Fantastic researcher and friend, Suzanne McClain has always been the most competent person in digging through the U.S. Food and Drug Administration records (FDA), tedious work which involves a lot of patience.
Here she has prepared a spreadsheet that shows the Johnson & Johnson meshes, and predicate devices used in order to clear them through the FDA’s 510K process, a short cut to the marketplace which the bulk of medical devices are approved under.
Transvaginal mesh is responsible for hundreds of thousands of injuries to women from around the globe, from mesh erosion to chronic infection and pain- all can trace their roots back to the ProteGen.
510(k) is filed by industry notifying the FDA it plans to sell a device… the FDA generally says okay. It is an approval to sell, not an approval based on safety or efficacy.
It’s a safety loophole that industry loves but Americans should watch out!
If you are to be implanted with a medical device be sure to ask to see whether it went through Premarket Approval (more stringent) or the 510(k) approval process. If the physician doesn’t know, he should. Tell him/her to find out. See the family tree of meshes below.
“I have tied many of these device clearance predicates straight back to the ProteGen Sling that was recalled by Boston Scientific on March 17, 1999.
In their recall notice, Boston Scientific stated “Use of the ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
“Therefore, none of the devices that can be tied to this predicate should have been cleared for market; they were cleared based upon a faulty device! Several of the devices were cleared based upon Premarket Approval predicates, and I am digging into exactly what that means a little more. I will post updates as they become available.
“I created this in Microsoft Excel and I have my spreadsheet protected against changes. Let me know if you have issues opening it, and I will see what I can do to make it more easily accessible.” Suzanne plans on adding the Prolift- the mesh kit created by J&J that did so much harm before it was quietly removed from the market two years ago.
Thank you Suzanne!!
Click in the link below!