Sphincter-Sparing Treatment for Anal Fistulas Successful

A novel anal fistula plug combines a synthetic bioabsorbable material with a design engineered to optimize operative success.

The Gore BIO-A Fistula Plug features bundled hollow tubes attached to a circular disk, which helps the plug stay in place, reducing the chance of a leading cause of fistula plug failure - the extrusion of the plug through the distal opening of the fistula tract. It also facilitates reproducible anchoring for dependable performance. The three dimensional (3D) structure of the tubes expands to fill the defect and facilitates rapid incorporation, helping to hold the device in place within the fistula. Each tube can be trimmed or removed entirely, so the device conforms for a precise fit.


The Gore BIO-A is constructed from Polyglycolic Acid:Trimethylene Carbonate (PGA:TMC), a synthetic, 100% bioabsorbable material which is backed by 15 years of research and clinical use, and has been successfully used to treat thousands of patients. It provides the patient’s body with a scaffold on which to build new tissue. Over time, as the patient begins to heal, PGA:TMC is gradually absorbed by the body, leaving no permanent material behind. The Gore BIO-A Fistula Plug is a product of Gore Medical (Gore, Flagstaff, AZ, USA), and has been approved by the US Food and Drug Administration (FDA).

“Clinicians have been searching for an alternative to current methods, which have a disappointingly high failure rate,” said Ron Anderson, general surgical products business unit leader at Gore. “The Gore BIO-A Fistula Plug has been engineered to offer a fundamentally new and reliable solution. This new device builds upon Gore’s heritage of innovation, high-performance technology and quality, which have enabled the company to create and bring to market many widely used products for surgical use.”

“Device dislodgement and degradation of the anal fistula plug by bacterial enzymes have accounted for some failures in the treatment of this condition in the past,” said Bradford Sklow, MD, an assistant professor in the department of surgery at the University of Utah School of Medicine (Salt Lake City, USA; www.medicine.utah.edu). “I believe the unique tube configuration of the Gore BIO-A Fistula Plug combined with a synthetic, bioabsorbable material presents an improvement in fistula plug design and may lead to more successful treatment outcomes.”

Anal fistula plugs are intended for the repair of anorectal fistulas, and are often used as a successful alternative to fistulotomy, fistulectomy, and other invasive procedures. Fistula repairs using a plug avoid dividing the sphincter muscles, thereby reducing the risk of incontinence. The fistula plug provides a scaffold for soft tissue repair and facilitates closure of the fistula, but failures can occur due to dislodgment of the plug from the fistula tract.

Related Links:
Gore Medical
University of Utah School of Medicine