Shouldn’t A Permanent Medical Device Implant Be Considered High-Risk?

by Searcy Denney Scarola Barnhart & Shipley

It really doesn’t sound like a question we need to be asking because it should be a matter of common sense.

Shouldn’t any medical device that is permanently implanted in the human body be put through a high degree of scrutiny for safety and efficacy so we don’t have to test it on the population like they’re lab rats? Of course so, but that’s not what happens.

About 90 percent of medical devices are approved by the Food and Drug Administration bypassing any outside assurances they are safe. Instead, we must rely on the manufacturers themselves to provide those assurances, the same group that will profit from the device sales. Obviously it is a formula for an intense conflict-of-interest, especially if your manufacturer is less than forthcoming.

Now, after many years, the U.S. Food and Drug Administration (FDA) is finally taking action concerning surgical mesh used in transvaginal prolapse repair. The FDA is proposing elevating the risk of the devices from medium (class II) to high-risk (class III). That new classification would require a greater scrutiny and require manufacturers to put the products through clinical trials, not unlike the process that drugs must undergo before they are approved. It only makes sense.

The FDA reports that it has received over 19,000 adverse event complaints about surgical mesh, which is the reason behind this reclassification effort.

Like other medical devices such as the DePuy metal-on-metal hips, the fast-tracking of medical devices to market with the “least burdensome” standard on the manufacturer shows the agency cannot possibly serve two masters – both industry and patients.

Why has it taken the agency so long to make this proposal? Back in October 2008, the FDA knew it was receiving reports of serious mesh-related complications and injuries such as mesh erosion, organ perforation, mesh shrinkage, chronic infections and pain. Yet the agency downplayed the complications as “rare.”

Fast forward three years and the FDA in July 2011 reversed itself after complication reports had jumped five-fold. The agency began calling mesh-related complications “not rare” and discouraged the use of mesh – warning that the benefits may not be worth the risks. Still, the devices remained a class II moderate risk designation.

Today with more than 70,000 lawsuits filed in courts around the country, not to mention around the world, it is absurd to continue to call the risk of pelvic mesh a “moderate risk.”

It is easy to file a comment in the Federal Register, but once the 90 day period closes, it is very likely that the reclassification of surgical mesh for pelvic organ prolapse will take place meaning any innovations will actually have to be studied before marketed. Knowing that mesh cannot pass a clinical trial, it will essentially put the nail in the coffin of pelvic mesh medical device innovation.

Remaining to be done is the reclassification of the same type of mesh used in the treatment of stress urinary incontinence. It too is polypropylene and subjects women to the same pain and intense life-altering complications.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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