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CBC MARKETPLACE: HEALTH » MEDICAL DEVICES
Medical devices: What happens when things go wrong?
Broadcast: April 1, 2003 | Reporter: Erica Johnson; Producer: Carmel Smyth; Researcher: Colman Jones
Judi Logan
Judi Logan's jaw implant has left her in excruciating pain

One in ten of us is walking around with some kind of synthetic body part: a pacemaker, heart valve, hip joint or breast implant.

Most of us believe medical implants are safe -- rigorously tested and closely monitored.

You might be surprised the number of faulty and sometimes dangerous medical devices Health Canada has allowed onto the market.

When something goes wrong with your car, you usually get a recall letter. It’s safe. It’s simple.

So simple, Judi Logan was shocked when something even more important — a replacement part in her jaw — went horribly wrong. No one said a thing.

“We got a recall notice for the van. For the springs. But never about the jaw. It doesn’t make sense.”

Logan got a jaw implant in Hamilton, Ontario in 1985. She didn’t find out how much damage it could do until 10 years later.

Now Logan is going blind in one eye. She has had six surgeries to rebuild her face and jaw. Brushing her teeth is a chore — she can barely open her mouth. She takes 10 pills a day to try to control her pain.

“The pain never stops. It’s a kind of headache you feel — like if you bashed your head in the wall it would feel better.”

Every day, thousands of Canadians get some kind of medical device implanted in the body. There are 16,000 on the market — pacemakers, new hip and knee joints — but Health Canada’s approval process means faulty devices are being sold, before they’re properly tested. Internal Health Canada documents the CBC requested back that up.

Marketplace teamed up with CBC reporter David McKie to create a database using Health Canada documents we obtained through an Access to Information request.

We analysed data on implants, part of a $5-billion industry in Canada. We wanted to know how often medical devices fail: just last year, 800 devices were faulty.

We found:

  • malfunctioning heart valves
  • hairs in “sterile” products
  • surgical screws that popped right out
  • a lens for the eye that clouds over

Ironically, Judi Logan got her jaw implant to treat a minor complaint: a clicking jaw and headaches caused by TMJ — or Temporomandibular Joint Syndrome. To stop the click, doctors slipped a piece of teflon material on top of Logan’s jaw joint.

Ten years later, in 1995, Logan got the implant removed. The implant had crumbled, making the body’s immune system go haywire and attack everything in sight.

Few implants tested

Pierre Blais
Pierre Blais warned Health Canada the jaw implant would probably break down

So why are devices that cause harm getting to market? Many manufacturers claim their new device is pretty much like one already being sold. That way, they can avoid extensive testing. Only a few types of implants are thoroughly scrutinized: those that could be deadly, if they fail.

In Ottawa, chemist Pierre Blais monitored medical devices at Health Canada for 14 years. He was fired for warning the Meme breast implant wasn’t safe and should be banned. Today, he's a consultant. He keeps a collection of implants gone bad, like Lyodura — a tissue removed from human cadavers.

"The people who made it couldn’t get it sterile so it transmitted diseases like Mad Cow Disease," Blais said.

Blais says Health Canada’s policy of not asking for much paperwork for the majority of medical devices is leading to problems.

“As things stand, everyone assumes that the Department and its entourage is protecting them or at least looking out for them. And it’s not the case."

Blais remembers studying the jaw implant Judi Logan and hundreds of others got. In three memos, Blais warned his superiors at Health Canada the implant would dissolve and was selling in Canada without a license.

“The Department had many chances to remove this material from the market.”

But it didn't. Now, Judi Logan fights constant fatigue.

"They let us all down badly. My life is forever changed. It just makes you feel like they just don’t care."

NEXT: One recourse: The class action lawsuit »


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MEDICAL DEVICES: MAIN PAGE ONE RECOURSE: THE CLASS ACTION LAWSUIT VITEK JAW IMPLANT: ORAL SURGEONS RESPOND VITEK SAFETY ALERT: JAW IMPLANT MEDICAL DEVICE LAWSUITS
MORE MARKETPLACE: ARCHIVES: HEALTH AND SAFETY

RELATED:
Improve inspections for medical devices: auditor general (March 31, 2004)

Canada needs medical device registry: doctors (September 24, 2003)

Canadians put at risk with medical implants (April 1, 2003)

Other media:

MEDEC is the principal trade association of the medical devices industry, its members accounting for more than 50% of the nearly $4 billion of medical devices purchased annually in Canada

Medical DeviceLink - the "platform website for the medical device industry"

EXTERNAL LINKS:

CBC does not endorse and is not responsible for the content of external sites. Links will open in new window.

Canadian regulations on medical devices:

The term "medical devices" refers to devices used for medical purposes, modifying body function or structure, diagnosing pregnancy, or used in the care of offspring. The regulation of medical devices is under the jurisdiction of Health Canada's Therapeutic Products Directorate (TPD)

The Food and Drugs Act Medical Device Regulations provide for the regulation of medical devices [PDF]

Sections 79 - 88 address the use of medical devices (including in-vitro diagnostic devices that may contain products of biotechnology) for investigational testing. Included in these sections is the information that must be contained in all of the following: the required records, the application for authorization to sell the medical devices and the device labels.

Effective January 1, 2003, new Canadian regulatory quality systems requirements for medical devices took effect. These requirements apply to: all Canadian and foreign manufacturers holding Class II, III and IV medical device licenses, all Canadian and foreign manufacturers applying for Class II, III and IV medical devices licenses, all Canadian and foreign manufacturers who have applied for Class II, III and IV medical devices licenses before January 1, 2003 and to whom those licenses are delivered after January 1, 2003

Medical Device Regulations in other countries:

USA - Food & Drug Administration (FDA) Center for Devices and Radiological Health

The FDA Medical Products Reporting Program - manufacturers, physicians, hospitals, consumers can report problems with medical devices and drugs

UK - Medical Devices Agency (MDA)

South Korea - Korea Food and Drug Administration (KFDA)

Japan - National Institute of Health Sciences (NIHS)

Sweden - Medical Products Agency - government site which provides specific information regarding CE marking, which is necessary to market medical devices in the European Community member nations

The Global Harmonization Task Force - the GHTF was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices.

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