FDA Approves TiMESH, a Revolutionary New Device for Hernia Repair - New Product

GP Surgical, a Nashville-based distributor of medical products, today announced the recent FDA approval of TiMESH, a revolutionary, new mesh device for hernia repair. TiMESH is the only composite hernia mesh made with titanium, offering U.S. surgeons and patients one of the most innovative and reliable new treatment options for the most common surgical procedure in America.

Light, strong and totally biocompatible because of its inertness and immunity to corrosion by all body fluids and tissue, titanium is one of few materials that naturally match the requirements for implantation in the human body. TiMESH's unique design combines the proven benefits of titanium with the comfort and flexibility of polypropylene. Cutting-edge nanotechnology is used to develop TiMESH with its ideal surgical mesh properties, including biocompatibility, resistance to infection and the ability to be recognized by the body as a solid titanium implant.

TiMESH is specifically indicated for laparoscopic and open surgery for the repair of direct or indirect inguinal, femoral, umbilical and incisional hernias; rectal, vaginal and apical prolapses; and parietal reinforcement of tissues and abdominal wall repair. Since 2002 more than 70,000 TiMESH have been implanted inpatients in Western Europe. It is now available to the 750,000 hernia patients seeking treatment each year in the U.S. and can be used during all hernia surgical procedures.

"There continues to be controversy among surgeons as to the best approach to fix hernias. The limiting factor of all techniques to varying degrees is pain after surgery and recurrence of the hernia," said Jonathan Yunis M.D., F.A.C.S., a Sarasota, Fla.-based surgeon specializing in hernia repair. "Laparoscopic hernia repair offers many advantages to open surgery, such as less discomfort after surgery, possibly decreased risk of infection and possibly a more rapid return to full activity depending on the patient. TiMESH will allow for more laparoscopic procedures because of its ease of use and cutting edge titanium technology."

A hernia occurs when the contents of a body cavity, usually portions of intestine or abdominal fatty tissue, bulge out of the area where they are normally contained. The term hernia is most often used to describe hernias of the lower torso. Inguinal hernias make up 75% of all abdominal wall hernias and are up to 25 times more likely to occur in men than women.

Posted 11th March 2004

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