Frequently Asked Questions
Your questions, answered.
Please find the information on our approved products at https://www.goremedical.com/en-emea/products.
If you don’t find the needed information, please send a request to our Field Sales Associates or local distributors.
For product availability, pricing and ordering in your country, please contact your local Gore office or one of the authorized partners.
If you have any questions about the suitability and approved indications of products, please contact your local Field Sales Associate or send a request to Customer Service.
Ordering can typically be done by phone, fax or e-mail.
There can be regional variances. Please contact your local sales office.
Gore collaborates with e-commerce providers for e-ordering. GHX (Global Healthcare Exchange) is our preferred e-commerce provider. Please send a request to Customer Service for more information.
Orders are generally shipped for next business day delivery unless otherwise noted. Shipments are subject to conditions beyond the control of Gore, such as weather, strikes and transport capacity.
Expedited shipping may be available upon request and may incur additional charges.
Products are provided sterile unless otherwise noted. In the case of non-sterile products, please send a request to Customer Service.
If you have any alternative questions, please contact your local office.
Gore's worldwide organizational structure, coupled with an integrated product distribution network, ensures that Gore medical products are approved and available in many countries.
Highly trained Gore representatives are in most regions around the world. Gore also utilizes Authorized Partners for distribution, sales and technical case support in many international markets.
These third parties have met Gore's qualifications to sell, distribute and support Gore medical products.
All product returns require a return authorization number which can be obtained by sending a request to Customer Service.
Products must be in their original packaging, unopened and in saleable condition.
Standard payment terms are net 30 days unless otherwise noted. Invoices reflect the price at the time of order fulfillment.
Please find the Instructions for Use at https://eifu.goremedical.com/
Please send a request to Customer Service, or contact our Customer Service by phone.
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.
References
- 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.
- 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.
25SS2035-EN01
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.
25SS2035-EN01
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.
25SS2035-EN01
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.
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
GORE® SYNECOR PREPERITONEAL MATERIAL
INDICATIONS FOR USE IN EUROPE: The GORE® SYNECOR Preperitoneal Biomaterial device is intended for use in the repair of ventral/incisional and inguinal hernias that may require the addition of a non-absorbable reinforcing or bridging material.
CONTRAINDICATIONS: The GORE® SYNECOR Preperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects.
GORE® SYNECOR INTRAPERITONEAL MATERIAL
INDICATIONS FOR USE IN EUROPE: The GORE® SYNECOR Intraperitoneal Biomaterial device is intended for use in the repair of ventral/incisional hernias that may require the addition of a non-absorbable reinforcing or bridging material.
CONTRAINDICATIONS: The GORE® SYNECOR Intraperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects.