TOPIC: Say what!! EQStudent + Dr. C == 20cc in the PP

Eq did you ever talk to the doc in Atlanta?
All I ever got from him was he could not get
Product lol. Please try and Rember who it was
In Florida doing PMMA. I would like that info.
Kcchief

kcchief wrote: Eq did you ever talk to the doc in Atlanta? All I ever got from him was he could not get Product lol. Please try and Rember who it was In Florida doing PMMA. I would like that info. Kcchief

Don't even consider PMMA in the US until you've seen some examples done with the bovine carrier. It takes 2 weeks to absorb, so we don't know how this effect the results.

@kcchief

From my consultations I believe that Morganstern was having difficulties getting the PMMA (NewPlastic and Metacril) from Brazil due to commercial import restrictions. If you are interested in getting the product yourself I believe he has the expertise and equipment and would do the procedure for you. The doc in Florida was Dr Billinski in Miami. I got the sense that he did mostly butt augmentation with a couple of penis. IIRC he sourced his product from Mexico.

Thank you EQ I emailed him and
He did confirm he would inject if I can
Get the PMMA. Didn't see info on the doctor
in Florida doing PMMA pe.
Kcchief

I think Sammy Passy will sell you Metacrill. But you are insane to even consider going to a Dr who will inject illegally. I doubt he has any bioplasty training and will almost certainly never have injected PMMA into the penis. Even if he claims to have done it, how can you believe him when he's already said he'll inject you with a non FDA approved product?

Very risky, would change your mind if I was you.... Just make sure he uses micro cannula's as if that get's injected into a vein, you can die or messed up lungs / brain

Have not decided yet, just researching the option.
Wouldn't his FFT filling be considered bioplasty?
I emailed him asking if he would use Metacrill, or
was he assuming I ment Artifill? He told me in the
Past he has injected Artifill in the penis and that was
the product he was not able to get any more.
Kcchief

No, fat isn't the same as PMMA. They use a specific technique when injected PMMA, so it comes out in threads, as opposed to pearls. I think they also only inject when pulling the cannula out. But the most important thing is that a Dr knows who the material behaves and that only comes through training and experience.

It's easy for him to get Arfetill. I could buy Artefill myself.

I seriously doubt he has ever injected Artefill himself.

What is so bad about going to Mexico, Spain, Prague or Brazil? Surely it's much better to go somewhere where Dr's no what they are doing and aren't breaking the law, than stay in the US?

Failing that, why not contact the Dr who uses Radiesse? But don't have PMMA in America, unless you come across a Dr that has experience using Artefill and you get to see some examples of PE using that brand. You have to remember the carriers aren't the same as those used in the Brazilian products and I'm not sure if bioplasty is viable with Artefill. Personally I've wondered if a longer lasting carrier might actually aid things, but apparently Dr C had suggested otherwise.

hoddle10 wrote: how can you believe him when he's already said he'll inject you with a non FDA approved product?

MD's in the US do not have to use "FDA approved" products. They can do almost anything they want as long as it is not banned by the FDA and they label it as experimental/investigational and you sign the necessary waivers. Case in point Alloderm/Belladerm/Repriza is not FDA approved for PE and several other procedure yet Surgeons use it "off brand" in a variety of applications. In fact most products go through those 2 steps before they can even begin the long road to FDA approval.

For what it is worth, I flew down to Atlanta to consult with Dr Morganstern who is a world renowned Urologist. In the end his stamp of approval of PMMA bioplasty based on his background and credentials was important in legitimizing the procedure. More important he is a resource for treatment of any serious complications which was very important to me before I seriously considered going ahead with the procedure.

In the end I went to Dr. C for the actual procedure. There is no substitute for experience when having any medical procedure IMO. Dr. C had done several hundred PMMA procedures by the time he did mine. Some of these new doctors here and in Europe still have < 50 under their belt and are still learning.

eqstudent wrote:

hoddle10 wrote: how can you believe him when he's already said he'll inject you with a non FDA approved product?

MD's in the US do not have to use "FDA approved" products. They can do almost anything they want as long as it is not banned by the FDA and they label it as experimental/investigational and you sign the necessary waivers. Case in point Alloderm/Belladerm/Repriza is not FDA approved for PE and several other procedure yet Surgeons use it "off brand" in a variety of applications.

For what it is worth, I flew down to Atlanta to consult with Dr Morganstern who is a world renowned Urologist. In the end his stamp of approval of PMMA bioplasty based on his background and credentials was important in legitimizing the procedure. More important he is a resource for treatment of any serious complications which was very important to me before I seriously considered going ahead with the procedure.

In the end I went to Dr. C for the actual procedure. There is no substitute for experience when having any medical procedure IMO. Dr. C had done several hundred PMMA procedures by the time he did mine. Some of these new doctors here and in Europe still have < 50 under their belt and are still learning.

I think you are wrong about this. I think there is a difference between "off label" use and using products that hasn't been FDA approved. Otherwise patents would be fairly useless.

I'd dismiss Dr Morganstern where PMMA is concerned.

EQ,
Did he say how much experience he has with PMMA
And pe? Was he only speeking of using Artifill? When
I spoke with him he was only vague and kept pushing FFT
saying he could not get PMMA.
Kcchief

hoddle10 wrote: I think you are wrong about this. I think there is a difference between "off label" use and using products that hasn't been FDA approved. Otherwise patents would be fairly useless.

Hoddle10, I do this for a living. How do you think products gets used before they are FDA approved? How do you think that Aftefill was able to be investigated then trialed before it even started the FDA approval process?

In any case lets say that Suneva Medical can get an injunction that Metacril infringes on Artefill US patents. They can get the FDA to put Metacril on the embargo list which will allow US customs to prevent the importation of Metacril into the US. That stops the product from entering the country.

Note it is not illegal to possess or purchase Metacril so if a doc has access to Metacril he or she can use it in any investigational or experimental procedure he or she sees fit.

@kcchief if you are seriously interested in having PMMA PE I would recommend Dr. C, that is who I used. If you want use Dr Morganstern I would contact him and ask him for any more specific details. I'm sure he can get you Artefill at $1200 per CC or $24,000 for product for a 20CC round + $5000 for his services if you so desire.

Hoddle and EQ,
Guys stop the bickering I not doing anything, just looking at options.
I greatly respect you both and agree with you and I will not be impulsive and make
A crazy decision. I still haven't herd from doc M on injection of
Metacrill and doubt he would do it. But I never herd doc Loria was
Looking at PMMA. Last I herd he still hoping the platinum procudure
Will work. His call person said I will hear more when he does his online
Web a nor.
Kcchief

hoddle10 wrote: As far as I can make out the manufacturer has to get an Investigational New Drug designation from the FDA, before it's tested on humans.

Now you are confusing Drug with Medical Device.

hoddle10 wrote: Wouldn't Metacril or New Plastic have to have bovine carriers to get a FDA 510(k) pre market approval? From what I've read about FDA 510(k), I'm pretty damn certain it would have to.

Why would any product need to have a bovine or any other type of collagen carrier to get a 510(k)?

I'll stop here, this is not going anywhere. The FDA, IP, and Medical Device research is not a topic worth discussing unless both parties are well versed in all the intricate details.

I apologize for bringing this up.