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

If the Biodesign Fistula Plug falls out, it simply means that the suture holding it in place has broken or dissolved. Return to your physician 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.

The Biodesign Fistula Plug is widely available around the world. Check with your physician to find out if the Biodesign Fistula Plug is available in your country.

Biodesign communicates with your body, signaling surrounding tissue to grow across the graft. This action supports your body’s own healing process by attracting cells and nutrients to the wounded area and allowing your tissue to restore itself. It also allows your body’s immune system to protect the graft from potential infection.

Yes. Over time, Biodesign remodels to become as strong as your own natural tissue.

Biodesign completely remodels into strong tissue. Once the healing process is finished, the graft is completely remodeled into your own tissue, leaving a permanent repair without a permanent material.

There are three main categories of tissue repair materials: Biodesign, synthetic mesh and biologic grafts.

Biodesign Biodesign Advanced Tissue Repair Products are a whole new category in tissue repair, combining the best attributes of synthetic mesh and biologic grafts. Biodesign is a natural material that communicates with the surrounding tissue to help your body restore itself, completely remodeling into functional tissue. The remodeling process also increases the graft’s resistance to infection. And, because Biodesign is not prone to stretching and your own tissue quickly replaces it, a Biodesign repair provides long-term strength, reducing the potential for the condition to recur. Biodesign is available in a variety of shapes and sizes designed to treat various conditions.

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, 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 cross-linked to strengthen the material. However, when these grafts are implanted, your body may respond to them as if they were a synthetic mesh.

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.

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.

Originally developed for wound care in the late 1990s, Biodesign has evolved to its present design and now is used in multiple areas of the body. Biodesign has been used in more than one million patients.

Biodesign is approved for sale in 91 countries. Your surgeon should know if it is available in the hospital where he or she practices.