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All Mesh “High Risk” in Australia

Uphold, Taranakiobgyn, NZ website

Mesh Medical Device News Desk, October 30, 2017 ~ In a quiet but striking move, Australia’s drug and medical device regulator has strengthened the classification of pelvic mesh, increasing the likelihood it will not be used, especially as a first-line treatment.

If you were not paying attention you might not have noticed an announcement last Thursday, October 26.

All pelvic mesh devices in Australia are to be reclassified from moderate to “high risk” over the next 24 months.

The announcement was made on the Therapeutic Goods Administration (TGA) website (here), the Australian version of the U.S. Food and Drug Administration (FDA).

The reclassification will begin in December 2018, for the larger pelvic organ prolapse (POP) mesh, used to treat falling pelvic organs.   That gives POP mesh manufacturers 14 months to make the change.

At the same time, the smaller “tape” or “slings” used to treat stress urinary incontinence (SUI) will be upgraded to high risk by December, 2020, a full 26 months away.

A three-year transition period to December 2021 is proposed to apply for other surgical mesh devices such as hernia mesh.

The TGA is part of the Australian Government Department Of Health and it regulates medicine, vitamins, med devices and blood products.

The change is significant.

After the dates above, mesh manufacturers must provide a “higher evidentiary requirement” before they are approved for sale.  If they fail to, the devices cannot be marketed.

Patient cards for implantable medical devices will be required for all new urogynecological mesh devices from Dec 1, 2018.  At that time, manufacturers of new permanently implantable devices will need to have a patient information leaflet in the TGA approved format.

The changes were approved by Health Minister Greg Hunt and follow an Australian Senate inquiry where women testified they felt like “guinea pigs” after their implants.

At the same time, the largest class action lawsuit in Australia is underway. Seven hundred women are suing Ethicon, a division of Johnson & Johnson, for defective mesh implants, both POP mesh and SUI mesh.  The class action trial began in July and is expected to take six months. See MND story here.

The founder of the Australian Pelvic Mesh Support Group, Caz Chisholm, told The Herald (here) that the problem has always been a lack of information to women considering an implant.

Caz Chisholm, Newcastle Herald photo

“No woman that I know in the support group of more than 1000 women was told by her surgeon that her device was high risk, or medium to high risk,” Ms. Chisholm said.  “Once these devices are re-classified, are specialists going to tell women the device they are about to be implanted with is high risk? I don’t think so.” 

Ms. Chisholm has pushed for an Australian Senate report due in late November. She slammed the TGA for “quietly announcing” the changes on its website after her group’s sustained criticism.

The U.S. FDA still classifies SUI mesh as moderate risk or Class II, despite the fact that it is a permanent implant and the subject of thousands of defective product lawsuits filed in the U.S.

In January 2016, the FDA reclassified POP mesh as high risk Class III (here) but gave the manufacturers 30 months to prove its safety or stop marketing the devices.   See MND story here.  ###

 

26 Comments

  1. Bejah Blue says:

    Hallelujah!

    No, no woman I know was told this device was high risk, quite the contrary. I noticed in my implanting surgeons photos from when I was implanted in 2010 and today, it is clear she has had plastic surgery on her face. This tells me a lot about her values. Nausea overcomes me…. Bejah

  2. bejah blue says:

    I am at the Rancho Mirage library waiting for my 4pm pain mgt appt in Palm Springs…being good, staying away from shopping to wait for my appt. It is a cloudy and cool day here, sort of how I feel. Sorrow pours over me. But something nice happened and I must focus on that. First I thought I was out of pain medicine yesterday morning. I prayed especially last night before bed. Fear of the pain cripples me. The night seems the worst. I made warm milk with rum. I had a draft of Port (Always a loved favorite…love to use it when making roasts but who can afford roast beef anymore). I also had aspirin, my muscle relaxant and my big BooBoo to keep me warm and comforted. I actually slept through the night (took sleep med.) and was unaware of pain. Thank you GOD. In the morning I thought of how I dreaded having to survive the trip down here and the day until I could fill my prescription at 5pm. Then I remembered that I had put my change purse and bottle of pain med. in the bag I take to church. There it was and their were still four pills in it, four .5mg Oxycontin. I thanked GOD for letting me find them. I am also thankful they still work so well, those tiny little white pills. My friend said I need to ask for 10mg. Why am I afraid to ask? Why should I be afraid to ask? I am not drug seeking. I do not have an addictive personality. Why am I made to feel like a sort of criminal, or weak…too afraid to ask a doctor for help. This is not right. My friend made me promise to ask today. I wonder what will happen. I feel I will be forced to seek additional help from a medical marajuana facility. They told me that no other doctor could prevent me from doing that but the pain mgt. doctor I see told me I am not allowed to seek pain medication from any other source. This is so confusing. I am resistant to being told what I can and cannot do also. I sense intimidation and I do not like that. Why do I have to be seen every 30 days? Do they not trust me? They have no reason not to trust me. I am very uncomfortable about all of this. Those who did this to me should feel uncomfortable, not me. But they do not. Not at all. They are oblivious, self righteous. Today when I got off of the bus from Yucca Valley and went into the mid century modern 7-11 for coffee I asked if I could have a slice of pizza. I often get two (for $2.00) but today I did not have enough money so got one and a small pumpkin spice coffee. Guess what happened. The girl at the counter put two pieces of pizza in my little box for one slice. She gave me a second slice! I did not discover this until I walked the eight or so blocks to Desert Regional Hospital where I sat to have my coffee and pizza. My heart was so warmed at her kindness…a nice attitude adjustment. Of course I broke apart the crusts and gave them to the birds. SS will be happy to know I took off the pepperoni first and pitched it in the flowerbed for the squirrels. I doubt they have Interstitial Cystitis or mesh implants. We must try to focus on what is good. It will strengthen us to face what is not. Love, Bejah

    • Carolyn says:

      Bejah, you always have the most cheerful attitude and it really warms my heart.I am on medical marijuana for nerve damage to my face, and it actually helps my mesh pain a little bit…not a lot, but enough to be able to get through my days with gratitude. I wish you many more sleep-filled nights and pain -free days sister.

  3. LB says:

    Same way as you Bejah blue except I’m male and have had no pain killers for over 15 months the doctors thru insurance think all you want is pills and I haven’t asked for 15 months. It is time to hold fda accountable for it all. They have had many people go to work lobbying for medical device and pharmaceutical corporations. We need to stand up before we all die voting for people that care about human beings not corporations!

  4. Disgusted says:

    Bejah,

    I feel your pain. It is scary when you’re at your last med. I use B&O for bladder/urethra pain. I save them for 9 pain. They are gold to me. I started needing them more frequently, especially with infections. I was worried I wouldn’t make it. But God got me through. I ransacked my drawers and found 2 extra. I signed a contract that says I can’t have any type of alcohol. They test my urine every time. I have to cath most of the time and it really bothers my urethra. I understand many issues associated with these and other drugs. My parents were alcoholics, they haven’t stopped alcohol. It is more for an escape from reality for addicts. I have never experienced any kind of euphoria from oxycotin. My Dr. told me it was because it was going to my pain. It has never made me pain free, just tolerable. The last few days have been rough, high pain. My husband thinks it’s because I walked on our driveway with him. 1/4 mile and sloped. Not steep. If I can’t walk a decent amount how will I ever get any muscle mass back? They are atrophied as it is. One hour of walking (I’m real slow) = severe pain for 2 or more days. I don’t do well being sedentary. It’s a nightmare.

    • Jane Akre says:

      I’m so sorry….it is interesting how the body uses narcotics to dull pain when it is needed not to crease any euphoria. The body is very smart.

    • Bejah Blue says:

      Gosh Disgusted, I know exactly what you feel when searching and finding those two more pills….I have been there so many times. I am so neurotic about losing them or having someone take them from my home that is one of the reasons I always divide my medication into four containers or even more and put them in different well known places. I also keep a little in my handbag and the bag I take to church and a dear friend who keeps some for me for the last week so I do not run out. I must confess I do not know what B+O is. It sounds like I should! Please spell it out for me. I can be a bit dense I guess.

      Also, I need to post about my visit with my pain mgt. doctor yesterday before I go offline. It was horrible. My friend told me I must ask for more pain medication, that I was not receiving enough Oxycontin. I was trying to find the courage to do that. When I went in the doctor berated me for not having an xray of my spine as promised the last time I was in a month ago. He was cruel and inappropriate and made incorrect assumptions. I made it clear that I had the xray of my spine that day and brought him a CD of the image that afternoon. I told him that I was told by the hospital that the radiologist report would not be available until the following day. The hospital assurred me that they would send him a copy at that time. I gave them the contact data. The xray was ordered by a different doctor, BTW. He knew that, I had explained it to him. He blamed me for not insuring that he also got a copy. Then he said that President Trump is again talking about the need to address the “drug crises” and has insisted that physicians reduce patient dependence on opioid pain medications. I fell apart and threw a fit. I was livid. I told him he had no right to treat me this way, no right to be accussatory regarding my spine image, I reminded him that my primary source of pain was the pelvic mesh sling (Wondering if he even knew what that was or cared or believed me). I also spoke of the Vulvodynia pain (How do I know it is not pudendal nerve pain???), the Intersistital pain, the urinary tract general pain and anxiety, the Bursitis (Is that really what it is???) and the lumbar sacral pain. Am I forgetting anything I always wonder. Does this young doctor think me a hysterical psychosomatic female? What was he taught in medical school? Finally he apologized. He told me he was the doctor and he cared about me. We argued. He told me when I told him I had taken a Physiology course as part of my psych major and I knew quite a bit about neurons, dendrites, axons, synapses, etc. He said, “You are clearly very intelligent” HA! He asked me to trust him. He said they are all upset about these restrictions. He asked me to take more Cymbalta and more of the muscle relaxant and said both of those would help with many of my nerve and other pain issues. He asked that I give this a chance to work. He asked me to cut my Oxycontin from 6 a day to 5 a day. What choice do I have. If any of you need any more information on this alteration of my personal plan please let me know and I will try to help. It is my impression that aspirin helps with some kinds of pain (I want to say bone pain) that opioids do not help with for reasons that remain unclear to me. Please everyone be aware that this may be hitting you all soon. It makes me wonder what the nature of the break out sessions in San Diego recently really was. I would love to see a roadmap! Take care all. Keep the faith and stand your ground. BTW he also told me I was not allowed to fill pain med scrips from any other source (Urgent care dr. in my own village). I said that I was glad I had that medication (10 5 mg. Hydrocodone) because it helped a lot when I ran out. It also gave me the opportunity to observe that the Hydrocodone (w/325 Acet) was NOT as effective at combating pain as the Oxycontin (also .5MG). Dr. also told me .5 mg is NOT a low dose. What say you, people? Thanks. Stay strong. Bejah

      • Still standing says:

        Bejah. Rest assured that the pain doctors who were in San Diego are not plotting against you or other people in pain. I was there. There were thoughtful discussions and sometimes agonizing stories. They are doctors who want to help people in pain but theyhave the long arm of government pushing them into this. To do otherwise would mean they trigger a DEA surveillance that can cripple a physicians practice. Part of this is driven by the perceived opioid addiction crisis, but another part by scientific research that shows that opioids are not the most effective treatment for chronic pain and the risks outweigh the benefits. This is not a capricious move against mesh women. It impacts over 100 million Americans who live with pain every day. It is not physician driven . It is politician driven

        I wrote about this happening here two years ago and pleaded for the readers to start having the conversation with their doctors. I was accused by others who post here of not knowing what I was talking about. Yet, here we are.

        Here is what is required of the person on opioid pain medication and their physicians now. The physician has to document in your charts that he/she has counseled you about all other viable options for pain management. YoU have to provide documentation that you have followed his/her recommendations. The physician HAS to have a plan in your chart for weaning you off opioids. That is the bottom line. It is and will continue to be a chilling state of affairs, but that is the chronic pain reality of today.

        Please do not fill another pain prescription by another doctor at a different pharmacy. Your doctor advised you well. If you decide to do that anyway, you risk being taken off all opioids completely and permanently. You have to follow your pain management doctors recommendations exactly. Please take this seriously. It is much to late for you to be proactive with this, so now, you just have to follow the rules as they are.

        I don’t know if this doctor has prescribed mental health counseling. Much has changed since you took your class in college. Pain science has totally changed just over the past ten years. It is now considered a biopsychosocial condition that has to be addressed in each area it is not about axions and dendrites as much as the
        central sensitization of nerves and how the brain processes pain messages. Psychological counseling is just as important as the other components. It is not the doctor saying you have a psychosomatic disorder. You don’t. But there is a brain process that can be addressed by retraining the brain, an area of neuroscience called neuroplasticity. A fascinating field.

        I wanted you to see this before you go offline. It is important for you to get this. Do the cymbalta, take the muscle relaxers. Muscle relaxers are actually most effective with your pelvic muscles, cymbalta for neuropathic pain. I could not take cymbalta but maybe you can so try that combination and keep track of what is working. I found that Savella totally eliminated my lower right side pain I have had since the mesh implant. I decided to quit taking it last month because it is so expensive, and the pain was back in literally two days. Be open to observing what works for you and trying different combinations of things that can ease your suffering.

        I hope is serves as a word of caution to other mesh women on opioids. The world has changed and not in a good way. Don’t wait to be surprised by a doc who says he or she is not going to fill any more pain meds for you at all. That is happening to many many people and there will be many who suffer too much over the next year. Please do what you can to figure this out with your physician.

      • Kitty says:

        All the over dose cases are heroine and Fentanyl. I am sure there are a few folks that take too much percocet or leave it out for kids to get at. People are made to believe that if u take Vicadin or oxycodone…you will eventually go to crack or heroine. We should be treated like oncology patients. I am very depressed today. I couldn’t go to work. Terrible dreams. It will pass. Ate more Poms. It’s best to have a good primary Dr to prescribe for u. The b—– that took some of the mesh out wanted me to go to pain management. I almost fell for that witches order. To tell u how she treated me and my husband would be hard for u to believe. She was trained by the BS GURU.
        .

        • Still standing says:

          Clearly, you are not the parent, child, spouse, brother, sister, or other family member of the 183,000 people in this country who have died from prescription drug overdoses in the past 15 years, 15,000 in 2015. We cannot trivialize these deaths, even in the midst of unnecessary pain that we are going through. Actually, primary care physicians are being asked to be the first line of defense in reducing prescription opioids for chronic pain, so, really, in the end, no one is going to escape this rough train ride.

          • Disgusted says:

            Still Standing,
            I understand what you’re saying. I know many family members have been affected by the addiction to oxycodone as well as many other drugs. I have taken savella, cymbalta, neurontin, lyrica and had bad reactions to all. I had a psychiatrist tell me not to take any drugs that have anything to do with anti-depressants. I wish they would work for me. I fear that I will be living in pain with no help. I feel they are handling this problem all wrong. My pain center has a contract, you have to have a safe to keep pills in. You can only take out 1 day’s supply at a time. They can call at any time and make me give them a pill count within 24 hours. They do urinalysis on me every time. If it is getting to the person with pain – it’s humane. It seems like they want to stop it all together. Pelvic pain is hard to address because it’s not well studied. Pain is subjective. I have seen addicts, probably the strung out ones, and they think about it all the time. Where/when they can get their next fix. I have a physical dependence, but not a psychological dependence. I have gotten off of them for 3 or more weeks at a time, however I have to lay in bed the whole time. Movement brings on my pain. The keep telling me about CRPS. I don’t buy the reasoning, it doesn’t relate to me. When I was in the coma, I came out of it and was in the hospital for 10 days. I never once asked for pain medication. I was bed bound. It stated in my records that I was taking oxycodone. Maybe you can explain CRPS in a way that I would understand. Right now it seems as if my pain is cause and effect. I have a close mesh friend who has the same thing. We talk about “paying later” when we do something. I was accused of being an addict in a ladies bible study of all things. She said the body will make up pain to get it. It hurt. I prayed for her (pray for those who persecute you) and about a month later she had some hip complaint, she came and apologized to me. There must be other components for addiction than just pain. Like lupus, etc. maybe there is a predisposition to this. May God help us all. Oxycodone is being addressed, but mesh is still being hailed as a gold-standard product in the US. A new way to torture.

            Bejah, B&O is belladonna and opium. It is for severe bladder/urethra spasms and I believe it also helps severe bowel spasms. It is the only thing that touches urethra pain for me. They say it is addictive, but I don’t think I use it enough for that. If I have a bad infection, even B&O doesn’t touch it and that’s how I know it’s an infection. They have put me on keflex, and I take 3 probiotics every day to counteract, still have thrush, diarrhea and stomach ache. They had tried macrobid, I still got the infections. I’m wondering if I should get my bladder out. Hopefully Dr. Peters will have wisdom for me when I see him.

    • Kitty says:

      Has anyone been able to get on J&J MDL? It’s been blocked for several days

    • Bejah Blue says:

      Disgusted, Did you read my post about my recent visit to pain management…they said Pres. Trump wants doctors to cut back even more on prescriptions for opioid pain medication because of the “opioid crises” in the nation so they cut my script from one .5mg every 4 hours to five a day (rather than 6 a day).

      He increased the muscle relaxant and the Cymbalta prescribed for the peripheral neuropathy in my legs two years or so post implant. He said it would help with all neuropathic pain and the muscle relaxant I mentioned elsewhere on this site would help with nerve pain generally and help balance the loss of relief from the Oxycontin.

      He also said that .5MG of Oxycontin is not a low dose. I thought it was the lowest. Is that not true?

      Finally, yes I did “rip him a new one”. I did it for Kitty!

      This is bad news. I hope this does not happen to the rest of you, but please tell us if you can, what happens to you with regard to pain medication.

      I would like to know why it is OK for the government to dispense opioid drugs and other class ! drugs to soldiers in war zones but then turn around and deny it to citizens of this nation in serious pain.

      Also, I think the pain caused by this poly mesh has been equated with cancer pain. How can that mean anything to me if I do not know anything about what cancer pain is. My friends dad is dying from cancer pain now (He is a smoker) and he is not in any pain from the cancer. He takes copious amounts of Hydrocodone for his “cancer cough” but that is said not to be painful. Can anyone explain any of this. Thanks all.

      I am sure my ISP will cut me off in the morning but I will continue to chatter and beep until then.

      If I do not have the opportunity later, I want to wish you all a happy Thanksgiving…and please do live as beautifully as you can…celebrate, gather people you care about, create memories, tell stories, build bonds, and celebrate what “they” can NEVER take from you…your humanity.

      Remember well that expression…. “Living well is the best revenge”. Who said that? Was it Lauren Bacall, or who knows, anyone? Love, Bejah

      • Disgusted says:

        Bejah, you will be missed. I’m sorry you’re going through this. So NOT FAIR! I know, life isn’t fair. Tired of hearing it. Hopefully, J&J will lose on their day’s in court. I just wish it was a criminal trial and not civil. Because this is mass depraved indifference they can get away with it. OJ had both trials. Why we can’t has to do with numbers. Tired of being a number, a guinea pig, lab rat, etc. Where are the people who fight for the decent treatment of animals? Don’t we count?

        Animals seem to be on the top of the food chain now, at least in our belief system in this country. (Just my opinion).

  5. Disgusted says:

    P.S. Severe pain while taking my meds. Nothing touches it, I’m afraid to go to ER – drug seeker. I just lay in bed, cry and try to distract myself.

    • Bejah Blue says:

      No, do not do that. Go and be a warrior. I know it is hard, I know you are weary but we must not give in. Feeling for you…Bejah

  6. Disgusted says:

    Jane, it is great to hear they are adding regulations. However, what about the women who come in before the regulations take place? Why not make them prove their safety first? It’s been on the market long enough. They say it is the most studied product ever. You can’t have it both ways.

  7. John P says:

    Again, Hernia Mesh is put on the “back burner”…Argh… I still suffer greatly, in agony, since mesh was put in me,(Without knowing) then the pains began!

    • Bejah Blue says:

      John it is not our intention to treat you that way…I guess we are just all so deeply ingrained in our own pain…truly so sorry. It is a human issue. We know that if I may venture to speak for us all just now. We would comfort you and thank you for speaking out here. Bless you. Bejah

  8. Denise says:

    I was told no risk at all that he had no complications was better than sliced bread. Found out after a lady 3 weeks before my surgery her bladder stopped working she lost her bladder than I lost my bladder as well. If I was told even medium risk would never of done it.

    • Jane Akre says:

      Denise, how horrible. I do hope you have excellent representation working hard on your behalf.

    • Bejah Blue says:

      My GOD…remember that you are not your body. It does not help much but try to always know first that you are your soul and the body is what we live in here in this life and our bodies do the best they can. I say this when I do not know what to say and want so much to comfort you. Bejah

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