The Americas Hernia Society held its annual meeting in March, and for the first time in its 22-year history, convened a panel to address long-term safety issues associated with hernia mesh implants.
“I think the questions that are being asked about the safety of hernia mesh are appropriate,” panel moderator Michael J. Rosen, MD, a professor of surgery and the director of the Hernia Center at the Cleveland Clinic in Ohio, said at the start of the 3-hour session. “We don’t have a lot of great data.”
In general, hernia mesh implants were allowed to come to market via the U.S. Food & Drug Administration’s (FDA) 510(k) clearance process. This program does not require implant manufacturers to conduct human clinical trials if they can demonstrate that a new product is “substantially equivalent” to another device that has already been subjected to the agency’s stringent premarket approval protocols.
What’s more, most of the predicate products used cited in 510(k) applications for hernia mesh were available prior to 1976, when the FDA did not require manufacturers to conduct any clinical testing for benefits, efficacy or safety.
Shirin Towfigh, MD, a surgeon at the Beverly Hills Hernia Center who co-runs the online discussion group (www.herniatalk.com), complained that too many people feel they aren’t being heard when they come forward with hernia mesh safety concerns.
“Patients have been hurt. We can argue the percentage; you can argue the demographics,” he said, according to a report published by General Surgery News. “But it’s not cool to have a hernia repair and not be able to have sex for the rest of your life, or to lose your testicle, or not be able to wear certain types of underwear, or not sit at a board meeting because you’re in chronic pain. That is not cool. And the patient perspective is real.”
Dr. Towfigh predicted that the growing controversy surrounding hernia mesh will eventually equal the storm that erupted over transvaginal mesh implants several years ago.
In fact, there are already more than 10,000 hernia mesh lawsuits pending in courts nationwide, mostly over multi-layer polypropylene implants manufactured by Ethicon, Inc., C.R. Bard, Inc., and Atrium Medical Corp.
Plaintiffs filing these cases claim that polypropylene, a type of plastic, is biologically incompatible with human tissue. In some patients, this incompatibility can trigger an inflammatory reaction that ultimately leads to hernia mesh failure, abscesses and scarring, organ damage, bowel obstructions, the need for revision surgery, and permanent disability.
According to panelist Mark Benvenuto, Ph.D., a professor of chemistry at the University of Detroit Mercy, the long-term effects of polypropylene on the human body aren’t well understood. Because there’s no publicly-available information on the catalysts used to produce the material, even less is known about how the manufacturing process might impact the effects of hernia mesh plastics on the body.
“There are different grades of this stuff,” he noted. “Are you exactly sure that the quality of a plastic going into it is precisely what it’s supposed to be?”