Composite mesh

Symbotex™ composite mesh

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Composite mesh

Symbotex™ composite mesh

Symbotex™ composite mesh is used for the reinforcement of abdominal wall soft tissue where a weakness exists.

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Indications, Safety, and Warnings

Description

Smart design.†,1–6 Smart handling.†,‡,§,◊,¶,1,5,7–8 Smart repair.†,‡,#,∞,††,1,2,7,9–11

Symbotex™ composite mesh can be used for minimally invasive surgery, such as conventional laparoscopic surgery and robotically-assisted hernia surgery, and open ventral hernia repair.12,13 Symbotex™ mesh brings improved ease of use as well as optimal repair performance for your patients, with excellent tissue integration and minimized visceral attachments.

Symbotex™ composite mesh is available in a large variety of shapes and sizes for laparoscopic hernia repair, with specific subranges dedicated to laparoscopic and open surgery.

Features

Smart design†,1–6

Innovative mesh features for streamlined performance

  • Established bioabsorbable film technology with good resistance to surgical handling†,1,5
  • Comprehensive shape and size portfolio for small, medium, and large defects†,5,6

Smart handling‡,§,◊,¶,1,5,7

Experience simplicity in hernia repair

  • Designed for easy mesh deployment†,5,7
  • Abdominal wall clinging effect for simplified mesh placement‡‡,5,8

Smart repair‡,#,∆,††,1,2,7,9–11

Designed to offer patients optimal hernia repair performance

  • Good level of tissue integration‡,#,1,7,9 and minimized tissue attachment thanks to the collagen film†,‡,∆,2,6–10
  • Helping to meet physiological needs through balanced mesh mechanical properties∞,2,11

Specifications14

Device classification Symbotex™ composite mesh is used for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.
Material composition
  • Three-dimensional 3-D textile monofilament polyester (PET) (white textile)
  • Non-absorbable monofilament polyester (PET) (green textile)
  • A bioabsorbable collagen film
Pore size 2.1 mm x 3.0 mm (white textile)
Sterilization method Gamma radiation
Shelf life 5 years

Frequently asked questions

Ordering information

 

Item number Size (cm) Diameter (cm) Units per box
SYM8OS — 8 1
SYM9 — 9 1
SYM12 — 12 1
SYM15 — 15 1
SYM20 — 20 1
SYM1510 15 × 10 — 1
SYM1510OS 15 × 10 — 1
SYM2520 25 × 20 — 1
SYM1710E 17 × 10 — 1
SYM2012E 20 × 12 — 1
SYM2015 20 × 15 — 1
SYM2015OS 20 × 15 — 1
SYM2515E 25 × 15 — 1
SYM2520OS 25 × 20 — 1
SYM3020 30 × 20 — 1
SYM3020OS 30 × 20 — 1
SYM3420E 34 × 20 — 1
SYM3728 37 × 28 — 1
SYM4024E 40 × 24 — 1
SYM4232 42 × 32 — 1

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Refer to the indications for use for complete instructions.

† Based on preclinical animal studies and benchtop studies. Animal data and benchtop testing are not necessarily indicative of human clinical outcomes.

‡ Based on preclinical animal studies. Animal data is not necessarily indicative of human clinical outcomes.

§ If the mesh is not cut (refer to instructions for use). Particular attention should be paid not to cut the green marking. It may no longer be centered and lose its functions if the mesh is trimmed.

◊ Not applicable for SYM-OS codes. Except in cases where transfacial sutures are used as well as meshes in open approach.

 Based on surgeon feedback and that 4/6 answers good or very good clinging effect.

# Tissue reinforcement and integration are indirectly assessed in clinical studies by the reported low recurrence rates.

∆ Minimization of visceral adhesions are indirectly assessed in clinical studies by the absence of adhesion complications. 

∞ Based on benchtop studies. Benchtop testing data is not necessarily indicative of human clinical outcomes. 

†† Clinical outcomes expressed by low hernia recurrence rates and improvement in the quality of life.

‡‡ Except in cases where transfacial sutures are used as well as meshes in open approach. Based on surgeon feedback and that 4/6 answers good or very good clinging effect.

  1. Based on internal test report 0901CR247b, Design verification report. July 2013.
  2. Based on internal test report 163005, Evaluate local tissue effects and tissue integration of Symbotex™ composite mesh versus Parietex™ optimized composite mesh after laparoscopic ventral repair. October 2013.
  3. Based on internal test report 162750, Evaluating local tissue effects, tissue integration and minimizing tissue attachment performance of Symbotex™ composite mesh versus Parietex™ optimized composite mesh. May 2013.
  4. Based on internal test report E41335/E41336CR022a, Design verification report. May 2014.
  5. Based on internal test report 0901CR252a, Preclinical study on pigs by surgeons for design validation of Symbotex™. June 2013.
  6. Based on internal report, Size and shape comparison chart. September 2013.
  7. Gillion JF, Lepere M, Barrat C, et al. Two-year patient-related outcome measures (PROM) of primary ventral and incisional hernia repair using a novel three-dimensional composite polyester monofilament mesh: the SymCHro registry study. Hernia. 2019;23(4):767−781. 
  8. Based on internal test report 0901CR261a, Observed clinging effect of Symbotex™ during design validation. July 2013.
  9. Abouzeid T, Mohammed A. Laparoscopic intraperitoneal onlay mesh for Spigelian hernia repair a prospective study. Egyptian J Surg. 2018;37(4):445−452.
  10. Design verification report 0901CR247b. July 2013. The report demonstrates the minimizing tissue adhesion performance of the mesh at four weeks.
  11. Based on internal test report E41335/E41336CR022a, Design verification report. March 2018.
  12. Based on internal test report TEX-FP-068c, Symbotex™ composite mesh, Ø08mm trocar compatibility. July 2019.
  13. Based on internal report TVX-20-020-CR-0001a, Robotically-assisted laparoscopic ventral hernia surgery with Symbotex™ composite mesh — impact on usability engineering. February 2021.

  1. Based on internal report TEX-FP-088c. List of hernia mesh products. October 2022.

This product is licenced with Health Canada as "SYMBOTEX COMPOSITE MESH (WITH FLAP)" and "SYMBOTEX COMPOSITE MESH FLAT SHEET" on Health Canada licence number "MDL# 96359 and 96361".