FDA’s New Safety Action Plan May Overturn Old Predicate Devices

//FDA’s New Safety Action Plan May Overturn Old Predicate Devices

FDA’s New Safety Action Plan May Overturn Old Predicate Devices

Family Tree of Meshes, Littman

Mesh Medical Device News Desk, November 26, 2018~ The FDA realizes that 42-year-old rules that regulate medical devices need updating. 

Patients of failed devices already understand that all too well.


Many of you weren’t even alive then, but those who were might remember that is the year that Steve Jobs and Steve Wozniak founded Apple Computers and created the first prototype for what would become the personal computer.

The film, Rocky was first released, 14-year-old Nadia Comaneci scored a perfect “10” on her uneven bar routine in the Montreal Olympics, and Georgia peanut farmer Jimmy Carter won the presidency.

FDA Office of the Commissioner, Silver Spring, MD

That is also the year that the Food and Drug Administration (FDA) started regulating medical devices, creating the largely hands off 510(K) clearance pathway that allows a device to make it to market with an exchange of paperwork and identifying a “predicate” device that the new one resembles, already on the market.

No clinical trials were needed.

Industry liked 510(k). Instead of years to the marketplace,the premarket approval that drugs must undergo, for a few thousand dollars and 90 days a new device could be cleared and ready to sell.

For decades, more than 90% of devices made it to the market through 510(k).

That is also how at least sixty new pelvic meshes made it to market – polypropylene mesh to shore up falling pelvic floor or organs, to support a sagging urethra or bladder.

But with no clinical trials, the fallout of that experiment can be seen today in the hundreds of thousands of defective product lawsuits filed around the globe and the claims of thousands of women who say their lives will never be the same.

So today the FDA announced plans to modernize the 510(k) clearance pathway, (here)  taking into account rapidly evolving technology, novel materials and electronic devices.  Much has changed in 42 years and the FDA wants to meet those changes relying on “modern safety and performance criteria.”

Currently the FDA’s, Center for Devices and Regulatory Health (CDRH) oversees more than 190,000 medical devices and thousands more enter the market every year.


Today’s announcement says the FDA wants to retire “outdated” predicates, that is a named predicate device older than ten years.

Currently the FDA’s, Center for Devices and Regulatory Health (CDRH) oversees more than 190,000 medical devices.  Twenty percent of the current 510(K) clearances are based on a predicate that is ten years old or older.

In the next few months the FDA will “consider” naming those older predicates and name the devices that followed using it as a model. *Note*  the words “consider following” is how the FDA frames that move.

ProteGen incontinence mesh, was made by Boston Scientific and marketed in 1996.

Suzanne McClain

MND researcher, Suzanne McClain found more than 60 pelvic mesh devices were approved naming ProteGen as their predicate.  That work was echoed by a British Medical Journal review of the 1985 Mersilene Mesh (Ethicon hernia mesh) and the ProteGen sling, also finding 61 devices that named them as a predicate.

There were no clinical trials evidence for the 61 devices at the time of approval.

Unfortunately, ProteGen was recalled from the market March 17, 1999.

“The use of the ProteGen in the treatment of female urinary incontinence is associated with a higher rate than expected of vaginal erosion and dehiscence and does not appear to function as intended.”

Dehiscence is a wound rupture at a surgical incision.

In short, the mesh was recalled after proving to be defective in ways that were harmful to patients, however, there is no regulation within the FDA to spark a review of those meshes that followed the lead of ProteGen.

In other words, a defective medical device can serve as a predicate.

In the next few months the FDA will “consider” naming those older predicates and name the devices that followed using it as a model. *Note* the words “consider following” is how the FDA frames that move.

To be clear, we don’t believe devices that rely [sic] on old predicates are unsafe, or that older devices need to be removed  from the market.  However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.. It would help the overall product environment continue to evolve in the direction toward more modern performance standards.”

Translation – the FDA may rely on more modern predicate devices which should meet “modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles.”

Other changes – a 510(K) submission is now 1,185 pages rather than 475 pages as it was a decade ago.

A few other changes are underway. Fewer 510(K) clearances occurred in 2017.

Generally more than 95% of devices make it to market easily through 510(k), but in 2017 that number was 3,173 devices, which was 82% of the total devices cleared to market. Presumably, the rest, 18% had to undergo a more vigorous review that involved some assurances of safety and efficacy.  ###


MND, ProteGen – The First Mesh, a 20 Year History , October 3, 2016 (here

MND, ProteGen Mesh – The Grandmother of Them All, July 13, 2014 (here

MND, Mesh-Injured Patient Researches ProteGen Mesh Predicate, November 18, 2011 (here

BMJ Open, December 2017, Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. (here



By | 2018-11-29T23:37:48+00:00 November 26th, 2018|News|11 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. Anon November 27, 2018 at 11:30 am - Reply

    Jane what is your take away on this change. Probably will allow past harm to go unpunished. I just have no faith in the FDA anymore. Seems they work to make pharma companies more profitable rather than protecting the public as they are supposed to be doing. What about the harm that’s already been done under.the.510 process. Little late for us wouldn’t you.say?

    • Jane Akre November 27, 2018 at 12:31 pm - Reply

      What about the harm that’s already been done? I suspect the FDA would say that’s being remedied by the court in product liability lawsuits, but as we know it really is NOT. I’ve been hearing stories of insurance swooping down to grab up the very last of a woman’s settlement dollars at greatly inflated prices. Do Not LET That Happen to YOU! Your law firm should negotiate that down. AND do not pay the 5% common benefit fund, let the firm pay that on your behalf… at the very least take it off the top, then you share the cost with them. I’d say this has been a disaster and everybody skates except the injured and the few who made it to trial. Just my opinion.

  2. M November 27, 2018 at 3:25 pm - Reply

    These new changes will Not relieve Ethicon of their responsibility to pay for the catastrophic harm that its defective devices have previously caused. Specifically the Gynecare Prolift system. At this point, I have very little confidence in any of our governmental agencies, including our Judicial Justice System, however, the U.S. Food & Drug Administration told J & J in a letter on August 24, 2007, to halt Gynecare Prolift sells until the agency decided whether the device was “substantially equivalent” to other products on the market, specifically its prototype, the Prolift + M. J & J continued to sell the vaginal mesh implant for nine (9) months after U.S. regulators told the company to stop marketing the device, according to court records. Warning….by the FDA, “you may not market the device until you have provided adequate information “on 16 potential deficiencies and received FDA approval, if you market the device without conforming to these requirements, you will be in violation of the Federal, Food, Drug and Cosmetic Act.” Ethicon ignored the FDA and continued selling the device without clearance. Ethicon never received PMA approval for the Gynecare System, the FDA (cleared) the device under the 510(k) clearance in May, 2008.
    In early 2012, the FDA asked the vaginal mesh makers for further safety studies. However, the Ethicon division notifies in a letter, dated June 4, 2012, to Judge Higbee and Judge Goodwin, that it asked FDA for permission to discontinue sales of four TVM devices and asked the agency to suspend requirements for additional studies on it’s Gynecare brand of products.
    No One is adequately checking the (pharmaceutical giants) hand. But we can thank FDA for forcing Ethicon to take these four harmful devices off the market.

  3. Mary November 27, 2018 at 4:07 pm - Reply

    …I inquire, about my investigation with FDA Office of Compliance, to FOIA at least 2x a month. Its been 7 months now.
    It would be great if the FDA would do whats right. The “clinical-trials” have unfortunately, been done on unsuspecting women, all over the world. Is there actually ANYONE, who was implanted, at least 4 years, and had NO problems?? A GOLD STANDARD should be supplied with numerous examples of a Perfect Outcome. I am really interested in hearing from “GoldStandard” recipients.
    Why arent they being sought out by manufacturers, to testify in these trials??? There should be NO “experts” without a permanent medical mesh device inside their body!!
    Yellow and Blue make Green!
    (Think Urine)
    I witnessed green sores all over my Mom. Her urine turned her catheter green!!
    I have Faith that the FDA will follow through with DoingNoHarm, because the manufacturers have shown no intentions of removing their stinking products from the market. Many Drs, as well as patients, do not know what Polypropylene is. Ask them!! America is slow on many things…but eventually America gets it right…or at least better.
    If the MeshMakers want to remain rich, they need to be developing products that are pelvic-friendly-NOW!
    Lives have been lost as well as destroyed and no one should have to suffer ever again!! The 1st Company to admit their mistakes, make amends, and move forward…will be the future product a woman could trust to use. To continue destroying these women with no remorse or compensation is evil and horrific. Good will win!’ I really believe that!!

  4. Toni November 27, 2018 at 5:35 pm - Reply

    Well Jane all I can say is it seems like you and a few doctors ie those who will admit these products are the culprit and try to help us remedy the damages as much as possible. May be our only true advisaries. Like using a bandade on open heart surgery after the fact. The damages are done but at least we have a few on our side. I feel the lawyers for the most part just after their paydays not really fighting. If they were this would be long over with much better outcomes for all who suffer.

    • Jane Akre November 27, 2018 at 9:01 pm - Reply

      My fear is without acknowledging the injuries will continue. Mesh makers won’t stop and doctors won’t either (unless they see the damage) unless and until they are sued.

  5. Aggravated November 28, 2018 at 9:52 pm - Reply

    Hi Jane ..well got my letter of settlement and it was very low and with the 40% for the lawyer and the 5% of whatever that is and of course the dr bill and surgery..so with all of that I get nothing..I havent signed the papers yet and I really dont know what to do..my lawyer called today and said sign it..all im seeing with this is them making money and me nothing..can they not fight this for me and ask for more..

    • Jane Akre November 28, 2018 at 10:50 pm - Reply

      And you would sign it why????? Once you do, you are forever forbidden from discussing the settlement and you case is closed. Depending on which manufacturer, your case may still have some legs . Lots of ifs there but again why would you sign for nothing so they can get their 40%? Will they reduce their fee as an incentive to get you to sign? Some law firms are doing that, but of course not advertising that they are.

  6. Really! November 29, 2018 at 12:09 pm - Reply

    Aggravated… do some research and weigh your options very carefully before you sign. Read and study the MDL statute 28 U.S.C. section 1407. You have Constitutional rights, specifically, Fifth Amendment 5th Due Process Rights. Our cases are (our) personal property, not the law firm’. Plaintiff’s chosen action is a property right that cannot be taken without Due Process of law. Alongside the settlement agreement should also be a notice of the right to return for trial as required by the MDL statute.

    Read the article entitled, One Size Doesn’t Fit All. Multidistrict Litigation Due Process and the Dangers of “Procedural Collectivism”.

  7. Really! November 30, 2018 at 9:22 am - Reply

    Aggravated….Read and study the entire articles. The articles will give you a clearer understanding of the legal MDL statute, especially a clear view of the somewhat unconstitutional/questionable process.
    Find the entire articles: The Long Arm of Multidistrict Litigation——Berkeley Law Scholarship
    One Size Doesn’t Fit All. Multidistrict Litigation Due Process and the Dangers of “Procedural Collectivism”

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