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FDA – What Are We Waiting For?

FDA logo 140 blueFDA-What Are We Waiting For?

It’s been months since the FDA said a word about mesh, and years since it’s known stronger action was needed. Meanwhile, more and more people are getting hurt. Sign our letter below to let them know how you feel.

Tell the FDA: Stop hesitating. Reclassify all pelvic mesh as high-risk.

FDA-What Are We Waiting For?

Prolift mesh kit, Ethicon, J&J

Prolift mesh kit, Ethicon, J&J

At the end of July, the Food and Drug Administration (FDA) closed its comment period for the public to weigh in on reclassifying pelvic mesh as Class III, meaning high-risk. As most readers of Mesh News Desk understand, that is the classification where it should always have been. To make a permanently implanted medical device anything less (moderate risk) does nothing to assure the safety of the public! As you may also know this proposal to reclassify did not include the same polypropylene mesh used to treat incontinence (SUI stress urinary incontinence) or hernia repair.

This leaves the thousands who are suffering from these implants with no options and business as usual for mesh manufacturers and the doctors who continue to promote mesh as a treatment for those two conditions.

Stethescope  wikiIncreasingly, doctors who are being identified as the experts in mesh removal, are weighing in that there are inherent problems with polypropylene mesh that need to be addressed before its continued widespread use. red flag waving

In other words, the red flags are waving.

Reclassification means that the mesh will have to be proven safe before it is marketed. It is a higher bar to reach and involves clinical trials. The leading theory is that mesh will never be able to reach those benchmarks for safety. And mesh manufacturers will not want to invest the millions necessary for the testing.

In essence, innovation will be stifled. That is the cry manufacturers put in the ear of the FDA, which seems to be leaning toward the concerns of the industry over the injuries of Americans.

Here’s What You Can Do

Prolene mesh

Prolene mesh

 

Add your name and comment to this letter:

https://actionnetwork.org/forms/tell-the-fda-reclassify-all-mesh-as-high-risk

 

By mid-November we’d like to have this petition sent to the FDA to insist it do its job putting people first. The next two weeks will be our gathering time for signatures.

First- Please sign this petition which will be forwarded to the FDA.

Then – Whether you can share on Facebook and tell 20 friends to sign on; Post on your FB group and make it an effort; Include your picture or a sharable graphic to bring attention to the issue – You all are very adept at making things happen.

Lastly- If you have a list of friends, send it to them as well. I will be putting it on the Mesh News Desk newsletter, going out today, to add another thousand or so to the effort.

FDA logo 140 blueNext on the Horizon- Doctors and Lawmakers!!

The FDA is apparently in no hurry to make things happen. The first mesh warning went out in 2008, the second, more serious warning in 2011! It said mesh complications were “not rare.” What are we waiting for?

Will your doctor or lawyer sign on as well?

In fact: FDA-What Are We Waiting For? Might be a very good campaign theme.   Hurry up FDA, make things happen and do so now!

As always, thank you for everything you do!   Warm regards, Jane A., Editor MND

Tell the FDA is a PDF version if you want to send one yourself!!!!

18 Comments

  1. Mary pat says:

    Jane – can we get a copy of the letter with a petition that people can sign? The good old-fashioned way that petitions were handled prior to internet? I think I could get more people to sign a written petition. I would like to try. Could you post a Pdf of the letter and petition on MND so we can print it ?

    • Jane Akre says:

      Mary Pat-

      The electronic version is the final version in which it will be sent. However I understand your concerns. Individuals can certainly send in their own letter. I will post one in PDF form on the site. Thank you!!

      • Jane Akre says:

        Tell the FDA: Reclassify All Mesh as High Risk!

        Add your name and comment to join our renewed call to the FDA to reclassify all transvaginal mesh as high risk. The FDA is currently considering a proposal to reclassify mesh for pelvic organ prolapse (POP), but most mesh is implanted for stress urinary incontinence (SUI).

        Add your name to our message to the FDA: Move quickly to reclassify POP mesh, and begin the process to do the same for SUI mesh. More women are getting hurt every day.

        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 ask 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. Moreover, we believe that it is critical to providing adequate protection to women to go one step further and to immediately reclassify mesh used for SUI as a Class III medical device.

        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 initiate 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:

        ________________________________________

        • DS says:

          Hi Jane

          As you know my wife had the Transvaginal Mesh put in to treat SUI and had to have two revision surgeries to remove the Mesh and has had nothing but complications after complications and has practically reined her life the way she new it. This product is poison for the human body and should be classified as 111 HIGH RISK NO IF AND BUTS ABOUT IT So if this is to revived by someone from the FDA this is signed by myself and my wife!

          • Bev says:

            Only a full removal will do. Partials leave you worse than before.

            Dr Raz at UCLA can do a full removal.

            If you find anyone else that says they can remove make sure that it is a full and complete removal.

  2. All Meshed Up says:

    Let us not forget the hundreds of thousands of Hernia Mesh victims also, please! Every day there are more and more hernia mesh implants and the complaints follow. We need to be united against ALL mesh products not just one or two. I realize that this newsletter is more tuned to women with TVT mesh but there are a lot of women who have been irreparably damaged by Hernia Mesh. This is not a discriminatory product! Men as well as women are implanted everyday with a PP product believing that they are now going to be fine and the Hernia is fixed. Thanks…..

    • Wade McCaughey says:

      Hey ALL MESHED UP!!!! Please call me I have been getting incresingly worse and I have lost your phone number.

      I need to get to some doctors that understand what is happening with me.

      Wade

      303-881-2664

    • Sandra Aadland says:

      CHRONIC PAIN for almost five years; mesh in four places, but, since I’m a CHRONIC PAIN (literally) patient, I’ve not had help and no guarantee that removal is the answer. I want to know if there are studies that need live human beings.

      This sounds drastic, but, my pain and suffering and not knowing why, perhaps, if a study or studies are performed, I can be the “dummy” I cannot lay here in pain, get turned away repeatedly, and expect progress.

  3. Jane Akre says:

    After talking t o doctors who are experts at mesh removal, the common wisdom is NOT to remove portions of mesh where there is no pain.. That does not take into account the feelings of the person who may want it all out! but there is a risk-benefit analysis that must be taken into consideration- surgeons don’t want to damage a person if it was not medically necessary to remove the offending mesh. I’ve now heard that from three different docs….Always learning something new!

  4. Moira Redmond says:

    Why are these products still being put in women? It is unbelievable.

  5. Richard Howden aka All Meshed Up says:

    Dear Moira, the real question should be “Why are they putting Surgical Mesh into any one when so many complaints have been made?” Since the early part of 2000, hundreds of thousands of complaints have been made to the FDA through their MAUDE data base. Most have been labeled “Non-conclusive because a sample of the “product” was not sent”. People who had a Hernia repaired by mesh, who then got sick and had to have it taken out were never given the option of keeping the mesh as evidence. I did have my Prolene mesh removed and had it stored in the Pathology lab. I told the FDA and Ethicon I had it, but neither were interested. If the FDA was as concerned about Mesh Victims as they are about Chinese Dog Treats, there would be a nation wide requirement for all removed surgical mesh be sent to The FDA and the Manufacturer for analysis! That requirement would also include a complete and detailed report by the Surgeon AND the Pathologist as to what condition the mesh was in when the patient was opened up and before the mesh was removed. But there is not a thing the FDA is doing to be PROACTIVE when it concerns Surgical Mesh. Even today, after years of complaints, and now with all of the Gynecological Mesh lawsuits, what is the FDA doing? NOT A DAMN THING.

    The FDA gets grants for research from these same Manufacturers. They go to big conferences and are wined and dined. The same goes for many Doctors that are more concerned with THEIR bottom line than a “few” “disgruntled” patients.

    For anyone that IS suffering from a Mesh Implant**** TREAT YOUR BODY AS A CRIME SCENE!***** Take pictures of what is happening with your body. Keep a journal that follows your medical condition and all contact and/or coorespondence with Doctors and Lawyers. Try to arrange for video during your removal to show exactly what the mesh looks like and what it has done to you. Have tyhe Doctor make a comprehensive report as to what he has found. AND KEEP YOUR MESH AS EVIDENCE!! Trying to piece together what has happened to you when it has been months or years will be very difficult. Best Wishes to All!

  6. DEBORAH says:

    And what they don’t get, is that mesh is as sharp as a needle! And when it is sticking out of you, it literally hurts, and can damage other parts of your body!

    J&J needs to own up!

  7. Bejah says:

    I thought the FDA’s advisory panel recommended reclass to level III last year. Why has it not happened? There is only silence. We must go over the head of those in senior managers. We must go to Health and Human Services and perhaps copy Eric Holder.

    Bejah

    Can we file suit against the FDA?

  8. Judy Valent says:

    This mess of MESH!!!! I start my day dealing with my husband who wonders will he live. He had prolene mesh implanted on the right and left side for hernias. Per the doctor the mesh was in excess and had many other issues! ARE WE ONLY ABLE TO GET ATTENTION FOR THE WOMEN AND IGNORE THE MEN? IS there no one out there that cares if a person lives 24/7 in extreme pain and NO hope? Is the FDA ASLEEP AT THE WHEEL? This is a form of a slow death! Are we no longer humans! Not only did the stuff that his life hell but every family member life’s changed because life changed completely! Lawyer’s … were are they? The Statue of Limitations should be the same as murder. This all comes from the wife with every day full of sorrow, stress and each morning will he be alive! ! I cannot believe the world is not paying attention! You are blessed if you NEVER heard of this medical device of poison! Please help!!!!!!!!!!!!

    • Jane Akre says:

      Judy- after asking many attorneys why there is no litigation involving hernia mesh ( there are afew cases) they said there is no FDA warning and it is still the standard of care. Start with the Hernia Society and go from there….. they must understand that this ‘standard of care” is killing people for the same reasons PP mesh in women is causing irreparable harm. Want to start the petition here?

      • Judy Valent says:

        Jane Arke I would love to start a petition. I am not sure the process but I do know that the life for a man is just as serious as for women! When infected mesh needs removed because of extreme pain, nerves cut, possible strangulation, so many issues that the surgeon who did the initial surgery does not even want to speak to the injured patient. Where did infected mesh come from that was implanted? Ethicon stated it was not theirs (but the records said so) to me but later I heard they stated it is there’s . Does no one seem to think that something seems odd! Where is JUSTiCE?

        Why is no one talking about this on the news? I have never seen such a hidden subject that is going to destroy so many Men and Woman. Why is everyone scared of regarding the truth of this so-called medical device? Every human deserves answers to who or what is taking their life and given some type of TRUTH and JUSTICE. What happen to the Hippocratic oath? “DO NO HARM”! If this is called the standard of care they have NOT seen or lived in our life. The damage mesh was removed by a wonderful surgeon but she used stitches instead of mesh in the repair process. How would any family want to hear these words everyday from someone they love “I want to die”. This is Not Standard of Care! GOD HELP OUR MEDICAL TRUTH!

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