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Mesh Down Under: Litigation in New Zealand Heats Up

Clare Berry- Mesh Down Under

Carmel Berry- Mesh Down Under

Mesh Down Under by CARMEL BERRY

5 April 2014

With the plethora of on-line petitions making their way onto social networking pages it seems astonishing that Charlotte Korte and I – two everyday Kiwi women have managed to have our petition accepted by the House of Representatives and passed to the Health Select Committee.

We took advice on the best way to approach the issue.  It was clear to us that we needed to be professional and reasonable and to give the Health Select Committee a wide scope for an inquiry.

By opening the scope as wide as possible it is harder for the Committee to ignore or decline the petition.

New figures released in New Zealand recently highlighted the huge disparity with the low number of Medsafe reports of adverse events (the same as the FDA’s MAUDE database) and the year-on-year increasing number of people claiming financial compensation from our country’s Accident Compensation Corporation. (ACC)

In a breakdown of the statistics we can see that surgical mesh complications are not uniquely a female or urogynaecological  problem.  The highest number of claims received in relation to mesh was for hernia injuries. Just slightly lower was the number of vaginal mesh injuries, followed by colorectal mesh injuries.

Of all the claims made, approximately one out of three were from men.

New Zealand’s Channel 3 news approached Medsafe to comment on the petition.  The ‘off the shelf’ response was that they were “continuing to monitor the situation”.

We simply have to question how they can possibly be monitoring the situation with only 19 adverse event reports to go by.

It is a fact that Medsafe had no web-based information, comments or links about the safety of Surgical Mesh until 14 January 2013 – and that came about following a lot of pressure from Mesh Down Under. (See Facebook group here).

From 2010 till 2013 there has been a 65% increase in the number of surgical mesh claims made to ACC – with the cumulative costs to New Zealand taxpayers growing exponentially.

And if the number of problems being recognised internationally is anything to go by – this is only the tip of the iceberg.

Medsafe also state “while they continue to monitor adverse event reports relating to the use of surgical mesh implants, our legislation only permits us to monitor issues once a medical device is in use and take action if a medical device proves to be unsafe.”

Part of the petition is to bring about change so that adverse event reporting is made to be mandatory.

The NZ  Medicines Act 1981 states that “If the Director-General has reason to believe that any medical device may be unsafe, he may, by notice in writing to the importer or manufacturer in New Zealand, state the reasons for his belief, and require the importer or manufacturer to satisfy him of the safety of that medical device.”

Without accurate reporting and data collection one has to question how he can possibly do his job effectively.

Derek Fitzgerald, Manager, Compliance Management, Medsafe Clinical Leadership Protection & Regulation Ministry of Health told me “With respect to the approval of medical devices for the New Zealand market – there is no pre-market approval process.  Our New Zealand legislation (Medicines Act 1981) does not require medical devices to go through an approval process before being placed on the market.

“Medsafe does not, therefore, assess information about a device, review clinical trials, review documentation and warnings or perform any other assessment before a medical device can be used.  The only requirement is that the sponsor (usually the manufacturer or the importer) must list it electronically on a database (operated by Medsafe) within 30 days of it being first supplied (this is not an assessment or approval).  This is unlike other parts of the world (Australia, North America and Europe) where some form of assessment is required before certain medical devices can be marketed. ”

In other words, No testing or clinical trials were required before these surgical mesh products were introduced into New Zealand!

And even if clinical trials or safety studies were required I believe it unlikely that the data exists.  In the April 2012 issue of the International Urogynecology Journal an article concluded that over the past decade, a huge number of new implants and ancillary devices have been introduced to the market. Most of these have become clinically available with little or no clinical data or research.

Of interest in September 2012 NZ Herald reporter Chloe Johnson interviewed Professor Ajay Rane who is vice-president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists. He said warnings from the US Food and Drug Administration (FDA) last year related only to the use of mesh in prolapsed pelvic organs and tissue. There were no official concerns over the use of mesh for hernias.

Rane said the mesh was not dangerous and the college supported its use. “If it was dangerous the FDA would have withdrawn it,” he said.

New Zealand System of Injury Compensation

Prolene mesh

Prolene mesh

So let’s look at the New Zealand system: established in 1974, mesh-injured patients can apply to receive government-funded compensation through the Accident Compensation Corporation (ACC).

In exchange, patients are required by law to give up the right to sue in New Zealand for damages arising out of any personal injury covered by the accident compensation legislation.

This prohibition applies even when a person chooses not to lodge a claim or is not entitled to compensation.

There have been many amendments to ACC law, of significance in 2005 where they replaced the term ‘medical misadventure’ with the term ‘treatment injury’.

This reform meant that ACC (or the client) no longer had to prove that a health professional had made an error, only that they had been injured during the course of treatment.

Approximately 30% of claims made to ACC for mesh-related injuries are declined.  21% are declined because the patient presents with no physical signs of injury.  This means that chronic pain alone is not covered.

We intend to have this issue addressed with the inquiry in an effort to change the criteria to reflect the most common complaint of mesh related complications – pain.

There are several other agenda items that we have sent to the Committee and I will write more about it in the coming weeks as we go through this ‘due process’.

 

 

One Comment

  1. This recitation of the New Zealand experience with surgical mesh is so very similar to the loopholes the implanted medical device injury enjoys in the U.S. The FDA clearance process requires a predicate device with clinical trial, but a loose interpretation of “substantially equivalent” that allows many iterations of a device over the years that have not been human tested. Adverse event reporting is fragmented and participation by medical providers is voluntary unless there is a fatality. The harmed patient is required to go to federal court for justice and barriers include tort reform damage caps and costly ‘discovery’ and expert witness requirements. Settlements are often negotiated with gag orders. The FDA is funded by medical device industry ‘user fees’ . ( You could not design a better certainty for conflict-of-interest! ) Savvy consumers who when “needing” an elective implant ask “What is the warranty on this surgical mesh, (hip, knee, etc.) and what are less invasive/permanent alternatives?” may prompt a revolution!

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