Frequently Asked Questions about GORE® SYNECOR Biomaterial

Can a patient with an implanted device made from polytetrafluoroethylene (PTFE) and poly(glycolide:trimethylene carbonate) copolymer (PGA:TMC) safely undergo radiation and/or chemotherapy?

Yes. The amount of radiation needed to degrade PTFE is substantially above the patient survival dose. No specific studies have been conducted to assess the impact of radiotherapy or chemotherapy on our PGA:TMC material. There is clinical evidence, however, of acceptable outcomes in patients receiving postoperative chemotherapy following implantation of GORE® BIO-A® Tissue Reinforcement.1,2 Additionally, GORE® BIO-A® Tissue Reinforcement is sterilized by means of gamma radiation at doses that are typically much higher (i.e., up to 500x) than therapeutic radiation doses.

Would a device made from PTFE and PGA:TMC be visible on CT or MRI?

Yes, the GORE® SYNECOR Biomaterial should be visible in CT and MRI images. Given the differences in density between PTFE and the rest of the body, PTFE will be identified by high-resolution imaging techniques, such as CT and MRI, both immediately following implant and after ingrowth. Other than being visible, the material will neither be damaged nor interfere with the imaging.*

*For the most current and complete MR safety information on any product, always refer to the Instructions for Use at eifu.goremedical.com.

Could a patient have an allergic reaction to a device made from PTFE and PGA:TMC?

The risk of a patient having an allergic reaction to GORE® SYNECOR Biomaterial is low. The permanent layer is made of PTFE, one of the most inert and biocompatible polymers available. The bioabsorbable layers are comprised of PGA:TMC copolymer, which has been found to be both biocompatible and non-immunogenic. The GORE® SYNECOR Biomaterial device is biocompatible for its intended use. 

References

  1. Mussack T, Chiapponi C, Stocker U, Ladurner R.  GORE Bio-A Tissue Reinforcement for pelvic floor defects after laparoscopically-assisted abdominoperineal resection.  Abstract presented at the 33rd International Congress of the European Hernia Society; May 10-13th, 2011; Ghent, Belgium. 
  2. Hernia 2011;15(Supplement 2):S4-S5. Abstract O-016.
    Gambardella C, Mongardini FM, Karpathiotakis M, et al. Biosynthetic mesh reconstruction after abdominoperineal resection for low rectal cancer: cross relation of surgical healing and oncological outcomes: a multicentric observational study. Cancers 2023;15(10):2725.
     

The information provided is intended to be general guidance based on the Instructions for Use (IFU) approved for the CE Mark and related jurisdictions. The information here is based on Gore knowledge from its research, and is not intended to be a replacement for the IFU or the education, training and professional judgment of health care providers (HCP). Licensed HCP remain responsible for making decisions regarding the use of medical technologies and the care of patients.

eIFU Symbol

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for markets where this product is available. RXOnly

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