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ProteGen Mesh ~ The Grandmother of them All

Suzanne McClain

Suzanne McClain

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.

Suzanne says:

“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!

ProteGen Research

Family Tree of meshes

4 Comments

  1. Terri says:

    Excellent work, Suzanne!

  2. Karen says:

    FDA Now Moves to Reclassify Transvaginal Mesh Kits as High Risk
    Seed Newsvine
    Austin, TX (Law Firm Newswire) July 14, 2014 – The FDA has announced new regulations pertaining to surgical mesh used in transvaginal surgery to repair pelvic organ prolapse.
    “The new regulations are supposed to impose greater levels of scrutiny on such products and mandate that manufacturers submit a pre-market approval application to have their product evaluated. Prior to issuing these new regulations, the transvaginal mesh kit was rated as being a moderate risk device. However, in the face of thousands of lawsuits against various mesh makers, the FDA had to move to do something. Because the mesh was rated as a moderate risk, there was no requirement to conduct human clinical trials before marketing it,” explains Bobby Lee, a personal injury lawyer with Lee, Gober and Reyna in Austin.
    The move to reclassify the transvaginal mesh products as high-risk means any further mesh products would not be marketed without trials and that if current mesh makers intend to keep selling their products, they must conduct safety studies. “While this is good news, it is a bit like closing the barn door after the horse has escaped. Testing existing products in light of the thousands of lawsuits for defective surgical mesh would seem to be redundant since it was inappropriately tested in a live, unsuspecting market over the last few years, with disastrous consequences,” points out Lee. “Clearly, settling the large number of lawsuits relating to defective mesh products may take many years.”
    Recent court documents indicate there are over 50,000 transvaginal mesh lawsuits filed in the U.S. District Court, Southern District of West Virginia by women allegedly injured by mesh products.
    The lawsuits are:
    · In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)
    · In Re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387)
    · In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2187)
    · In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326)
    · In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation – MDL No. 2327)
    · In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)

    • Kitty says:

      I’m not sure I understand this. Does this mean that we no longer need X number of comments on regulations.gov.? It’ done?

  3. charles says:

    Thank u also ms suzzanne. Your tree is impressive . Please ,in your opinion, where did the mentor tvt-o tape fit in and also if mentor was sold to coloplast and then to ethiccon? When and where was the small pore size considered the manufacturing defect any settlement details involving mentor and ethicon would be appreciated, again thank you for your time

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