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.
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.
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 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:
“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.
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