Fistulas

Fecal incontinence is typically caused by surgeries that damage the anal sphincter muscles. Incontinence is unlikely with the Biodesign as its placement does not require cutting the sphincters.

If the plug falls out, it simply means that the suture holding it in place has broken or dissolved. Return to your surgeon to discuss the situation.

Some drainage is common for 2-4 weeks after the fistula plug has been placed. Drainage may even occur for up to 12 weeks as the fistula tract heals.

Anal and rectovaginal fistulas rarely heal on their own. Getting them to close will require treatment.

Biodesign is widely available around the world. Check with your surgeon to find out if the Biodesign is available in your country.

Biodesign is an advanced tissue repair material that allows the body to restore itself.

Once in place, the body infiltrates Biodesign with cells and new blood vessels. Over time Biodesign is completely replaced, so you can have a strong repair without any foreign material in your body long-term.

There are two main categories of tissue repair materials:

Synthetic Mesh These are sheets of man-made materials (polypropylene, polyester, silicone or polytetrafluoroethylene) that permanently remain in your body. While they offer strength for a repair, they may cause problems. For example:

• You might be able to feel the mesh in your abdomen, causing discomfort.
• Synthetic mesh can erode into surrounding tissue or organs, resulting in pain and tissue damage.
• Your body might respond to synthetic mesh as a foreign material and surround it with scar tissue.

Biologic Grafts Derived from human or animal tissue, biologic grafts typically allow cells to grow into the graft and replace it—a process called remodeling. Some biologic grafts are made from skin tissue, which makes them prone to stretching and bulging. Other biologic grafts are chemically altered to strengthen the material. However, when these grafts are implanted, your body may respond to them as if they were synthetic mesh.

Biodesign: A Next Generation Biologic Graft Biodesign is a next generation biologic graft shown to reduce recurrence rates when compared to other biologics. That's because once in place the body completely remodels Biodesign into strong, organized tissue.

And unlike synthetic mesh, nothing is left permanently in the body to cause problems down the road.

Biodesign is based on a technology originally developed in the late 1990s. Since then, it has been continually improved into its present design, named Biodesign, and is used in multiple areas of the body.

Several steps in the manufacturing of Biodesign ensure its safety as a graft. All Biodesign products are made of porcine material that undergoes thorough cleaning and disinfection using controlled medical device manufacturing procedures. Biodesign is provided as a sterile medical product.

Biodesign is approved for sale in almost every country across the globe. Your surgeon should know if it is available in the hospital where he or she practices.

Any surgery has potential for complications. Talk to your surgeon for more information. The following complications are possible with the use of Biodesign surgical mesh: bleeding, infection, abscess, induration, acute or chronic inflammation (initial application of surgical graft materials may be associated with transient, mild, localized inflammation), allergic reaction, visceral adhesions, fistula formation, seroma formation, hematoma, extrusion, recurrence of tissue defect, and delayed or failed incorporation of the device. See Instructions for Use for specific complications related to a particular product.