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#58431 06-11-2006 02:44 PM
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Well that's one more thing I will change when I am Queen of the World. These devices should be available to everyone who needs one NOW. Let people sign a release, but for heaven's sake, let the people who need them have them! Safeguards are good, bureaucracy is not.

#58432 06-11-2006 02:50 PM
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minniea Offline OP
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I still don't understand why our medical world can figure out how to create a "working" penis to turn a woman into a man yet can't figure out the salivary gland??


SCC Left Mandible. Jaw replaced with bone from leg. Neck disection, 37 radiation treatments. Recurrence 8-28-07, stage 2, tongue. One third of tongue removed 10-4-07. 5-23-08 chemo started for tumor behind swallowing passage, Our good friend and much loved OCF member Minnie has been lost to the disease (RIP 10-29-08). We will all miss her greatly.
#58433 06-11-2006 04:18 PM
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If salivary glands were essential for sex, it would happen sooner. But, lets not go there.

Jerry


Jerry

Retired Dentist, 59 years old at diagnosis. SCC of the left lateral border of the tongue (Stage I). Partial glossectomy and 30 nodes removed, 4/6/05. Nodes all clear. No chemo no radiation 18 year survivor.

"Whatever doesn't kill me, makes me stronger"
#58434 06-11-2006 05:49 PM
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Ha ha ha! How true - we can spend millions on erectile dysfunction and hair loss, etc. but short change research for AIDS, cancer, OCF etc. It is, after all, a market driven society. Look on the bright side - now that we have conquered ED and hair loss and now the boomers are turning up with cancer so the heat is on the researchers now. We haven't accumulated all of this wealth and inheritences just to have our lives cut short. Like Dylan said back in the 60's "The times they are a changin""

The whole issue with the FDA is that people or companies wanting to sell medical devices in the US have to prove safety and efficacy before they are allowed to market them. It is to protect the US public.

It is a multidimensional issue - true, some components may have previous clearance, like the implant screw, but if there is a new manufacturing process involved then the biocompatibility testing has to be done over. Materials from the manufacturing process may have an adverse effect. Raw materials themselves are often confusing to manufacturers lacking regulatory experience, I actually encounter this a lot. They assume that because a certain material is FDA approved, that it can be used in the body but the truth is that the FDA only approves raw materials that are to be used in food containers, to insure that harmful substances are not leached out into the food.

The un-implantable device is still used in an "intact body channel" i.e. the mouth so biocompatibility would still have to be performed (although not to the level of standards that the implant would with blood, bone and long term exposure) . It is also indicated to "modify or alter the structure of the human body", i.e. stimulate the salivary glands so it meets the criteria of the definition of a medical device.

You could always move to Israel.

Doctors can do want they want (from a surgical perspective anyway) - if someone wants a sex change - that is not regulated by the FDA. And here again, they make big money on this procedure. It's an elective procedure the same as a face lift or boob job.

Comparing surgical procedures and medical devices and like comparing apples and oranges.

Be comforted in the fact that when you have procedures done, using medical devices, that they will safe and efficacious and not injure you.

I would ceratinly be happy to take them as a client and obtain their clearance to market or pre-market approval. I have well over 100 510K clearances in a wide variety of devices and applications.

510(k), by the way, refers to Section 510(k) of the Food, Drug & Cosmetic Act. The definition of a medical device can be found in Section 201(h)


Gary Allsebrook
***********************************
Dx 11/22/02, SCC, 6 x 3 cm Polypoid tumor, rt tonsil, Stage III/IVA, T3N0M0 G1/2
Tx 1/28/03 - 3/19/03, Cisplatin ct x2, IMRT, bilateral, with boost, x35(69.96Gy)
________________________________________________________
"You are a mist that appears for a little while and then vanishes" (James 4:14 NIV)
#58435 06-12-2006 11:52 AM
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minniea Offline OP
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Great info Gary, you are so correct that we are a market driven society. Only here can a 9th grade dropout that has a talent for teaching a child to tumble make more per year then our public school teachers. $50 an hour for a private, and believe it or not, I pay it! AND, I know how to teach tumbling, but try teaching your own child, lol.

Not to beat a dead horse, but my questions are more about a transplant. I'm reading that they are now taking and moving a radiation patients salivary gland before that patient begins radiation, moving it out of the radiation field. Then they move it back to it's original location so it can function properly. That option, obviously, isn't there for most of us anymore. So, why can't an organ donor's salivary glands be transplanted into people like us? That is my biggest question.


SCC Left Mandible. Jaw replaced with bone from leg. Neck disection, 37 radiation treatments. Recurrence 8-28-07, stage 2, tongue. One third of tongue removed 10-4-07. 5-23-08 chemo started for tumor behind swallowing passage, Our good friend and much loved OCF member Minnie has been lost to the disease (RIP 10-29-08). We will all miss her greatly.
#58436 06-12-2006 01:51 PM
Joined: Nov 2002
Posts: 3,552
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The organ donor thing is a good question. There are always problems with rejection so lifetime drugs are given to control this. Maybe it's not possible to make a transplanted gland functional, or, more likely, the insurance companies don't have it on their schedule for reimbursement. You would be surprised how many medical devices fail in the market place because the insurance companies won't reimburse. It is the true driving force, hidden behind the scenes.
More experienced companies work on the reimbursement issues first. I am sure that given the choice between your drinking more water and an expensive medical procedure (along with expensive anti-rejection drugs for life (and constant monitoring), they would choose not to reimburse. I am surprised that they will even reimburse for gland relocation.

What blows my mind is that basketball players make more then brain surgeons.


Gary Allsebrook
***********************************
Dx 11/22/02, SCC, 6 x 3 cm Polypoid tumor, rt tonsil, Stage III/IVA, T3N0M0 G1/2
Tx 1/28/03 - 3/19/03, Cisplatin ct x2, IMRT, bilateral, with boost, x35(69.96Gy)
________________________________________________________
"You are a mist that appears for a little while and then vanishes" (James 4:14 NIV)
#58437 06-15-2006 06:09 PM
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You guys need to think outside the box more.

All a person needs is a plane (or boat) ticket to a place that is not influenced by the FDA. Yes warranty work might be a problem but there are some nice places to visit say around February?

Thank you Jerry, I'll contact him and report here if anything comes of it.


Mark, 21 Year survivor, SCC right tonsil, 3 nodes positive, one with extra-capsular spread. I never asked what stage (would have scared me anyway) Right side tonsillectomy, radical neck dissection right side, maximum radiation to both sides, no chemo, no PEG, age 40 when diagnosed.
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