FDA Archived Material on Pelvic Mesh

//FDA Archived Material on Pelvic Mesh

FDA Archived Material on Pelvic Mesh

Mesh Medical Device News Desk, October 10, 2017 ~ The U.S. Food and Drug Administration has been looking at the issue of pelvic or transvaginal mesh for more than ten years now.

Though slow to act to recall mesh, to follow up on ordered studies, to create a medical device registry, there have been some decisions, such as reclassifying mesh for pelvic organ prolapse to Class III.  

It is worth reminding ourselves what’s going on with this so-called watchdog agency.

**Note many of the long-standing FDA releases on mesh including Public Safety Notification have been moved or cannot be found in the archive. MND is trying to track them down. 

Archive-It is a data archive business.  Here is a list of the articles mined from within the FDA by Archive-It.

FDA Related Information from FDA Website

This link is no longer active:

This is the January 2016 order that reclassifies POP (pelvic organ prolapse) mesh to Class III. Tremendously important in that manufacturers now have to prove the safety and efficacy of their product BEFORE it is sold via clinical trials.

This link is no longer active:

This link is no longer active:

This is the July 13, 2011 order that finally says mesh complications are “not rare” and a complete turnaround from the 2008 safety communication that said they were rare! See under Purpose:

White Paper July 2011 on What the FDA knows to date on urogynecologic surgical mesh. 15 pages.  Its link to 2008 says it has been moved.

News release on July 13, 2011 announcement that POP mesh poses risks.

Not found:

Not found:

 

Some of you may have been in attendance of the September 8-9, 2011 expert panel on pelvic mesh.  Some of you may have testified.  The transcript is here but the testimony from many injured patients is not. Janet Holt- Page 86.  Sherri Palm Page 89.   Note* The FDA said it would be monitoring pelvic mesh used for SUI.  It has not done so to date!

 

FDA Public Health Notification, October 20, 2008, updated July 13, 2011, This is the one that says the complications from POP and SUI mesh are “rare.” This after the FDA received over 1,000 reports from nine surgical mesh makers of complications that were associated with surgical mesh devices used on women and placed transvaginally.

By | 2017-10-10T17:39:34+00:00 October 10th, 2017|FDA News|13 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

13 Comments

  1. Bejah Blue October 10, 2017 at 8:20 pm - Reply

    THIS IS SHOCKING, DEEPLY DISTURBING. I want to know who in the FDA is responsible for the removal of links, for “archiving” and all the rest of this. I want to know who they report to, who gave final approval of these actions and if they all occurred in the same period of time. Thank you Jane for bringing this criminal activity to the light of day. Tell us what we can do that would be a meaningful response, as meaningful as your reporting. Let us contact FDA and other government watchdog organizations. Clearly any attempt to report or complain to the FDA directly is FUTILE! We should all be incensed and take action. Lets talk about this. I am sorry but what I see is Jane working for us as we sit on our as**s and do NOTHING. I feel very sad and disappointed and ANGRY.

    Finally, if someone in New Jersey and or Washington DC is trying to reach me know that I will not answer unless you identify who you are first. Those are the rules of engagement.

    Bejah

    • Jane Akre October 11, 2017 at 1:10 pm - Reply

      Bejah… from time to time things are archives. Let’s not assume it is for nefarious reasons….Agreed, FDA is not keeping on top of this issue, is not forcing manufacturers to quickly resolve issues, is not keeping track of SUI injuries, does not have any reliable post approval monitoring or device registry…. very poor performance overall…

  2. Anon October 12, 2017 at 2:54 pm - Reply

    We should not be surprised nor angered, We Already Know. FDA checked out a long time ago and unfortunately we are not the first medical device victims that they dropped the ball on. We have been trying to understand FDA’s role for years now, as it relates to our safety. It is painfully obvious that consumers health is Not the FDA’s concern. Please… save your energy for the court room, for your continued efforts to fight the Pharmaceutical giants for the financial support that we so rightly deserve.

    • Anon October 12, 2017 at 4:40 pm - Reply

      ……..so rightfully deserve. Sorry!

    • Bejah Blue October 24, 2017 at 10:27 pm - Reply

      Very succinct, well stated and perceptive. Thanks for the course correction and astute commentary! Bejah

  3. Diane October 13, 2017 at 6:14 pm - Reply

    I am currently having serious medical issues due to a polyprolene hernia mesh that I had put in eleven years ago. I can’t get any doctor to admit that it’s the mesh causing problems. I’m now trying to finding a doctor that will take it out. I feel like I am dying a slow and painful death.

    • Jane Akre October 14, 2017 at 11:19 am - Reply

      Tell us where you are located…. there may be a mesh removal expert near you… Can you travel? Do you have insurance?

    • Kitty October 15, 2017 at 10:12 am - Reply

      Go to Mayo Cvclinic. Rochester MN. Dr Elliot is not quick with knife. You don’t want your guts rpped out after 11 years. MAYO Clinic us #1 Hospital.

      • Kitty October 15, 2017 at 10:12 am - Reply

        Correct…CLINIC. THANKS

    • Bejah Blue October 24, 2017 at 10:32 pm - Reply

      You may be dying Diana, that is how I feel…it is as if my body is speaking to me somehow. Finding a supportive and courageous physician is a good idea, if that is possible. Taking it out as this point…may cause more problems that it solves. That is the sad truth and I share that truth with you. I am in a similar position. When I read of the efforts of women who have attempted removal, esp. several times and are terribly wounded I am sick at heart and fearful of attempting it, not that I could as in my case I was told by experts that in my unique case they would refuse to attempt it. Be careful. It may be better to live as long and as well as you can than to suffer more by having surgeries that just make things worse in the end. Take care, Bejah

  4. Norma October 21, 2017 at 8:49 am - Reply

    Thanks for taking away my womanhood! Your have destroyed so many lives Caldara and got away with it!!!

    • Bejah Blue October 24, 2017 at 10:34 pm - Reply

      Norma, Do not assume they have gotten away with it. Sometimes it is hard for us to see the ways in which the Universe creates balance, to put it very simply. Bejah

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