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Author Topic: PMMA Approved In US  (Read 2043 times)

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Offline MitchMiller

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  • Posts: 464
PMMA Approved In US
« on: November 13, 2006, 09:37:44 PM »
I didn't realize ArteFill had been recently approved until this article appeared on Medscape.

FDA Approvals: ArteFill


November 13, 2006 The US Food and Drug Administration (FDA) has approved a nonresorbable dermal implant for the correction of nasolabial folds.

Nonresorbable Dermal Filler (ArteFill) for the Correction of Smile Wrinkles

On October 27, the FDA approved the first nonresorbable, aesthetic injectable dermal implant (ArteFill, made by Artes Medical USA, Inc) for the correction of nasolabial folds.

Unlike currently available dermal fillers, the product provides a permanent support structure for wrinkle correction. The implant is composed of polymethylmethacrylate (PMMA) microspheres (diameter, 30-50 microns) suspended in a water-based carrier gel containing 3.5% purified bovine collagen, 92.6% buffered, isotonic water for injection, 0.3% lidocaine hydrochloride, 2.7% phosphate buffer, and 0.9% sodium chloride.

Approval of the dermal filler was based on data from a double-blind, multicenter, prospective clinical trial of 251 patients who were randomized to receive the test implant or a collagen control (Zyplast, made by Allergan, Inc). Improvements were evaluated using a validated facial fold assessment (FFA) scale (score range, 0 = no folds to 5 = very deep folds with most edges well defined and some redundant folds).

Results showed that whereas mean improvements from baseline FFA scores did not differ significantly between groups at 1 month, patients receiving the test product maintained their improvement at 6 months compared with a return to baseline values for the collagen controls (mean scores, 0.77 vs 0.00; P < .001), an effect that persisted at 1-year follow-up.

Safety profiles between the 2 groups were comparable and consistent with those of other dermal fillers. Adverse events included lumpiness, persistent swelling or redness, and increased sensitivity at the injection site.

Use of the implant is contraindicated in patients who display a positive response to the required skin test, those with severe allergies as manifested by a history of anaphylaxis or history/presence of multiple severe allergies, and patients with allergies to any of the product constituents. It also should not be used in patients susceptible to keloids formation or hypertrophic scarring or for the purpose of lip augmentation.

According to a company news release, a comprehensive training program will be offered to dermatologists, plastic surgeons, and cosmetic surgeons to optimize their use of the product. The implant and skin test are expected to be available during the next 45 to 60 days and are not marketed outside of the United States.

Offline allanq

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  • still life with pills
Re: PMMA Approved In US
« Reply #1 on: November 16, 2006, 07:34:16 PM »
Does anyone know how much ArteFill costs? It would be interesting to compare its cost to that of other PMMA products that are available in Mexico and Brazil.

Allan
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Offline philipba

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Re: PMMA Approved In US
« Reply #2 on: November 17, 2006, 08:24:03 AM »
Hello again!

Thanks to everybody for the wonderful messages you have sent me.  I really appreciate it!

I am concerned about the myriad of doctors who have "jumped" on the PMMA bandwagon.   In one way, this is good because I believe the product is THE solution to lipoatrophy.

HOWEVER, there are two major problems:

1. There are now various formulations available which all carry the PMMA.  Some of these are good, and some unknown.  The addition of bovine collagen accomplishes one major objective:  TO RAISE THE PRICE of the product and enrich those who are marketing it.  The collagen is ultimately completely absorbed by the body and therefore is unnecessary.

2. I feel compelled to point out that doctors in places such as the U.S. and Mexico, who are raking in obscene profits using this product are a blackeye to the medical establishment. Extreme Profiteering through the suffering of others is reprehensible.

Please consider all of your options before having treatment.

I would suggest going to see the PMMA "pioneer" in Brazil.  I don't know of another doctor who is not only the MOST skilled, but also, due to his personal commitment to the HIV community is providing treatment for a little more than his own costs.

In the same spirit, my partner and I have started our non-profit foundation and free service to assist HIV positive patients to find the best solutions without being taken advantage of.

Please feel free to contact me with questions.  That is what we do.


Best,

Philip
email: p461nyc@hotmail.com

Offline chadnla

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  • Relaxed in SoCal
Re: PMMA Approved In US
« Reply #3 on: November 24, 2006, 10:09:19 AM »
I would look for pricing of $5,000 and up depending on locale (in the U.S.).  This is considered a permanent treatment (implant) not a filler so recurring treatments will no need to occur every 3 or 4 months. I've seen some of there results of patients out to 5+years and it does seem to have good results even out that far.
"I do not believe in a fate that will fall on us no matter what we do. I do believe in a fate that will fall on us if we do nothing."

Offline Catman

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  • Blessed with more than 9 lives! + since 1986
    • Who is the Catman?
Re: PMMA Approved In US
« Reply #4 on: March 04, 2007, 12:11:53 PM »
My treatment with PMMA resulted in a $4000 final cost. I've had 100cc's used in two treatments and my last and third session is in April. Three sessions with a six week gap between each so that the swelling goes down and the doc can get an idea where the touch ups are needed to eliminate any gaps. It looks swell and worth every penny. It's price will go up in a few months so take advantage now if you have the money and want to use this "permanent" solution. It is partially approved but I heard than it will begin to be manufactured in the USA and 'that' is when the price will go up a lot! Costs do vary from doctors and the amount the patient needs of the product also varies, so this price does differ among patients. Good luck.

(modified to replace an incorrect letter in a word)
« Last Edit: March 04, 2007, 12:57:45 PM by Catman »
Catman

Meow to the birds
Meow to the tree's
Meow to the end
of this dreadful disease...

Offline mjmel

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  • Posts: 2,069
Re: PMMA Approved In US
« Reply #5 on: March 04, 2007, 12:46:16 PM »
Here is a link to a thread in which this was discussed and questions were posed that were left unaddressed by philipba.....

http://forums.poz.com/index.php?topic=6070.msg118541#msg118541

The cost of Artfill will be expensive, I surmise.  I suppose for the safety net (real or imagined) of being in the US medical system, some clients will pay inflated prices. I just don't understand why philipba has to perpetuate bogus statements like he does. He tries to discredit the clinic in Mexico in this and another thread in this forum.

edited for content and spelling errors
« Last Edit: March 04, 2007, 01:17:15 PM by mjmel »

Offline Catman

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  • Blessed with more than 9 lives! + since 1986
    • Who is the Catman?
Re: PMMA Approved In US
« Reply #6 on: March 04, 2007, 03:09:57 PM »
Well my doc buys his PMMA from Europe and that is why I think I got it at a much lower price than the one I'm seeing posted on this thread. Everything in the USA is more expensive and we the clients suffer the consequences $$$! The product from Europe is called Artecoll and in Canada I believe it is Artefill. The one my doc uses is low on collagen and maybe that's why the price is a little lower. It doesn't even need an allergy test because of the low quantity of collagen.
Catman

Meow to the birds
Meow to the tree's
Meow to the end
of this dreadful disease...

 


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