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.
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.
“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
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.”
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.
“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.
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. ##