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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This link is no longer active: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This link is no longer active:

This link is no longer active: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.

10 Comments

  1. Bejah Blue says:

    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 says:

      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 says:

    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.

  3. Diane says:

    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.

  4. Norma says:

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

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