Heard of PMMA (Medical Grade) OR Dr Casavantes?

[Skeptical One]

eqstudent

Would you mind detailing the correspondences with the doctors you spoke to regarding PMMA, its efficacy, and its safety record? Thanks.

Obviously Artefill has been used in the States, what I was trying to say was that it has not been used broadly due in part to costs, and in part to misinformation. If there are some who have access to Artefill at significantly reduced costs, that is news to me.

The point isn't whether contacting competent doctors is in order, the point is that those who are clearly void of the (appropriate) details concerning PMMA are most inclined to speak out. Or so it seems.

[eqstudent]

dd72 Another excerpt from the Cohen Commentary

"Second, it is critical for physicians to differentiate
one PMMA implant from another, as they have markedly
different EM appearances, which are probably related to
their biologic behavior in humans. For instance, Arteplast,
the first-generation PMMA implant from Suneva Medical,
Inc., is vastly different from ArteFill, the third-generation
iteration of Arteplast. Newplastic looks more similar to
Arteplast, which was known to have a high rate of clinically
relevant granulomas."

IMO, NewPlastic which is used by our guy Dr C., appears to be more like the first generation ArteFill grandparent product with likely higher granuloma rates and small non smooth particles which have a greater potential for migration and more serious complications!

[smartman]

eqstudent,

(( One point which I have not seen posted here is that ArteFill and NewPlastic are very different. Some of the improvements that ArteFill achieved over the problematic Artecoll (including smooth similar sized microspheres) do not appear to be in NewPlastic.

Please see Aesthetic Surgery Journal 30(3) I have posted a short excerpt

“ArteFill is distinctly different from Newplastic. The spheres are more uniform and there are virtually no nanoparticles. ArteFill is a material made of 80% bovine collagen and 20% smooth PMMA microspheres ranging in diameter from 30 to 42 microns, mixed with 0.3% lidocaine. Newplastic, on the other hand, is a suspension of 30% PMMA microspheres in a nonimmunogenic solution made with hydroxicellulose, methylparabene, propylparaben, and water. Included are images (Figures 1 and 2) showing the electron microscopy (EM) differences between Newplastic and ArteFill…” ))

I have mentioned before that the carrier (the vehicle) in Artecoll and Artefill (bovine collagen) are different from Metacrill and Newplastic (cellulose), in the first two you need to have a skin test one month before the procedure ( a chance of bovine collagen allergy) but in the other two as we know no need for skin test. But if we ask ourself why they use bovine collagen and not the simple hydroxicellulose in the 1st two products ?? The answer for that is you need a stronger and heavier carrier (e.g. bovine collagen) to carry these microspheres in a better way and I think it will distribute the beads in a more even way in the injected area . BTW the cellulose will be absorbed much quicker (as far as I remember within 24-36 hrs) than the bovine collagen .

Also Artefill+the other new products are better because their beads have a smoother surface and not electro-static (the older pmma products their beads have irregular surface+more electro-static ---> a chance of granuloma formation)"Lemperle" .

I had
1) Artecoll in one side of my face (due to old trauma) cheek bone augmentation in 1996 ( I had skin test on my arm one month before the procedure ) by Prof. Lemperle in Germany (so it is now 15 years ) .

2) Metacrill penile injection (2008+2009) in Brazil (so it is now 3 yrs from the 1st session) .

Thank god I have never experienced any complications (no infection+no granulomas what so ever ) the new collagen feels like part of my body's tissues .

[smartman]

eqstudent,

It is true in Arteplast (the old generation of pmma) there was a high rate of granuloma formation, Lemperle had succeeded and he found the reason for that (as I mentioned before irregular surface+electro-static beads) so he made more smoother surface and not electro-static beads -->reduced the chance of granuloma formation e.g. Artecoll+Artefill .

Artecoll+Artefill sure they are better than Metacrill+Newplastic , but I am sure Newplastic doesn't look similar as Arteplast because I have asked Lemperle in the beginning of 2008 after my alloderm experience (2007) about pmma penile injection in Brazil that I read in the internet and I reminded him that I was his patient in 1996 (Artecoll) and I have asked him to give me some doctor's names whom he trust and about their pmma products he told me the most experience doctors with pmma injections (in his opinion) are Dr.Samy Passy in Brazil (metacrill) and Dr.C. in TJ (newplastic) for penile bioplasty, of course he mentioned Dr. Marcio Serra in Brazil but he doesn't do any penile injection. He told me I trust these doctors and their results and he told me also I can go ahead with either Metacrill or Newplastic (sure he said they are not as good as Artefill but they are ok esp.if you have the injection by anyone of these experience doctors). Believe me if you meet Lemperle surely you will say that he is a nice gentleman and very kind to his patients and he will always try to help you, and if Newplastic looks similar to Arteplast sure he would tell me not to do it. But I could send him an e-mail and ask for his opinion.

[eqstudent]

Jun 27, 2011 15:50:17 GMT -5 smartman said:

... but I am sure Newplastic doesn't look similar as Arteplast...

I am just quoting what Dr Cohen who is on the Advisory Board for Artefill's parent company wrote.

aes.sagepub.com/content/30/3/438.full

[smartman]

I have just sent an e-mail to Lemperle .

[supa]

Excerpts from "The Polymethylmethacrylate Effects on Auricle Conchal Cartilage : Report of 21 Cases" (Aesthetic Surgery Journal 2010 30: 434):

This research project was approved by the Bioethics Committee on Human Research from Pedro Ernesto
University Hospital (HUPE) and all procedures were carriedout at the outpatient surgical facility at Rio de Janeiro
State University. All patients admitted to this study signedan informed consent about both known and potential side effects of PMMA before the injections were administered.
The medical records of 21 patients (14 women, seven men; age range, 18-77 years) admitted to our institution
during a 16-month period between 2007 and 2008 were retrospectively reviewed. All patients were clinically diagnosed
with prominent ears on the basis of physical examination. Patients with immunosuppression orlocal infection were excluded from this series.
Each patient’s skin was prepared with 70% alcohol andsterile gloves were worn during the procedure, respecting
the principles of asepsis and sterile technique. Local anestheticof 2% lidocaine was injected as a wheal, after which each patient received 0.2 mL of Newplastic injected
through a 27-gauge microcannula immediately over the conchal cartilage retroauricularly in the right ear. The time interval from Newplastic injection to surgicalexcision through an otoplasty ranged from 180 to 450days. Each patient underwent the same excision procedurein the interest of safety, completely removing the Newplastic injected previously. The conchal cartilage was
excised en bloc with the overlying skin (Figures 3, 4). Thesample was kept in formalin and then submitted to histopathologic analysis.

According to Lemperle et al, the microspheres are not
phagocytized because their diameter is greater than the
phagocyte diameter. Consequently, migration should be
prevented, preserving all of the material at the infiltrate site.
In this study, however, we observed microsphere phagocytosis
in 100% of the patients, which directly contradicts
these findings and highlights the possibility of migration..
Our findings support the observations of McClelland,
confirming potential phagocytosis, especially with particles
smaller than 35 microns, which make up the majority of
particles in the Artecoll implants. Therefore, migration and
phagocytosis is a distinct possibility. It also corroborates the
results from a study by Rosa et al,10 who showed absorption
of PMMA particles in mice.
Despite the fact that the mean size of Newplastic’s
microspheres is cited as 40 microns, the phagocytosis in
100% of our samples demonstrates the possibility of its
diameter being smaller than 35 microns and consequently
capable of migration. The active fibrosis phase seems to
be complete in four months, and a stable architectural
structure is achieved within six months,1 so we chose a
six-month time interval from injection to excision to reach
the minimum necessary period to achieve this stable
structure. However, there are reports of granuloma formation
even 10 years after foreign material implantation.11
Despite the 315-day mean duration of our Newplastic
implant period, the granuloma incidence among our
patients was 0%. There was a unique case of a myxoid
degeneration of the cartilage that happened only six
months after the filler injection, showing that mild skin
reaction and the short duration of exposure to the material
did not prevent cartilage degeneration.


Conclusions
[After injection and excision of PMMA over the conchal
cartilage in 21 patients, microsphere phagocytosis was
found, which brings into question its permanence.
Based on our data, the possibility of migration exists,
but further studies are necessary to fully assess the
implications of our results. Our study also showed that
there was formation of a thin fibrous net, which should
help to maintain the material at its infiltration site.
Likewise, there was no material extrusion during the
evaluation period.
The minimum chronic inflammatory infiltrate did not
cause any perichondrium or cartilage alterations in 95% of
the samples; however, in 5% of the samples, thickened
angiogenic areas with mild myxomatous degeneration
were formed in the adjacent cartilage. There was no association
between the incidence of tissue alterations and the
mean length of PMMA injected into the conchal cartilage.
Thus, the potential consequences of PMMA application
adjacent to cartilage cannot be predicted over time, and
the possibility of myxomatous cartilage degeneration is a
serious risk to the patient with the potential to cause permanent
deformations of the cartilage skeleton.

[Skeptical One]

Jun 27, 2011 16:49:31 GMT -5 supa said:

After injection and excision of PMMA over the conchal
cartilage in 21 patients, microsphere phagocytosis was
found, which brings into question its permanence.
Based on our data, the possibility of migration exists,
but further studies are necessary to fully assess the
implications of our results.

Interesting, does that suggest that the bottom range for New Plastic particles dip below 35 microns? I understand 40 is the average quoted for New Plastic (which should prevent phagocytosis), but it appears, according to this article, that such risks are prevalent with smaller beads (below 35 microns ??).

I'd definitely like to get Dr. C's take on this since he uses the product quite frequently. Their office reports no migration issues so I wonder what it is about their approach or application that might alleviate or eliminate the risks suggested in the above article.

[eqstudent]

@s.O. from Dr Cohen Commentary Article

"Prior studies of Artecoll indicated that microspheres
larger than 20 microns are not readily phagocytized.2 If
one examines the EM photographs of Newplastic and compares
them to ArteFill, one can see there are numerous
nanoparticles and irregularities of sphere size and shape
in Newplastic, which may explain the findings of phagocytosis
in 100% of specimens."

Again I would recommend getting that issue or just Dr Cohen's article. The EM pictures very clearly show the difference between ArteFill PMMA and NewPlastic PMMA!

In case it is not clear supa has posted excerpts to the article that Dr Cohen has commented on in the same journal issue! Thanks supa

[Skeptical One]

eqstudent

thanks for clarifying that, I'll be reviewing the entire journal article tonight.

It is also good to note that this article was in 2010, making it very recent and even more relevant.

[dd72]

I just talked to wade and he said that the beads are 40-60 microns. He also said in another study they compared it to artifill and it was very similar. Ofcourse his opinion is bias being he's in the retail side of new plastic pmma. But he said he will double check and get back to me. It's very disheartening if it's true it's similar to arteplast. It being a dynamic organ its prone to more risk and complications.

[supa]

I might be able later to paste in this thread the EM pictures of Cohen's article.

By the way, which source states that 40microns is the average diameter of Newplastic's particles? Cannot find it on the website of the manufacturing company: www.biomedical.med.br/site/en/default.asp

[supa]

Moreover guys, at the cost of sounding like an anal stat teacher (I am not), two parameters are necessary (and sufficient) to caracterise the size of the particles (under the reasonable assumption of gaussian distribution, which I am confident would be confirmed by carrying out a standard statistical hypothesis test on a product's sample):

1) the mean (i.e the average)
2) the standard deviation

According to basic statistics, even if the mean were actually 40 microns, administered samples could contain undesirable amounts of tiny particles if the standard deviation is too high.

With an analogy: at school you might be only concerned with your average mark of your assignments, say it is B. But it is not the whole story. In particular, here, at our "phalloplasty university", we are also concerned on how many Grade C you scored, even if they are sort of conceiled in the output of the averaging out process.

[capital]

Very interesting article indeed. I have no medical background but if I am right, this paper focuses only on the risk of phagocytis and migration (no signficant problem with granulomas in this very limited experiment). They also notice the formation of a thin net that might prevent this risk to some extent.

So the question is: what is the risk associated with a partial phagocytis of the particles and what kind of migration could be expected, in the area of the penis?

@ep : how is your redness now? Do you notice any change? Did you get an answer from for Dr. C? I hope it's not anything serious.

[capital]

supa : that's what you can read on the Newplastic website ( www.biomedical.med.br/site/en/processo.asp) :

"Newplastic consists of solid polymethilmetacrilate microspheres of smooth surface suspended in hydrogel. Looking for quality excellence in raw materials, a selection and purification process of the PMMA microspheres was developed so that they have a standard medium size of 45μ. The size of the microspheres avoids phagocytosis, for particles smaller than 30µ can be phagocyted by macrophages"

It would be interesting to know what kind of selection they make to avoid nano particles...