What you need to know before having that knee or hip replaced

Is this the FDA’s most shameful scandal?

If you think that approvals of new drugs are done in a slipshod way, wait till you hear how the FDA okays the new “parts” that are put inside our bodies.

It’s called the 510(k) clearance program. And the FDA takes it about as seriously as a clearance sale at Macy’s.

Can you believe this: The parts used for knee and hip replacements don’t have to be tested for safety, or even to see if they work.

All that a company has to do for fast-track approval is to show that what it’s trying to sell is “substantially similar” to something else on the market.

That’s it.

But if you need to have a knee or hip replaced, there is one way to protect yourself from the pain, suffering and serious illnesses that these unproven replacement body parts can cause.

When a Johnson & Johnson’s subsidiary called DePuy got approval from the FDA in 2005 for its “state-of-the-art” hip replacement system called the ASR, doctors were courted and bribed to use it.

And they did so in droves.

But five years later over 96,000 of these “metal-on-metal” hips were being recalled. Even today, Johnson & Johnson still has a website and toll-free hot line to help you with the “support” you may need for “recall-related medical care.”

And it’s not just the DePuy hips that are being recalled. Other brands are failing as well. And so are knee replacements.

Many patients have had to get “revision” surgery — or put more plainly — a do-over. That means being subjected to more pain and, of course, the risks of another operation.

But while these newer devices, with smooth-sounding names like “ceramic-on-ceramic” or “metal-on-metal” (that the DePuy hip was) sound good on paper, having one in your body can be another story.

One expert says they are based more on “engineering” data than on real-life use. Sort of like building a model plane and expecting people to fly in it.

Dr. Art Sedrakyan, an associate professor at Weil Cornell Medical College, has been studying hip and knee replacements for some time.

In a new study, he found no convincing evidence to support choosing the new, high-tech sounding implants. They appear to be no better — and many times are worse — than older, tried and true ones.

And those findings were even more astonishing since the study was done in partnership with the FDA!

Dr. Sedrakyan argues that we need to stop and ask why such higher-tech implants are needed in the first place when older ones work just as well.

He and his team looked at five, new (but well-known) devices already in use. And they discovered that “none” of them “were found to be safer” or better compared with “established” ones that have been used for some time.

And the newer kinds of implants have required up to twice as much “revision” surgery as older ones.

Another benefit of going with previous “models” is like prescription drugs, the longer something is on the market, the better chance that any problems would have already come to light.

Dr. Sedrakyan’s advice for anyone undergoing a hip or knee replacement is to first, ask your doctor what kind he’s going to use. He may not even have been in a position to choose, as that’s often the hospital administrator’s job.

Then, find out how long the hip or knee device has been in use, and if it’s actually been “proven” to be safe and effective. And don’t just settle for how popular the implant is or how many patients it has been used in.

Remember, those DeyPu hips were once the most popular ones on the block.

And also remember that you’re not buying a kitchen appliance you can easily return if it doesn’t work, but something that’s going inside your body.

Hip and knee replacements are hardly ever done on an emergency basis so you have time to do your research — and to demand that your doctor or the hospital do theirs.

Sources:
“Too little research supports newer joint implants: study” Kathryn Doyle, September 25, 2014, Reuters, uk.reuters.com

“No convincing evidence to support use of new hip and knee implants review finds” ScienceDaily, sciencedaily.com