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

I\'m not well versed in the bureaucratic technicalities of the FDA but one has to wonder why no doctor (the likes of a Dr. Loria who was attempting to practice penile bioplasty with a permanent filler) in the U.S. simply hasn\'t obtained Metacril or NP already. Or for those doctors who use Artefill, why not offer Metacril or NP as a cheaper alternative? And why would this Doctor in Atlanta request the patient obtain the product and bring it to his office? Isn\'t that kind of weird? All I\'m saying is that, if it were not illegal to use metacril or NP in the U.S., why isn\'t there a single U.S. cosmetic practitioner not using it, or at the very least, offering it as an alternative? And let\'s not count the Doctor in Atlanta as one who would apply in this regard.

My understanding (which is very limited I must admit) is that off-label use is still a product designated with an FDA-approval (for some ultimate purpose), and products without FDA approval is more-or-less basement injections. My aforementioned musings only reinforce this understanding. Correct me where I\'m mistaken.

@EQStudent

I don\'t want you to stop posting if you indeed have information about the distinction and legality of Metacril/NP/Linnea Safe for use in the U.S. I think it would be beneficial as a forum to establish whether or not pursuing penile bioplasty with a non-FDA approved brand (i.e. Metacril) with a U.S. doctor is even legal (let alone wise)?

@SO I would like to conclude this with a few statements of facts. If you wish to continue this topic please start a new thread and I will participate to the best of my ability. This really has nothing to do with my PR and I am starting to regret honestly answering kcchief\'s question.

Question 1) Are there Docs in the US doing PE Bioplasty and Butt Augmentation Bioplasty with non Artifill PMMA products
Yes and I have named 2 that I know for a fact but there are certainly others. I m not sure why this appears to be a shock since it has been discussed on this forum for at least 18 months, note this thread: phalloboards.websitetoolbox.com/post/Pmm...ates........-5374563 and here: phalloboards.websitetoolbox.com/post/Any...n-in-Atlanta-5410889

Question 2) Is it Illegal for US Physicians to perform experimental or investigational procedures with any material they deem valid
As long as the procedures and/or materials are not prohibited by the FDA the Physicians can proceed at their discretion. Note they can do so even if the manufacturer states that is not approved for the experimental purposes that the Investigator intends: See LifeCell\'s statement on Alloderm and the fact that docs still use it for PE!

Question 3) Can Physicians Import and Market Metacril or NewPlastic into the US
Those products are on the FDA commercial exclusion list based on exclusive use rights granted to Artes until patent expiration 06-09-11 (recently granted FDA extension to 06-09-16) They cannot be imported and marketed in violation of those exclusive rights. Any such imports will likely be seized by customs.


@SO I am certainly not going to try to debate the reasoning behind how docs can use non-Artefill PMMA in procedures in the US, and certainly not with anyone not versed in the details of the FDA and Medical Research rules. I have 3 people on my team at work each with >15 years experience in the various FDA processes and policies and I don\'t like listening to their convoluted reports to me. I will leave that rational to the docs and their legal and compliance teams.

@EQStudent

Just FYI, the two links you provided regarding use of non-Artefill PMMA are not adequately addressed. Both are vague, no actual specific brand is stated.

To me the implication that a non-FDA PMMA is being used in the states is as legitimate as Dr. Loria\'s magical cocktail. In the end, there is no clear proof that Metacril, NP/Linnea is being used in the U.S. That isn\'t to say it has never been used before.

I agree with you, however, that if this specific topic were to continue, it would best be done so in a separate thread. I ask all members & moderators to respect EQ\'s progress report and desist from this specific topic (legality of Non-Artefill PMMA in the U.S.).

A late happy birthday to your pmma penis mate.

--What is the status of your \"chronic inflammatory reaction\" from the nodule you had. Is it gone or comming back every now and then ?
If it remains are you planning on a incision maybe or just let it have it\'s own way. Did more occurre?


--Do you ever turtle like \"pig in the blanket\" style to any extend?
(like its being highlighted in hunkchunks current thread)
phalloboards.websitetoolbox.com/post/PMM...ERS-6295995?trail=15


I would like to see a further away flaccid pic of your junk by the way. Voyeurism. And checking if i would be happy with that, which i guess i would.

greetings