The 510(k) Process – Safety Forgotten

//The 510(k) Process – Safety Forgotten

The 510(k) Process – Safety Forgotten


By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP

The 510(k) process is relied upon by the medical device industry, including pelvic mesh manufacturers, such as Ethicon/Johnson & Johnson, Atrium Medical Corporation, and Davol/Bard, to quickly get devices marketed in the United States.  (The term “510(k)” is derived from the statutory section that created the premarket notification process, section 510(k) of the Federal Food, Drug and Cosmetic Act.)

510k 231 wide

This procedure is substantially less rigorous than the premarket approval (PMA) process that evaluates the safety and effectiveness of other medical devices.  A PMA submission, the most stringent premarketing application required by the FDA, requires clinical trials and other scientific evidence to prove a device is safe and effective.  The 510(k) process does not.

This lack of regulatory review has enabled manufacturers to sell mesh for pelvic hernia repair, pelvic organ prolapse (POP), urinary incontinence and other uses without any convincing evidence that mesh is safe and effective.  As a result, too many mesh patients have suffered.

In a 510(k) submission, the focus is not on the safety and efficacy of the new device.  Instead, the 510(k) process determines only whether the new device is “substantially equivalent” to a legally marketed “predicate” device.   A device is substantially equivalent if it has the same intended use and same technological characteristics as the predicate device.  It does not have to be identical.

The 510(k) process is flawed.  Since the predicate device can be a device marketed before May 28, 1976 (before federal law required a 510(k) submission) or a device that was cleared through a previous 510(k) submission, the 510(k) process compares a new device with another one that was itself never reviewed for safety and effectiveness.

Since the predicate device was never reviewed for safety or effectiveness, a 510(k) clearance provides absolutely no assurance that a new device is not harmful.  So, today pelvic mesh products are marketed based on claims of substantial equivalence to predicate mesh devices that were never reviewed for safety and effectiveness.  And, those predicate devices were marketed based on earlier mesh products that were cleared for marketing without any assurance of safety.

Prolene Mesh

Prolene Mesh

The 510(k) submission provides minimal information to the FDA.  The submission includes technological information about the new device, proposed labeling, a comparison to the predicate device, and the conclusory statement that the new device is substantially equivalent to the predicate device.   Clinical or other scientific studies are provided in less than 10% of all 510(k) submissions.

Review by the FDA is quick.  A decision, based solely on the information provided by the manufacturer, is usually made within 90 days.  The FDA “clears” the device for sale.  It does not “approve” the device.    Denial of substantial equivalence is rare – only about 3% of 510(k) submissions are rejected by the FDA.

Moreover, if a manufacturer claims the new device is a “modification” of a device already marketed and is for the same indication, the modified device can be sold without a 510(k) submission.  The FDA has stated that a 510(k) is not required for every modification and believes the manufacturer is best suited to determine whether one is necessary.  Thus, a manufacturer can avoid even the minimal 510(k) process if it takes the position that a new device is a modification of a mesh product already on the market.

The pelvic mesh manufacturers have profited enormously from a regulatory scheme that permits the sale of a device, intended for long-term implantation in the body, solely on the manufacturer’s substantial equivalence claim and without any scientific evidence proving that the new device is safe and effective.

Institute of Medicine logo

Institute of Medicine logo

It is no surprise that the independent Institute of Medicine (IOM), asked by the FDA to evaluate the 510(k) process, concluded in its 2011 report (here):  “the 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.”  The IOM emphasized that the 510(k) process is unworkable “as long as the standard for clearance is substantial equivalence to any previously cleared device.”  Consumers deserve better treatment from medical device manufacturers who profit from a broken regulatory process.

Dan Bolton – a plaintiff’s lawyer for thirty years – has been fighting the pharmaceutical industry almost since the day he began his career.  Mr. Bolton continues that fight today at Keller, Fishback & Jackson ( where he oversees the pharmaceutical and medical device practice.  The firm, with offices in Los Angeles, Newport Beach, Oakland and New York, has a nationwide presence in mass tort actions, including hernia and transvaginal mesh litigation.   Mr. Bolton’s keen understanding of, and creative approach to, pharmaceutical litigation has led him to represent plaintiffs throughout the country.  Mr. Bolton was even the subject of an editorial in The Wall Street Journal critical of his success on behalf of plaintiffs.

Other Relevant Articles Regarding FDA 510 K Approval Process:


By |2018-06-05T10:53:05+00:00January 23rd, 2014|Featured|10 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. vardin1 January 25, 2014 at 10:28 am - Reply

    Market a broken product so that clears the way for other manufacturers to market MORE broken products to put into the human body that never should have been put in there to begin with! Really? I’m certain that if our ‘law makers’ had this happen to their families there would be a change and FAST. We are disposable? Guinea pigs for experimentation? Expendable? Mesh doesn’t just hurt you it hurts the whole family and friends. We don’t deserve this. We never asked for this and yet we’re paying the price while they get rich off of our suffering. Outrageous!

    • Jane Akre January 25, 2014 at 7:41 pm - Reply

      And they were almost all predicated upon the ProteGen mesh which was removed from the market for being adulterated! A broken medical device can still serve as the basis for a new approval as a “substantial equivalent”

  2. John January 25, 2014 at 10:42 am - Reply

    Safety forgotten ????… safety never even considered in the first place!!!

  3. jade January 26, 2014 at 12:31 pm - Reply

    Interesting that the first “adulterated” mesh sling device, “ProteGen”, manufacturered by Boston Scientific, was aptly named! The word “protegen”, having Spanish roots, is the “present conjugation” of the word “proteger”- translated into English its meaning is – protect, to defend.

    I have to wonder if Boston Scientific would choose the same moniker for its initial mesh kit if it knew what it knows today!

  4. Richard Howden February 9, 2014 at 11:04 am - Reply

    I have often posted on Topix that the 501K process has been flawed since it’s inception. The idea was right but what no one thought of was what happens when the Manufacturers figure out it is an open door. I have improved my car. It still has 4 wheels, 2 doors and carries 4 people. It has seat belts, window wipers and mirrors. We call it the Pinto! We promise this one won’t blow up when it’s hit! The wording of the 501K process also seems to be vague enough so the FDA cannot be blamed but the manufacturer still has been “Ok’d” by the FDA as far as the consumer is concerned. It is good to know that the FDA has a corner of the market of CYA.

  5. ML March 1, 2014 at 1:51 am - Reply

    When we have Johnson & Johnson quoted as saying “You don’t have to get it 100% right. When you get it 60%, go! Any more time that you spend trying to figure it out, you’re going to lose in the speed that you’re missing out on,” it’s that mentality that is being encouraged, replicated and rewarded at an alarming rate.

    • Jane Akre March 1, 2014 at 10:09 am - Reply

      Nice website and so accurate ML…. thanks for writing!

  6. Angela March 30, 2017 at 1:04 pm - Reply

    How much longer ? Will it take to get awarded for all the surgeries , pain.suggering , never ending pain . Loss of life as I knew it , , it’s starting to look like the ones that have got settelments , are only ones who will. I can’t stand up let alone walk lost more then they could pay me , it’s sad can’t see dr I want out side my state , all I do is go dr no fun joy they took that to my abelity to enjoy life so hurt sad mad confused

  7. Angela March 30, 2017 at 1:06 pm - Reply

    I wrote it

  8. Angela g April 29, 2017 at 12:11 am - Reply

    I can’t get a wheel chair that don’t hurt to sit with n,when I can sit up ,sex is just a memory, had mesh put in 2012 removed 2014..the damage doesn’t stop ,diapers live life looking out a window , appendix burst , about died . Was quarantined, peel infection . Cry depressed lots meds .cnstant bladder infections . , pain management just takes edge off , stone h ,nerves died wouldn’t process food , implant in stomach , surgery every four years to put new battery in , long rides to dr cause such pain . No money to get things make life easier . Trying raise 9 year old . I look older feel three times my age nerve damage . Lower back pain , don’t eat everyday , or e waited long time , no one has Any idea if I will get money , maybe after I’m gone , I had a will done , they poisoned my body I’m slowly painfully dying , and they could care. Less , no remorse ,no compensation . People have law suites no perment injerys , an become welthy , be nice to go out side on a scooter if I could afford one . J & j havnt showed me they care an sure they havnt you . I pray for all the hurting lady’s suffering wrongly , go to get help an get your lives destroyed . I don’t think I’ll make it threw another surgery so if I don’t j & j you won’t to comfort my family no amt is worth a life , what would you do it it were your mom wife daughter ? Need settlement now not when dead to make now a little easier more comfortable , help stop hurting make up what went wrong . Can’t fight what you know you created !

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