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Frequently Asked Questions about GORE® DUALMESH® 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 there ever been an allergic reaction to GORE® ePTFE patch products?

No. Since ePTFE is one of the most inert and biocompatible polymers available, there has never been a confirmed allergic reaction to a Gore ePTFE product.

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.

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, dissect and re- approximate.

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.

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

The microstructure of each side of GORE® DUALMESH® Biomaterial is engineered to perform best with the tissue it contacts. The 'smooth' side, having a small pore size, is placed adjacent to the bowel and resists tissue attachment. The 'rough' side, with a more open pore size, is next to the tissues that surround the bowel where tissue incorporation is an advantage. Proper orientation of the patch is important to the success of the repair; improper orientation could lead to adhesion formation due to the intense ingrowth response.

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.

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® Biomaterial in a hernia repair?

The GORE® DUALMESH® Patch, made completely of ePTFE, is ideal for hernia repair because it; 1) will result in the permanent repair of the abdominal wall, 2) has ingrowth characteristics that mimic normal tissue healing, 3) easily assumes the conformity of the abdominal wall musculature anatomy, and 4) cuts easily without fraying.