Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Sunday, August 23, 2015

New Zealand: Stryker strikes out with FAILED metal hips!


One woman's toxic surgery ordeal

9:55 AM Saturday Aug 22, 2015
David Fisher is a senior reporter for the NZ Herald.
Lynne McKay had both her hips replaced in 2007 with metal implants.
• The implants failed, causing her intense physical pain and violent mood swings.
• When the implants were eventually removed in 2012, a company representative attended the surgery and took photographs.
• A Health and Disability Commission investigation found no fault with McKay's medical care.
• About half the 5,000 metal hip implants given to New Zealanders have proved defective in some way but follow-up is left to the companies and surgeons involved.
"When I licked my lips I could taste metal," says Lynne McKay, who has had six hip replacements in six years. "There was a metallic film on top of the water in the toilet and I was having to clean it every day. I was peeing [metal] ions."
The new life she expected to come with her double hip replacement in 2007 never arrived. Instead came fears of madness and near-constant misery, which only partly abated when the metal hips were removed after being recalled as faulty in 2012.

The time in between was awful. Almost immediately, there was pain. Inside McKay's body, the connection between the ball and the cup created a "grinding" which produced an "ionic soup".
When McKay walked, she heard "click, click" as the ball ground against the edge of the cup. Unknown to her, there were "actual chips coming off the back. And the [metallic] dust". The joints - when they eventually came out - were abraded, ground and scratched.
Her body was "trying desperately to sort it out" by collecting the metal fragments into tumours around the hip area. "There was a tumour the size of a small hen's egg."
Then came other changes. "About two years after having my hips done, in hindsight, I started to experience toxicity."
McKay had yellow, green and blue curtains, which first dulled, and then lost their yellow tones. At first she thought the curtains were fading, then she realised she was losing her ability to see colours. She started to experience hearing loss and tinnitus, and had frequent unexplained rashes.
McKay thought she was losing her mind. "I couldn't hold a thought. I was always in tears. My words weren't coming out right. I was cutting my nose off with all my friends. I thought I had Alzheimer's. I really thought I was losing the plot."
With her life falling apart, McKay tried harder to keep it together. She walked the streets for hours doing letterbox drops to build a massage business, which was suffering. "I was desperate for work. I was begging people. I really lowered my professional life. I was fighting for my life on a lot of different levels without knowing what was going on."
Understanding arrived in 2012, when the Stryker Mitch THR (total hip replacement) System was subject to a recall notice. A blood test showed McKay had high levels of chromium and cobalt in her bloodstream. Normal levels are between zero and 20 microscopic nanomoles per litre. McKay had 326 nmol/l. Cobalt was also high - safe was 0-16 nmol/l but she had a 378 nmol/l reading.
Mackay believes her metal hips poisoned her. It's a belief shared by other implant patients with elevated cobalt and chromium readings. The British Medical Journal raised this in 2012 in a story on regulatory failure around metal-on-metal implants, saying the ongoing uncertainty around the impact of the metal ions would never be tolerated in drug regulation.
There is still argument in medical circles as to whether the high levels have any effect, even though concerns have been raised for more than 40 years. The official position is that the long-term effects are unknown.
For McKay, not knowing is unacceptable. She says efforts should be made to find out the effects of metal ions in her body, rather than adopting a "wait and see" approach.
But then, she's long lost faith that the medical system will listen to her.
Back when she was a believer, the former registered nurse anticipated life-changing results from the metal hips surgeon Rocco Pitto put into her body during surgery at Middlemore hospital in 2007.
She was 50 at the time and life had become increasingly painful. "I got to a place where I could only walk to the letterbox with two walking sticks."
Diagnosed with dysplasia, a condition in which abnormal growths form at the joints, she had both hips replaced in March 2007. In hip replacements, the femur is removed for an artificial replacement; in McKay's case, the metal stem was attached to a metal ball that moved inside a metal cup, mimicking the worn-out original.
The metal hip replacements were enjoying a resurgence in surgical popularity, with the belief they would be more durable and last longer than ceramic or plastic alternatives. But by 2010, concerns were raised widely about the safety of metal-on-metal with the recall of a DePuy-branded device.
In April 2012, the recall notice for McKay's device went out.
The Lancet medical journal raised the alarm with a study showing 6.2 per cent of implants had to be replaced five years after being put in. It compared to 2.3 per cent for ceramic-on-ceramic implants and 1.7 per cent for metal-on-plastic types. British figures showed McKay's implants - the Stryker Mitch THR System with an Accolade femoral stem - had a revision rate of 8.8 per cent over four years. The alert to surgeons in Britain included advice that they screen patients annually for the presence of chromium and cobalt in the body.
In New Zealand, documents released under the Official Information Act show Stryker initially wanted to class the notice as a "safety alert", saying it no longer distributed the device in New Zealand. Medsafe wrote back to say it did not agree and insisted the notice be classified as the more serious "hazard alert", effectively matching the British response.
The letter announcing the recall on the Mitch head went out to surgeons on April 13 2012. Under the New Zealand system, the state has no role to play in contacting surgeons.
Instead, the regulator - Medsafe - asks the medical device company to make contact with the surgeons to whom it sold the implants and for them to notify patients. The OIA papers show Stryker didn't hear back from all surgeons (who it calls "customers" in emails to Medsafe) who used the device until three months later on July 6 2012.
SCCZEN_110615NZHJOMCKAY01_620x310.jpg
McKay believes her metal hips poisoned her. Photo / Jason Oxenham
In McKay's case, Pitto's recalls were handled through Middlemore Hospital. Furious at the impact on her life over the past five years, she says she developed strong feelings of anger and frustration towards Stryker.
She wanted to sue. She wanted justice: "I had asked for medical photographs to record the damage to my hip. The kids had started to tell me I needed to collect things for class action."
She wanted to get Stryker into court and sue the company for the grief it had caused.
When McKay went into surgery in July 2012, she says she had no knowledge of - and did not consent to - a Stryker representative being among the gowned and masked surgical team preparing to operate. She says she objected strongly and was even more upset on waking after surgery to see on her notes: "The representative of Stryker Medical was attending today's surgery and also took some photos."
McKay: "That's when I lost it. Those photos were my evidence of what had happened to me." The faulty parts were also removed.
Though Pitto later told a Health and Disability Commission investigation he did discuss consent with Ms McKay, the Counties-Manukau District Health Board has said he didn't need her permission to have a Stryker representative in surgery and didn't ask her. The board also told the Herald - and Ms McKay says it's the first she's heard - that the Stryker photographs were not of the surgery but only of the faulty parts, removed from her body. She can't see the images to assure herself - the board says Stryker has deleted the photographs.
There are no signed consent forms showing permission was granted for either Stryker's presence, or the company's decision to take photographs or for the removal of the faulty parts. In all those cases, the health board says no consent was needed. It says consent is not required when someone is part of a surgical team.
For McKay, it felt as if the system was aligned against her - and even aligned with the company she blamed for the faulty part
In the end, McKay had a further three operations - a total of four hip replacements in 13 months after the recall. The replacement of the first metal hip in July 2012 was a failure - it dislocated less than two months later and needed replacing in November 2012.
One foot after another, neither working properly, "I fought to keep moving," says McKay. The replacement hip went in backwards so was replaced again on May 29, 2013. And then it was the other side. The right hip was revised in August 2013 and she then went into recovery for a year, getting $257 a week from ACC with a small accommodation top-up. Now, at least, "the metal taste was gone and energy levels were back up. But I'm in constant pain." She hisses with frustration.
"I'm sick of saying that actually. I walk like a drunk woman. I've no sense of stability in my hips. It hurts me to walk upstairs. My body is managing the indiscrepancies in core balance muscles but I pay for it in other ways. The body reorganises itself around weak muscles.
"I'm back massaging but I have to do it differently. I do my gardening and my housework on my knees."
McKay doesn't want anyone's sympathy. She's angry with nothing to strike out at. A complaint to the Health and Disability Commission talked of the "benefit of hindsight" and said Pitto's professional practice was appropriate given the knowledge at the time. Pitto declined to speak to the Weekend Herald.
And that's it. The metal hips that went bad inside her body were never approved for use in New Zealand, because our system doesn't require approval for medical devices.
The surgery took place largely in public hospitals, paid for with public money, and the taxpayer has since supported her recovery with a (meagre) salary supplement. ACC has never kept track of how much it cost the public to cover surgery to replace defective products or to cover rehabilitation afterwards.
No public body is taking action to discover the extent of the issue and whether it could have been handled better. When a group of Kiwi patients set off to Britain courts to unsuccessfully sue Stryker for negligence, they did so without Government support.
A spokeswoman for the Counties Manukau District Health Board pointed to a Health and Disability Commission investigation which found "the care provided to Mrs McKay was appropriate in the circumstances.
The DHB acknowledges the distress and pain that Mrs McKay has suffered as a result of the metal on metal hip implant and apologises that she had to undergo further surgery to replace the device."
A spokeswoman for Stryker said the company had "strict policies" guiding the behaviour of its staff in and out of operating theatres and investigated any complaints against them. The company would not provide a copy of its policies and would not comment on the specific case.
The scale of the issue is difficult to gauge. A Medsafe briefing counted about 1200 metal-on-metal devices that were recalled or subject to hazard notices. A further 1300 metal-on-metal devices had failure rates so high that surgeons were advised to check on their patients regularly.
In some cases, the surgeons who carried out the operations have died or retired - Medsafe's hope is that their successors will reach out on their behalf.
Health Minister Jonathan Coleman's office hasn't had any briefings on the issue in the past two years.
A spokeswoman says the regulatory system worked as it was meant to - but that system is about to be completely overhauled. "Health care is always rapidly changing, including emerging technologies, and we need to look at how legislation can better support that."
A law for the new regulatory scheme is expected to be put before Parliament next year and will "regulate the quality, safety and efficacy/performance of all therapeutic products across development and manufacture, market entry, and use".
Among the patients given the 2500 implants that were never good enough, McKay and a small cluster of unknowns have had extreme adverse experiences.
"I worry about what the future holds after being toxic for so long," McKay says. "Sometimes you just have to suck it up and get on with it - but somebody should be accountable."

Implants approved before risk known

Metal hip implants were recognised as a risk to patients after they were approved for use, says a surgeon who advised the Australian Government on the technique.
Surgeon Peter Devane - a hip replacement and revision specialist - says metal implants and metal caps on affected joints grew in popularity through the 2000s although use varied around the world. New Zealand was more conservative than most.
Devane was part of the system that cleared the devices for use in Australia. Between 1998 and 2008 he sat on the orthopaedic committee of Australia's Therapeutic Goods Association, the body that advises government on which devices can be used. The Australian system approved products under guidelines developed by the Global Harmonisation Task Force, a collection of volunteer regulatory bodies and medical device companies from around the world. At the time, metal-on-metal hips were in the "2b" category which meant they faced few regulatory hurdles because they were considered to be a modification of a previously-approved product.
From about 2007, work began to upgrade the categorisation to reflect a higher risk, but metal-on-metal hips had already gone through. Devane says governments were left playing catch-up. A British Medical Journal article later labelled it regulatory failure.
In New Zealand, the use of the products peaked in 2007. "Then those reports on metal-on-metal started coming out. We were aware of them - regulatory bodies were aware of them. By 2010, metal-on-metal was down to 3 per cent (of hip replacements)."
The comparative low number of replacements here - about 5000 replacements - tempered the surgeons' responses. "We didn't want to create a panic culture because it's not as big a problem (as abroad)," says Devane.
New Zealand's regulator Medsafe doesn't have an "approval process". In a statement, it told the Herald: "The [New Zealand] legislation does not require any form of pre-market assessment of medical devices." Medsafe takes guidance from other regulatory authorities -including the TGA - while medical device companies sell direct to surgeons.

Medsafe has "no mandate to approve medical devices or to monitor their import into the country", the statement said. Instead, companies are obliged to register devices on a database. "A notification on the database does not signify that a medical device has been 'approved' in any way."

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