - maintaining 100% of its strength at 56 days - unlike biologic grafts which demonstrate accelerated degradation in the presence of bacteria. Additionally, Phasix™ Mesh offers the benefits of rapid tissue incorporation with organized and functional collagen at the repair site, while offering high repair strength through the critical healing phase.  

The Basics of Phasix™ ST Mesh 

Phasix™ ST Mesh combines two market-leading technologies into one product: monofilament resorbable Phasix™ Mesh and a proven hydrogel barrier based on Sepra® technology. It handles, sutures and fixates like a synthetic mesh, while facilitating trocar deployment during laparoscopic placement.

Phasix™ ST Mesh combines Phasix™ Mesh and a proven hydrogel barrier based on Sepra® technology into one product. While the monofilament mesh supports functional healing and a strong repair, the hydrogel barrier is designed to minimize tissue attachment to the visceral side of the mesh for intraabdominal placement.

Phasix™ ST Mesh is a biologically derived scaffold with a hydrogel barrier for intraabdominal placement. It has been designed to provide the repair strength of a synthetic mesh and the remodeling characteristics of a biologic. Additionally, its longitudinal stripes aid with orientation and visibility during placement.

The ST hydrogel barrier is designed to minimize the risk of tissue attachment, resorbs within 30 days, and has over 10 years of clinical application.

Absorbable & Dissolvable Hernia Mesh Basics

 

Biologic vs Synthetic Mesh

 

Biologic

Synthetic

   
 

 

 

 

Phasix™ Mesh and Phasix™ ST Mesh: Results and Case Studies

 

More than 10 clinical studies with more than 950 patients studied
Phasix Clinical Compendium

References

 

For more information, please contact your local sales rep to learn more

2. Internal market research, data on file, 2015.

3. Liang MK, Li LT, Nguyen MT, Berger RL, Hicks SC, Kao LS. Abdominal reoperation and mesh explantation following open ventral hernia repair with mesh. The American Journal of Surgery. 208.4(2014):670–76.

4. Itani KM, et al. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012;152(3):498–505.

5. Annor AH, Tang ME, Pui CL, Ebersole GC, Frisella MM, Matthews BD, Deeken CR. Effect of enzymatic degradation on the mechanical properties of biological scaffold materials. Surgical Endoscopy. 26.10(2012):2767–778. 6. Harth KC, et al. Effect of surgical wound classification on biologic graft performance in complex hernia repair: an experimental study. Surgery. 2013;153(4):481–492

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