Blog

Read this before you get your knee replaced

Dr. Brian Goldman · CBC · April 3, 2017

 

 

 

 

More than sixty thousand Canadians per year and climbing get knee replacement surgery. 

A U.S study published last week in the British Medical Journal finds that a good number of patients south of the border may be getting new knees before they need them.

The study by researchers in the U.S. and the Netherlands looked at just under 4,500 patients with osteoarthritis of the knee and those at high risk of arthritis. They looked at the impact of knee replacement surgery on patients and the cost of the surgery to the system. Overall, each patient benefited somewhat from the surgery with better quality of life. For patients with moderate arthritis, the improvement was modest; for those with severe arthritis, it was substantial. When they looked at the cost of the surgery plus hospital charges, they found that knee replacements were cost effective only in patients with bad arthritis. The authors concluded that knee replacement surgery should be restricted to more severely affected patients.

This is a U.S. study. So you may be wondering how relevant the conclusions are for Canada. One Canadian orthopedic surgeon told me the study is spot on. Money is wasted on people who shouldn't have knee replacements and, many patients end up worse following surgery. Far too many need a second operation to fix problems that were caused by the original replacement, such as stiffness and instability of the knee – often due to surgery that should not have taken place.

The Canadian Institute for Health Information tracks the rising number of repeat surgeries that are being done on Canadians who have new knees put in at a relatively young age. Surgeons who fix botched replacements surgery say the original surgeon replaced the knee even though the arthritis wasn't bad enough. Perhaps the patient complained of a lot of pain and the surgeon replaced the knee without knowing if replacing the knee would fix the pain. They say patients aren't being properly informed of the risks of surgery, and aren't being prepared for what they must do to recover from the operation. The provinces and the federal government have been more focused on wait times. Studies like this one have put outcomes and money wasted on the radar screen.

Sunnybrook's Holland Musculoskeletal Program has developed an award-winning model of patient care. The Holland Program has centralized management and triage of all referrals for joint replacement surgery. Instead of an orthopedic surgeon handling referrals, that job goes to an advanced practice physiotherapist or APP. APPs have additional training in assessing patients with arthritis. They triage patients and refer them to the orthopedic surgeon only when there is objective evidence that that the patient needs a new knee.

The APPs and the surgeons assess the patient's function, and use measurable criteria to score patients. Twenty-eight per cent of the patients the APPs see do not need surgery. Those patients get education on how to manage their arthritis. Patients can demand to see the surgeon, but that seldom takes place because APPs are good at what they do.

At first, the orthopedic surgeons there were a bit skittish about the new approach because they were used to seeing the own referrals. Some were frankly afraid they'd lose business. Now, they love it when APPs assess and screen patients. Before, they had to sift out the patients who needed new knees from those who didn't, and they had to deal with patients who were disappointed that they weren't getting surgery. Now, they have confidence that when the APPs say a patient needs a new knee, they need a new knee. Like me, family doctors are just guessing who needs surgery; the APP knows. 

Fewer patients needing surgery means patients get seen faster and discharged faster. In my book, that's potential a win for every stakeholder.

To me, the bottom line is that patients should not demand a new knee. Instead, they should demand an assessment of their arthritis that is both thorough and objective. You'll know it's both if you are asked a lot of questions about how you function at home, and if you are watched by the health professional as you walk and do other standardized testing.

For my money, an APP is well qualified to assess you and to decide if you need surgery now, or if it can wait. Studies have shown that compared to physicians, APPs are just as good and maybe even better in diagnostic accuracy and the effectiveness of their treatment advice. APPs have also been shown to spend healthcare dollars as wisely and maybe even more wisely. Currently, APPs have started to take hold in Ontario. I think we need to see them right across Canada.



Above all, do not be disappointed if you are advised that you don't need a new knee today. There is always tomorrow.







Link: https://www.cbc.ca/radio/whitecoat/blog/read-this-before-you-get-your-knee-replaced-1.4052504

How safe is your medical device?

CBCMenu

• 
  
• Top Stories
• All Shows
• Podcasts
• Schedules
• LISTEN LIVE

White Coat, Black Art

How safe is your medical device? Even regulators may not really know

White Coat Black Art · 

Dennis Fegan with his grandchildren. Fegan's Vagus Nerve Stimulator was implanted to control seizures caused by epilepsy, but it instead stopped his heart. (Catherine Modlin/Submitted by Jeanne Lenzer)

Listen to the full episode26:30

The medical world has caught a severe case of the tech bug.
Cutting-edge medical devices are joining pacemakers, lenses and artificial hips and knees implanted inside millions of patients, and for the most part, they're improving the lives of patients.
But in her book The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It, Jeanne Lenzer details disturbing stories of recalls, hacking, injuries and even deaths related to medical devices that go largely untested and unregulated.
She told White Coat, Black Art host Dr. Brian Goldman that to find the root of this unregulated market in the U.S., one has to go back to 1976 when the Food and Drug Administration (FDA) took control of the medical device industry.

"At that point there were already a lot of devices on the market and in people's bodies; everything from pacemakers to nerve stimulators and spine implants. So what the FDA did was they said: 'OK, you guys are already all on the market, we will grandfather you in,'" said Lenzer, who has written for BMJ, (formerly the British Medical Journal) New York Times Magazine, The New Republic and other outlets. 

Author and journalist Jeanne Lenzer's new book The Danger Within Us chronicles the untested, unregulated medical device industry. (Submitted by Jeanne Lenzer)

 "To make matters worse, they told companies: 'Now if you want to add new devices you can simply say that your device is similar or substantially equivalent to a device that's already on the market.'"
This approval method means many devices on the market have never been tested on humans, and some have not been proven clinically safe or effective.

• CBC News: Metal-on-metal hip implants since 2006 may be more likely to fail: study

Moreover, Lenzer said, it's extremely hard to discover (let alone track) how many devices have been sold or implanted into patients.
"The FDA doesn't require manufacturers to tell them how many people are even implanted with their devices. It's a black hole," Lenzer said.

The surgeon who took his hip out described what he saw as an "automotive crank case full of dirty oil." The tissues had turned to black mush.- Jeanne  Lenzer

For example, the DePuy metal-on-metal hip implant ended up poisoning some patients, leading to a recall and lawsuits against the maker.
The metal hips parts grated on one other, releasing chromium and cobalt, causing metallosis.Lenzer described the case of a U.S. surgeon who had to have his own metal-on-metal implant removed.
"The surgeon who took his hip out described what he saw as an 'automotive crank case full of dirty oil.' The tissues had turned to black mush," Lenzer said, adding that cobalt poisoning can also cause thyroid disorder, heart failure and brain problems.

If the U.S had a mandatory registry for devices the way Japan, Australian and other countries do, patients who had devices implanted at U.S. hospitals might have been saved from needing a heart transplant after the device poisoned its host.

Jeanne Lenzer's new book details the unregulated medical device industry. (Submitted by Jeanne Lenzer)

Dr. David Urbach, surgeon-in-chief at Toronto's Women's College Hospital, says that Canada is also in need of better tracking of medical devices.
In a study published last year, he and his colleagues poured over 10 years of medical device records filed with Health Canada.
"We weren't able to find the rate of recalls mostly because we weren't able to determine how many devices are out there," he said, echoing the situation in the U.S.

Seizure-control device stopped patient's heart

The patient at the heart of Lenzer's book is a man named Dennis Fegan, a former firefighter from Texas.
Fegan had hard-to-treat epilepsy and a Vagus Nerve Stimulator (VNS) implanted in 2000 to help control his seizures.
But by 2006, he was repeatedly collapsing and losing consciousness. In July of that year he ended up in an ER after his parents found him passed out in his home.
According to Lenzer, doctors discovered that the VNS wasn't stopping Fegan's seizures: it was stopping his heart.
"His heart was stopping so long, he was passing out and having seizures from a lack of oxygen to the brain." Lenzer said.
Doctors deactivated his VNS, but Fegan was never able to sue the manufacturer, Cyberonics, because a U.S Supreme Court ruling prevents patients from taking device-makers to court over FDA-approved devices.
The VNS had only been conditionally approved by the FDA because of "a high rate of deaths among the test subjects" — a fact that wasn't required to be told to patients, said Lenzer.

Can you imagine if patients were told, "Gee, we've got this new device, it might maybe help you. But it also might kill you.... Would you like to try it?" I mean this is sheer insanity.- Jeanne Lenzer

It was later approved for treating depression, even though studies showed it wasn't effective for the condition.
It was one of several devices approved against the advice of FDA scientists in what's come to be known as Device-gate,Lenzer said.
"The FDA scientists unanimously rejected a number of devices, saying these are unsafe, they shouldn't go on the market and they didn't want to approve them. When suddenly a phone call was made by ... a congressman to FDA managers, and FDA managers overruled their own scientists," she said.
The medical device industry is currently estimated at close to $200-billion a year in Canadian funds. Lenzer says profits, and the industry's close relationship with the FDA, seem to take priority over patient safety.

While Canada has not seen a scandal the liked of Device-gate, Urbach says there is a lot of room for improvement in our system. 

Dr. David Urbach says he removes gastric bands every week at Women's College Hospital in Toronto. (Michael Wong/Women’s College Hospital)

As in the U.S., many devices on the Canadian market have not been tested in humans or have been assumed to be safe because they are modifications of existing devices.
"I don't think we really know these products for certain are safe and effective. There may be unknown risks to all of these medical devices," he said — even though these risks are likely to be "small."
Urbach says many doctors aren't aware that Health Canada relies on citizens to file reports about devices and adverse events.
He says the manufacturers have a "huge incentive to innovate, create new products and put them out on the market," and the public assumes that the newest technology must be the best, even if that's not always the case.

Giving patients a voice

So what's a patient to do?
Lenzer said patients are finding their voice in advocacy groups set up to hold companies to account.
Both Lenzer and Urbach advise patients to ask questions about any device, to check existing databases for additional information and to question the need for the device in the first place.
Urbach suggests asking questions like, "Is this absolutely necessary? Are there other alternatives? What's the consequence of not having this particular device used?" are questions Urbach suggests.
Lenzer says part of the solution has to come from lawmakers.
"We really need to make the kind of policy and political and health-care changes that will make a difference for patients,' she said, adding that she herself has an intra-ocular lens implant following removal of a cataract.
"Part of my frustration that led me to write this book is that it's disappointing to see devices that are useful tarred by the fact that there are many devices that are causing harm. I want to separate them out so we can all be more secure that ... we know more about our devices before they're put in our bodies." 





Link: http://www.cbc.ca/radio/whitecoat/how-safe-is-your-medical-device-even-regulators-don-t-really-know-1.4577995

White Coat, Black Art on CBC Radio

The unregulated world of medical devices

27 MINS

0:00:11

0:27:12