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ProteGen – The First Mesh, a 20 Year History

Family Tree of Meshes, Littman

Family Tree of Meshes, Littman

Mesh News Desk, July 25, 2016 ~ ProteGen – The Grandmother Mesh

Of the sixty or so pelvic meshes that were or currently are on the market in the United States you may not have heard of the ProteGen mesh, a model designed and manufactured by Boston Scientific. The ProteGen was the first transvaginal mesh approved in the U.S. in November 1996.

It has the distinction of being the “grandmother” or prototype that served as a model for most of the permanently implanted pelvic meshes that followed.

Boston Scientific had beat their competitors in terms of marketing efforts, which were put into play shortly after forecasters predicted the aging baby boomers would be in need of pelvic mesh support to treat prolapse and incontinence post surgery.

In 1996, ProteGen began marketing after being cleared through the Food and Drug Administration’s (FDA) 510(k) premarket notification process as manufacturers file to seek an approval to market and sell, not based on safety or efficacy. The clearance number is #K963226.

The “K” in the clearance number stands for the K in the 510K FDA code that allows for clearance without clinical trials after an exchange of paperwork, the naming of a “predicate device” that is the “substantial equivalent” of the new device, a few thousand dollars and a wait of about 90 days.

The entire process is a significant gesture of the device industry and relies on its honesty and integrity. From what we’ve learned about the thinking of device manufacturers and their rush to get the product on the market, the confidence in the quality of their product is not necessarily warranted.

After November 1996, a flood of new competitor devices made it to market. Ethicon’s Tension Free Transvaginal Tape (TVT) was cleared by the FDA in January 1998 naming ProteGen as a predicate device. The TVT-O (obturator) was also cleared for market based on the ProteGen model.

Altogether dozens of devices named the ProteGen as a predicate. If they were not directly linked, they were predicated on some other devices that were based on ProteGen. Mentor, Ethicon, American Medical Systems, Gyne Ideas, Tyco, Caldera all either named ProteGen as their direct or indirect predicate (substantial equivalent).

All of these pelvic mesh implants were approved through the fast-track 510(k) process with the knowledge that “No performance standards applicable to surgical mesh have been established by the FDA,” as was stated in the 510(k) Summary for the In-Sling.   As is the lack of a standardized process for approval isn’t concerning enough, the ProteGen sling, was recalled from the market by Boston Scientific on March 17, 1999 for some troublesome complications.

The reason stated – “The use of the ProteGen in the treatment of female urinary incontinence is associated with a higher rate than expected of vaginal erosion and dehiscence and does not appear to function as intended.” Dehiscence is a wound rupture at a surgical incision. In short, the mesh was recalled after proving to be defective in ways that were harmful to patients.

This recall should have been a huge red flag for the FDA, who’s job through their approval process is keeping Americans safe by ensuring that the process. If a predicate device is defective, those that follow should be carefully inspected for the same issues.

Sort of like the 1977 recall of the Ford Pinto because of its tendency to erupt into a  fuel-tank fire following a rear-end collision. Imagine if there was a family of automobiles based on the Pinto design? Would they be subject to a recall or at least a review to see if they share the same safety deficiencies as the Pinto?

But ProteGen did not set off a different review process for pelvic mesh devices. Even though it was recalled due to it’s harmful effects, there is was no effort within the FDA to more thoroughly inspect the medical devices that were developed based as “substantial equivalents” to the ProteGen.

Even though the ProteGen is history, most of its entire family of successor meshes remain on the market and we know from more than 100-thousand lawsuits what has happened.

For the same reasons that mesh manufacturers are being shunned for discreditable marketing and manufacturing practices, the FDA needs to share in some of the blame.

In 2011, the Institute of Medicine said the now 40-year- old 510(k) approval process is obsolete and needs to be revised in order to provide the assurance of safety and effectiveness of medical devices before they are approved to be used by the public. The Protogen is a perfect example of the need for change.

11 Comments

  1. Christy says:

    Johnson & Johnson already know they are about to burn & pay, & hopeful be criminally prosecuted for what they have done to continue to take-away & destroy our lives‼️ We women that fight another day to survive their damage, we’re not made to be their lab expieriements for their greed! Judge Goodwin, please take care of us innocent women who have had to pay the ultimate price for their defects & cover-ups! I know it’s in God’s hands & I believe in your judgement to make sure us mesh victims that took major loss of life, you will do the right thing & help us by making them pay for what they have done! The consequences should stand strong, your honor! Mesh lives matter too❣

  2. Sea says:

    It appears I fall into this category. Now, it has been said I need “botox” or a pacemaker in my bladder …..???? Does anyone know about this ????

    • Still Standing says:

      Sea, botox is used to keep your bladder from having spasms, which can cause urine retention or other voiding problems. I have not used these injections. The pacemaker, I assume, is the Interstem, which is an implantable device that helps with voiding issues as well. However, it comes with its own set of problems. My doctor encouraged this, but I decided against using it. Please research this thoroughly before you make a decision. I have had bladder cocktails that helped. I had continuous UTIs until this year,when I started D-mannose, a supplement that prevents bacteria from adhering to your bladder. It has made a great difference. Also, has your physician suggested pelvic floor physical therapy? The work they do can really help improve your bladder function. I would certainly give that a try before having any more invasive therapies. It takes some hard work to get everything functioning together, but dont give up. You can get to a better place. Just please make sure you are fully informed as you move forward.

      • Sea says:

        THANK YOU so much for your advise …I am not doing either of these ..but trying to find if there is anything else to help me ….really bummed out …..GREAT PLACE to come and share with others while J has done a remarkable job to help all of us ….THANK YOU SO MUCH … Sea

  3. toni says:

    Does our government FDA not have some common sense when doing these approvals being 510K or whatever they want to call it? Naming a predicate devise that has been recalled because it is defective but OK the next one that is substantially like the defective implant. Why is it that our government has no liability when we are the ones paying their salaries as taxpayers. Well as long as we can work and not loose everything due to health issues these products caused? There seems to be no accountability of our government. yet they can sue and fine these companies and get money so can whistleblowers . But the people who are paying the ultimate price with their health are just cattle waiting in line for the slaughter. This country is killing the little guy or girl who are at their mercy and our system is broken. We all seem to be lab rats which I might say are probably more protected by animal rights than we are. This just gets more and more unbelievable the more we know. This should be front page scandal all over the world news but we can’t even get mainstream media attention at any level. Who is paying who in very high positions for hush money. I think it is terrible our government fines these companies our AG from different states now suing for money. None of the injured will benefit from that. Just more legal ways to get money from these companies is my opinion. Why is everyone benefiting from our pain and suffering? Come on people open your eyes.

  4. Bejah Blue says:

    Christy, I hope you are right but I am so weary of it all and these days I wonder if they will ever suffer the consequences of what they have done. We read of their annual profit, the numbers that make their CEO appear successful as they measure success in that world and that seems to be the extent of the reality that the larger world sees. It is as if we are irrelevant in the larger picture of global economics and considered acceptable loses by those who measure such things. What is the probably outcome in a war where the good guys are already wounded? If Judge Goodwin were going to do anything meaningful to help us that would have happened by now. I think he is just managing the situation and that was his mandate. Manage it until so much time passed that it grew faint as issues do in the fullness of time, as we pass away or move away or become so ill we cannot speak. To Sea, I have not heard of pacemakers for the bladder, sounds very strange, I have heard of using Botox in the bladder, I think successfully. You know you need to do it every so often, right? I have not heard of any bad side effects. I once had botox injected in my spine in a two year study and it helped me, FYI. I think if I were you I would opt for the Botox. Take care all, Bejah

  5. Barbara M says:

    What is un real to me is I know it is hard to sue the government but if there ever was a case I would think this is it to use recalled medical implants using the 510-k law knowing this was not the intended use! And also allowing us to be used as human lab rats for untested toxic plastic never approved for human use we would never have consented to would certainly show disregard for human life
    Why are not lawyers jumping on this lawsuit???

  6. toni says:

    As far as I know from what I have been told it is not possible to sue a government entity. Sad when we pay them to protect us and they protect the companies that hurt us. Fox watching the hen house really. Reform needs to happen but again that is not an easy thing to do either. We are pretty much at the mercy of these Companies government and FDA. This needs to come out to the public. Maybe we could get Hilary and Trump to throw stones at each other on this subject it would be one way to make it public.

  7. Elreana says:

    I have been waiting for over two years.They have suggested botex and other procedure to correct their problem. My quality of life is none about right now ..I lost my job,my car and I am about to be home less. BC of their problem not to inform ppl about this useless product..

  8. jan says:

    Protegen caused the same damages as the ones now.
    Apprently Boston scientific settled approximately 800 cases with the same affects.. from protegen. .
    And the still went ahead to destroy more women’s lIves
    It’s all about the money to hell with who it affects
    But they altered our bodies and butchered our insides WHY for the love of money
    This is wrong for any manufacturers to try and play God
    We will never be the same and just like those 800 before us they want us to settle for nothing and not talk about it
    Well you should not be able to have both ways
    Your company should be jailed..Boston scientific also stated way back before bellwether cases they have 185 Billion dollars to fight us.. well it has been proven so many times you designed a killer a device that does not function properly. .
    So take your 185 billion devide it up for us injured and will be for life and put more with it to settle properly.
    To me your company is Satan because you are always out to destroy the good..
    I am not in any bellwether case nor do I want 10mil r even more
    I want justice I want to be honest but it’s hard to be honest with a company that would stab you in the back
    To me you are up there with Hitler in what you did to us women

  9. Diva 64 says:

    Thank you Jane ever so much for the fact that You, created the MESH NEWS DESK , to keep us all informed. yOU DO A WONDERFUL JOB, KEEPING UP WITH IT ALL, AND REPORTING.
    GOD BLESS YOU. DO WE HAVE PERMISSION TO REPRINT YOUR ARTICLES TO SHARE WITH THE MEDICAL COMMUNITY, OR IN NEWSPAPERS THAT THE PUBLIC RECEIVE OR ANY OTHER OUTLET THAT WILL LISTEN.

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