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What Happens if the FDA Revokes a 510K Should All Predicate Devices Follow?

What Happens if the FDA Revokes a 510K Should All Predicate Devices Follow?

June 3, 2014

The 510 (K), is a clearance the government gives to medical devices based off of substantially equivalent  or similar device (known as a  predicate device) already placed into one of the three classification categories.  To super simplify let’s say a Crazy Straw was a new medical device and needed a substantially equivalent device, in order to gain governmental approval, (so a regular straw would serve as the predicate or equivalent).

This is an important point as there are over 40,000 medical mesh cases in the United States alone where the material called polypropyleneis called into question regarding saftey.  If the FDA were to pull one make of the vaginal mesh and all others used the THAT mesh as the equivalent or predicate it would stand to reason if it was approved that way then it should also be removed from the market that same way. It would also stand to reason a polypropylene recall would cost the device industry billions (and the government would likely not get their cut of the billions).

And further still with if the FDA made a deal with a company (behind closed doors without public awareness) and the company “decided” to take the product off the market shouldn’t all others who used that product as the predicate be pulled as well? Or should a company just sell to avoid accountability?

Suzanne McClain has done extensive research on Mesh and specificlly the MAUDE reports that are meant to protect patients

Found out that the FDA had made major changes to the way in which the MAUDE database is accessed, and what type of information can be pulled when I was asked to do a little more research on surgical meshes. I was unable to access it in the same manner, as when I had initially researched the surgical mesh devices in the previous couple of years.

I used to be able to access the 510K clearances of devices based on key words; and I could find what I was looking for relatively easily; I was able to access the Adverse Event Database in the same manner. On 10/29/2008, Johnson and Johnson/Ethicon/Gynecare had 851 adverse events displayed on the MAUDE Database; as of 10/11/11 that number had been reduced to a mere 23 cases.

I used the same criteria to do this research each time, and it is as follows: Device name: Mesh, surgical, polymeric Manufacturer: Johnson and Johnson Report Date: 05/12/99 through 10/29/08 The report would only allow the first 500 records to be accessed, and the last record in the initial search was dated 08/08/04.

I then pulled a supplement report changing the dates to 08/01/96 through 08/17/04; I added a week to make sure there were no additional reports filed on 08/08/04, and disregarded those that were duplicates. The supplement report covered the first 351 reports not actually listed in the first report, but the two reports combined add up to the same number of reports that the FDA had originally listed.

One now has to be so specific in their searches, as you noted above when researching the Relieva Stratus Microflow Spacer adding or deleting certain key words, that it is impossible to pull a report with any type of accuracy. I spent two full years researching bladder meshes; not only the one that I was injured by, but at least 60 others. Of the 60+ devices I researched, there was one common denominator; the predicate device, (meaning substantially equivalent device) that the FDA allowed manufacturers to use to gain clearance for their products for market. I printed off all of these documents prior to the changes being made to the database, and can prove everything I have written regarding how these devices can all be tied back to a recalled device.

I have actually only written about the first 30-35 devices thus far, and my articles can be found on CNN i-Report, and the articles can be found by clicking on the following links:

http://ireport.cnn.com/docs/DOC-416625 http://ireport.cnn.com/docs/DOC-422675

I have also started a petition on The Petition Site: http://www.thepetitionsite.com/1/-the-danger-of-surgical-mesh-and-the-push-to-have-it-removed-from-the-market/

Maybe it is time I access these documents and cover the remaining meshes. In case any of the manufacturers are monitoring this, I have these documents stored in a secure place. Prior to the FDA changing the search criteria on their MAUDE database, I was able to tie the clearances of 60+ surgical mesh devices, either directly or indirectly straight back to the ProteGen Sling that was recalled in 1999.

In the FDA’s Enforcement Report dated March 17, 1999, the reason stated for this manufacturer recall was “Use of ProteGen in the treatment of female urinary incontinence is associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended” yet the FDA continues to clear surgical mesh devices whose manufacturers have submitted documentation that can be tied straight back to this device. There is something SERIOUSLY flawed with this process.Had the FDA acted responsibly, all devices that had used the ProteGen Sling as a predicate would have been pulled from the market immediately.

So, to answer your initial question, “ARE FDA MAUDE REPORTS A FRAUD?,” I would say that yes, the fact that there is no uniformity to access the correct number of adverse events on file proves that the MAUDE Database is an inaccurate reporting and researching tool. The adverse event reports of late (at least for the product that I addressed above) are significantly lower than when I performed my initial research prior to 2011. You are also correct in saying that “math is either hard for the FDA or MAUDE Reports can come and go…” My research also proves this!

And shouldn’t any patient, consumer or taxpayer be suspect when a company decides to pull a product and not sell a fully engineered and successfully sold product?

Johnson & Johnson Ethicon Acclarent May 2013 Stop Selling Stratus Or should we be concerned this product (that according to Johnson & Johnson’s own account) should be off the market and is still being sold (AND on ebay?)  And what happens if a patient has a problem?  Can a MAUDE report for a product that’s no longer available in the United States even be done??  The FDA system is flawed, doesn’t have a plan in place for standardizing MAUDE Reports and appears fears losing billions if all polyproprlene was RECALLED!

So if Stratus was a predicate device for any others what happens to them since Johnson & Johnson’s Ethicon’s Acclarent decided to take this profit producing product off the market.

Stratus 510 (k)

Certainly warrants greater investigation, don’t you think?

  • Pastor Jim

    Ethical thinking in the medical industry?! It’s this kind of thing that cost you your Maserati, lady.;-)

    BTW, have you read Bakan’s book “The Corporation” or seen the most excellent documentary based upon it? It’s right in your wheel house, methinks.

    June 3, 2014 at 5:12 am

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