FDA refusing to inspect dangerous new medical devices

The medical device industry is using us as guinea pigs — all with our government’s blessing!

When you’re wheeled into an operating room, whether it’s for a heart stent or a new knee, you deserve to know that only the best materials and tools are being used.

But it turns out that even your surgeon can’t say for sure.

That’s because a new Ivy League study proves that the FDA is letting dozens of medical devices hit the market every year that have never been tested on humans.

It’s part of an outrageous government program that’s forcing American citizens to participate in dangerous — or even deadly — medical experiments without their consent. And thanks to a new bill making its way through Congress, things could get a whole lot worse.

Don’t tell, don’t ask“The program has served American patients well.”

That’s what one FDA honcho had to say about the agency’s process for screening and approving new medical devices.

Seriously? I’ll have some of what he’s drinking.
Because a new study in the Journal of the American Medical Association proves that the FDA’s medical device program isn’t designed to serve us at all. In fact, it uses us as lab rats while device makers rake in billions.

Researchers from Yale Medical School found that close to 100 percent of new medical devices are never tested before the FDA lets them on the market.

Even high-risk devices, like a heart implant or a replacement valve, might only be tested on a small group of patients before they’re sent off to be used by thousands.

What could possibly go wrong with that plan?

How about a recall for a stent to treat brain aneurysms?

Or the thousands of patients who received a hip replacement called Pinnacle Complete and found that the only thing “complete” about it was the pain it caused when it leached dangerous metal ions into their blood.

And just a few months ago I told you about the “new and improved” metal knee joints that were actually requiring twice as much surgery as the older devices.

The FDA sometimes requires post-approval safety studies, but researchers found they’re rarely ever completed. And this is years after the devices have been approved and gone on to cause havoc.

Doctors don’t have (and never will have) “the data we need to make the best decisions for our patients,” said Dr. Joseph Ross, the Yale professor who led the study.

And if you’re wondering how we ever ended up with such a boneheaded policy, well, it’s not just the FDA’s fault this time. It looks like our so-called “representatives” in Congress deserve plenty of blame.

You see, in 1977 Congress passed the FDA Modernization Act that included something called “least burdensome provisions.” That means the FDA can put up as few roadblocks as possible when a company is trying to rush a new medical device to market.

Can you believe it? Who writes — or even votes for — this stuff?

Of course the law gives some lip service to safety, but the message is crystal clear: Don’t block the pipeline.

And as bad as it’s gotten over the past 38 years, it looks like we haven’t seen anything yet.

Just last month I told you how the House of Representatives passed the 21st Century Cures Act, which would make it even easier for medical device makers to get approval for their new gizmos.

Fortunately, there’s still time to stop that disaster from becoming law. Write your Senators and tell them to reject the bill and to start requiring real safety tests on medical devices that are being used on us every day.

Remind them that they’re supposed to look out for our interests. And that doesn’t include letting billion-dollar corporations force us into medical experiments we don’t even know we’re part of.

Sources:

“FDA approval of medical devices involves shockingly little research” Joe Satran, August 14, 2015, The Huffington Post, huffingtonpost.com