Biological hernia-repair mesh expensive and unnecessary: study

Last Updated: 2016-02-03

By Larry Hand

NEW YORK (Reuters Health) - Using expensive biological mesh for repairing abdominal hernia walls, instead of using low-cost synthetic mesh, has added unnecessary costs and is not supported by evidence, according to a new report.

Senior author Dr. Edward H. Livingston of the University of Texas Southwestern Medical School in Dallas told Reuters Health doctors may assume the biological "devices have been tested in some rigorous way to support the claims that the companies or the salespeople make. That may not be the case."

Dr. Livingston, who is also deputy editor of JAMA, and colleagues conducted a literature search of published articles on the use of biological mesh between 1948 and 2015. They found only 20 articles, mostly case studies involving patients at single institutions, with only three comparative studies and no randomized clinical trials.

In all, the studies reported on outcomes for 1,033 patients, but they varied widely in follow-up time, meshes used, patient-selection criteria, and operating techniques. They also varied widely in reporting clinical outcomes such as fistula formation and infection, and recurrence rates ranged from 0% to 80%.

The researchers also searched the U.S. Food and Drug Administration's online database for 510(k) material and device clearances.

"All biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbiological predicate devices that, on average, were one-third less costly," the researchers reported in JAMA Surgery, online January 27.

They queried the Delivery Network and Group Purchasing Organization to determine a median price for mesh materials. Prices for biological mesh ranged from $4.1 per cm2 to $33.16 per cm2, with a mean of $19.15 per cm2 - 3.5 times the price of synthetic mesh.

Overall, the team found insufficient evidence to warrant the extra costs. "There is no published literature, to our knowledge, describing the overall use of biological meshes relative to their nonbiological counterparts," they wrote.

"Part of the problem is no one's really paying attention, because the patient is not paying for it and the surgeon is not paying for it. I'm not sure what surgeons should tell the patients. It's a really odd situation because nobody is in the financial loop with all of this. They just use this stuff and the patient's insurance pays for it," Dr. Livingston said.

The issue goes beyond just hernia meshes to all 510(k) materials and devices, he said. "If we're going to control health care costs, then I think every physician has the responsibility to ask: How did this come to market and should I be committing the health care enterprise to all this expense?"

"If there's a randomized clinical trial that shows that it's as good or better than some other material, then fine. Then you can use it based on that particular study," he continued. "But if you find out that it was shown to be substantially equivalent to a material that's been around forever and that's really cheap, there's no reason in the world for you not to use the less expensive material."

Dr. Benjamin K. Poulose, of Vanderbilt University Medical Center in Nashville, Tennessee, who co-wrote an accompanying invited commentary, told Reuters Health by email, "The central messages are twofold: 1) surgeons should take the time to critically evaluate if a particular implant has real benefit to patients or is cost-effective, and 2) our regulatory approval process or device surveillance process needs to be better."

"I think surgeons should first and foremost be honest with patients about what we can and can't do for them," he continued. "Unfortunately sometimes the constraints and current incentives in our health care system make this a really difficult discussion. I also think that patients should be 100% involved in these discussions and informed as much as possible. But we live in a health care environment where information is not always available or difficult/impossible to access currently."

"There are many ways to improve the current situation in terms of implanting devices in people and seeing how they do. Medical specialty-based registries are becoming increasingly important in answering several of the unknowns, but more support is needed for them to make sure the quality of the information is high," Dr. Poulose said.

"This is really complex and depends on a lot of factors," he concluded. "The bottom line is, we need more high-quality information to help us make these decisions."

The Hudson-Penn Endowment Fund at the University of Texas Southwestern supported this research. The authors reported no disclosures; two commentators reported disclosures.

SOURCE: http://bit.ly/20qKTS1 and http://bit.ly/1VvpNuW

JAMA Surg 2016.