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Find Your Mesh in the 510(k) Process

Prolene Mesh

Prolene Mesh

For those readers who want to know more about the mesh they may have had implanted for pelvic organ prolapse, stress urinary incontinence or hernia, the process is made easier if you have the Medical Device approval number from the FDA.

Below is a handy list of 510(k) approvals which you must look up under the manufacturers name. Click through the manufacturer, find your mesh and see its approval “K” number under the 510k decision which is how it’s classified within the FDA.

Under an FDA 510(k) approval process a similar device already in existence needs to be named by the manufacturer. The new device must be the “substantial equivalent,” whether it actually is or not.  On that basis, the manufacturer is issued an approval to sell the device.

Once you have the 510(k) approval number of your device, you can search the MAUDE database within the FDA for any adverse event complaints. Note* Mesh is known as “mesh, surgical, polymeric.”

Here is the resource to look up your mesh via company name:

http://510kdecisions.com/

How to post an Adverse Event with the FDA and search the MAUDE database:

http://meshmedicaldevicenewsdesk.com/fda-notices/how-to-post-an-adverse-event-with-the-fda/

 

 

 

9 Comments

  1. Suzanne McClain says:

    This is fabulous information, Jane! Thank you for posting. If you will remember, a couple years ago when I was researching all of these mesh products, how I told you I had cracked the FDA site and had figured out how to search easily. Shortly after that, they changed the FDA website to make it almost impossible to locate any information, and I have struggled with it since then.

    Again, thank you so much for posting and for sticking with us on this journey!

    {{{{{hugs}}}}}

    Suzanne

    • Jane Akre says:

      Suzanne-I am in awe of your research abilities…. those tricky little 510(k) numbers are all here… but you were the very first one to link almost all of the meshes to the ProteGen which was removed from the market! I hope you are recovering after your mesh explant… you so deserve it! ~ja

  2. danyelle says:

    thanks Jane… this shows that my soft tissue patch was approved in October of 1993, but mine was implanted in July 1993, just ahead of approval.

  3. A meshed-up nurse says:

    Thanks Jane. And I’m wondering about something. I always thought the FDA’s 510(k) was really a “clearance” process, not an “approval” process. Basically, if there is a “predicate” device, even if it’s been removed from market and deemed “defective” by the FDA (for example, the original Protagen that the FDA itself called “adulterated and misbranded”), than the FDA has NO choice, under existing law, but to “clear” it for market. I believe this is the loophole that Congressman Edward Markey (and Jaye) tried unsuccessfully to close. Can you or someone please elaborate on this further? Thanks….

  4. g guest says:

    some women were lied to by attorneys on tv, when women did not know much about mesh at all. when ads came on tv, not knowing the attorneys were going to send them without telling them to courts so far away from home. THEN TO HAVE THOSE ATTORNEYS, THAT LIED AND DELIBERATELY WOULD NOT ANSWER CLIENTS CALLS, EXCEPT TO TELL THEM TO DO THNGS, LIKE ME FOUND OUT THAT ATTORNEYS WOULD NEVER ASK THEIR CLIENTS TO DO. COVERING AND TAKING INO, AND MORE LIES TO DROP THEM.

    WHAT ATTORNEYS HAVE OTHER WOMEN FOUND TO PRACTICE OUTSIDE THEIR STATES TO REPRESENT THEM IN MESH CASES, THAT WILL ANSWER QUESTIONS AND ESTABLISH TRUST WITH CLIENTS, AND HAVE 2 WAY CONVERSATIONS, NOT 1, 1 WAY SHOWS SOMEONE IS HIDING SOMTHING AND CANNOT BE TRUSTED. MESH WOMEN NEED TO BE GUIDED NOT LIED TO, AND THEY SHOULD NOT HAVE HAD TO TRUN TO INTERNET FOR THE ANSWERS , BUT HAD NO CHOICE , DUE TO DOCTORS AND NURSES LYING, MORE BUTCHERING AGAIN BY DOCTORS THEY TRUSTED TO REMOVE MESH, AND LIED MORE TOO.

    Any women mesh damaged , that can give attorneys names to practice outside of state , that answer questions and guided, through this time , of hell, not by just doctors and nurses and cover up, but those attorneys that can be trusted to prove their profession and are truly standing for the women and men damaged for life.

    NEED INFO, PLEASE.

  5. danyelle says:

    How do I know if mine was the soft tissue patch approved 11/1993 or the one approved 10/1995?

  6. g guest says:

    Some women fortunate to get mesh removed, I’d like to hear how they are doing with infections, and pain since removal of mesh. Does anyone know how the mesh moves and gets into other body parts and causes problems. The longer you wait what chances of getting mesh out? A shame these companies will not set up funds that is costly , back and forth out of state for women to get to the doctors that know what they are doing and have some knowledge of removing the mesh, This should have been done in the first place of those doctors that implanted the mesh.

    Heard cr bard got over 3 hundred and something million by the government to supply military, looks like the government is not going see what they did to humans , criminal. They get awarded the more they cover up with not testing products and heeding warnings from experts that the mesh was not fit to be implanted in humans. cover up by government, , FDA, AND MORE. WOMEN ARE GETTING NOTHING FOR PAIN AND SUFFERING, AFTER THESE COMPANIES AND GOVERNMENT IN POWER GOT GREEDY, in medical the only ones that will get anything are the attorneys , some of them are , covering up for mesh , since the mesh companies in their area provide jobs, they are not going to hit these companies up as they should and mention in courts they should be charged with crimes done for their greedy money, THE JUDGES SHOULD KNOW THAT TOO! WHY DO THEY NOT SEE THEY KNEW AND IT WAS A CRIMES ON EVERYONE INVOLVED, DOCTORS TOO!

  7. Willie says:

    I am a 62 yr old male who had an “Umbilical Hernia” back in 12/31/01 and it was for an umbilical hernia.

    My wife took care of me for 4 months and my weight stayed at 206 for 8 months and then in the 9 month I started to drop the pounds and got down to 171by 1/1/2010 and went in for another “Umbilical Hernia removal.

    On 2/24/2010 they put in a TVT Mesh and there was a string sticking out of my belly button. My wife took photo’s of my stomach everyday and then I went to aDr that was pulling this string(I guess it was that” and he was lifting me and my stomach off the table and then cut it and I assumed he put “Neo sPORIN” BUT INSTEAD HE PUT sulfer on the area. Now I have no INNER Belly button and now it takes me up to 5-10 minutes to urinate. I am now on Lacix at 20 mgs a day, and my stomach is still hurting me and the Attorney we hired, the Dr. got to him and had to “PAY HIM OFF”, so now I have NO DR.S to do this surgery since my name is all over this damm state.

    Trans Vaginal Tape is what I have made by Ethicon,Ethicon&Gynecare.

    I do alot of praying with my wife and I have pains 60% of the time. I am so sorry that I was found back in 1985, other wise I would Not be disabled and working with my son who I lost prior to being born, and I know that if it’s bothering me, it is bothering my wife.

    I wish to God that someone would Please help me, anyone out of the “BIBLE STATE” and I feel the DARK ONE IS HERE”

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