You and your surgeon have chosen to use GORE Subcutaneous Augmentation Material (S.A.M.) for your facial contouring surgery. The following information is provided to help you understand the nature of the implant material, how it is used, how your face will feel after it is inserted, and possible complications associated with its use. If you have additional questions about the implant or your operation, please do not hesitate to ask your doctor.

What is Gore S.A.M. made of?

GORE S.A.M. is made of a material whose scientific name is "expanded polytetrafluoroethylene" (ePTFE); some configurations may also include fluorinated ethylene propylene (FEP). Both are nontoxic polymers that are used in many different kinds of medical products that are implanted throughout the body. Unlike some other materials, ePTFE is not "rejected" by the body, so implants made with it can remain in place permanently and no "anti-rejection" treatment is necessary after the implantation surgery. In addition, among the 4 million ePTFE implants to date, there have been no confirmed cases of an allergic reaction to the material.

Unlike a silicone implant, an ePTFE implant is a porous, solid material. Its porosity allows the body's s tissue to grow into it. Flexible and soft to the touch, ePTFE is very strong and extremely unlikely to stretch or tear.

GORE S.A.M., indicated for facial plastic and reconstructive surgery, is inserted subcutaneously ("deep beneath the skin") and augments the contour of your face.

How is the GORE S.A.M. material inserted?

Your surgeon will make a small incision at the implantation site. Tissue from the area will be gently lifted and a small tunnel, or pocket, created for the implant. While ensuring that the implant remains sterile, the surgeon will trim it to fit your facial contours, insert it into the pocket, and may secure it in place. The time required for this procedure will depend on which area of your face is being treated. The incision may be closed with stitches that your surgeon will remove in a week or so.

How will my face feel after my operation?

Your surgeon will discuss what you can expect as you recover from your specific operation. Generally some discomfort, aching, stiffness, numbness, and swelling should be expected after any kind of facial implant surgery. These feelings may last for a week or more.

Although the GORE S.A.M. Is compatible with your body's natural tissue, it is an artificial material and not the same as that tissue. As a result, the area of your face where the implant has been inserted may feel somewhat different "to the touch" after surgery, even after the swelling from the procedure has gone down.

What are the possible side effects of facial implant surgery?

All operations carry some risks, including those resulting from anesthesia, which your surgeon will discuss with you. Scientific studies have found the GORE S.A.M. to be a very safe product. The product is supplied sterile to your surgeon. Specific complications associated with its use are unlikely but they can occur. Possible adverse effects include excessive swelling and bruising on or below the skin, infection, formation of a fistula (an abnormal opening between tissues), extrusion (part of the implant comes through the skin), induration (hardening of the area operated on, formation of a seroma (a dense pocket of fluid below the skin), and inadequate healing, or excessive facial contouring.

Your surgeon will give you detailed instructions and guidelines to follow as you recover from your operation. The best way to prevent complications from surgery is to follow your surgeon's instructions carefully.

If a problem begins to develop or you have any concerns at all about the results of your operation or the healing process, call your surgeon immediately. There are many effective treatments for any complications that can occur. Early consultation with your doctor is extremely important.