web analytics

Are FDA MAUDE Reports a Fraud? A Case Study

Are FDA MAUDE Reports a Fraud? A Case Study

Directly from the FDA MAUDE Google Search May 5, 2014

Updated 5/27/2014 (Stratus has not been on the US market since May 15, 2013)

And yet it’s available today on ebay???? Things that make you go hmmmmm

Johnson & Johnson Ethicon Acclarent May 2013 Stop Selling Stratus

Stratus on ebay 5 27 2014MAUDE Reports Mandatory Requirements final

MAUDE data mandatory from the FDA represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.191.

How can a MAUDE Report be both mandatory and voluntary? 

Can MAUDE reports be edited by the Manufacturer?  Can the FDA indiscriminately take down MAUDE reports?  These reports, though not by design, have helped patients recognize problems with manufacturer’s devices and in turn put pressure on the FDA to make changes, like in the mesh trials.  It should concern all when there are such inconsistent and contradictory actions and langue on their own site, that’s set to protect us.

We’ll use Johnson & Johnson’s Ethicon’s Acclarent’s Stratus Microflow Spacer (Ethmoid and Frontal) and Adverse Events with the two products to demonstrate a point.  The point is:  math is either hard for the FDA or MAUDE Reports can come and go, but who gets to decide?

And today just minutes apart on the FDA MAUDE website:

FDA Acclarent Ethmoid total final

FDA Acclarent Frontal 5 5 2014

 

AND MOMENTS LATER….

FDA Acclarent Frontal 5 5 2014 2

Same product went from 5 Adverse Events to 2 in a matter of seconds on the site; and then there’s this screenshot from 2012 that clearly shows 10 Adverse Events.  Even if the both products and their Adverse Events  were added together….it still does not add up.

FDA Stratus Inconsistent Data final

1 Comment
  • Suzanne McClain
    Reply

    May 5, 2014

    Hi Melayna,

    Thank you for bringing this to the fore-front. I actually 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 use 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!

    May 5, 2014 at 9:45 pm

Post a Comment