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New Zealand Mesh Survivors Speak to Parliament About Pelvic Mesh Injuries!

Carmel Berry and her family, Auckland New Zealand

Carmel Berry and her family, Auckland, New Zealand

New Zealand petitioners and co -authors Charlotte Korte and Carmel Berry will present in person to the New Zealand Health Select Committee tomorrow concerning pelvic mesh injuries in their country.

Carmel tells Mesh News Desk, 

“Our submission reflects almost all the points made in Elaine and Olives Scotland submission!  We all worked on these independently so it is extremely validating that we have all highlighted all the relevant key issues.”

Here is the notice to Parliament.

http://www.parliament.nz/en-nz/pb/presented/petitions/50DBHOH_PET3197_1/petition-of-carmel-berry-and-charlotte-korte-that-the

New Zealand

New Zealand

 She continues, “The issues are the same here in New Zealand. We have 4 million people and in the past three years nearly 500 people have made claims to our Accident Compensation Corporation (ACC) for treatment injuries relating to mesh surgery complications.  Not all are uro-gynaecological –  perhaps 60%.   We have evidence to suggest that only about 10% of possible claims are ever made to ACC, which would indicate that many patients suffer in silence or are fortunate enough to have private health insurance.”

In New Zealand the ACC pays for medical mishaps, falsely advertised drugs and devices and defective products. Pelvic mesh has been in the headlines for years for costing the country millions of dollars to help mesh-injured women. New Zealand Heather 200

As is the case in Scotland and the U.S., underreporting is a major issue there because it is not mandatory to make a report to Medsafe, New Zealand’s version of our Food and Drug Administration.

Berry says, “I have proof that they generally don’t do it – or if they actually do then Medsafe refer the matter back to the manufacturer to investigate!!”  Berry says, “I have been personally told by a surgeon that it is unnecessary to file a report because ‘it serves no purpose’.”

In other words, mesh makers are in charge of investigating themselves.  The same situation exists in the U.S. If an adverse event is reported to the FDA, it will get back to industry to inquiry about the complaint, whether it be injury or death. Generally the manufacturer will say the problem does not appear to be mesh-related.

Berry says, “I have been personally told by a surgeon that it is unnecessary to file a report because ‘it serves no purpose’.”

Dr. Paul Hutchison, NZ Health Select Committee

Dr. Paul Hutchison, NZ Health Select Committee

Dr. Paul Hutchison is the Chairman of The NZ Health Select Committee, Parliament Buildings, Wellington. Here is his government page.

On February, 14, 2014, the federal court hearing about 70,000 pelvic mesh cases in the U.S. granted Ethicon’s motion to dismiss all claims from New Zealand including loss of consortium for husbands.  Judge Goodwin decided the ACC was an adequate remedy to hear the claims in that country.

Ms. Berry asked me as the editor of Mesh News Desk to submit a letter in support. Here it is:

 ###

To:  Dr. Paul Hutchison, Chairman of The NZ Health Select Committee, Parliament Buildings, Wellington.

Dear Dr. Paul Hutchison,

I applaud you as Chairman of the New Zealand Health Select Committee for opening your ears and eyes to the realities of surgical pelvic mesh and the women’s lives it has left behind.

I am very fond of your country. I had the honor to address an audience at your Parliamentary Building in March 2000 and found a warm, welcoming reception by members of the Green Party, who were very interested in the GMO-Free Zone of Nelson, NZ which was in the headlines at that time, and the assorted parallels in the United States.

It was a very exciting time, especially the plane ride into Wellington!

I am an award winning journalist of more than 30 years experience. I’ve spent a great deal of time writing about medical and legal issues and find the story of pelvic mesh the most horrendous account of corporate insult and injury I’ve ever reported.

The women who will appear before you on Wednesday, July 2, are among the finest, courageous women I’ve had the honor to become acquainted with as internet friends and supporters. Each one of them has had their lives affected by pelvic mesh, made of polypropylene plastic and permanently implanted to hold up different areas of the pelvic region weakened by childbirth.

I am not mesh injured but for three years I’ve been the editor of Mesh News Desk, an online resource for medical devices and specifically pelvic mesh. I thought I would raise the profile on this story which was and continues to remain under the radar.  I’m hoping Mesh News Desk and the thousands of readers have helped raise that profile.

Since 2009, the stories I’ve heard have been horrendous.

Most women had no informed consent from their doctors, in other words, they were not warned what their life might be after a mesh implant. Chronic infections, nerve damage, mesh migration, degradation, mesh cutting them internally, systemic and autoimmune issues, an inability to walk and function is the norm for many women.  Many must curtail their careers and go on disability. Many women are referred to “pain management’ or living on drugs for the remainder of their lives. Some women have ended their lives due to the pain which is likened to ten times childbirth.  Some have died due to the many attempts to have the mesh removed since it is intended to be a permanent implant.

What is the financial cost? We do not know in the U.S. because medical devices are not monitored through a registry, they are not even checked for safety and efficacy with clinical trials before marketing. In short, medical device makers enjoy a free range of entry into the marketplace under the “least burdensome” standard of the U.S. Food and Drug Administration (FDA).  The clinical trials have become the women themselves.

The “least burdensome” standard should mean the least burdensome on the patient not the product manufacturers that have the most to gain. Sadly, that is not true in the U.S.

At the present time, our FDA has asked for public comment to see whether mesh used for pelvic organ prolapse should be reclassified to a high-risk category (Class III) which will require testing prior to marketing.  While our reclassification only covers mesh for pelvic organ prolapse or POP mesh, from my experience, all mesh seems to be causing injuries in a large percentage of women including mesh used as a treatment for stress urinary incontinence, often called “tape.” It is all made of polypropylene and the complications reported by the women are the same.

Only when “adverse events” jumped five-fold did the U.S. FDA issue a public health warning in July 2011 that mesh injures are “not rare” and that the use of mesh should be limited in most cases.

See it here:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

Common sense would dictate that all of these mesh products be removed from the market until we start asking the questions to determine why so many women are having life-altering problems?

Scotland has just shown that common sense.

Scotland Health Secretary Alex Neil, From BBC News

Scotland Health Secretary Alex Neil, From BBC News

Health Secretary Alex Neil stated in June that the number of real mesh injuries is not known and is likely to be ten times the number who have come forward since the reporting of complications is not mandatory, a situation identical to the U.S. He is afraid there are many more mesh-injured women who are suffering in silence, without doctors who recognize the injuries and perhaps without the internet to connect them to others who will understand.

In short, we have an enormous problem and our regulators and no one understands the full scope. The safety nets we assume are there – the federal health regulators, the manufacturers, the medical societies, the doctors, the warnings – all have failed women. The safety nets are broken and the women have fallen through – your wives, mothers, sisters and friends at an enormous cost to society, the women and their families. Bankruptcy is a common outcome and often husband leaves their wives because of a lack of understanding. This truly is a family issue!

Please let’s do the right thing for the people of your country and do not follow in the footsteps of the U.S. where more than 75,000 defective product lawsuits have been filed. There are more cases filed in one court than for any previous defective product including Fen-Phen and Vioxx.

So far product liability lawsuits against manufacturers among them Johnson & Johnson, C.R. Bard, Boston Scientific and American Medical Systems, have revealed the companies knew there would be problems with pelvic mesh, but they marketed the products anyway targeting what they hoped would be a lucrative baby boomer market. The trials continue as manufacturers would rather fight the women in court than help resolve the situation they have created.

This only adds cruelty to insult and injury.

As a professional journalist who has covered this issue since 2009, I ask you to show the common sense that Scotland has shown and stop this practice until the manufacturers are forced to show it can be used safely and until women have full and complete informed consent. There are too many unanswered questions and the injuries are too horrendous to not act immediately.

I am available to answer any questions you may have. Thank you for showing the respect to these women they deserve.

It has been an honor to address you today.

Stay well and best wishes~

Jane Akre, Editor, Mesh Medical Device News Desk

http://meshnewsdesk.com

(904) 613-2828

 

 

24 Comments

  1. Mary pat says:

    Jane, your letter leaves me speechless! Your writing skills are stellar. Thank you so very much. New Zealand, the eyes of the world are watching you. Take heed to Jane’s words! Good luck to Carmel and Charlotte! We are with you in spirit. My prayers are with you! I did not know that Judge Goodwin dismissed NZ cases. That is unbelievable. NZ should outlaw mesh on that basis alone. So Judge Goodwin wants the ACC to mop up the mess that big pharma made? Unbelievable.

  2. msm says:

    Jane, you are my hero! The truth is so clear in you letter and it demonstates the plight of mesh victims well.

    I didn’t find a court order dismissing the cases. Perhaps the judge didn’t let them get that far. He said that he would “bulldoze” the cases through his court. I picture a landfill where the bulldozer operates constantly to cover up the garbage. Ironic comparison?

    Unfortunately, many of our appointed judges are members of a generation that has always devalued women as a whole. They grew up when women stayed home and were kept “barefoot and pregnant”. Women were to serve their masters (husbands) and to be seen but not heard. Many doctors of that generation (and even some younger) use a term to describe some female patients who present with “issues” they can’t resolve. It is “3 F’s” – fat,female,and forty. That’s been the attitude of our medical community for decades and it seems to prevail today. Shameful. Women suffer while they slap each other on the back and make jokes about these difficult women as they stroll along the golf course. The “good ole boy” network lives on.

    Thank you helping us to be heard now. Perhaps these other countries will cast light on just how backward the US is in regulating medical devices and still puts dollars over patients. Our country continues to put the proverbial “fox in charge of the hen house”

    • Jane Akre says:

      Thanks MSM, you are always a welcome contributor. I don’t know who you are but your comments are always right on. Remember -Judge Goodwin said he only wanted women ages 40-60 who represented the middle range of injuries….That leaves out a whole host of severely injured women over the age of 60 and under the age of 40 who are some of the most injured.In a way the desk was stacked early on in my opinion.. It was good to sit there and watch the proceedings. Hope someone else can join me August 19 in WV. Thank you! ~ ja

      • msm says:

        I just love our judicial system. How can a judge make such biased statements?

        What will happen on August 19? I was hoping to follow the Pattison trial against AMS but it has been continued indefinitely. I think he’ll wait until the current offer is accepted or rejected. Heaven forbid a plaintiff should see the results of a bellwether trial in 2325.

      • Kitty says:

        IMMUNE RESPONSE =INFLAMMATION=PAIN ITS ABOUT THE PLASTIC STUPID. msm—you know thats satire–you are smart and I love you. Jane I love you too. thanks so much. When will you be in WVA. I will be going to FLA Aug 14.

        • msm says:

          Up at 3am wanting to claw my skin off again! I found this:

          http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112322/

          Not only is it interesting, but the related articles on the right show some of what they knew as far back as 2005 about mesh degradation, infection,inflammation, etc. In hernia mesh as well as transvaginal mesh.

          I’m really p-o’d about waking up like this and knowing it’s not going to end. I have acquired a TENS unit that I turn up almost to the max setting so it distracts from the itching. I place one pad on the left as low as possible on my abdomin and the other on the inside of my right thigh. It’s better than nothing. How I would love to go one night without this. I really am losing my mind.The worse thing is that there is no end in sight.Seriously considering just having EVERYthing removed. I’m never going to use it in this condition anyway.I fear it still wont solve the problem. I want to SCREAM!

          • msm says:

            Trying to figure out what made everything flare up again like it was a couple of weeks ago. Started Clinamycin cream. Guess what it contains. Propylene glycol. It used in everything from antifreeze to cosmetics and fragrances. The FDA considers it “generally safe”. We know how that goes.I’m no chemist but I know it relsted to polypropylene.

            ” it was also found that PG provoked allergic reactions in patients with eczema and other skin allergies, even in formulations of much less than 50%.”

            In the past few years, I have become highly sensitive to perfumes and to some plastics (non-latex). Sooooo, is the root of my current situation likely due to my body’s reaction

            to propylene and related polymers/derivatives? Is the fact that it has developed immediately after mesh implantation and increased local to the surgical site after partial removal indicative of an allergic reaction? Proof enough for me! Now what!?!

          • Terri says:

            Jane, Your letter is amazing, thank you will never be enough for all you have done and continue to do for mesh injured.

            MSN, I am curious about the itching, I am awoken at night with severe itching on my arms, shoulders and have clawed at my skin because it’s between a severe itch to feeling like a stinging feeling.. the ONLY thing that has helped and “I have tried everything under the sun” is rubbing vicks vapor rub on it. I still have it happen even since mesh removal.

  3. Our history of elevating business/corporations over people has come back to ‘bite us on the bottom’! Even in the USA that purports to be democratic/diverse/equal, profit and $$$ speak louder than evidence-based-medicine. Harmed patients and their advocates have been systematically ‘de-selected’ from speaking at medical conferences where cost and credential barriers were not effective. Unfortunately, these aggressive and powerful medical device corporations are now global and behave as a profitable feral opportunists and prey on all of us. Exposing the true costs to each citizen of this high-cost exploitation of our common funds (tax/government supported benefits like disability, medical and social security programs) is essential. Many thanks to the brave women of NZ and their supporters!

  4. Elaine says:

    Carmel and Charlotte, all the very best for tomorrow, please take comfort knowing that women everywhere are supporting you both.

    I echo all that Jane has said in her excellent letter to Dr Paul Hutchison and I hope that the New Zealand Health Select Committee recognises what Scotland’s Health Minister Alex Neil and Public Petitions Committee did – it is not about the data we have it is about the data that is missing and without accurate data, consent can never be truly informed.

  5. Sandy says:

    So the Patterson case against AMS will not be started in Aug now?!!!! I am so sick of this judge if that is true. I want AMS to go in front of a jury! I want to see how they try to defend themselves. This is just all too much any more!

    • msm says:

      The Saga of the AMS Bellwethers

      Starring Judge Goodwin and a cast of evil defendants and questionable attorneys.

      Extras and supporting roles are played by plaintiffs.

      Seriously though, this is from the court website:

      MDL 2325 Bellwether Trials

      Updated 5/16/14

      By PTO # 172, the remaining bellwether in this MDL, Pattison v. AMS, 2:12-cv-7154, has been continued until further order of the court.

      Updated 5/6/14

      The following cases have been resolved and their trials (scheduled for June 2, 2014, July 7, 2014, and August 19, 2014) cancelled: Serrano 2:12-cv-03719; Jilovec 2:12-cv-05561; Weiler 2:12-cv-05836; Fontes 2:12-cv-02472; and Najor 2:12-cv-6722. The remaining bellwether in this MDL, Pattison v. AMS, 2:12-cv-7154, remains scheduled for August 19, 2014.

      Updated 3/11/14

      The first and second bellwether trials in this MDL have been continued from April 7, 2014 and May 5, 2014 to June 2, 2014 at 8:30 a.m. and July 7, 2014 at 8:30 a.m. The cases will be tried seriatimin the following order: Serrano (2:12-cv-03719); Jilovec(2:12-cv-05561); Weiler(2:12-cv-05836); and Fontes(2:120cv-02472).

      Updated 10/08/13

      The first bellwether trial in this MDL is set for April 7, 2014, at 8:30 a.m. The second bellwether trial is set for May 5, 2014 at 8:30 a.m. In December 2013, the court will determine which bellwether cases (2:12-cv-02472; 2:12-cv-03719, 2:12-cv-05561, 2:12-cv-05836) will be tried on the above dates. “

    • pam says:

      All women are getting sick of this judge and more in some more states where cases have been filed for 2 years . but was put off filing for a time by attorney’s. too long they know women that were damaged severely, no funds to get to doctors soon enough ,have no hope, and for over 5 years still on their sorry merry go round of doctors lying.

      Who do we get to back us in truth, when chemical companies know they have lying support that lied in the beginning , FDA, doctors, nurses, investors, politicians, and more, boards of medical profession, health run states, gov , reps, and lobbist for these all made money, from these to keep it covered up for so long.THE DOCTORS TYHAT DID MINE KNEW MINE WOULD NOT,COULD NOT BE REMOVED.EVER. 1 OF THE DOCTOR’S UROLOGIST MOVES AROUND DOES NOT STAY LONG IN AN AREA DOES MESH AND MOVES,WHILE COLLEAGUES HERE LIE FOR HIM. WHEN I ASKED WHERE HE HAD MOVED TO, 4 MONTHS AFTER MY MESH IMPLANT, (also did not know about mesh law suits, I knew something was wrong, infections , pain and more not ever before) I WAS TOLD HE LEFT THE STATE FIRST, THEN i said I was told he hadn’t ,the nurse spoke to the dr she said coming down the hall that also was in mesh surgery, calling him by name, she asked where he was, (sarcastically) I HEARD HIM SAY HE MOVED WITH HIS HORSES. My anger exploded, after they got big money, this was what I got no mercy, That is what I have got 98% of the time since then,I say, they cared less about destroying my life, and getting rich for all and lying., NOW WHAT COURTS ARE DOING, NOI END TO PAIN , INFECTION, NO HOPE. THEY NEED TO FINISH THE JOB THEY STARTED WITH ME, THIS iS AS SADISTIC AS PEOPLE HAVE EVER BEEN IN HISTORY OF MAN KIND. except for hitler, saddam and more dictators. I do not want to die in this pain, fighting infections, and being their guinea pig for medical . research. I deserve to be put to sleep peacefully, not to wake up again, not to die for their continued lies if this is their way of entertaINMENT FOR THE RICH AND POWERFUL, I do not want to die this way. even an animal in pain can be put to sleep for about 45.00, bring one of the lying scum low life to me, I WILL THROW SOME MORE BLOOD MONEY IN THEIR FACE, 45.00 TO STOP WHAT I KNOW WON’T STOP WITH DOCTORS AND LIES. . WE HAVE SOME SORRY PEOPLE IN POWER THAT ABUSE THEIR POSITIONS FOR MONEY AND POWER. I WANT TO DIE, MY CHOICE, MERCY, NO MORE, I deserve better than what animals get in pain, 45.00 to be put to sleep to stop my heart .no more pain and lies. This was done most evil by evil people in cover up and lies.

      • msm says:

        Don’t give up, Pam. That’s what they want. That’s how they win. Hang in awhile longer.

      • Kitty says:

        Pam I just read your post–You are amazing the way you go after these people. Pam–please stay strong.,–I have learned so much from you. Justice will prevail.

  6. Sandy says:

    I also read that it is believed that AMS will try to do a global settlement! What! Sorry but every person every case is different. I will not be included in a global settlement, that’s like having a Judas goat in front leading the rest to the kill. How long do we have to wait? I have heard they will wait until you have to agree just so you have some kind of money. What a crock!! I am tired of all of this. I use to pray for Judge Goodwin. I think he needs a come to Jesus moment!!!!

  7. msm says:

    Oh my goodness! AMS is starting 2 studies. One study named “Embrace” and the other named “Harmony”. (Anyone else feel sick at these names? How dare they!)

    The studies will involve POP mesh to be implanted in a 494 patients in each study. (Magic number expected to yield magical results?)

    They are “post-market surveillance studies”. In other words, the 988 women will be human guinea pigs and AMS continues to sell the products in the meantime. The studies will involve a two-year enrollment period and continue thereafter for three years. They claim this is “substantially longer” than other trials involving the devices. If I’m not mistaken, there are longer studies published through the National Institute of Health.

    We all know that the effects from mesh can smolder for years depending on a variety of factors before erupting into devastating injuries, pain and illness. But, three years is about the average statute of limitations so I guess they figure that will prevent the filing of suits in the future.

    It is a risk vs. benefits study so if 450 women survive 3 years with mesh and 49 don’t, that’s just under 10% failure (magical numbers). How many of those will drop out for “unrelated reasons” as determined by docs employed/funded by AMS. Will that reduce it to an “acceptable” percentage of failures?

    There will be no independent studies in a lab testing forces and pressures on cadaver tissue. No bio-mechanical simulations, no real testing. Just put in the mesh and see what happens. They have already conducted those studies on all of us! AND THE FDA IS ALLOWING IT ! No independent studies at all. They are directed and funded by AMS. The fox is still in control of the hen house.

    http://www.consumerinjurylawyers.com/legal-news/ams-launches-first-of-two-transvaginal-mesh-safety-studies-ordered-by-fda

    • stopmeshimplants says:

      It is interesting that the studies will conclude in 5 years. I began having some symptoms from the mesh 5 years after it was implanted. The more serious complications and pain issues became much more obvious after 6 years. I am assuming none of these women will be informed about the real issues of mesh or they would not be signing up for the hell we are living every single day! It breaks my heart when I hear women say they had their mesh implant surgery a year ago and they are just fine. I pray they do not have any complications but I know for a fact that many will suffer and it is just a matter of time.

      • msm says:

        The more I thought about these studies last night, the madder I got. This HAS to be illegal! They know that POP mess complications “are not rare”. The FDA clearly states this. So AMS is going to be allowed to put these women in danger of disasterous, life-altering injuries in order to do what? Gain permission to sell the product? No. They’re already doing that and will continue to do so.

        I want to read the consent form these women sign. If it is to be a double-blind study (the only way to truly evaluate this), none of these women will know whether or not they received mesh. If the sling will come from the patient’s own tissue, a second incision is required to harvest the graft so the patient will obviously know what they got. This can skew the results. Will the subjects of the study be offered compensation? Both groups? What method will be used to indicate a positive result or a failure? The same surgeon will the same AMS traing will be doing all of the implants so there’s an important variable. The same is true with the native tissue which requires

        more skill.

        There are already subjects available. According to mesh supporters, there are tens of thousands of successful mesh cases in the U.S. Why aren’t they used. The aren’t as many with native tissue but there are enough. No further harm will be done. That’s what has been missing in other studies. Women are going to know what material they received and that will affect their subjective response. So there will be no true control group. How will these new “studies” provide any new information worth risking injury to more women?

        If I’m wrong, tell me. Let’s discuss these studies. If AMS is only trying to satisfy FDA’s request and has no concern about harming more women, then it needs to be stopped! Who is looking over the shoulder of AMS? The FDA (whose reputation would be severely injured if a study such as this determined that they cleared a dangerous product). Who is looking over the shoulder of the FDA on this study? Does Health and Human Services even know that this going on? Who actually approved this study. Not the agency – the PERSON. That is who is responsible for further injuries as a result of this study.

        Let’s discuss this. How can we get the FDA in on the discussion? How about a hearing before Congress involving AMS, the FDA, the surgeons involved, and current victims plus women who have already signed up. This needs to be debated on a public forum. It needs to be documented that it was investigated and approved as a valid study that poses no known harm to human subjects.If Dr. Oz can be grilled by Congress over product promotion, certainly a hearing is warranted it this case.

        • msm says:

          This reminds me of the studies conducted on mentally “defective” subjects in insane asylms in the 50’s and 60’s. It reminds me of the involuntary sterilization of “retarded” people decades ago. These studies were not made public for decades. Well, the AMS studies are public now and can be stopped now.

        • Mary pat says:

          Msm – you are so right! We have to do something!

    • Kitty says:

      The names of the mesh are repulsive.

  8. pam says:

    to live on anti biotics and pain meds for the rest of my life, I just can’t see.They got mad as hell, when I got off all meds before mesh, anti depressants, , I WAS TOLD i COULD NOT GET COUNSELING FOR TRAUMA I WAS GOING THROUGH BEFORE MESH ,UNLESS I WOULD TAKE THEIR DAMN DRUGS. i told the woman to take the drugs and ram them up her butt, and walked out. Now this, back on drugs,for pain. damn them!

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