Thank You All for Telling the FDA to Reclassify!!

//Thank You All for Telling the FDA to Reclassify!!

Thank You All for Telling the FDA to Reclassify!!


Thank you,,, thank you…. thank you!

I talked to the FDA today  and they say that it could take many months for individuals within the FDA to read all of the comments made to a Petition to reclassify pelvic mesh as High Risk!    Some of you may have posted that you wanted to be private so you might not see your comment on the FDA site.  Also if a group submitted, such as Mesh Survivors, that shows up as one comment.

Apparently there was an unusually high number of comments registered.

I asked if there is any disadvantage to not being considered individually and the docket guy said no…. it is the content that is important.   It actually becomes cumbersome to count each letter rather than to go through a letter with many signatures.

I’m very grateful to Corporate Action Network and their support of the easy to register form which they then gathered and got to the FDA before the deadline.  Making it so easy meant people didn’t have to be intimidated finding the right words to express their outrage.  Their heart and their technology is brilliant and I’m so thankful to them for their support on this issue!

CAN worked on the J&JHurtsWomen campaign and is in this for the right reasons- to speak back to corporate abuses!! I know I’m grateful for all they provided at no cost and with no agenda other than a grassroots campaign to make change happen.  Thank you CAN!

So according to regulations –  First- there was an expert panel, gathered September 8,9, 2011 (here) as well as a White Paper (here) authored by those inside the FDA; then this Petition, then the comment gathering period.  When that concludes, the FDA with decide to reclassify or not to reclassify.

The process works much too slowly however there are likely people within the agency who would like to fast-track this. That White Paper is a great piece of work.

Yes… 488 of you signed onto the reclassification petition here in addition to the others who added their voices directly to the FDA Petition to reclassify mesh to high risk! Thank you,,, thank you…

By | 2014-07-31T18:36:33+00:00 July 31st, 2014|FDA News|25 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.


  1. Sandy August 1, 2014 at 9:08 am - Reply

    Jane you really get all the credit! I signed it but if it wasn’t for you I would not have known I could do this! Thank you for your endless work and support. You are awesome! Regardless how this turns out you will always have my gratitude for all you have done and the doors you have opened for me. God Bless You Jane!

    • Jane Akre August 1, 2014 at 11:31 am - Reply

      Sandy thank you but I worked closely with Action Network… the arm of Corporate Action Network and they really deserve the recognition. They excel at using technology online to gather individuals to spark change! Kind of like old fashioned campaigning in the internet age. Here

      They made it easy to organize folks after some outreach and made it easy to sign the petition… Otherwise I fear some people would have quit, not know the right words to say. They created free of charge to us the Johnson&JohnsonHurtsWomen and Wearemeshsurvivors campaigns.

      They should be commended and thanked – We were ALL given a gift! Thank you CAN!!

  2. All Meshed Up August 1, 2014 at 9:23 am - Reply

    I hope that 488 signatures makes a difference. I find it rather disconcerting that this process started in 2011 and it took 3 years to get to the comment period. How many men and women have been permanently damaged because the FDA would not get off their ass and do the right thing? I’ll use the Baby Carriage or Chinese Dog food situations as an example! The FDA uses ALL of it’s Federal power when a dog dies from bad food or a Baby smashes a finger in it bassinet or carriage. It fines, sues and attempts to imprison company officials when THAT sort of thing happens. But when J&J/Ethicon, AMS, Bard/Kugel, Endo or one of the other myriad of Mesh Manufacturers has a product that does damage to 1000’s of men and women, the FDA turns a blind eye, obfuscates, lies and protects those manufacturers. The FDA is being paid off by these corporations to do just that. There can be no other explanation as to their lack of interest and their slow pace of inquiries, investigations ( I use that one VERY loosely ) and prosecution.

    I will say this to the day I die, the FDA is crooked as hell and are being paid off by these Manufacturers!

    Combine that with the co-operation that the Lawyers have with each other, no matter which side they are on, and how they work together in Court to make it easier for themselves and we have a conspiracy. The Manufacturers are not being affected by these Court cases. They are still selling a majority of their products even with all of the complaints and law suits! Everybody is making money off of our suffering and damaged bodies. From the Manufacturers to the Doctor that installs the mesh to the Doctors that examine you when you have a problem with the mesh to the Doctor that removes and “repairs” to the Lawyer you hire to represent you. They all are making money and we are losing everything. And the FDA does NOTHING! Why should they care? The Dog Food company didn’t pay up so go after them! The Baby Bassinet manufacturer didn’t throw anything into the “General Fund” so they are not playing the game properly and thus are sued out of existence. But the Mesh Manufacturers give money to the FDA for grants, give money for seminars, conferences, hotels and entertainment. Many of the same Lawyers that are supposed to be representing YOU are attending these conferences too! The Manufacturers know how to keep the ‘wheels greased’ and the FDA knows how to show appreciation. If I am wrong, then why after so many years and so many complaints are there not any prosecutions, major investigations, Congressional Inquiry or more recalls? Why is it that even after a Court case finds that 20,000 women were damaged by a Medical Mesh Implant that was supposed to help them the FDA is mute? Follow the money……..

    • Jane Akre August 1, 2014 at 11:22 am - Reply

      Agreed All Meshed Up… but I believe there are some people inside the FDA who understand the problem, maybe not as well as we all do,, and are trying to urge change… but that comes slowly with a federal agency. In the meantime, more mesh is being implanted and more will suffer… Thank you! ~ ja

    • Kitty August 1, 2014 at 3:10 pm - Reply

      meshed up—you are so negative–It’s hard to read what you write—–but there certainly is truth in what you say. Hope the Motley Crew will take Albright all the way to MA supreme court—-and then to the US supreme court. Let’s see if they really care about their clients. I.

      • pam August 1, 2014 at 6:26 pm - Reply

        kitty, let me make an apology, for yesterday, and off the wall, I KNOW, i was was not well at all, but was so glad to hear the results of reclassifying mesh. . The stress sometimes, of years suffering with mesh and all that has gone on, makes my thinking and post not clear . I AM SO SORRY ABOUT THAT, but I TOO AM A WOMAN MESSED UP BY MESH AND WANT TO SPEAK OUT AGAINST IT,

        i understood and agree with all meshed up. I use more blunt words, I know , but what I SEE IN THE MESSAGE FROM ALL MESHED UP, IS , (WE ARE NOT RICH WOMEN, THE VAST MAJORITY OF US DAMAGED BY MESH NOT BY A LONG SHOT), make it short and blunt, so many times , pay offs by those in power and big business and more, , does corrupt some courts, I AGREE, that FDA was paid off to not sound a loud trumpet to Americans more than just touching on it, since so many women were lied to by doctors, , we heard of their nice vacations and meetings, to push mesh implants and they had to have those doctors to do their dirty work. . You have to se it many times in action, to speak, that because of pay offs and favors, sometimes, the guilty walk out laughing, and the price is nothing done like with mesh. The battle is not over, and for some women that careless what other women will suffer, I AM SO HAPPY ABOUT THAT WIN , RECLASSIFYING, MESH, BUT WHY DIDN’T MORE WOMEN DAMAGED BY MESH SIGN THAT PETITION? MEN ALSO DAMAGED BY MESH SHOULD HAVE SIGNED AND TOLD THEIR STORY TO AND ASK FOR A BAN ON MESH. THIS petition as I saw it had nothing to do about being kept silent and gagged , to not signing petition. To me the gag order was only to protect the guilty and truth to not to be gotten out about mesh and damage, that FDA should have been the ones to order a nation wide alert daily , and more to warn people about mesh at the first knowing about the damage women were suffering. and men. gag order should have never been ordered by courts , about mesh damage. NEVER.

        JANE i will stop there , if I CROSSED THE LINE ANY WAY , REMOVE MY COMMENT,

        • Kitty September 10, 2014 at 8:11 pm - Reply

          Hi Pam I know you are not with us anymore—but I am going over old e mails. I miss you I hope you are doing OK

          I know you must be pleased with the trials.

      • All Meshed Up August 2, 2014 at 10:37 am - Reply

        Hello Kitty, I apologize if my posts are negative but I have reason to be. Since being implanted with Prolene mesh in November of 2006, I ( like so many others ) have been through hell. I have had 5 surgeries and lost a testicle. I now have another mesh in me, a Kugel Small Oval with ring. I am in pain 24/7 and the surgeon I saw in May tells me there is nothing that can be done for me. I will be in pain, dealing with bowel problems ( above and beyond just getting old ), infections and not able to have sex without lots of pain afterwards. I have not one iota of hope that I might be able to sue Ethicon or Bard for what has been done to me. I have called, talked to and co-operated with the FDA’s Office of Criminal Investigation. I have contacted 26 Attorney Generals Offices to ask about any investigation concerning mesh implants. And every day I try to help people on the Hernia Topix page. I am sorry for being negative but everything that I have been through, read, seen, heard and experienced has shown me that I,we have been guinea pigs and I am sick of it!

        The Lawyers are making huge sums of money off of us. The Doctors, for the most part, could not care less as long as they are making money. The Courts and MDL’s are not set up to help us but to expedite the system. They are set up and run to get us out as fast as possible with as much profit to the Lawyers and as little pain as possible to the Manufacturers. And we have an FDA that is taking money from the Manufacturers and ignoring what we all are going through. And I am sorry Jane, but a Few people in the FDA that “Care” is not doing us a damn thing. I talked to people and investigators who, when asking for my records and all the material I had collected, were very sympathetic. But as soon as they got what I had, I was told that I would never see the results of their supposed investigation and Good Bye.

        Every day I see advertisements for Mesh Injury Lawyers and “You too could have Substantial Settlement”! What a crock of crap! We are forced like cattle into a pen called an MDL where we have to wait to see if we get to be free or are we slaughtered. That is how I see it as someone who has talked to a few who were deemed damaged enough to get $4500.

        Yes I am negative. I am mad. Really mad at the Medical Community who goes along with all of this and closes their eyes. I am mad at the FDA who refuses to protect us. I am mad at the Lawyers that pick and choose then screw over their clients in the end. I am mad that I can no longer live my life as I did but have no alternatives because of the damage done to me. But every day I get up and try to make it a good one. I try to do the best I can through the pain. Yes I am negative. I am negative about what has been done to me and so many others. It keeps me going……..

  3. Tambrea August 1, 2014 at 11:19 pm - Reply

    I actually received good news today, even with the bad . I have an infection from the mesh hell! My Dr told me since she has met me only 3 months ago she is no longer recominding anyone to have the mesh implant! The small victorys turn into Greater ones!

    • Kitty August 3, 2014 at 7:13 am - Reply

      Meshed up——-The mesh led to a partial castration I am so sorry. I do apppreciate your anger.

  4. msm August 3, 2014 at 6:27 pm - Reply

    Too bad the new FDA regs won’t apply to all mesh. Tens of thousands of women each year will be implanted with mesh mid-urethral slings that remain Class II and continue to be referred to as “the gold standard”.

  5. Jane Akre August 3, 2014 at 11:29 pm - Reply

    Pam- It is understandable never to trust medical professionals again,,, I hear that all of the time. You are speaking for many.. I’m sorry.

  6. All Meshed Up August 4, 2014 at 9:10 am - Reply

    Hello again Kitty, I never thought of it as a partial castration. Putting it that way makes me cringe. In the product warning section of the Prolene mesh, apparently there is a small notice saying that if you have to have the Prolene removed and it had been put in for an Inguinal Hernia, more likely than not the male will lose a testicle BECAUSE of the way it is installed around the inguinal nerve canal. That little nugget of info was never revealed to me until after everything was done, said and gone!

    I wanted to expand my explanation about being mad and negative. After so many years of dealing with my own mesh problems and trying to help in some small way, other Mesh Victims, I want to see arrests and prosecution. When will we see J&J, AMS, Boston Scientific or other manufacturer executives in handcuffs, being berated by Congressional Inquiries and being sent to prison? We have the evidence of these executives hiding and destroying documents and lying to the Medical Community and patients about Mesh safety. J&J destroyed 100’s of 1000’s of documents but not a damn thing is done! We have evidence going back many years that show that these companies were aware of and knowingly sold dangerous products. J&J had a Gynecological Mesh product on the market that was NEVER approved of but they were allowed to quietly take it off the market without any prosecution. None of this makes any difference apparently to the Justice Dept or to the FDA.

    When will we see the FDA brought to task concerning their cozy ( I believe illegal ) symbiotic relationship with these manufacturers and the “Grant” money, trips and perks they get from them? Why is it that the man in charge of the MAUDE data base last year said that he saw no problems with mesh products and the data base indicated just that. What planet did that idiot come from? Time and time again, the FDA sides with the manufacturers when it comes to mesh. No other medical product on the market today would be allowed to injure/damage so many men, women and children as mesh has and is! We have huge Lawsuits with 20,00 women injured by mesh. We have Hernia Lawsuits concerning men and women numbering in the thousands yet the FDA does nothing. And the numbers increase everyday but no one gives a damn and the FDA just keeps allowing more Mesh ‘products’ to pass through the 501(K) process. Mesh is not only damaging people physically but is wiping them out financially.

    And finally, speaking of finances, the Lawyers that are involved in these MDL’s are treating Victims like cattle and THAT needs to be rectified as does the MDL’s process.

    What I want is prosecutions and imprisonment for these executives. I want to see heads roll at the FDA. And I want to see a Fund set up ( just like the Mesothelioma Fund ) for Mesh Victims so we do not have to be subjected to the MDL system and would not worry about money or medical care. But I doubt very seriously those things will ever happen because we are just ordinary citizens and no one gives a crap about us or what has been done to us. Until Nancy Pelosi or some other famous “powerful” person gets a Mesh problem, no one will do a thing to help us. And why is it that no Famous personalities have been implanted with Mesh? Is Mesh just being used on us “shlubs” out here and not the rich and powerful? I’ll get mad and negative about that later…….Best Wishes All!

    • msm August 4, 2014 at 10:55 am - Reply

      Very well said!

      I am looking at the on-going IRS investigation and the VA investigation and wondering why not the FDA as well. The IRS deals with one group – taxpayers both personal and business. VA deals with one group – our courageous veterans. The FDA deals with multiple entities. It is more than just “food” and “drug”. It covers everything from vitamins to catfish. From aspirin to chemo. From thermometers to surgical robotics. From biofeedback to electroconvulsive therapy.

      I could go on but you can see what has happened. The FDA has become too big NOT to fail. If there is a congressional investigation, it would be so far-reaching and discoveries so astounding that it would shake the confidence of the American people to their core! Manufacturing and importing would come to a standstill. Companies would go bankrupt. Politicians found to have their hands in the pockets of the companies who have put the most of us at risk (including our babies) will be put to shame. Heads would roll at the FDA and the Dept. Of Health and Human Resources. There would be so much fallout that congess isn’t going to touch it. After all, whose pockets are their hands in?

      If the American people had any idea just how much the FDA affects their lives, they would be mortified. It’s time the media took it on. But then, who are their sponsors? ….

  7. All Meshed Up August 4, 2014 at 1:58 pm - Reply

    It is very difficult for anyone that has not been affected by Mesh to understand all that entails being a Mesh Victim. What reporter is going to do a story about Mesh without calling the FDA? When they do that, the FDA says that we are wrong, that we are just disgruntled people that did not have a Court case, Drug addicts, have a mental problem or just stupid people that have no idea what we are talking about. That ends any story you were hoping you get into the paper or on Radio or TV. The fact that there are so many Lawsuits with tens of thousands of complainants going against every mesh manufacturer throughout the world should make all of this easy. But it does not. Why? Because the FDA is being paid off. They get too much money for seminars and money for ‘grants and research’ that most likely goes into a slush fund. The FDA does not want to help us go after their ‘gravy train’. Not only because of the loss of revenue but also, as you stated Kitty, the light would shine on all the FDA’s insider dealing with the Medical Manufacturers. Can you imagine the outcry when the American public finds out that the FDA has not been there for us but has turned into a bureaucracy that cares more for itself?

    I believe there is a Conspiracy within the FDA to stop or slow down any major reporting about the dangers of Mesh. As of today I have had 3 computer attacks that targeted my mesh records and documents. I have posted on Topix page for 6 years now. In the past 5 days I have posted my contact info on the Topix page so that Mesh Victims that have gone through the MDL process can contact me . 5 times I have made that post and every one of them has been deleted. Bruce and I compared notes an hour ago and figure that both he and I have had many of our posts deleted. Now why in the hell is that? I have posted my e-mail several times over the years but now that I ask Victims about MDL experience I cannot? Why is that? Is pressure being put on the Administrators?

    Why is it that we cannot get proper media reporting of the Mesh problem affecting up to a million people in the U.S.?

    Why can we not get a Senator or Congressman/women to take us seriously?

    Why are the States trying to get money from the Manufacturer but nothing is done for the Victims?

    Why is it that we have several Mesh organizations for one type of mesh or the other that ask for donations but do nothing for Victims?

    Money money money money money money.

    • msm August 4, 2014 at 3:05 pm - Reply

      “Justices Shield Medical Devices From Lawsuits”

      I wonder if this reporter is still around.

      • All Meshed Up August 5, 2014 at 7:02 pm - Reply

        Hello MSM. The link that you posted was the Supreme Court ruling that killed my Lawsuit and Bruce Rosenberg’s as well. When that decision was made it was immediately interpreted within the Legal community that any Medical Device that had been “OK’d” by the FDA was then exempt from possible Product Defect lawsuits. Basically, anyone at that time that was trying to sue a Medical Device manufacturer for a defective product, lost their representation. I had 3 Law Firms working cases for me. They all dropped me within 3 or 4 days. Jane can check on this one but there were several hundred cases concerning Pace Makers that short circuited in the patient there by electrocuting him. Or the other problem these Pace Makers had is that the battery that powered the Pace Maker burned up inside the patient with expected results. ALL of those families that had lost loved ones no longer had a case either. All of you have read this from me ad nauseum but I have not been able to get a Lawyer since that time.

        Anyway, that decision by the Supreme Court, whether by design or not, covered the Medical Manufacturers butt’s big time. Did they make that decision to do that very thing? Who knows and who cares because the end result was that a lot of people got screwed and the Manufacturers got off scott free.

        It is a shame about Pam. It is difficult to be a Mesh Victim when you feel as if everyone and everything is against you.

        Best Wishes All…….

    • Kitty August 5, 2014 at 8:34 am - Reply

      The reason is no one has the guts to get a flash mob together in front of a Drs’ office I will be there whenever

  8. Jim Savlen August 4, 2014 at 3:02 pm - Reply

    My wife had the J&J mesh product installed in 2000 followed by 11 years of documented complications. At that point in time the mesh sling was replaced by another doctor. In his report he mentioned finding extensive scarring but no actual material supposedly? The lawyer handling the case said they requested the sling product information from the original surgery in 2000 but said it was no longer available since the hospital is not required to keep the records after 7-10 years. Curious to see if there is any way to obtain the records or if this is even possible. What a nightmare. I would hate to thing J&J is going to be off the hook for their own negligence. The lawyer handling the case said she is only eligible for being a ‘Tier 2’ candidate since the material inserted in 2011 is still present and never removed.

    • Jane Akre August 4, 2014 at 5:08 pm - Reply


      I’m unaware that J&J has set tiers. did she have surgery in 2000 or 2011?

      • Kitty August 4, 2014 at 6:10 pm - Reply

        Meshed up—Again-I am so sorry for your loss. We need to march in to Wash if we get no word from FDA. PAM—did you have a hysterectomy along with your Mesh?

    • Kitty August 5, 2014 at 4:23 pm - Reply

      Jim did your w3ife have posterior mesh? I believe that would be for rectocele.

    • All Meshed Up August 5, 2014 at 6:46 pm - Reply

      Jim, if your wife’s surgery was covered by Insurance, they should have copies of the OP report that includes all medical products used on her and implanted during the surgery. If you had a Lawyer in this time, He/She may have those records as well. Best Wishes……..

  9. Jane Akre August 5, 2014 at 11:11 am - Reply

    Pam- You are out of line and have been for awhile. I have no relationships with lawyers in fact they would rather women not talk amongst themselves in my opinion, which is what this format provides. No one called your attorney and I refuse to be accused of things I am not guilty of. Pam you need to go away now. You have become an annoyance and an extension of the negative forces within this community. Thank you and goodbye.

  10. Kitty August 5, 2014 at 4:08 pm - Reply

    Pam—I am so sorry for your paranoia. The only reason I asked you that is that I had one along with the mesh implant. That can affect a woman. Im sorry if you took it the wrong way.

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