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FDA Must Reclassify Synthetic Mesh Now!

October 2, 2014Prolene Mesh 300

 

Margaret A. Hamburg, M.D.

Commissioner, Food and Drug Administration

Department of Health and Human Services

 

Jeffrey E. Shuren, M.D., J.D.

Director, Center for Devices and Radiologic Health

Food and Drug Administration Department of Health and Human Services

 

Dear Drs. Hamburg and Shuren,

We, the supporters and members of the We Are Mesh Survivors Coalition, respectfully request that pursuant to 21 C.F.R. §§ 10.30, the FDA immediately reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP) as a Class III ‘high risk’ device. We understand that the FDA is currently reviewing a proposal to reclassify mesh for that treatment, and we request that the proposal be adopted promptly.

We wish to supplement that existing request by respectfully requesting that the FDA also reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of stress urinary incontinence (SUI) as a Class III ‘high risk’ device.

As the FDA itself has documented, reports of adverse events surrounding implantation of pelvic mesh are legion. As of 2013, more than 85,000 individual lawsuits were filed against mesh manufacturers as a result of these injuries.

The FDA reports that from January 1, 2008 through September 30, 2011, it received 1,876 reports of complications associated with surgical mesh devices used to repair SUI.

As reported by the FDA, the most common complications reported through Medical Device Reports (MDRs) for surgical mesh slings for SUI repair, in descending order of frequency, include: pain, mesh erosion through the vagina, infection, urinary problems, recurrent incontinence, pain during intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems, and vaginal scarring.

We fully support the FDA’s issuance of a proposed order to reclassify surgical mesh for the treatment of POP as a “high risk” Class III medical device that requires premarket approval.

Given the number and severity of adverse reactions to pelvic mesh, the FDA should immediately reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP) as a Class III ‘high risk’ device and consider similar action for non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of stress urinary incontinence (SUI).

Class III designations will prevent more American women from being injured by these devices. Thank you for working to protect the health of American women.

Sincerely,

We Are Mesh Survivors Coalition and the following individuals:

 

George Sheldon, AG Candidate Florida

Jane Akre, Editor, Mesh News Desk

Pamela Wise, Mesh Survivor

Elizabeth Way, Mesh Survivor

Robert Fish, son of mesh-injured woman

 

9 Comments

  1. Jane Akre says:

    We need to expand the call to the FDA to include SUI and hernia mesh ASAP! This is a medical crisis and the FDA is ignoring its own numbers.

  2. Kitty says:

    Jane—-You have plenty of information from previous blogs and anyone that blogs gives you permission to use their comments.

  3. Lana Keeton says:

    FDA does not make decisions based on emotional letters. Give them scientific information and/or something new. Another rehash plea on SUI or hernia mesh may keep your website alive (tried and true news ploy..if it bleeds, it leads…on the evening news), but the FDA does not operate on the same premise as the evening news.

    Mesh should be recalled and banned, not used to mutilate more women in clinical trials. Sure reclassification is a positive step I agree with but it is still a step destroying thousands more lives that should be skipped!

    Mesh is not okay. Period.

    Lana Keeton

  4. All Meshed Up says:

    The FDA is not going to get rid of mesh. I doubt we will see a damn thing from them this year. Next year they will spend more time and money on ” assessing the situation”. They will call in the usual suspects, that if checked, will be industry shills and mouth pieces for the Mesh Manufacturers. They will hum and haa, put it out for public discussion, put it back in a panel for discussion, put it in a tin can, bury it for a few more months, pull it out, look at the results and say they cannot come up with a conclusion and start all over again.

    No one is going to do anything for us. The FDA MAY get around to the re-classification at some point but will allow a “newer and safer” model of the same crap through the 501(K) process then have a big news conference and say how great they are for saving so many women from this horrible product. Then they will go back to the same thing they have been doing for years concerning Mesh Victims. Nothing. I have NO faith in the FDA as it stands right now. There is too much money involved, too many people are relying on that money and so the FDA will not change a thing. That is my prediction. I hope to hell I am wrong.

    I know this will cause a bit of an up roar with the folks that get 4 or 5 women to stand outside a building with a placard saying STOP MESH. Until we can get several hundred people stopping traffic, blocking the FDA entrance or marching on Congress in Washington D.C. I doubt anyone will notice us. We are the Guinea Pigs and just as the Asbestos sufferers did not get help until they were almost dead, the same may happen with us. I mean, $1.6 Billion dollar fund set up did not garner a single News Report worth mentioning! That amount of money being awarded to a group of injured should be enough to report on, don’t you think? But it is not. Until we have a Senator (that is not running for office and just talking B.S. ) or a Congressman actually engaged in our fight we will get no where.

  5. All Meshed Up says:

    I apologize for being a gloomy gus about all of this but I have good reason. As I sit at my computer this morning I am experiencing a “Bad Day”. Lying down does not help. Sitting is painful and it hurts to breath from what feels like pressure from my surgical area. I have a solid, no doubt, who the hell punched my right hip, pain. I have dealt with this since this time in 2007. This month in 2007 I still had the Ethicon “Prolene” mesh in me and the pain was getting worse, I was getting sicker and I had just started talking to Bruce Rosenberg. The Doctor’s had decided that getting the nerve cut was a good idea. I had a nerve block that lasted long enough for me to drive half way home from Denver. That little bit if time without any pain was the temptation I needed to agree with the Doctors. I had the nerve cut. It did not work and actually caused it’s own set of problems. Since that time I have had 4 other surgeries and still have a Kugel with the plastic ring in me. All the Doctor’s have told me that trying to get it out without it being an “emergency” is too dangerous. The Femoral Artery is too close to the mesh and associated scar tissue and could be cut “too easily” by a Doctor trying to get to the mesh. The possibility of me bleeding out on the table is too great a possibility, no one want’s to take the chance.

    Since 2007, I have talked to Bruce, worked with Bruce and collaborated with him by informing the FDA about Mesh problems. Bruce has spent huge amounts of time and money informing the FDA, The Department of Justice, The Attorney General’s Office ( both Federal and State ), Doctor’s and Mesh Victims. I have not spent the time and money that Bruce has, but I have tried to do the same as he has. TO THIS DATE, I have not seen anything to indicate that anything we have done, other than inform other victims, have done anything! We have handed over enough evidence to at least get investigations going on the Federal level. We, and I do mean we, have been lied to by both Federal and State investigative representatives. We have been told that the information we turned over was “Staggering” “Overwhelming” “An Eye Opener”. Doctor’s and Law Enforcement alike have seen the evidence, agreed that it was “devastating” and have done nothing.

    As Mesh Victims and Survivors, what is the one thing that we all want? To get back to where we were before we were implanted with mesh, right? The likelihood of that is pretty remote. So we have been permanently injured. Not temporarily, permanently. The FDA does not recognize this nor do a lot of people. This includes our Husbands, Wives, Children, Family friends and employers. That is quite a burden to carry when all you are trying to do is make it through the day when you are in so much pain.

    Please do not think that I am giving up because that is not my style. What I am doing is being realistic in the face of the experience I have had in trying to stop the manufacture and distribution of mesh. They have more Lawyers than we have money and More Money than we have Lawyers. And the Mesh industry and all that goes with it, the Good, the Bad and Very Ugly, feeds it. It cannot be otherwise because if it was not, we would never have come to this point in time with so many Mesh Victims and Survivors! If we have this many victims we should be able to get some attention now that there are and with huge monetary settlements that have recently come about. But we do not. No matter the evidence given, the numbers reported or the protests made we can’t get on the evening news except as a little blurp on the Health report.

    We need 10,000 Mesh Victims, Mesh Survivors, friends and family to march on Washington D.C. next year. Not just Gynecological Mesh victims but all mesh victims. Graphic signs, news reporters and pissed off mesh victims! What a concept. We cannot get the information out if we are not listened to. 4 or 5 people standing on the corner is not going to work anymore, if it ever did. Bruce and I have talked about this for 2 years and it is about time to see it through. This year make your New Years resolution: 10,000 Mesh Victims March on Washington! No More Mesh Damage to anyone!

    Sorry Ladies, there is my rant. I’m in a lot of pain today so please excuse me. I hope I may have inspired some of you to help make our plan, your’s also. Let me know. Best Wishes…..

  6. Summer says:

    Let’s March. It will probably be the only way to get the coverage that we need

    • Jan Urban says:

      Yes it is a meager attempt by the attorney’s. My anxiety levels are high and it keeps me from shutting off all my dismay about our situation. I read and write day and night about the suffering and the mishandling of this Mesh Device. I can’t stop. I’ve started emailing all the women senators tonight. There are 20 of them and 74 women in congress asking for a congressional investigation. As far as a Mesh Walk on Washington. Buses for transportation are reasonably priced and can make pickups along the route, whereby you only have to drive to a designated pickup site. Walmarts are always near highways in the past and I think now they allow bus trip riders a parking area. We should pick a date of importance that women’s rights were won or at the fore front in history. Our rights having certainly taken a few steps backwards with pelvic mesh. We have to check hotel rates and package deals and reservations for those needing accommodations.Those that wish to, can sleep on bus. There is a lot to be done. Do we have to notify them in Washington or should we surprise them? Let’s Get Busy….

  7. Kim says:

    I have seen many marches with hundreds of thousands of people go virtually unreported in Washington. The media is owned by six corporations that get their ‘marching orders’ (pun intended) from the unholy alliance between government and the corporate world, which includes big pharma and all of the medical device manufacturers. Lawyers too!

    The fight has to be that the 100,000 mesh injured/survivors stand together and refuse to settle for the peanuts these companies are offering.

    Keep getting the information out on alt-media sites. Kudos to Jane.

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