To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Breakthrough Technology Reduces Post-Surgical Complications URL: http://www.pslgroup.com/dg/2D082.htm Doctor's Guide June 23, 1997
PHILADELPHIA, June 23, 1997 -- The country's leading surgeons gathered in Philadelphia today to learn about a revolutionary new technology recently cleared by the U.S. Food and Drug Administration (FDA) that can help prevent or reduce one of the leading causes of post-surgical complications -- the formation of internal scar tissue, or adhesions. The surgeons learned about this new advance as part of an educational symposium on the "Prevention and Treatment of Adhesive Small Bowel Obstruction" held at this year's annual meeting of the American Society of Colon and Rectal Surgeons. The new technology, called Seprafilm(TM), by Genzyme Corp., is made of a translucent sheet of bioresorbable material and is the first anti-adhesion product cleared for use in both open abdominal and pelvic procedures. "The ability to limit or eliminate adhesions is one of the most significant advances in medicine, and it's something people have been trying to do for decades, if not longer," said symposium instructor Steven D. Wexner, MD, Cleveland Clinic Florida. Before the surgical incision is closed, Seprafilm(TM) is placed over the surgical site and surrounding organs and tissues, reducing the formation of adhesions by preventing internal tissue surfaces from sticking together. Post-surgical adhesions will form in more than 90 percent of the 3.1 million Americans who undergo abdominal and pelvic procedures annually. Adhesion formation is a natural consequence of surgery that occurs when the body tries to repair itself following the trauma of incision, cauterization or suturing, or as a result of handling or drying-out of tissue due to exposure. At the site of such damage, internal tissues that normally remain separate often become joined together, causing fibrous scar tissue to form. This process generally occurs within the first few days following surgery and can lead to further serious complications, including difficult re-operations, small bowel obstruction, female infertility and chronic debilitating pain. Until the introduction of Seprafilm(TM), there was no surgical technique or pharmaceutical product that could effectively prevent or reduce adhesion formation. As a result, more than 446,000 procedures are performed annually to remove adhesions, costing the U.S. health care system approximately $1.2 billion annually, not including indirect costs. While adhesions can affect people of all ages, economically, the impact is particularly significant in the Medicare population, those 65 and older. Although Medicare patients represent only 15 percent of the U.S. population, in 1995, they accounted for nearly 50 percent of bowel and rectal surgeries, the most common cause of post-operative adhesions. In 1996, adhesion treatment among this population cost over $700 million. Meeting an Unmet Medical Need Adhesion formation is the bane of every surgeon and surgical patient's existence, causing up to 74 percent of intestinal obstructions. Also, six out of 10 patients who undergo abdominal procedures have had some form of prior surgery, often resulting in the formation of adhesions. Therefore, surgeons may have to spend a considerable amount of time -- from minutes to several hours -- dividing adhesions before the current procedure can begin, prolonging patient recovery and increasing overall surgical risk and cost. Adhesions are also associated with up to 20 percent of female infertility cases and are found in up to half of patients experiencing chronic pelvic pain. The long-term clinical outcomes of anti-adhesion products on these complications have not been determined in clinical studies. However, clinical findings have shown that when used in abdominal surgery, 51 percent of Seprafilm patients had no adhesions where the product was placed, versus only 6 percent of patients in the control group. Clinical gynecologic findings also reveal that patients treated with Seprafilm had 37 percent fewer adhesions to the uterus than patients who were not treated. In both trials, Seprafilm was shown to significantly reduce the incidence, severity and extent of adhesions. Genzyme Corp., is a biotechnology and health care products company, focuses on developing innovative products and services for major unmet medical needs. Genzyme General, a division of Genzyme Corp., develops and markets pharmaceuticals, genetic diagnostic services, and diagnostic, surgical and specialty therapeutic products. More medical news about: Genzyme Corp. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. 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