Frequently Asked Questions about GORE® DUALMESH® PLUS Biomaterial


Can a patient with an ePTFE patch safely undergo radiation therapy?

Yes. The amount of radiation needed to degrade ePTFE is substantially above the patient survival dose.

Has the GORE® DUALMESH® PLUS Biomaterial been known to cause allergic reactions?

While the materials used in the antimicrobial technology are not known to be allergenic, people with a hypersensitivity to chlorhexidine or silver should discuss this with their physician.

The two antimicrobial preservatives act synergistically to inhibit microbial colonization of the device and resist initial biofilm formation on the device for up to 14 days post implantation. What remains after that time is a non-absorbable patch constructed entirely of expanded polytetrafluoroethyle (ePTFE) material.

Since ePTFE is one of the most inert and biocompatibile polymers available, there has not been a confirmed allergic reaction to a Gore ePTFE product. 

For complete information regarding indications for use, contraindications, precautions and instructions see the published Instructions for Use (IFU) found on the eifu.goremedical.com website. 

How will ePTFE show up on CT, MRI, x-rays or Ultrasound?

Because of the density differences between ePTFE and the rest of the body, high resolution imaging techniques, such as CT and MRI, will reveal ePTFE, both immediately following implant and after ingrowth at longer time frames. X-rays offer a fairly low resolution level and will not show an ePTFE product. Ultrasound can be impeded in the immediate post-operative period until cells and fluids fill the internodal spaces of ePTFE. Once this has occurred, the sound waves can pass through the material and allow imaging below the patch with ultrasound. Prior to this, it may be impossible to image through the product.

What are the differences between the two sides of GORE® DUALMESH® PLUS Biomaterial?

The GORE® DUALMESH® PLUS Biomaterial is a permanent, tailorable surgical mesh composed of expanded polytetrafluoroethylene (ePTFE) with two functionally distinct surfaces, a smooth side and a textured side. The material is impregnated with the PLUS antimicrobial compounds. The smooth surface is designed to minimize visceral tissue attachment to the device. The smooth side is intentionally darker in color than the opposite, textured surface to help in orientation during surgery. The textured side contains a CORDUROY Surface which is designed to encourage host tissue incorporation. Some configurations also possess macropores or holes to facilitate a more rapid tissue fixation. The GORE® DUALMESH® PLUS Biomaterial and GORE® DUALMESH® PLUS Biomaterial with Holes are designed for intraperitoneal placement.

What is a hernia?

A hernia is defined as a protrusion or projection of an organ or a part of an organ through the wall of the cavity that normally contains it. An abdominal wall or ventral hernia often arises in the muscles of the abdomen wall where a previous incision was made. An inguinal hernia occurs in the groin (the area between the abdomen and thigh). It is called inguinal because the intestines push through a weak spot in the inguinal canal, which is a triangle-shaped opening between layers of abdominal muscle near the groin.

Should a hernia be repaired?

A hernia does not get better over time, nor will it go away by itself. In fact, they usually grow or get worse over time. Hernias can become a serious health threat. There is a risk of developing a problem with incarceration or strangulation of the bowel, which is a surgical emergency.

For more information on hernias please visit: https://www.goremedical.com/eu/conditions/hernia

Is it possible to re-operate through a Gore patch product?

Yes. Because Gore patch products mimic the natural healing of tissue, normal scar formation develops. As a result, surgeons have reported numerous successful re-operations through implanted Gore patch products, finding the healed material easy to identify and dissect.

For complete information regarding indications for use, contraindications, precautions and instructions see the published Instructions for Use (IFU) found on the eifu.goremedical.com website.

What is the difference between GORE® DUALMESH® Biomaterial and GORE® DUALMESH® PLUS Biomaterial?

GORE® DUALMESH® Biomaterial and GORE® DUALMESH® PLUS Biomaterial differ only in the antimicrobial treatment. The GORE® DUALMESH® PLUS Biomaterial is impregnated with silver carbonate and chlorhexidine diacetate. These two agents act synergistically to inhibit bacterial colonization of the device for up to 14 days after implantation.

Why use GORE® DUALMESH® PLUS Biomaterial in a hernia repair?

The GORE® DUALMESH® PLUS Biomaterial, made of ePTFE, is uniquely designed for hernia repair because it:
1) Is constructed of ePTFE, which makes it soft and compliant
2) Has a bulk material with a node and fibril structure designed to encourage host tissue incorporation
3) Offers a unique antimicrobial coating designed to inhibit bacterial colonization for up to 14 days post implant
4) Has a smooth side that is intentionally darker in color than the opposite, textured surface to help in orientation during surgery
5) Has a CORDUROY Surface that is textured for early fixation and extensive neovascularization.

 

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