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

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

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

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.  ###

By |2017-04-20T10:36:33+00:00April 20th, 2017|FDA News|4 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Kitty April 24, 2017 at 11:49 am - Reply

    Actually..I’m confused . I believe POP is still on markget…but cannot be done transvaginally??Please advise. Thank you Jane. Thank you for everything that you do gor us.

    • Jane Akre April 24, 2017 at 12:08 pm - Reply

      Most POP mesh has been removed from the market voluntarily and secretly by the manufacturers. That way they didn’t have to do the 522 studies. They include Prolift and Prolift M+, Avaulta, Pinnacle and Pinnacle LIte in the us only. Uphold LITE vag support system is undergoing 522 review,, s is Upsylon Y-mesh by Boston Sci. It remains to be see if they will eventually be approved under new stricter compliance with safety and efficacy. Believe it can still be used transvaginally, remember PO mesh was reclassified to a stricter Class III but manufacturers were given 30 months to do so, That means at the end of 2018, theoretically they can use up what remains on hospital shelves. foolish to do so unless they want to be brought into a medial malpractice action.

  2. Kk May 12, 2017 at 1:09 am - Reply

    Then why tell women they need these devices if women can live without them . This none life-threatening issue we women deal with . Then let us and leave us alone . The DOCTORS AND PHARMACEUTICAL CAME KNOCKING AT THE DOOR OF MILLIONS OF WOMEN .KNOWING WHAT , WHEN,WHERE,AND HOW THIS ISSUE WAS GOING TO PLAYOUT .
    HOOKS AND BLUE PLASTIC IN A WOMEN BODY . THIS IS ONE BIG JOKE !!!! You know this reminds me of the movie Lucy ,again with blue plastic !!!

  3. Stephen Arden July 3, 2017 at 8:20 am - Reply

    I think high-risk medical devices should be taken into serious considerations before giving approval because public safety is far more important than personal interests of stakeholders.

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