FDA’s Shuren on Tightening Future FDA Review of High-Risk Devices

Jane Akre
April 20, 2017

Dr. Jeffrey Shuren, CDRH

Mesh Medical Device News Desk, April 20, 2017 ~ FDA’s Jeff Shuren writes about how to serve two masters, public safety and the need of manufacturers for fast access to the marketplace for high-risk devices. Can anyone serve two masters?

For seven years, Dr. Jeffrey Shuren has headed the Center for Devices and Radiological Health (CDRH), the medical device division of the U.S. Food and Drug Administration (FDA). He oversees high-risk medical devices all the way to crutches and band-aids.

In this essay, published in April in the New England Journal of Medicine (NEJM), Dr. Shuren appears to be assuring the public that the FDA has a handle on high-risk when it comes to medical devices.

We know from 150,000 defective product lawsuits filed over transvaginal mesh in the U.S. alone, that the agency failed in its mission to assure the safety of high-risk medical devices it cleared for market.

Dr. Shuren believes safety is assured by classifying medical devices into three categories – class I for low-risk devices such as eyeglasses and bandages; class II for moderate-risk devices such as such as nebulizers and blood glucose meters. Transvaginal mesh fits into this category.

It’s difficult to imagine that transvaginal mesh, a polypropylene plastic, permanently implanted through incisions in the vagina, falls into this category, but it does.

High-risk or class III and new moderate-risk devices (about 4% of all devices) generally require clinical evidence that risks do not supersede the benefit.

A year ago, the larger transvaginal mesh used for pelvic organ prolapse (POP) was finally reclassified into class III, six years after that recommendation from an expert panel convened by the FDA that met in September 2011.

FDA's 522 Surveillance page

As a result, most manufacturers have quietly taken their POP mesh off the market. That relieves them of having to conduct post-approval studies. The FDA mandated 522 reviews (see more on 522 here) are currently underway but the public cannot find out what they reveal. Only if you file a Freedom of Information Act request, and have a lot of patience to wait can you find out what the studies are revealing.

See the 522 Post-Market Surveillance Plan Page here.

Unfortunately for the implanted women, the damage has already been done.

Meanwhile, far more meshes for stress urinary incontinence (SUI) are still in class II and are cleared by naming a similar “predicate” device already in commerce. No clinical trials are necessary.

Dr. Shuren sums it up when he says “Regulators expect data that are provided by device manufacturers to reflect the risk profile of the device.”

We know from trials so far that mesh manufacturers sit on data they do not want exposed about risk and the potential for injury. Experience should tell us that we cannot rely on device manufacturers to provide data to accurately reflect the risk profile. That just doesn’t happen.

The FDA is trying to serve two masters. First, the industries that want devices more quickly on the market, and second, the public, that wants safety above all.

How do you serve two masters? The public ends up with cheap and fast approvals over safe and effective devices.

Dr. Shuren says that conducting a large randomized controlled double blind study on an implantable device may be impractical or unethical due to its risk.

But that’s essentially what’s happened.

Allison W. Shuren, Partner and Co-Chair of the FDA/Healthcare Practice Group at D.C.-based Arnold & Porter, LLC

Looking ahead, Shuren says bench studies and studies on animals, and computer- based modeling may allow for smaller clinical trials. Sponsors from industry will develop clinical trial design.

Again Shuren says it may be appropriate “to accept a greater degree of uncertainty in order to expedite the availability of the device for patients.”

Expedite is not what Americans expect of their FDA.

In the case of transvaginal mesh, there was no need to expedite a pathway to approval because incontinence is not a life-threatening, debilitating disease. It is a condition that most women live with, to some degree, for years. Prolapse as well, is inconvenient but not painful or a danger to life.

An “expedited pathway” to address “unmet medical needs” using the “least burdensome” standard (on the device maker), is a formula for disaster.

Is it any wonder that so many have fallen into the gaping holes of the safety net that is supposed to be our FDA?

Interestingly, neither author notes any financial conflicts of interest. Dr. Shuren’s wife is a prominent lawyer whose clients include pharmaceutical, medical device and biotechnology companies. ###

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