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Author Topic: FDA to start clinical trials on Cassavantes's version of PMMA  (Read 13601 times)

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Offline Inchlingblue

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FDA to start clinical trials on Cassavantes's version of PMMA
« on: January 24, 2009, 06:45:56 PM »
I came across the following info online, does anyone have any more details about this?

Pre Marketing Approval (PMA) has been granted by the
FDA for the PMMA preperation used by Dr. Casavantes, known as New
Plastic. We can expect clinical trials to start in 2009. Sevaral
nationally known, key physicians who have worked in facial
reconstruction have joined this effort. A full list of
participating centers will be made available soon.


Offline Peter Staley

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #1 on: January 25, 2009, 08:52:59 AM »
I actually talked with Casavantes last week on the phone.  I had some questions about the version of PMMA he used, and the method used for implanting it (both are different from what Clinic'estetica uses, where Casavantes used to work).  He didn't mention this trial, but I'll ask him about it the next time we talk.

Here's a nice website he created explaining NewPlastic (what he calls "Medical PMMA"):

http://www.medicalpmma.com/

Offline Inchlingblue

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #2 on: January 25, 2009, 05:24:02 PM »
Peter:

Since you specifically talked to Cassavantes about his version of PMMA and will be talking to him again, maybe you can help me with a specific question I have about his PMMA. Does it use bovine collagen (like ArteFill does)? I know that with ArteFill, a skin test is required about a month before-hand in order to determine if there  any allergic reactions. I assume that Cassavantes's PMMA does not have bovine collagen, since I haven't heard of any allergy tests that are done, but I want to make sure.  Any info you may have on this would be greatly appreciated@!

Offline Pepino2

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #3 on: January 26, 2009, 05:20:17 PM »
I had my 1st PMMA treatment performed by Dr. Marcio Serra in Sao Paolo last year.  I asked him the question as to what was the difference between his PMMA formulation and Dr. Casavantes.  He told me that his was strictly a saline solution (which explains why I did not need an allergy test).  He told me that while he has always been very transparent about his formulation, the Tijuana clinic fomulation was more of a "secret". 

Does the FDA publish what the solution is?  Does any body know?

I'm very happy with my results (am seeing him again this coming saturday actually - in Rio).  I am not saying that a bovine based collagen is not good, however it would be nice to know the solutions used by each doctor as they are essentially free to make them as they see fit.  PMMA is only the platic bead component and does not imply a specific bovine collagen or strictly saline solution.

:)

Offline Peter Staley

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #4 on: January 28, 2009, 09:45:19 AM »
It is NOT a bovine base.  It's a saline base.  The product is called NewPlastic, from Lebon Laboratories in Brazil:

http://www.laboratoriolebon.com.br/site/produtos_interna.php?id=2
(anyone read Portuguese?)

They are a registered and regulated pharma company in Brazil.

Offline Texgymrat

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #5 on: February 24, 2009, 11:09:38 PM »
Peter:
You said you talked with Casavantes about some questions about the version of PMMA he used and the method used for implanting it - both are different from what Clinic'estetica uses.  I had my treatment done at Clinic'esterica by Dr. Gloria Morales in May 2007.  The results are still holding up but want to get it touched up.  So was wonder what the differences are and why Casavantes treatment would be better.  Thanks.

Offline Peter Staley

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #6 on: February 25, 2009, 10:48:08 AM »
I'm actually seeing Casavantes at the end of next week for my own "touch-up" (hopefully my final PMMA treatment).  I'll be much more informed about their differences after my visit.  Remind me to post here during the week of March 9th.

Offline bubba53

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #7 on: March 03, 2009, 12:05:07 PM »
  Hi Peter

       Have clinical trials for this new treatment begun,if so do you know what cities will have participating doctors. I was in the clinical trials for new fill (sculptra) in Miami under Dr Peter Engelhart,who is sadly gone.this product sounds much more perment and would appreciate any info. thanks,Wade
"Who put the pepper in the....Vaseline  ? "

Offline Texgymrat

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #8 on: April 06, 2009, 01:44:19 PM »
Peter:

How did your treatment with Dr. Casavantes go?  Is he seeking FDA approval and what are the differences from the other PMMA treatments done in Tijuana and Brazil?  Thanks.

Offline Peter Staley

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #9 on: April 07, 2009, 12:12:35 PM »
I'm very happy with my recent (and last!) touch-up facial filling, which Dr. Casavantes did (http://www.drcasavantes.com). 

He uses a version of PMMA from Brazil called NewPlastic, which is made by Laboratório Lebon -- a regulated Brazilian pharma company.  It would be up to this company to seek FDA approval in the U.S., and I haven't heard of any plans in this regard.  They have a page on the drug here, but it's in Portuguese, and only loads properly in Internet Explorer.

The reason I chose Casavantes this time was his training in Brazil with an implant technique that bills itself as less risky than the traditional needle injections which Clinic'estetica and others use.

It's called bioplasty, and is best described on his Medical PMMA website here:

http://www.medicalpmma.com/
(click on the "Grafting" link for a description of the technique)

Instead of a traditional needle, they use a grafting device (shown below) with a trigger that injects the PMMA as needed.  Instead of a sharp-pointed needle, which cuts through everything (including blood vessels), they use a "rounded tip microcannula" -- basically a very thin rounded-tip needle with a little hole on its side just below the tip, where the PMMA injects from.



As with my previous PMMA fillings at the Clinic'estetica, the only pain I felt was during the lidocaine injections -- and those aren't fun.  But once my face was numbed up, the bioplasty itself didn't hurt.  However, the sounds of the procedure can be a bit disconcerting -- you can actually hear the microcannula ripping through your skin.

Once the lidocaine wore off, I felt little to no pain (amazing, given how much that needle got pushed around in my face).  It seems that its ability to push aside stuff rather than cut through stuff as it's inserted ends up causing far less damage.  There was definite swelling that was tender to the touch, but this subsided within 48 hours.  The skin also had some yellowing, indicating internal bruising, but this cleared up completely within about 5 days.  I only had one small visible bruise -- less bruising than my previous fillings which used sharp needles.  Even that bruise might have been caused by the lidocaine needle rather than the microcannula needle.

Dr. Casavantes has posted a video of him doing a standard bioplasty procedure -- not for the squeamish!  I'm glad I didn't watch this video before I went:

http://www.veoh.com/videos/v858373NhGGJcZw


Offline YaKaMein

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #10 on: April 08, 2009, 12:56:30 AM »
Peter,
Am happy to hear it went well. I'm trying to encourage someone locally to consider the procedures.
Now, you'll be even more handsome. -YaKa
09/11 Endocrine Consult
08/11 CD4 328 14.9% VL 0
 Disc'd Bactrim DEXA -3.1 Tscore
03/11 CD4 338 14.7% VL 0
11/10 CD4 300 14.3% VL 0 <20copies
07/10 CD4 336 14.0% VL 0 DEXA -2.7 Tscore
03/10 CD4 308 13.4% VL 0 Vit D normal
01/10 Began FOTO
11/09 CD4 274 13.7% VL 0 Chol 173 Trig 131
07/09 CD4 324 13.5% VL 0 DEXA -3.1 Tscore lumbar
03/09 CD4 207 10.9% VL 0
11/08 CD4 227 10.3% VL 0 Chol 176 Trig 156
04/08 CD4 228 9.5% VL 0
01/08 CD4 194 9.0% VL 0
09/07 CD4 176 8.3% VL 0
03/07 CD4 130 9.5% VL 0 Chol 261  Trig 227
12/06 CD4 109 6.4% VL 0
09/06 CD4  88 5.5% VL und desens'd rtd to Bactrim
08/06  Began Atripla
07/06 CD4  59 5.0% VL 145 Chol 117 Trig 104
06/06  Bactrim rash, X2 Dapsone
 EFV & Truvada Chol 128 Trig 131
05/06 CD4  6 (2.0%) VL 78667 only V179D mutation Dx PC MAC

Offline Texgymrat

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #11 on: April 08, 2009, 11:10:51 AM »
Thanks Peter...great information.  Do you have any info on costs for the newer procedure?

Offline Peter Staley

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #12 on: April 08, 2009, 11:42:06 AM »
They charged me $1,375.  However, it would cost more if I had had more PMMA injected.  This was a minor filling compared to my first visit years ago to Clinic'estetica.

Also, this new thread included some news I didn't know -- Clinic'estetica is also using microcanullas instead of sharp needles.  Sounds like the latest craze in face filling techniques.

Offline panda

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #13 on: April 11, 2009, 02:35:18 AM »
Hi,I have so pro questions that means a lot to me due to some bad experience and I will appreciate honst answers - please.

Where is his clinic locate (dr casaventas) ? is he also in Tijuana ? is it somewhere close to Clinica estetica ?
Does he give any guarantee that if after like one month there results disappear- he will do a "refill" on his acconut  ? I mean , I can go there , put everything I have , first it looks good mostly cause it swallow but 3 weeks later its all gone - nothing left . what is happening in this case ?

Are there any leggs, bott and hipps photos I can see ? But I need to see photos for 2 month a head after the treatment .

What is the estimated cost? for bott ? leggs ? hips ?

Appreciate any reply,

Thanks ,

Offline mjmel

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #14 on: April 13, 2009, 08:19:28 AM »
Panda, my responses in bold.


Hi,I have so pro questions that means a lot to me due to some bad experience and I will appreciate honst answers - please.
Sorry that you had a bad experience. I know this will sound odd, but are you absolutely sure your previous procedure failed? Have you waited about 3 months.

Where is his clinic locate (dr casaventas) ? is he also in Tijuana ? is it somewhere close to Clinica estetica ?
Does he give any guarantee that if after like one month there results disappear- he will do a "refill" on his acconut  ? I mean , I can go there , put everything I have , first it looks good mostly cause it swallow ( swollen?) but 3 weeks later its all gone - nothing left . what is happening in this case ?

Your other course of action could be to contact Dr. Casavantes and ask these very questions you pose here. His email is posted on his website. He will answer; give him a few days. Sometimes he is at his other office in another city.
http://www.drcasavantes.com/
Last comment: At first there is swelling. Then, swelling goes down after about a week. With some products it takes 3 months to fulfill optimum results. I am assuming you were told about the 3 months time span. Were you? Do you have before and after pictures of yourself that you can refer to help assess any improvements? Can you ask the folks who performed your prodcedure to send you the ones they have? Again, I assume the clinic you went to did take pictures. What I am getting at here is: (1) wait 3 months
 (2) that you may have had improvements but not as much as you had hoped to achieve with one visit. Usually it takes the initial visit plus a follow-up to fill in those areas that seem to be lacking. It takes two visits to achieve completed results.
Don't expect  guarantees, panda. It would be the exception rather than the rule in cosmetic procedures.


Are there any leggs, bott and hipps photos I can see ? But I need to see photos for 2 month a head after the treatment .

What is the estimated cost? for bott ? leggs ? hips ?


Offline panda

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #15 on: April 13, 2009, 12:55:34 PM »
Thank you so much for your reply ,
Ho yes - I have waited more then 3 month at the time , it only got worst.
At the begining it all looked so good and I was so happy but then later all I was left with was lumps...
I leave very far , I do not have the ability to go for a follow up but I was told the the 1st session will give me a nice look which IT  ABSOLUTELY DIDNT, and I am so frustrated and sad about it.
I didn't expected to be like I was 15 years ago but still , to remain with NOTHING? Nothing at all?  This is why I do expect to get any guarentees... its not fair for me , to come all the way from Israel, endless flight's hours , pay lots of money and then what ?
I wrote Dr CASAVENTAS already , hope he will be able to send me some photos cause at his website, there is nothing u can see except face photos... I want to see bodies photos but u know what? it is very confusing , cause I was also taken photos before and after, the "after" are so impressive BUT the after were taken at the same day, and then few days later, right...what u see on the photo didn't ;ast so what exactly is it worth ?
I just dont know what to do..
Cause I leave in Israel I prefer to do it somewhers in europe so I tried to contact the clinic in Madrid but the dont give me any information , they english is very poor, I asked for some photos , they refused , how can I trust them ? I asked here if there is anyone who did this treatment in europe but so far got no reply so I realy dont know what else to do.

Offline Miss Philicia

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #16 on: April 13, 2009, 01:34:11 PM »
I've long ago decided to accept my disfigured body as part of the Greater Poz Army™ and publicly embrace my "new me" -- I'm ever so wary of all of this eternal picking and prodding of needles of speculative treatments, jaunts to Mexico and Brazil, and extortionary prices for side effects that pharmaceutical companies should be liable for.

I could, should I wish, receive periodic Sculptra injections a mere 2 subway stops from my abode, and for free no less, but I'm just not into it.  Yeah, I've considered it, but in the end I think I'm just going to wear this face as a badge of success.  A big fuck you to the world and to the AIDS stigmata mayhem.
"I’ve slept with enough men to know that I’m not gay"

Offline bubba53

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #17 on: April 16, 2009, 09:52:43 PM »
    Hey Miss P, I can't afford the costly jaunts to South America either,I went through the sculptra route already myself,only they were not free.I'm near the top of their sliding scale and paid almost full price,(they don't last long anyway)but however I would like to be involved in the clinical trials for the new version of PMMA ,I hope that info will be posted.I too wear the battle scars of a long time survivor,and I will welcome a trip to the beauty parlor .  I feel good, and someday I'm going to look good again! Point is, if you can get juiced up with sculptra for free until the PMMA is available ,Go for it !  Be well,Bubba
"Who put the pepper in the....Vaseline  ? "

Offline panda

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #18 on: April 24, 2009, 11:41:08 AM »
Hi ,

I have been lately in touch with Casavanta's clinic ... asking questions ...
I got a real good impression and I justed wanted to know if one of you guys that have did the leggs or butt ... if you have photos for after a month to send my private email address ...
It just .. I need to be sure this is realy work and stay ...

Offline Peter Staley

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #19 on: April 25, 2009, 09:35:53 AM »
Panda -- PMMA is a permanent filler.  I have never heard of someone's PMMA fading away over time.  However, a patient can experience additional fat loss even after getting some PMMA filler, at which point the patient might want more PMMA.  I did this recently, but I could still feel the previous PMMA in my face -- it hadn't gone away.

Most folks I know who have had PMMA fillings in the face have been quite happy with the results over time.  However, some who have it done in the buttocks report being a little less satisfied.  This is largely due to how much filler needs to be injected to obtain a gay man's ideal of a bubble butt.  Since you pay for PMMA by the vial, filling the butt can cost a great deal of money. 

Regardless, the before and after pics you can find on Clinic'estetica's website, where Casavantes used to work (and where they do the exact same procedures with PMMA), will give you a good idea of what PMMA looks like in the buttocks:

http://clinicestetica.com/Gallery/64/#Photo


Offline panda

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #20 on: May 01, 2009, 10:15:20 AM »
Hi , U probably dont know my "history"
I am female , 34 years old from Israel ..
I did already one session of face, butt , leggs and hips 2 years ago of PMMA, the results looked real good while I was there, after i got back home it was still all swollen.. but 2 weeks after, when the swollen gone I was sad to find there was no PMMA left except few lumps, that's all , nothing else ... It was so shocking cause at the begining I looked so goods and I felt like human being again but it lasts only 2 weeks and I returned to be my own shadow..
This is not about few years later but a matter of few weeks later.
This is why I hesitate to do it again , I mean how could I know this wont happen again with CASAVANTE;S treatment ?or maybe there is something wrong with my body ? How am I supposed to know ?
I dont have money now for all the flights, hotel and the treatment, but I realy want to do it and I have to save money for that, the problem is that for the previous treatment it was like throwing away the money, like flashing it i the toilet .. so how can I know this wont happen again ?

Offline Peter Staley

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #21 on: May 04, 2009, 12:38:12 PM »
There's always swelling from these procedures, and once that goes down, you're invariably left with a less full look than when you looked at yourself immediately after the procedure. 

Whether you are happy with the results will depend on two factors I suppose -- how much filler they use, and what your expectations are.

During your consultation, be very specific about what your expectations are -- find some old pictures, and say "make me cheeks look that plump."  Or find someone else's buttocks pics that match what you'd like, and insist on that much filler.

You might have to make more than one trip depending on how much filling you need or ask for.

As I've linked to before, our blogger Dave went to Casavantes, and her's his before and after pics (his after pic was taken weeks after his appointment):

http://blogs.poz.com/dave/archives/2009/02/do_you_think_i_1.html

If you don't see much difference in his before and after pics, then you will definitely not be satisfied with additional PMMA fillings.


Offline mjmel

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #22 on: May 05, 2009, 08:28:43 AM »
Well stated, Peter.
One has to have realistic expectations or returns on money spent.

Mike

Offline panda

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #23 on: May 06, 2009, 12:24:52 AM »
You totaly not understand .. its not about my expactatin,, there was NOTHING left for real. I know its rare but this is what happened with me  , about the link u sent , I have seen this already , nice redults with the face but I see not pictures of leggs or butt.

Offline bobino

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #24 on: May 09, 2009, 01:47:07 AM »
Hi Panda,

For what it's worth, a dermatologist I spoke to who performs filler treatments (usually with Sculptra) told me that he has had a couple of patients who see no results from the treatment.  He had no explanation for why some people don't respond to the treatment.  But it appears that the fillers just don't work for some people.

John
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Offline panda

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #25 on: May 09, 2009, 04:10:34 AM »
Is it mean it wont work if I'll do it again this time at Casavanta's ? I realy dont know what to decide ... Its gambling... I do kmow the pmma Casavanta's usung is the best quality ,

Offline bobino

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #26 on: May 10, 2009, 11:35:43 PM »
Panda,

I wish I could give you an answer, but I can't.  I don't have the expertise, and I don't know anyone who does.  My hunch, though, is that if the treatments at Clinic'Estetica didn't work, then I can't see why Casavantes's treatment would work.  Both are using PMMA, so if you didn't respond to one, it would seem that you probably wouldn't respond to the other.

Why don't you try asking Dr. Casavantes himself and see what he says?  I would hope he'd give you an honest assessment of what you might reasonably expect.

One point of clarification -- are you saying you've seen NO benefit at all from the first treatment?  Obviously, if you have a severe case of lipoatrophy, you'll need more than one treatment to achieve the desired fullness. 

John
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Offline lindogatito2004

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #27 on: May 16, 2009, 06:48:00 PM »
Does anyone know about any trial clinic in USA ? I would appreciate ur help...I can't go to Mexico to get it done. Thanks

Offline panda

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #28 on: May 18, 2009, 12:14:43 PM »
Dear jOHN ,

For your question , no ! there was no benifit at all.
I am in contact with Dr Casaventas's clinic and so far we are getting no where , they keep on asking me for photos and they are also not so sure if they will be able to assit me. I am just so desparate. :'(

Offline Inchlingblue

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #29 on: May 18, 2009, 12:28:45 PM »
I am in contact with Dr Casaventas's clinic and so far we are getting no where , they keep on asking me for photos and they are also not so sure if they will be able to assit me. I am just so desparate. :'(

Since you already went to Cassavantes's office for treatment didn't they take photos of you when you were there? With digital photography being so convenient, I thought most plastic surgeons did this with all patients nowadays.

Offline bobino

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Re: FDA to start clinical trials on Cassavantes's version of PMMA
« Reply #30 on: May 21, 2009, 01:12:17 AM »
Since you already went to Cassavantes's office for treatment didn't they take photos of you when you were there?

She went to Clinic'Estetica.
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