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Bioresorbable Phasix™ Mesh

Expanding your options.

Enabling strong repairs.

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A reliable alternative

Every patient is unique. Bioresorbable Phasix™ Mesh provides a reliable alternative to permanent mesh     

—expanding your hernia repair options to meet individual patient needs.

Backed by 5-year data

Supported by 5-year data,1-3 more than 35 clinical studies 4 and over 185,000 implants globally, 5 Phasix™ Mesh provides a strong, reliable repair.

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Composed of P4HB

PhasixTM Mesh is composed of poly-4-hydroxybutyrate (P4HB), providing critical strength during the initial healing phase with rapid tissue ingrowth and vascularization through its open-pore monofilament structure.6,7

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Predictable long-term strength

PhasixTM Mesh gradually and predictably degrades within 12 to 18 months leaving behind a durable, functional repair with over 3x the strength of the native abdominal wall.8

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Clinically proven outcomes

After Phasix™ Mesh remodels, a strong, durable repair remains—demonstrating low recurrence at 5 years,1 lower risk of mesh-related complications9 and improved quality of life.10

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Strong repair, real life impact

Indications

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Reference
  1. Buell JF, Flaris AN, Raju S, Hauch A, Darden M, Parker GG. Long-term outcomes in complex abdominal wall reconstruction repaired with absorbable biologic polymer scaffold (Poly-4-Hydroxybutyrate). Annals of Surgery Open. 2021;2(1). doi:10.1097/ as9.0000000000000032.
  2. Roth JS, Anthone GJ, Selzer DJ, et al. Long-Term, Prospective, Multicenter Study of Poly-4-hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up [published online ahead of print, 2022 Aug 17]. J Am Coll Surg. 2022;10.1097/XCS.0000000000000363. doi:10.1097/XCS.0000000000000363
  3. Talwar AA, Perry NJ, McAuliffe PB, et al. Shifting the Goalpost in Ventral Hernia Care: 5-year Outcomes after Ventral Hernia Repair with Poly-4-hydroxybutyrate Mesh [published online ahead of print, 2022 Sep 16]. Hernia. 2022;10.1007/s10029-022-02674-y. doi:10.1007/s10029-022-02674-y
  4. Publications available upon request.
  5. Data on file at BD. Phasix™ Mesh, Phasix™ ST Mesh, Phasix™ Plug, Phasix™ ST Mesh with Open Positioning System and Phasix™ ST Mesh with Echo 2™ Positioning System.
  6. Martin DP, Badhwar A, Shah DV, et al. Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res. 2013;184(2):766-773. doi:10.1016/j.jss.2013.03.044
  7. Scott JR, Deeken CR, Martindale RG, Rosen MJ. Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair. Surg Endosc. 2016;30(9):3691-3701. doi:10.1007/s00464-016-5057-9
  8. Deeken CR, Matthews BD. Characterization of the mechanical strength, resorption properties, and histologic characteristics of a fully absorbable material (Poly-4-hydroxybutyrate-Phasix™ Mesh) in a porcine model of hernia repair. ISRN Surg. 2013; 1-12.
  9. Buell JF, et al. Initial experience with biologic polymer scaffold (Poly-4-hydroxybutyrate) in complex abdominal wall reconstruction. Ann Surg. 2017 Jul;266(1):185-188.
  10. Messa CA 4th, Kozak G, Broach RB, Fischer JP. When the Mesh Goes Away: An Analysis of Poly-4-Hydroxybutyrate Mesh for Complex Hernia Repair. Plast Reconstr Surg Glob Open. 2019;7(11):e2576. Published 2019 Nov 27. doi:10.1097/GOX.0000000000002576

Fully absorbable, derived from naturally occurring materials

Phasix™ Mesh is an open monofilament mesh scaffold composed of poly-4-hydroxybutyrate (P4HB), a fully-absorbable polymer derived from naturally occurring materials.

P4HB gradually and predictably resorbs within 12-18 months, degrading into its 4HB monomer—a natural human metabolite found in the brain, heart, liver, kidney and muscle that is eliminated from the body via hydrolysis.1

  • Healthy tissue ingrowth1-3

  • Long-term strength and predictable durability1,4,5

  • Promising results in the presence of bacteria6 6-8*

*No mesh is indicated for use in infected or contaminated fields.

Watch how P4HB works

Healthy tissue ingrowth

Early repair response

Preclinical and in vitro testing have shown that Phasix Mesh rapidly incorporates while the body naturally initiates an early "repair" response by preferentially up-regulating the anti-inflammatory macrophage.9,10 

Preclinical data suggests that an early up-regulation in anti-inflammatory macrophages leads to a regenerative repair while other materials preferentially up-regulate the pro-inflammatory macrophage leading to fibrosis and encapsulation.11-13

Long-term strength and predictable durability

Long-term repair strength even after Phasix™  Mesh degrades

Strength in the presence of bacteria*

Promising results in the presence of MRSA6-8

As P4HB is remodeled, the body naturally responds by producing antimicrobial peptides (AMPs).9,10 Traditionally, immunology studies link AMPs to fighting bacteria.14,15

Bacteria colonization 7 days post inoculation in preclinical testing1

What’s left behind

Strong functional repair at 52 weeks

As Phasix™ Mesh remodels, it is replaced with functional tissue1-3—leaving behind a durable repair with over 3x the strength of the native abdominal wall.1

3x the strength of the native abdominal wall at 52 weeks1*

70% of PhasixTM Mesh strength is still retained at 12 weeks

*Preclinical and in vitro data on file. Results may not correlate to clinical performance in humans.

Let’s talk about adding Phasix™ Mesh to your practice.

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Reference
  1. Deeken CR, Matthews BD. Characterization of the mechanical strength, resorption properties, and histologic characteristics of a fully absorbable material (Poly-4-hydroxybutyrate-Phasix™ Mesh) in a porcine model of hernia repair. ISRN Surg. 2013; 1-12.
  2. Martin DP, Badhwar A, Shah DV, et al. Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res. 2013;184(2):766-773. doi:10.1016/j.jss.2013.03.044
  3. Scott JR, Deeken CR, Martindale RG, Rosen MJ. Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair. Surg Endosc. 2016;30(9):3691-3701. doi:10.1007/s00464-016-5057-9
  4. Deeken CR, et al. Characterization of the mechanical properties and host tissue response associated with fully absorbable poly-4-hydroxybutyrate mesh with and without absorbable hydrogel barrier. White paper.
  5. Preclinical data on file. Results may not correlate to clinical performance in humans.
  6. Lake SP, Stoikes NFN, Badhwar A, Deeken CR. Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model. Ann Med Surg (Lond). 2019;46:12-16. Published 2019 Aug 13. doi:10.1016/j.amsu.2019.08.004
  7. Stoikes NFN, Scott JR, Badhwar A, Deeken CR, Voeller GR. Characterization of host response, resorption, and strength properties, and performance in the presence of bacteria for fully absorbable biomaterials for soft tissue repair. Hernia. 2017;21(5):771-782. doi:10.1007/s10029-017-1638-3
  8. Preclinical data on file. Results may not correlate to clinical performance in humans.
  9. Pineda Molina C, Giglio RM, Gandhi RM, et al. Comparison of the host macrophage response to synthetic and biologic surgical meshes used for ventral hernia repair. J Immun Regen Med. 2019.
  10. Pineda Molina C, Hussey GS, Eriksson J, et al. 4-Hydroxybutyrate Promotes Endogenous Antimicrobial Peptide Expression in Macrophages. Tissue Eng Part A. 2019;25(9-10):693-706. doi:10.1089/ten.TEA.2018.0377
  11. Brown BN, Londono R, Tottey S, et al. Macrophage phenotype as a predictor of constructive remodeling following the implantation of biologically derived surgical mesh materials. Acta biomaterialia. 2012;8(3):978-87.
  12. Mantovani A, Sica A, Sozzani S, Allavena P, Vecchi A, Locati M. The chemokine system in diverse forms of macrophage activation and polarization. Trends Immunol. 2004;25(12):677-686. doi:10.1016/j.it.2004.09.015
  13. Tidball JG, Villalta SA. Regulatory interactions between muscle and the immune system during muscle regeneration. Am J Physiol Regul Integr Comp Physiol. 2010;298(5):R1173-R1187. doi:10.1152/ajpregu.00735.2009
  14. Vandamme D, Landuyt B, Luyten W, Schoofs L. A comprehensive summary of LL-37, the factotum human cathelicidin peptide. Cell Immunol. 2012;280(1):22-35. doi:10.1016/j.cellimm.2012.11.009
  15. Wang G. Human antimicrobial peptides and proteins. Pharma. 2014;7(5):545-594. doi:10.3390/ph7050545

Proven performance

Backed by 5-year data,1 more than 40 clinical studies2 and over 185,000 implants across the Phasix™ Mesh family,3 Phasix™ Mesh provides a strong, reliable repair.

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Proven clinical outcomes at 5 years1-3

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40+ Clinical studies4

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Over 185,000 implants globally5

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More than 3,000 patients studied4

Backed by 5-year data

Buell study

In a longitudinal 5-year follow up of 73 complex abdominal wall reconstruction patients, Phasix™ Mesh demonstrated lower recurrence, SSI and complication rates compared to Strattice™ Tissue Matrix.1

 

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Roth Study

In this prospective, multi-institutional study evaluating P4HB VIHR in comorbid patients with CDC Class I wounds, five-year outcomes following VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes.2

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Talwar study

In a longitudinal 5-year follow up of 43 ventral hernia repair (VHR) patients, reported quality of life following VHR with Phasix™ Mesh improved immediately and continued to improve 5 years following repair.3

Download Talwar study

Extensively studied

The Phasix™ Mesh family of products is supported by more than 35 clinical studies.

Download clinical evidence compendium

Let’s talk about adding Phasix™ Mesh to your practice.

Sales Form
Please fill out the form and a sales representative will get in touch with you.

Capability

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Reference
  1. Buell JF, Flaris AN, Raju S, Hauch A, Darden M, Parker GG. Long-term outcomes in complex abdominal wall reconstruction repaired with absorbable biologic polymer scaffold (Poly-4-Hydroxybutyrate). Annals of Surgery Open. 2021;2(1). doi:10.1097/ as9.0000000000000032.
  2. Roth JS, Anthone GJ, Selzer DJ, et al. Long-Term, Prospective, Multicenter Study of Poly-4-hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up [published online ahead of print, 2022 Aug 17]. J Am Coll Surg. 2022;10.1097/XCS.0000000000000363. doi:10.1097/XCS.0000000000000363
  3. Talwar AA, Perry NJ, McAuliffe PB, et al. Shifting the Goalpost in Ventral Hernia Care: 5-year Outcomes after Ventral Hernia Repair with Poly-4-hydroxybutyrate Mesh [published online ahead of print, 2022 Sep 16]. Hernia. 2022;10.1007/s10029-022-02674-y. doi:10.1007/s10029-022-02674-y
  4. Publications available upon request.
  5. Data on file at BD. Phasix™ Mesh, Phasix™ ST Mesh, Phasix™ Plug, Phasix™ ST Mesh with Open Positioning System and Phasix™ ST Mesh with Echo 2™ Positioning System.

Your partner in hernia repair

As the category leader for bioresorbable mesh and hernia repair, BD is committed to providing an innovative portfolio, services and solutions that focus on advancing outcomes—for patients, clinicians and health systems.

Surgical education and support

HerniaU

Sponsored by BD, HerniaU is a dynamic online resource for hernia repair education events, including live surgeries, case studies, lectures and comprehensive cutting edge surgical training courses.

Visit HerniaU
BD Surgical Education

Through live online events, the BD Hernia Surgical Education program is committed to providing updated information on advanced soft tissue repair technologies and techniques.

Visit BD Surgical Education

On-call clinical support

Medical Information

Connect with our Medical Information (MI) team of surgeon consultants via email (medical.services@bd.com) or phone (800.562.0027) for answers to specific technical and clinical questions on BD hernia repair products and related procedures.

Download MIS contact information

Surgeon locator sign up

Ready to reach patients actively looking for hernia solutions?

Sign up to be listed in the Surgeon Locator at HerniaInfo.com.

Let’s talk about adding Phasix™ Mesh to your practice.

Sales Form
Please fill out the form and a sales representative will get in touch with you.

Capability

Product Line

Reference
  1. Buell JF, Flaris AN, Raju S, Hauch A, Darden M, Parker GG. Long-term outcomes in complex abdominal wall reconstruction repaired with absorbable biologic polymer scaffold (Poly-4-Hydroxybutyrate). Annals of Surgery Open. 2021;2(1). doi:10.1097/ as9.0000000000000032.
  2. Roth JS, Anthone GJ, Selzer DJ, et al. Long-Term, Prospective, Multicenter Study of Poly-4-hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up [published online ahead of print, 2022 Aug 17]. J Am Coll Surg. 2022;10.1097/XCS.0000000000000363. doi:10.1097/XCS.0000000000000363
  3. Talwar AA, Perry NJ, McAuliffe PB, et al. Shifting the Goalpost in Ventral Hernia Care: 5-year Outcomes after Ventral Hernia Repair with Poly-4-hydroxybutyrate Mesh [published online ahead of print, 2022 Sep 16]. Hernia. 2022;10.1007/s10029-022-02674-y. doi:10.1007/s10029-022-02674-y
  4. Publications available upon request.
  5. Data on file at BD. Phasix™ Mesh, Phasix™ ST Mesh, Phasix™ Plug, Phasix™ ST Mesh with Open Positioning System and Phasix™ ST Mesh with Echo 2™ Positioning System.

Related Product Families

Reimbursement

The BD Soft Tissue Repair 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.

Reimbursement

   

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