“Application of Evidence-Based Value Analysis: Standardization of Surgical Mesh Products”
In this White Paper, Winifred Hayes, a medical efficiency analyst, known as, “Your Outsourced Research Partner,” tells hospitals how to save money buying hernia mesh by being more efficient.
Problem: In the case of hernia mesh, hospitals buy mesh from a limited number of vendors and pay top dollar. To save money, some hospitals place a payment cap on the cost of the medical device.
But what has been missing is any consistent and structured reasoning as to why these meshes are purchased and the outcome of the meshes used, largely due to a lack of quality clinical data. Enter the Hayes Evidence Based Value Analysis (EBVA). (here)
She looks for the mesh products that represent a “true health benefit” and which “should be eliminated because of efficacy or safety issues.” A hospital or practice that follows her recommendations will cut costs and presumably offer the best medical services, she says.
Asked by a health system client to use the EBVA approach, this client spent nearly $1.1 million on 18 different surgical meshes for hernia repair. The client didn’t understand why there were so many apparently similar products on the market for hernia repair. Surgeons may request a certain product based on perceived ease of use and expectations. Varieties include:
*Synthetic meshes – characterized by dense polymer, pore size, elastic and a consistent overall structure. Synthetics include polypropylene, polytetrafluoroethylene (PTFE), polyethylene-terephthalate (polyester) and nylon (polyamide). They are nonabsorbable and remain in the body, not absosrbing with biologic tissue.
*Composite meshes – can be absorbable and nonabsorbable polymers. Composites merge biologic mesh with synthetic.
*Biologic meshes – can be made from human tissues, porcine, bovine and equine to form a collagen-rich matrix.
Note* Biologics are much more expensive than polypropylene. This facility spent:
Polypropylene (4 products) $71,000
Polypropylene composite (5 products) $154,000
Other synthetics (6 products) $191,000
Biologic (3 products) $697,000
Now for the Elimination
Using the FDA website and the MAUDE database for reported adverse events, concerning hernia repairs including infection, hematoma, seroma, chronic postoperative pain, as well as hernia recurrence rates, the researcher looked for the strongest evidence from large, multicenter, randomized clinical trials (RCTs).
There was no published evidence relevant to outcomes for 7 out of 18 brands of meshes used by the facility and she found the evidence inadequate to judge the relative performance of the majority of 18 meshes used by the client.
“We found a paucity of evidence for any given mesh product, with no published evidence relevant to the outcomes of interest for 7 of the 18 brands of meshes used by our client.”
Twenty of the studies did not reveal any information about the potential financial conflicts of interest. Six studies revealed the authors had received funding from mesh manufacturers.
Adverse Events of Hernia Mesh:
“Depending on the type of hernias being repaired, for the polypropylene meshes used by our
Infection, hematoma, and seroma (fluid pocket after surgery) rates ranged from 3% to 61%
Postoperative pain rates ranged from 3% to 20%
Recurrence rates were less than 10%
“A wide range of rates (< 20%) was reported for the expanded PTFE, polyethylene, and biologic
meshes used by our client.”
Five of the meshes used by the client were associated with a large number of adverse events in excess of twenty reports per year! One was even in the process of being withdrawn from the U.S. market due to concerns about the potential for serious adverse events.
So as a result, Hayes recommended 12 surgical meshes be removed from the client’s list of products largely because of a lack of published research and the large number of adverse events, high infection rate or post operative pain. MDND hopes to find which ones didn’t make the grade.
Savings: $518,000, reducing the annual budget by about 50 percent.
How much would be saved if all of these hernia mesh operations had a positive outcome? And how do we know unless patients are followed for at least several years?