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New Zealand Mesh Injured Campaigners Make Changes with Govt Petition

from The Nation, NZ television

from The Nation, NZ television

Mesh Medical Device News Desk, June 15, 2016 ~ They are mesh injured but that has not stopped Mesh Down Under campaigners from being heard by their government. 

Their campaign began more than two years ago. Charlotte Korte and Carmel Berry, both implanted with pelvic mesh which had caused complications, petitioned to Parliament’s Health Select Committee to encourage a nationwide investigation into how pelvic mesh was introduced into their small country and its devastating effects.

They were relentless.  They created the Mesh Down Under Facebook Support group and website (here).

Their petition (here) covered how the “Little Country” of New Zealand followed the lax regulations of the U.S. that allow medical devices into the marketplace with no clinical trials and no testing for safety and efficacy. The petition outlined the lack of adverse events reporting. With no device registry and little actual reporting, the entire country was in the dark about the actual number of complication for both pelvic and hernia mesh.

Finally, the government listened.

The Health Select Committee recommended that a national registry be created to keep track of mesh implants, not unlike the VIN number on a car that allows faulty airbags to be tracked. The committee recommended relevant medical colleges investigate the best informed consent procedures. Coding for mesh surgery should be consistent and surgeons should be trained on the use of mesh and for mesh removals, said the government. Doctors should be encouraged to make reports of complications.  The recommendation also include expanding the role of the medical device regulatory body, Medsafe, to establish the quality and safety of a medical device before its used in the country.

Carmel Berry tells Mesh News Desk that the current regulation of medical devices like surgical mesh is decidedly hands off. Medsafe is the business unit of the Ministry of Health but it does not assure safety and efficacy for citizens.

Carmel and Charlotte

Carmel and Charlotte

“No one, repeat, no one, in any regulatory authority in New Zealand has the legal mandate to investigate the safety or efficacy of any medical device before it is introduced for use in New Zealand, this includes devices that are used and intended to be implanted, permanently, to stay there inside that person’s body forever and ever, until they die. “ ~ Carmel Berry

 

The government has 90 days to respond to the recommendations.  A request for a full investigation into mesh debacle in New Zealand was rejected.

The campaigners are hopeful this will form the basis for drafting new legislation to replace the antiquate Medicines Act 1981 and its Regulation. 

 

No Problem Selling Mesh in New Zealand  

Plastic mesh

Plastic mesh

Berry outlines just how easy it is to sell a new medical device, such as pelvic mesh, in New Zealand.

A new device can be promoted to doctors and surgeons when the “sponsor” registers it within 30 days. Reliance then is on the integrity and track record of the device maker.  Safety and efficacy?  The country will determine the safety of a device when complication reports come in.  Problem is there is no mandate to report adverse events and no registry to track them.

What’s been created is a purported safety net with no safety.

So far, New Zealand has paid about $10 million in compensation to mesh injured while the country has only registered a couple hundred adverse events.

In a gesture to the mesh industry, in New Zealand there is no recourse through the court, a class action or MDL, no personal injury or defective product lawsuits as exists in the U.S. Instead the ACC (Accident Compensation Corporation) provides no fault personal injury coverage for all residents hurt by products.

In other words, taxpayers cover the downside when a device goes wrong.

And ACC will not fund surgeries out of the country.

Last year, ACC did a study on mesh in New Zealand from 2005 to 2014. It found, more than 56,000 devices had been sold in the company and the complication rate ranged from nine percent to the mid teens. See it here.  Dr. Robert Bendavid, a hernia mesh removal doctor from Toronto called the study superficial and meaningless in an interview with The Nation.

Medsafe, the business are of the Health Department, insists mesh is safe when instructions are followed by an appropriately trained surgeon.

The device registry will presumably provide regulators with some way to better understand the scale and scope of complications from mesh implants. It was a device registry in Australia that first alerted that country to the need to recall defective metal-on-metal hip implants. The U.S. does not have a device registry but is said to be working on one.

Berry says,  It is terribly and incredibly embarrassing, our country is supposed to be recognised as ‘forward thinking’, ‘innovative’ , we are proud to be. This time, our regulators have their head in the sand, no disrespect to anyone, but please understand, like, let’s say like an Ostrich. (NOT a NZ native bird),  

Ostriches have three main strategies when attacked. They can run away, they can kick, or they can try to hide.  The Kiwi (The Bird, not the fruit) … is an industrious, careful, nocturnal, self-sufficient, shy, intelligent, curious, tactile, clever, tidy, famous and let me add, handsome native bird.    

The juxtaposition between the symbolic use, and the reality of our icon, Proudly Kiwi, and our legislations is, I’ll say it again, embarrassing.   

Let’s challenge New Zealand’s regulators, advisors, health officials, as well as the surgeons, doctors, hospitals, nurses, all health professionals, you know who you are… stand up, get your metaphorical heads OUT OF THE SAND.”   

 

The Nation

The Nation

Front Page Media Coverage

The controversy has generated front page media coverage. On July 11, a magazine style broadcast, The Nation, introduced Heal or Harm?  and featured Charlotte Korte, Carmel Berry and Chrissy Williams and how they live their compromised lives today.

Carmel shakes, Charlotte can’t work and another woman, Chrissy Williams spends 20 hours a day in bed. Presented by Mike Wesley-Smith, resembles the prestigious 60 Minutes in the States. See it here.

On June 3,  Radio New Zealand came out with a strongly worded program claiming surgical mesh is “literally destroying lives.”  Listen to it here.  Charlotte Korte laid out the issues and one of the few mesh complication surgeons in the country spoke with outrage. Dr. Hanifa Koya, a gynecologist from Wellington, NZ, said she’s never seen a group of people so seriously injured.berry and korte go to committee in 2014

“Stop being arrogant,” she said to the medical societies who turn away injured women or who try to minimize their pain.  She told the radio audience about the J&J fraud investigation in California and Washington state as well as the Chinese resin debacle of Boston Scientific. Dr. Koya encouraged the old system of having an ethics committee in every hospital to better protect patients.

Dr Koya was joined by Auckland University Professor of Gynaecology Cynthia Farquhar who told an audience on TVNZ (here) that doctors worldwide adopted transvaginal mesh too quickly without proof it was safe. She and Dr. Koya support the recommendations just released from the Health Select Committee.

Winston Peters

Winston Peters

And in a surprising turn the head of New Zealand First, Hon. Winston Peters called for a halt in the use of surgical mesh.   “The government should have stopped the use of surgical mesh at the first signs of severe complications – people must come first, not dollars.

New Zealand First is the conservative political party in New Zealand founded 23 years ago and is known for supporting senior citizen benefits and opposition to immigration.  The party works with both major parties in New Zealand, the National Party and Labour Party. Peters notes hundreds of claims have been made to ACC. No amount of reviews and investigation will protect new patients from complications.   ##

 

22 Comments

  1. Kirsty Datar says:

    We mesh injured women of Australua call for our country to monitor all mesh implanted women. There are so many ongoing debilitating complications and are unable to get the surgical, medical and rehabilitation help we need. We call for a full independent inquiry into transvaginal mesh in Australia. We do not know yet how many women are implanted. We do not know yet how many women are suffering consequences of mesh complications. We do not know yet how many of us have suffered erosion into the vaginsl wall, bladder, urethra or bowel. We do not know yet how many have developed autoimmune diseases dud to the Foreign Body Reaction to the toxic mesh.
    We need help now with URGENT removals of this degrading polypropylene mesh from our pelvic regions.

  2. V says:

    I just want to tell all of you my experience after the mesh is removed. You are still going to have the same problems as before but now I am dealing with the scar tissue from the removal along with nerve damage. I have had several series of steroid shot in my vagina and that pain is almost unbearable! I’m suppose to go to physical therapy but I can’t afford the drive and the copay not to mention the thought of something inside my vagina. I hardly go anywhere and my time is spent in bed just getting up when I have too. That’s my life. My husband and son just come by my bedroom door to talk to me. I have so many medical issues, most all of what everyone else is going through. I’m only 61 and I get around worse that my 89 year old grandma did. There is no amount of money to compensate for ruining the rest of my life. I’m bitter and all of this has affected me emotionally. It is so hard to look forward to anything. I pray for all of us.

    • Jane Akre says:

      Not to put a damper on women who are waiting for their explants. Some women do fairly well and return to a normal life.

      • V says:

        I did not mean to “put a damper” on anything. Just saying removal is not a cut and giving you my experience. Tere will be new symptoms as well as the old ones. Some may not have the same as me. But I’m worse. Scar tissue is horrible pain as well as nerve damage.

        • Still Standing says:

          V, thank you for your candid comments. I think all of us have a visualization of being made whole by having our mesh removed, everything back to normal. I have experiencedgood improvement after most of my mesh was removed. But the “good improvement” is based on my new “normal.” If I compare what I can do now to my pre mesh self, I would have to say no, not enough improvement. However, , if I judge my improvement against my post mesh hell, then I have definitely improved. It is not a cure for sure. However, I am so thankful that I had the mesh removed. It didnt all get done in one surgery but it got done eventually. I do still have some mesh that just couldnt come out.

          As you mentioned, scar tissue, adhesions, can be extremely painful especially in the pelvic region for several reasons. Scar tissue is less elastic than regular pelvic tissue. Our pelvic area is a central hub of our body. Scar tissue attaches to everything and anything, restricting movement in what should be a very fluid part of our body. This can cause great pain in itself, but also because adhesions can impact other intricately intertwined body functions. Pelvic scar tissue contributes to bladder and bowel issues as well. I’m sure most of us are aware of these. Constipation can be a very painful complication of scar tissue. This, then, generates more pain and a cycle of pain becomes our body’s default response. Each surgery generates more adhesions, so they build up over time. During one surgery, my physician spent almost two hours just removing adhesions so he could get to the mesh.

          If you have not learned how to massage and release scar tissue, you should learn how to do this important healing regimen. Scar tissue can be released years after the trauma. My PT taught me and it initially and briefly caused more pain, but it eventually provided relief. I still do it several times a week. I know many cant afford the copays for PT, but there are multiple online resources that can teach you how to do it. Just starting with very short and very gentle abdominal scar rolling and massaging can help. While nothing can provide us a “cure”, even small improvements in pain can significantly improve our quality of life. If you are interested in learning pelvic scar management, just type those words in your search engine and you will be directed to sites that explain the process. Isa Herrera, in her book “Ending Female Pain”, explains scar management really well. Her book is a goldmine of pelvic pain management education. It became my post mesh recovery bible. I purchased it through amazon.

          • Bejah Blue says:

            Wonderful advice as always SS. I realize I can do this with the scar from my hip replacement. I wonder if I could use my little TENS unit on it….or my pelvic area!!! I think that may be a good idea but will get an OK from someone first.

            Hope you are well and happy.

            No one has changed my pain medication BTW and in fact the physician said she will not reduce patients pain medications until the government provides a adequate, comparable and reasonable alternatives! There is that oath they take. A physicians responsibility is to their patient, not the government.

            BTW since you are a friend of the decision makers please tell me why I can go to Europe and buy a medication tomorrow that I can not buy here because the FDA has not cleared it (Yet they clear our pelvic mesh on some flimsy previous version statement). There are people who are dying because they can not get these medications. In Europe mfg.’s reimburse for cost allowing for this humane sale of life saving drugs but we do not. Why?

            And we must remember that the government of this nation is run by the people (in theory) and for the people so doctors refusal to reduce pain med. is the right thing to do. I rest my case. So there! 🙂

        • Rebecca O says:

          Hi are there other Dr who can take full mesh mesh removals, near NM, and accept medicade, centennial insurance .

          • Jane Akre says:

            I wish I knew docs in NM…. there is Michael Hibner in Phoenix, Dr. Raz at ucla, dr Walker in Orlando, Veronikis is st louis, Miklos and Moore in Atlanta, dr Margolis in San Francisco area

          • V says:

            I only know of my Dr. in North Carolina from Duke.

          • Still Standing says:

            If you are on Medicaid, you may have a problem going out of state for surgery since Medicaid is state funded. Might be advisable to start a request now with your doctor’s recommendation for surgery. It could take a while to get that ball rolling. Younwould probably need tomhave a comsult with a surgeron,mthen apply for iMedicaid in your state to let you go out of your network.

          • Bejah Blue says:

            Jane, I think Milkos and Moore also opened an office in Beverly Hills (Amusing!) but maybe they could not keep it open for some reason. I can’t imagine why.

            Bejah

          • Bejah Blue says:

            Rebecca, You will probably need to travel a bit because New Mexico is so wonderfully empty! Best bet there would be maybe Santa Fe or Alb. It is more important that you go to the best person you can afford not how far it is. You will live with this the rest of your life. I would drive across country if I had to. Ask Jane about Angel Flight West. Best wishes,

            Bejah

        • Bejah Blue says:

          You’re OK V, We are here, we hear you. Got your back. SS is a good person and has a lot of wisdom to share. Do try what she has suggested and know that you are not alone.

          Bejah

          • V says:

            Thanks Bejah! I appreciate that and I’m going to try! I always feel better when I read yours and still standings post! Both of you have first hand knowledge and the ability to put that in writing. Thanks for being the hand holding me up.

          • Still Standing says:

            V, we arent holding younwith our hands, we are holding you with our hearts. Bejah,what a fine pain doctor you have to refuse to travel this slippery pain slope. I hope she will be able to continue to put her patient’s needs first. The CARA bill has passed chambers, not sure when/if Obama will sign. Will keep you posted. It will take quite a bit of control out of the hands of physicians,unfortunately.

  3. Meshie says:

    V… I know where you are coming from, I had my removal of mesh only, (arms still in) in 2013 and until April of this year I have struggle with so many new problems and new pain new rashes new lumps.. I wish I had never had a partial removal. I don’t know what happened in April, but I feel I have turned a small corner and can at least smile on some days. so maybe the partial will turn out all right it just takes time to heal. I am still not 40% but I can smile some!

    • V says:

      All of mine was removed at one time including the arms. Now the scar tissue is so bad that it feels like it’s still there. I am glad you are getting better.

  4. V says:

    Meant to say ” not a cure”

  5. toni says:

    Wow what has happened to this country. While about every developed nation has government on their side and looking into what is really going on with these manufacturers and the harm they have and continue to unleash on women all over the world. Our leaders sit and try to get elected. Empty promises and let these manufacturers run all over us the justice system and our health for the almighty $. It is so pathetic it just makes me sick. Where are our leaders when this has obviously ruined so many lives and health conditions. They are happy to take money for political reasons. May as well call it what it is a dam bribe so these companies can continue to unleash there poison on unsuspecting recipients. Oh well I guess some of the States are jumping onboard and going to get money for all the harm done. But think about that?They will win because they know the truth and they have the government to back them. So were does that leave us who have lived with the suffering the loss of work the loss of jobs the loss of homes weve worked for yrs to keep. The loss of intimacy with our significant other or spouse if we are lucky enough to have one who understands and cares enough to stick around with all the havoc that is left to us from these horrible known harmful implants. Everyone will get a payday on the backs of the women who have truly suffered. While the government the media the courts stick their heads in the sand and ignore what this is truly about suffering of women who simply trusted a medical community and the FDA and the government to watch out for us after all we are the taxpayers and people who have paid for these rights.

    • Jane Akre says:

      Unfortunately, many members of Congress are feeding at the same trough – that is money from Big Pharma…..I’ll never forget the hearing where Marsha Blackburn form Tennessee, yelling at Jeff Shuren, shouted ‘My constituents want to see changes…” she said referring to faster device approvals. her constituents were medical device manufacturers, not you, her “human” constituents.

  6. Bonnie S says:

    I hope to have something done I want my mesh out of me going to see doctor Twiss tomarrow.

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