in ten of us is walking around with some kind of synthetic body
part: a pacemaker, heart valve, hip joint or breast implant.
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.
something goes wrong with your car, you usually get a recall letter.
It’s safe. It’s simple.
simple, Judi Logan was shocked when something even more important — a replacement part in her jaw — went
horribly wrong. No one said a thing.
got a recall notice for the van. For the springs. But never about
the jaw. It doesn’t make sense.”
got a jaw implant in Hamilton, Ontario in 1985. She didn’t
find out how much damage it could do until 10 years later.
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
pain never stops. It’s a kind of headache you feel — like
if you bashed your head in the wall it would feel better.”
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.
teamed up with CBC reporter David McKie to create a database using
Health Canada documents we obtained through an Access to Information
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.
malfunctioning heart valves
in “sterile” products
screws that popped right out
lens for the eye that clouds over
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.
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
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.
people who made it couldn’t get it sterile so it transmitted
diseases like Mad Cow Disease," Blais said.
says Health Canada’s policy of not asking for much paperwork
for the majority of medical devices is leading to problems.
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."
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.
Department had many chances to remove this material from
it didn't. Now, Judi Logan fights constant fatigue.
let us all down badly. My life is forever changed. It just
makes you feel like they just don’t care."