Like many surgical facility leaders, the hospital administrator assumed that biologic meshes must be superior to synthetic meshes when it came to providing a durable hernia repair. After all, she reasoned, biologic mesh costs around twice as much as synthetic and not just because biologic is made of human or animal skin or small intestinal tissue harvested from pigs, but because it's superior in the clinical outcomes that matter most with mesh: recurrence rates and infection rates. Plus, she'd heard from many of her surgeons who began to use biologic meshes in the 1990s in an effort to reduce the infection rate, chronic inflammation and foreign body reaction associated with the use of prosthetic mesh for complex abdominal wall hernia repair.
But first the administrator wanted proof, compelling clinical evidence that biologic mesh would improve the outcomes of her surgeons' abdominal wall reconstructive surgeries enough to justify the added case costs. So she commissioned the ECRI Institute to conduct an independent review and objective study that paralleled the model of Consumer Reports.
After an expansive review of the last 5 years of mesh literature 57 references in all, including systematic reviews, cost-effective analyses and randomized control trials ECRI returned its verdict: They're equivalent. There are no data to say that synthetic or biologic is superior to the other in terms of minimizing recurrence rates and complications like painful adhesions and wound infections.
"All the data point to equivalence," says David Snyder, PhD, senior research analyst in ECRI Institute's Health Technology Assessment group. "There's nothing wrong with either product. It's just that the clinical evidence says they're equivalent."
ECRI Institute's search of the literature found recommendations that you reserve biologic mesh for contaminated or infected surgical fields patients with a previous infection (abdominal wall or mesh), active infection or intraoperative contamination or in revision surgery (most likely due to an infection).
Dr. Snyder points to a clinical practice guideline from the European Hernia Society that recommends that further studies are needed to determine the cost-effectiveness of biologic mesh. One cost analysis he reviewed showed that biologic mesh is twice as expensive as synthetic: $17,000 vs. $8,000.
"Biologic meshes are enormously expensive and the recurrence rate is way too high," says Mark Reiner, MD, a general surgeon at Mount Sinai Hospital in New York, N.Y.
Biologic mesh has long been marketed as a material that addresses the problems associated with permanent synthetic mesh, including chronic inflammation and foreign body reaction, stiffness and fibrosis, and mesh infection. Studies have shown that the risk of wound complications is unreasonably high when permanent synthetic mesh is placed in contaminated fields. Cavallaro et al., argued that biologic mesh should be used in contaminated fields because 50% to 90% of synthetic meshes placed in that setting required removal.
"I'm an evidence man," says Dr. Snyder. "Except where there's already an infection, to me there's no compelling evidence that biologics would be better or more useful than synthetics."
Straight-stick laparoscopic inguinal hernia repair is a technically complex and challenging procedure. Could the surgical robot simplify the procedure?
Without a doubt, says Mark Reiner, MD, a general surgeon at Mount Sinai Hospital, who last month at the Midtown Surgery Center in New York City performed the first-ever total extra-peritoneal hernia procedure using a robot.
Dr. Reiner says the 3 operating arms of the robot allowed for 360 ? rotation, versus the 180 ? of the human wrist. The movements of the robot were also more stable, removing the tremor that exists with human hands. The robot's 3-D optics provided Dr. Reiner with high-quality images in real time. This increased visibility let Dr. Reiner reduce the risk of inadvertent injury to nerves, blood vessels and other vital organs.
"The robot makes it easy to sew and manipulate the instruments inside the abdominal cavity," says Dr. Reiner. Suturing the mesh in rather than tacking it in with staples lessens the patient's pain and discomfort, he adds.
He says the surgeon can control all 4 of the robot's arms: 3 operating arms 1 to retract and the other 2 to operate and 1 camera arm. "It's easier than having an assistant," he says.
Biosynthetics: a new class of hernia mesh
Due to the moderate durability and substantial cost of biologics, mesh made of biodegradable polymers instead of animal or cadaver tissue is gaining in popularity. Biosynthetic or resorbable synthetic mesh has become more widely used for large ventral hernia repair and abdominal wall reconstruction, says Bruce Ramshaw, MD, FACS, the co-director of Advanced Hernia Solutions and chairman and chief medical officer of Surgical Momentum.
"Similar to the biologics, resorbable synthetic meshes are designed to provide mechanical strength as well as a temporary scaffold structure for tissue ingrowth during the critical period of wound healing," says Dr. Ramshaw. "Unlike biologic mesh, resorbable synthetics have relatively predictable mechanical properties, including compliance, elasticity, strength and fracture, as well as rate of absorption and degradation."