Fully Absorbable Mesh for Ventral Hernia Repair and Soft Tissue Reconstruction
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.1 With rapid tissue ingrowth and long-lasting strength, Phasix™Mesh provides a strong, reliable repair when patients need it most.
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*
Preclinical testing confirms vascular integration and incorporation, with abundant mature collagen at 52 weeks. Gradually transfers load to native tissue over time*
As Phasix™ Mesh is remodeled, it is replaced with functional tissue, ultimately resulting in a strong repair at one year*
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.
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.
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:
The Phasix™ Mesh family also offers the following benefits
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.
BD-76012
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.
BD-16443
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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.
BD-16443
The BD Phasix™ Reimbursement Hotline is available to answer your questions.
The hotline can be reached via phone or email.
(800)614-7965 | reimbursementsupport@bd.com
Any email or voice mail will be returned within 48 business hours. For information on physician billing, please contact your respective professional society.
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.
Phasix™ Mesh and Phasix™ ST Mesh Sizing
Phasix™ Mesh comes in the following sizes:
Phasix™ Mesh comes in the following sizes:
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
BD-46830
