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

Jane Akre
November 27, 2018

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Today's announcement says the FDA wants to retire “outdated” predicates, that is a named predicate device older than ten years.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

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