Results from a clinical study led by Luca Ansaloni, MD, showed Cook Medical's (Bloomington, Indiana) Biodesign Inguinal Hernia Graft causes less postoperative pain and discomfort while creating a repair as durable as synthetic mesh when used in Lichtenstein's hernioplasty procedures, the company reported this week. As published in a recent issue of the American Journal of Surgery, the three-year, 70-patient study determined that patients treated with Biodesign Inguinal Hernia Graft experienced a lower level of postoperative pain as compared with synthetic mesh-based procedures, Cook said.
The randomized, double-blind inguinal hernia study examined the efficacy of the Biodesign graft in treating 35 men compared to 35 men treated with synthetic mesh. Research findings showed that 11% of patients treated with synthetics experienced chronic postoperative pain that limited daily activities, most often resulting from the mesh characteristics as opposed to surgical technique. By contrast, patients in the study treated with the Biodesign graft experienced a lower degree of postoperative pain both at rest and when coughing or moving. Additionally, at three-year follow-up no evidence of hernia recurrence was seen in the study patients treated with the Biodesign graft, according to the research.
Inguinal hernias occur when soft tissue, generally part of the intestine, forces its way through a tear in the lower abdominal wall or through the inguinal canal and creates a bulge that can be painful when coughing, bending or lifting heavy objects. According to the National Institutes of Health, inguinal hernias are more common in men and often develop as a result of the frequent heavy lifting, coughing or straining. While hernias aren't necessarily dangerous themselves, they can lead to life-threatening conditions if left untreated, Cook noted.
"Based on our research findings, biologic grafts are extremely effective when treating inguinal hernias," said Ansaloni, a general surgeon at St. Orsola-Malpighi University Hospital (Bologna, Italy). "Not only did [study] patients recover quickly after receiving the Biodesign Inguinal Hernia Graft, but they experienced less pain and discomfort as compared to patients who were treated with synthetic mesh."
According to Cook, the Biodesign Inguinal Hernia Graft incorporates attributes of a biologic graft – resistance to infection and complete remodeling – with the added benefits of moderate price, ease-of-use and ample shelf life for on-site availability. Upon deployment, the graft reinforces the repair of surrounding tissue and, over time, communicates with the patient's body, signaling surrounding tissue to grow across the scaffold where the repair is needed. The Biodesign graft is designed specifically for reinforcing the inguinal floor and designed to meet special challenges including resistance to infection, encapsulation and erosion, the company said.
Last year Cook launched an informational microsite – CookBiodesign.com – for its Biodesign grafts to provide abstracts of clinical studies, research articles, news, and treatment success stories for the company's Biodesign products (Medical Device Daily, Oct. 19, 2009).
"The potential complications associated with the use of synthetic mesh in treating inguinal hernias can cause a significant decrease in quality of life for patients while also increasing procedural recovery time," said Andy Cron, VP of Cook's surgery strategic business unit. "This study comes at a very important time, as the medical field continues to debate the benefits of biologic and synthetic treatment options. Dr. Ansaloni's research reinforces our efforts to leverage biologic solutions that provide hernia patients with a natural, lasting solution."
In June, Cook reported data that showed the Biodesign Hernia Graft is safe and effective in treating chemotherapy patients suffering from hernias for which synthetic mesh is not a viable option. According to that study, Biodesign is particularly effective at treating high-risk patients with preoperative abnormal wall morbidity, gastrointestinal perforation and those patients receiving hyperthermic intraperitoneal chemotherapy or cytoreductive surgical procedures. The graft also proved to reduce postoperative adhesions, reduce the risk of surgical site infection and eliminate enterotomies of fragile bowel after chemotherapy during subsequent surgeries in that study (MDD, June 30, 2009).
Amanda Pedersen, 229-471-4212;