The Looming Specter of "Recalled" Medical Devices, Implants and Prostheses

The day the term "fast-track approval" entered FDA's glossary I knew it would be misused. The excuse that it will be used only for accelerating the manufacture of drugs for "incurable" diseases and for giving a ray of hope to cancer patients was wide open to be manipulated.

That knowledge came from of my own bad experiences in trying to prevent a cardiac device entering the hearts of countless citizens of our country. Of course, I was and am a small fry who had the audacity to put my job and future in front of a mighty freight train of a giant greedy pharmaceutical company.

And the final result: Soon I was on the streets of New York looking for another job and the device entered the hearts of living humans who now have to undergo more unwanted surgeries which they tried to avoid in the first place. Even Heads of States are coming all the way to New York to get it implanted into their hearts.

All because, the failures of the device which were unraveled during the clinical trial phase were conveniently covered up later.

How did they silence me and get rid of me?

They brought in a guy from Middle East through Canada. From the first day of his arrival as my boss, he refused to give me more data for analysis. Then he started overwriting my findings and wiped out all adverse findings painstakingly gathered on the device under trial.

Next happened the most ridiculous drama that would have ever happened in any high-rise workplace in downtown Manhattan: my "boss" started piling up garbage from the waste bin in the room on to my table before my arrival. Once I caught him red-handed in the act. Naturally, this led to verbal altercations and thus paved the way for my ouster.

And all this to get a medical device approved for getting implanted into unsuspecting human bodies!!!????

Unfortunately, greed will make its ugly head and get the upper hand somewhere on the way to drug and device approval despite FDA's best efforts.

Let us not forget FDA, though found wanting now, had a glorious past. It was the singular, valiant stand of a woman FDA official that prevented the entry of Thalidomide into USA and thus prevented the birth of countless Americans with no limbs in their bodies.

Thank God for creating that woman as our nation was a goldmine for manufacturers of sedatives and tranquilizers, especially in the nascent days of babyboomerism. Thalidomide would have got a easy entry into our country had it not been for this one woman-army holding the fort for all our citizens.

But, somewhere along the long trek from that glorious past, we threw both caution and ethics to the winds. Our drug and device approval process also got watered down from very strict tests to moderate tests to some tests.

And now it has finally arrived at the ultimate denouement: no tests. What was supposed to help cancer patients has deteriorated into a free-for-all farce.

Thus, fast-track has deteriorated to no track. Untested and unproven technologies have made their way into the heart and bodies of countless Americans.

The shocking findings of a recent study by researchers prove this:

Nearly 71% of medical devices approved during the 2005-2009 period were never tested in human trials. Some have very serious consequences and some really endanger the lives of the patients.

What was the reason for such utter carelessness?

"Those devices resembled similar products already approved or are in the market: so don't require any stringent inspection."

Thank God, our law-enforcement officials do not go by such "flawed" logic of our medical device examiners.

Looking or working similar does not mean all the devices are the same inside.

So the "cancer of greed" that is spreading through the medical device field happens in three steps:

- They first make a sham of clinical trials in the same way my employers acted by preventing the recording of complications detected during the trials or even overwriting them. Fear and threat of loss of jobs force the affected employees support such criminal activities. Or they will face the same fate I did.

- The "white-washed" report is then filed to FDA for fast-track approval as if all devices are for the good of cancer patients or for those suffering from "incurable" diseases.

- FDA, already fooled by the fake report in front of them, compounds the sin by giving the approval based on the flawed argument that the device looks and works like a similar device already in use.

And now the specter of "recalled" human parts looms in the horizon. As if, the implants and prostheses inside the human body "look and work similar" to automobile parts, so can be "wantonly" recalled. As if getting implants out of human bodies is as simple as driving a "recalled" car to the dealer.

Yes, litigation will follow with million-dollar compensations in tow with hefty legal fees eating into much of that.

One question remains:

They can fire small fries like me and feel safe. They can fool the FDA by erasing the entries we dutifully entered on their databases. They can even shell out millions to pay compensations in case of litigation.

But, can they, even with their billions of corporate money power and vain gimmicks, ever bring back a precious American life lost due to a faulty device? Yes, just one human life?

After a few weeks of "headaches" and "heart burns" due to unemployment, I found a new job and moved on with my life. And, for the next decade my previous employers were smug with the "apparent safety" they felt in fooling Americans into getting their faulty device implanted into their bodies.

But now, according to grapevine, their headaches and heart burns are just beginning.