Blumenthal, Business, FDA, Federal Food Drug and Cosmetic Act, Food & Drug Administration, Healthcare, hip, Karen Riley, Medical device, UNited States
What isn’t being published is the truth regarding the medical device world.
by Howard Sadwin
If we obtained data in USA re: hips 2004 – 2008, procedures, adversities reported to surgeons, FDA etc. we could be better prepared to deal with this disaster. Also enlighten people with all the FDAs new ideas and actions.
Unfortunately, the FDA neglects to face facts: there does not seem to be any control of basics now and back in time regarding medical device manufacturers. All these new actions, new punishment, new data on devices, etc. if you paid for all the information email@example.com it would cost me thousands of dollars and all I would be getting is proposed actions to be taken and under tight scrutiny of FDA a lot of paper, when in reality it appears the medical device world dictates the rules.
By the time anyone can agree right and wrong and implementation of an established penalty system and an understanding of what the FDA is trying to say, a medical device could fail, be replaced by another, it could fail etc. on the good side there will be more success stories than failure stories.
I mentioned once before if you go through a red light, you pay a fine, go to jail or go to court, end of story if your medical device harms a human being because of the product, you pay a fine ( high enough to rattle the board of directors) and put a stop to the medical device world dictating the rules.
Mr. Blumenthal is a positive note for changing this system, however, monitoring these devices was a stipulation made in approval of some hip devices, why was this not acted upon when these same devices began hurting people, if proper action wasn’t implemented back then, how are they going to change the necessary actions to be taken against a device manufacturer when it fails ?
Why do we make things so difficult; what is the harm in publishing and broad casting the truth, “ If you have a metal on metal hip and are experiencing problems seek professional help”.
Repetition of this type of information will help a fair amount of people, as you know, and this is one of the most important things we can hope to accomplish quickly.
The comment in Barry’s article as spokeswoman for the FDA Karen Riley studies had shown that current 510k approval process was remarkably safe. I ask myself what is she basing her comment on?
People need to be informed about who runs the show, the FDA or the medical device world . Getting new devices on the market is great the quicker the better, who is this better for Market Share or humans?
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jackie anderson said:
I SAY ITS TIME TO HAVE THESE COMPANIES WHO MAKE THESE THINGS STAND UP AND TAKE NOTICE, IF WE DON’T THEN THERE WILL CONTINUENTO BE GOING THROUGH THE SAME THINGS WE ARE. I AM LESS THAN 2 YEARS POST OP AND HAVE A ELEVATED LEVEL OF METAL AND CHROMEUM IN MY BLOODWORK AND MY HIP HURTS ALL THE TIME. I HAVE A GRINDING VIBRATING FEELING EVERYTIME I BEND MY LEG FROM A STANDING POSITION. I SHOULD NOT BE GOING THROUGH THIS, I AM ONLY 46, 44 WHEN IT WAS DONE. BUT WHATEVER THE AGE, THAT DOES NOT MATTER. IT IS TIME TO GET WHAT WE ARE PAYING FOR, WE ARE GOING THROUGH SURGERY, RECOVERY AND MORE AND STILL NOT WELL. MINE IS A MOM BIOMET IN WHATCH I HAVE HEARD LOTS OF COMPLAINTS. MY VOICE CANNOT BE HEARD ALONE, IT WILL TAKE MORE THAN ME TO CHANGE SOMETHING, WHO ELSE IS GOING THROUGH THINGS LIKE THIS?? I WOULD LOVE TO HEAR FROM YOU. ~PAIN IN TEXAS~ JACKIE ANDERSON
you are right – this should not be happening at all – I had a similar experience with a S&N THR and just had it replaced 3 months ago – 3 years after the first S&N hip. Now my bones are healthy and growing and strengthening – before they we being killed off by cobalt chrome poisoning.
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