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Womens Health Issues

SURGICAL MESH PETITION
The problems associated with the use of surgical mesh have been the subject of articles in previous issues of the AWHC newsletter. (1) When the AWHC first became aware of the issue we wrote to Medsafe and the Health & Disability Commissioner about the totally inadequate and unsafe processes for approving the use of the surgical mesh and other medical devices in New Zealand. The response from Medsafe was unsatisfactory and not in the least reassuring, and the HDC refused our request that he undertake a thorough investigation into this issue.
 
The AWHC also wrote to PHARMAC which is in the process of taking over responsibility for the purchase of all medical devices. This resulted in two AWHC members attending a meeting of PHARMAC’s consumer advisory group in March last year via teleconference. It was clear that it was going to be some years before PHARMAC is able to do anything about the kinds of medical devices that the Council is concerned about. They have started assuming responsibility for medical devices with the purchase of dressings and other wound care products. PHARMAC’s control of surgical mesh devices is a long way down the road.  
 
Two years ago Carmel Berry, one very courageous woman, set up a website and Facebook support group as a way of reaching out to other women who have been seriously harmed by the surgical mesh and were seeking information and support. (2) Injured with surgical mesh in September 2004 Carmel’s report about the mesh is the earliest dated adverse event reported to Medsafe, the Ministry of Health agency charged with ensuring that the New Zealand public is protected from unsafe medicines and medical devices.
 
Medsafe
Medsafe has now received 57 adverse event reports, yet in the three year period ending 31 March 2013 the Accident Compensation Corporation (ACC) received 421 claims and paid out over $2 million in treatment, rehabilitation and compensation for treatment injuries associated with mesh.
 
In 2008 Medsafe conducted its own investigation into the use of this device and concluded that the problems were due to the lack of adequate training into how to insert the mesh, rather than it being an unsafe product. How convenient.
 
Over 50,000 law suits have been filed in the USA specifically about pelvic organ mesh products. Some New Zealand women have joined the numbers in what is known as a Multi District Litigation which is similar to a class action.
 
Despite the horrific amount of damage this device has caused, and the costs involved in terms of human suffering, and ACC and private insurance pay-outs, the New Zealand government agencies have done absolutely nothing to stop the ongoing carnage.
 
Carmel has determinedly kept the issue in the public eye via her website, two appearances on TV3, and at the end of May she and Charlotte Korte, a fellow advocate, were interviewed on National Radio’s Nine to Noon programme after they petitioned the Health Select Committee for an independent inquiry into the use of surgical mesh in New Zealand. (3)
 
Carmel and Charlotte are not alone in having suffered severe ongoing complications after having the mesh implanted. The two women outlined what had happened to them on the Nine to Noon programme. Neither of them was made aware of the risks and side effects of having a mesh implant, and neither was told that it was extremely difficult or impossible to be removed.
 
When Carmel first complained about her experience with the mesh back in 2004 she was told she was the only one, and was led to believe that no-one else in the world had had the problems she reported. She was referred to a pain clinic, to a psychologist and then a psychiatrist. Her claim for ‘medical misadventure’ to ACC was declined. It took nearly two years before a different surgeon acknowledged that it was a ‘known complication’ of mesh. Carmel told the AWHC “I knew the pain was very real, and it started on the day of the implant surgery. I just couldn’t prove the link to ACC.” She has had several revision surgeries but continues to live with chronic pain.
 
When Carmel began to read about ‘transvaginal mesh’ (TVM) lawsuits in the US she made contact with the first woman who had received a jury verdict against a mesh manufacturer. Validated at last Carmel realised that she was amongst thousands of women worldwide that were experiencing the same complications after a mesh implant.
 
Charlotte had her mesh implanted to treat bowel prolapse in 2010, and suffered extreme pain and could hardly walk. Her experience and investigations led to her discovering that there were many others, men as well as women, who had been severely harmed by surgical mesh.
 
More recently, another Auckland woman who underwent surgery in October last year to repair a vaginal and rectal floor prolapse was told by her surgeon that he would not be using mesh as it wasn’t being used any more. After weeks of unrelenting pain following the surgery, the woman found out that he had in fact used mesh. She then set about laying a complaint with the Health & Disability Commissioner who has now received at least seven complaints in the last two years. (4)
 
The petition
Having failed to get any government agencies to take action, Carmel and Charlotte have refused to accept defeat and have presented a petition to the Health Select Committee calling for a full independent inquiry into the use of surgical mesh in New Zealand.
 
It is not just gynaecological mesh causing problems,” Carmel told us. “Of the 421 ACC claims, 189 are related to hernia mesh complications. People don’t claim for treatment injuries on a whim, these are patients that are at their wits end having waited a reasonable time for normal healing, and being told that their symptoms would “settle with time.” Obviously they didn’t.”
 
The two women acknowledge that there are a high number of women having complications after pelvic floor repairs, or stress urinary incontinence procedures with mesh. They are not alone as they have been supported by   Dr Hanifa Koya, a gynaecologist at Wellington’s Wakefield Hospital.
 
Dr Koya has removed more than 50 of these surgical implants. She says it is not only the training that is the problem, it is also the competence and supervision of the use of the different types of mesh. “NZ has very poor regulations, and the manufacturers and distributors have discovered there is a very lucrative market for their products here, and New Zealand is a dumping ground for these devices,” she said whilst talking on National’s Nine to Noon programme. Dr Koya was very clear and extremely eloquent about the issues surrounding the use of the various kinds of mesh. She was also very clear about the fact that women are not being adequately informed prior to having a mesh implant.
 
Dr Koya told Nine to Noon: “Medsafe cannot justify anything because Medsafe does not listen. It did not even listen to ACC at the outset. It has never listened to any of us. So doctors usually don’t want to write to Medsafe. There is total under reporting. Most doctors are protecting each other and thinking we should not even fill out the surgical accident form, so they are not doing it.” (3)    
 
Medsafe, ACC and the HDC all need to work together, and this is what will be presented to the Health Select Committee, she said. The AWHC agrees, but getting them to do this is a Herculean undertaking.
 
Here is where it gets murky
Also appearing on the same Nine to Noon programme was Associate Professor Malcolm Frazer. He is the urogynaecology spokesperson for the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), and the immediate past vice chair of the Urogynaecological Society of Australasia.
 
He was less forthcoming on radio than he has been in print.
 
The professor wrote an article on the transvaginal mesh (TVM) for RANZCOG’s O&G magazine back in 2012. The declaration of interest at the end of the article states:
“Malcolm Frazer holds contracts as a preceptor for Johnson & Johnson Gynecare as well as American Medical Systems mesh products for which he receives a fee. He has received financial support from both organisations to attend scientific conferences as an invited lecturer.” (5)
 
The latest issue of O&G magazine features another article by Malcolm Frazer which was co-authored by Dr J Oliver Daly. This article outlines some of the events around the use of the transvaginal mesh. It describes the decline in the use as well as the commercial availability of TVM products around the time that the FDA altered the risk classification of TVM from a low-risk device to a high-risk device. (6)
 
“If this was not enough, the medico-legal industry is in a feeding frenzy … there are said to be hundreds of class actions currently in progress, with several commencing in Australia,” the authors state.
 
“Unsurprisingly, patient advocacy groups have been vocal in their condemnation of mesh products. This has become a deeply emotional and personal issue for some, which is understandable given the reported morbidity caused in particular cases.”

Constant pain does tend to make people emotional, especially when nobody told them prior to the surgery that this is a not uncommon outcome of having a mesh implant, and removal is almost impossible.
 
The lessons learned
The concluding section of the article describes “the need to recognise the lessons offered by the mesh revolution of the last decade:

Unchecked commercial interest and clinician zeal accelerates the adoption of medical products at a faster rate than the naturally conservative evolution of medical practice would normally allow. This increases the risk of exposing patients to unknown harms that may exceed any perceived benefits.

Before adopting a new product or technique, ensure level-1 evidence is available for its overall benefit. Failing this, use of such products should only be under the auspices of a well-designed study with long-term monitoring of important outcomes. This recommendation should not be optional and national regulatory bodies need to be more critical and vigilant in this regard.”
 
This was precisely what Professor Quinlivan pointed out during her presentation at the National Women’s Health Annual Clinical Report day several years ago. (1)
 
“If we look back critically and honestly at the introduction of TVM, we can perhaps admit to ourselves that we were too easily persuaded about mesh benefit when the evidence was clearly incomplete and sadly remains so to this day. When the next innovation emerges we can at least ensure we and our patients are better prepared to meet and benefit from it.” (6)
 
If the doctors can’t see the wood for the trees – and experience shows us that they usually can’t when it comes to the latest lucrative “revolution” in health – then it is up to Medsafe and the Ministry of Health and the Health & Disability Commissioner and ACC to take prompt and protective action.  
 
Under the current system patients are actually being treated as guinea pigs. Drugs and medical devices continue to be unleashed on an unsuspecting public without adequate testing and post-marketing surveillance and monitoring. The transvaginal mesh is just one example of this. The victims of “the mesh revolution of the last decade” deserve far more than a Health Select Committee hearing.
 
This scandalous saga must be the catalyst for significant and immediate change that includes a far greater level of oversight and regulation of medical devices, more protection for patients, and better compensation
.
 
References

http://www.womenshealthcouncil.org.nz/Features/Womens+Health+Issues.html
http://meshdownunder.co.nz/
http://www.radionz.co.nz/national/programmes/ninetonoon/20140522
http://www.3news.co.nz/Surgeon-used-mesh-without-womans-consent/tabid/423/articleID/342298/Default.aspx
Malcolm Frazer. “Transvaginal mesh: How should we interpret the evidence available for the use of transvaginal mesh in prolapse surgery?” O&G Magazine Volume 14 No 2 Winter 2012.
Malcolm Frazer & Dr J Oliver Daly. “Decline and fall: Lessons learned from the troubled history of transvaginal mesh kits.” O&G Magazine Volume 16 No 1 Autumn 2014. 


June 2014






PROBLEMS WITH SURGICAL MESH COST MILLIONS

The October 2011 issue of the AWHC newsletter featured an article on the use of the gynaecological mesh and the serious complications that many women have experienced as a consequence of having had this medical device implanted. After placing the article on the AWHC’s website, the Council has been contacted by several women with horrific stories of what the mesh has done to them. Over the past month a number of articles have also appeared in the NZ Herald with further examples of the devastating problems caused by mesh implants in both men and women. (1) (2) (3)

The AWHC’s October 2011 article about this medical device outlined how the mesh was able to be marketed and used without having to undergo clinical trials either in the USA or in New Zealand. It also stated that “New Zealand has Medsafe to ensure that the New Zealand public is protected from unsafe medicines and medical devices.”

It appears that Medsafe has been less than successful in protecting the public when it comes to surgical meshes – as well as hip implants and other medical devices. According to the articles in the Herald there have been 600 claims to the Accident Compensation Corporation (ACC) involving meshes since 2008. Only 389 have been accepted, with ACC paying out $3.1 million in treatment and compensation to people with post-surgical complications. (1) (2) 

These complications include erosion through the vaginal epithelium, infections, severe pain, urinary problems, recurrence and/or incontinence, bowel, bladder and blood vessel perforation during insertion, and the requirement for additional surgical procedures. The US Food and Drug Administration (FDA) revealed that women have died from complications after mesh surgery for prolapsed pelvic organs. In her presentation in Auckland in 2011 Professor Julie Quinlivan described the horrendous and permanent disfigurement involved in many of the attempts to remove the gynaecological mesh. 

The FDA began issuing safety warnings regarding the use of the mesh in late 2008. In the US there are now thousands of lawsuits underway. In New Zealand there have been complaints to the Health and Disability Commissioner (HDC) although it is not known if any have been successful. One woman told the Herald that her complaint had been dismissed. (1)

Despite the increasing controversy and groundswell of complaints, the mesh is still being implanted in hundreds of New Zealanders. Women report not being warned about possible complications and risks, and there is absolutely no information on the Medsafe website about the mesh.

But one brave woman has established her own website –
http://meshdownunder.co.nz/#

References
1. http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10837440
2. http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10838873
3. http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10841865


November 2012


The Gynaecological Mesh

The use of mesh to surgically repair uterine and vaginal wall prolapse has been around for more than a decade. It is now a widely-used procedure for pelvic organ prolapse (POP) and for the treatment of stress urinary incontinence.

Pelvic organ prolapse is a common condition that affects many thousands of women worldwide, and surgery rates to correct prolapse have been steadily increasing throughout the western world.

There are two types of mesh used in surgery: biological and synthetic. While the use of mesh quickly became the treatment of choice, there is now considerable anxiety and uncertainty about the long-term outcome of these interventions. Some of the currently available mesh materials and techniques using mesh in gynaecological prolapse surgery have been found to be associated with significant morbidity. (1)

At the National Women’s Clinical Report day held on 16 August 2011 guest speaker Professor Julie Quinlivan referred to the problems associated with the use of mesh. During her PowerPoint presentation she posed the question: “Should you be using vaginal mesh outside of a trial setting?” and went on to highlight the concerns that have been raised in medical journals and by the US Food & Drug Administration (FDA). (2)

Prompted by increasing numbers of adverse reports the FDA issued a safety advisory in October 2008 regarding the use of mesh. A new FDA safety advisory released in July 2011 stated that there are serious concerns over the use of vaginal mesh for the treatment of vaginal prolapse and incontinence.

The FDA reported that the occurrence of serious complications with the use of vaginal mesh is not rare, and mesh use is not proven to provide improved outcomes when compared with native tissue repairs. The FDA-reported complications associated with vaginal mesh include erosion through the vaginal epithelium, infection, pain, urinary problems, recurrence and/or incontinence, bowel, bladder and blood vessel perforation during insertion, and the requirement for additional surgical procedures.

A New Zealand example of what can happen with the use of vaginal mesh can be found on the ACC website in a treatment injury case study that describes the horrific injuries sustained by “Jane, a 48-year-old mother of three.” (3)

In her presentation to those attending the NWH Annual Clinical Report day Professor Quinlivan outlined how medical devices are cleared by the FDA and how some are able to avoid having to undergo clinical trials before they are put on the market.

Medical devices are classified thus:
• Class 1 (low risk)
• Class 2 (Mesh, contact lens solution, external hearing aid, etc)
• Class 3 (high risk)

The process for class 2 has two options. The first option is used by the pharmaceutical industry when they want to market their device as having FDA approval. To obtain FDA approval clinical trials are required, making this option more expensive.

The second option is much cheaper and is referred to as the 510k option. It involves a payment of $US510,000 which clears the product for market without the requirement for clinical trials, but it means that the device does not have the status of having been approved by the FDA and it cannot be marketed as having FDA approval.

When the device is one that is similar to other medical devices already on the market, eg hip joint replacements, the 510k option is used.

The manufacturers of medical devices are of course highly motivated to classify any new device as Class 2 and get them quickly on to the market, usually with a massive advertising campaign claiming that it is much better than anything else currently available.

Professor Quinlivan reported that 113 devices were either withdrawn from the market or recalled between 2005 and 2009, and 71% of them were Class 2 “510k” devices! (2)

New Zealand has Medsafe to ensure that the New Zealand public is protected from unsafe medicines and medical devices. Medsafe is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand. (4)

For a medical device to be legally supplied in New Zealand it is required to be notified to a database operated by the Ministry of Health. This database, known as the Web Assisted Notification of Devices (WAND) is used to collect information about the range of medical devices supplied in New Zealand, the manufacturers that produced them, and the individuals or organisations responsible for supplying them.

While the supply of medicines and medical devices in New Zealand is controlled under the Medicines Act 1981, the Act does not include provision for any pre-market assessment or approval system for medical devices. Neither is there a requirement for medical devices to be approved by any overseas medical device regulator before they can be supplied here, says Medsafe senior advisor Robert Jelas. New Zealand relies on medical device regulators in countries with “robust pre-market approval schemes” such as Canada, Australia and the European Union.

This means that in New Zealand medical devices can be used on the unsuspecting public without having undergone any clinical trials.

References
1. Royal College of Obstetricians and Gynaecologists. “The Use of Mesh in Gynaecological Surgery.” Scientific Advisory Committee Opinion Paper 19. April 2010.
2. http://nationalwomenshealth.adhb.govt.nz/language/en-nz/health-professionals/general. Part 2.
3. www.acc.co.nz/PRD_EXT_CSMP/groups/external_providers/documents/reference_tools/prd_ctrb094968.pdf
4. www.medsafe.govt.nz/other/about.asp#w
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