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Refer to: Advisory panel calls for revamping FDA approval process for medical devices

Good morning: I just read your article “ Better screening urged for medical devices” it appeared in the Sarasota, Herald Tribune.

I, have no hip, and I am confined to a wheelchair, spent 9+ months in the hospital, 12+ major surgeries etc. but I live.

I have read,researched, approvals, results of medical devices. Although I am not a doctor nor a lawyer, at times I feel like one.

I have responded to other patients that have suffered through the failure of various medical devices.

I am trying to get an invitation or interview discussing what happened to me.

My opinions, ideas, and thoughts come from within me, not from anger, nor vengeance. I believe I can help, as a lay person, straighten out a mess that has changed the quality of lives for many people who don’t understand, nor do some people know of a problem, nor do they know what to do.

I am living testimony of a worst case scenario, but I can answer questions and direct suggestions first hand.

I have always paid more attention to someone explaining a situation if they have lived through the experience.

I believe the 510k if written in simplistic form so I could even understand the conversation is step one, keep it simple.

I believe this segment of government should be a separate group, comprised of doctors, mfg representatives and laypeople. If logic and common sense replaced the too many pages of words. Is necessary.

There should be definite basic rules, these rules need be implemented by an investigative force that has the authority to impose any necessary fine if you break the law.

If you go through a red light you broke the law, and you will pay a fine or suffer the consequences.

This group should have direct contact with the president or fact similar, to avoid all the unnecessary red tape (simplify a system that is overwhelmed with documents,groups etc. this will narrow down the finger pointing).

The medical device companies seem to complain about the length of time for approvals, they contend extra time will cost us more money. Probably this is the case, however those costs are passed down to us. There is talk of going to Japan for approvals of medical devices because it’s cheaper, and approvals are quicker and third world countries can increase their bottom lines by an increase of sales.

These things could be true, however, Market Share and Financing should never take priority over the quality of life we believe in, nor should the price of health and well being be compromised at any cost, certainly not to human beings. WE have become the Lab Rats for adequate testing of these devices.

Granted we all are in need of physical help especially as we age, and these companies have helped.

I rarely read actual, reliable test results on hips,or knee devices. I read what certain professional athletes say, but are they endorsed by the company? I never see real numbers, that I can believe, posting worse case scenarios, nor do I read articles that are readily available and in a format I can obtain and understand. I rarely see companies posting actual test results that were to be updated and provided to the government, who then would notify the public.  Only if a disaster strikes do we push a button, and everyone runs around pointing fingers, forming new groups to oversee the wrong groups etc.

Case and point my device was denied in 2004 by a 3/2 vote. Some of the denial reasons: the statistical data was a group controlled by the inventor of the device, so the information could have been tainted, the FDA was concerned that the affects of metal ions in our bodies was unknown, because there was no substantial evidence,  there were other data and information missing so they were denied. In 2006 using the same information under the 510k plan the same device was approved by 3/2 vote??

During this same time frame several companies paid the Federal Government $311,000,000 fine , to stop an on going investigation as to kickbacks and questionable marketing practices. I think this may still be going on: read articles about PODs, the government is investigating these.

There is a tremendous amount of work to be done in order to correct these things with the hope of them not happening again.

Unless we begin with correcting the basics all we are doing is putting a band aid over a cut.

Simplify the process, implement rules and regulations, and enforce them asap. Not every one will be happy, but those that aren’t happy about initiating these changes have not experienced first hand the damage that can happen to you or me, today, tomorrow, next month or whenever. You can’t simply say I know, unless you live through what I am living through.


Howard Sadwin

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