TOPIC: 125um microspheres and collogen

4johnybravo I will PM you Prof. Lemperle\'s new e-mail ,you can ask him directly ( I have asked him if you can contact him directly ; he said :- he can arrange it for you but he wants to know how much you want ?? These beads are 40 microns as clean as Artefill-microspheres even better ).

Please, update me and good luck.

I will ask Prof.Lemperle if he can contact his friend Dr.C. and inform him about this new pure cheap 20% PMMA product from Germany :-

5000 X prefilled 1 ml syringes @ 20% ( for only $ 7500 I am sure Dr.C. can get it much cheaper than that from Lemperle esp. if he buys a great amount ) this 5 Litre will be enough to do penile injection for around 250 persons (if around 20 ml injected per person) so does that mean each round (e.g.20 c.c.\'s @20%) will cost Dr.C. only $30 or even less than that

I have talked to Dr. sammy passy on the phone and via e-mail for his prices and know the amount of PMMA i need is only affordable thru making it myslef, i have somone who will do the injections for me here in the USA, i just need the product, sammy passys prices are too high, far too high, and for whats in metacril i can make the amount i need at a fraction the cost that sammy would sell it to me for..

Dr.Samy told me before that he sells Metacrill you can try to send him an e-mail and ask him about the cost (it could be cheaper), but I really advise you; you should find a doctor who is expert and well-trained in pmma injection .


N.B. PMMA injection under untrained person can cause disaster (skin necrosis or even pulmonary embolism --> death ; esp if a sharp needle is used)
This email address is being protected from spambots. You need JavaScript enabled to view it.

The easiest way is you can buy Metacrill from Dr. Samy Passy in Rio. , but don\'t forget the most important thing with PMMA injection is the experience of the treating doctor and his technique and the usage of a blunt micro-cannula .

Definitely I would find an experienced doctor to do the injection for me and no one else.

autoclavesporetesting.com/ethylene_oxide_EO_sterilization.htm

This method is not cheap.

So E.O. is the way to go for PMMA, which Ive yet to research ethylene oxide and contact labs that use the gas but, they prolly charge more. I guess its not a good idea to oxidize the pmma beads, but i need a turn key source for sterilizing my two materials, i was gonna premix cmc with pmma in 10ml syringes and have them e-beamed, simple, but now if what your saying about chain linking in polyethylene,and how it may cause chain linking in pmma as well, then I should reconsider e-beam, having to pay one company 410$ to sterilize one thing and another company to sterilize my pmma in E.O. Any E.O. sterilizing labs you know of that are easy on the wallet? I almost do wanna just risk having my premixed syringes e-beam and risk it.. I know i just sounded stupid saying that, but nutek e-beams other peoples pmma in syringes already and it just makes me wanna go that way but i wish i knew to what degree does irradiation Cross link in pmma and to what degree it oxidizes the outer surface of the beads...

I guess if the 500grams of carboxymethylcellulose is in a gas permeable bag then E.O. would sterilize the powder I have.

Smartman, if you HAD to make your own pmma injecatble filler, and already had 500grams of 38-45um pmma beads, and had 500grams of Pharmacy USP grade high viscosity Carboxymethylcellulose powder, and had luer to luer transfer adapter and sterile water for injection, needing to mix them all together, would you premix syringes or have each powder sterilized first them mix and have sterilized? E.O. cannot penetrate a prefilled syringe correct? so itas contents must be out in the open on a tray right?

I never thought needing to mix pmma,CMC,and sterile water into a syringe would be such a hassle but I\'m GOING to stick with it till the end, eventually i get this down and have a turnkey process for myself.... if u would like to move this discussion to email This email address is being protected from spambots. You need JavaScript enabled to view it.. i got my paypal account up and running...$ two head are better than one.

1)) What I ment for muscle augmentation (as you have mentioned too) you need 30% conc. and with this conc. it will give you almost the same texture as muscle and that is what we are looking for and not firmer, BUT if you increase the conc. i.e. >30% e.g. 40-45% i.e. more beads approx. (12-13.5 millions of pmma beads per 1 cc.) ---> you will have a hard collagen which will feel like a bone, of course that is due to the increased number of beads /1cc. which means :- a) the total increase in the surface area of the beads and b) the distances between beads became shorter .

In my case I had 30% metacrill injected in my penis between the dartos and buck\'s fascia, when my penis is flaccid it feels soft (like a relaxed biceps muscle) but during rock-hard erection it feel so firm or to put it in a better way \"hard\" (like a contracted biceps muscle) ---> imo the reason for that is the new collagen and the beads are squeezed between the two fascias during erection.

So back to your Q. :-

\"are you stating that pmma in the bicep would not feel like a squishy gummy bear covered in collagen and that it would feel like a hard piece of bone graft? I several people who say that the pmma in thier muslces doesnt bother them and it feels fine,\"

NO, the 30% conc. in the biceps will feel natural (and it doesn\'t feel like a hard piece of bone graft) it feels just like your muscle tissue softer when the muscle is relaxed and firmer when the muscle is contracted, so as I mentioned before 30% is the perfect conc. for muscle augmentation, (sure it will be injected in the deep spaces).

But with the injection of 40-45% conc. (which it has never be done for muscle tissue augmentation)--> the new collagen will feel a hard piece like bone (imagine that feeling a piece of bone-like in your muscle in a relaxed and in a contracted state).


Sorry, may be it was my fault (may be I have extended my post and I wrote more information as in general about pmma\'s conc.s) so there was may be a misunderstanding .

---

2)) PMMA will be flexible at a temp. of 105 deg.C. and it will melt at a temp. between 160-200 deg.C

A) So as we know PMMA should be sterilized at a low temp. and Ethylene Oxide gas\'s boiling point is 10.73 deg.C. and that was one of the reason they use E.O. gas for pmma sterilization.

E.O. will all viruses, fungi and bacteria (and most important its spores) (but it is a flammable, toxic and carcinogenic)

The FDA\'s recommendation for pmma sterilization is EO (ethylene oxide) gas e.g. :-

PMMA in intra-ocular lens it is recommended to use EO gas

www.dahlgren.in/intra-ocular-lens.html#pmma-intra-ocular-lens

www.expertconsultbook.com/expertconsult/...bn=978-1-4160-3225-0

But the other mean reason why the FDA had recommended E.O. gas and not e-beam for pmma sterilization imo (and it will be the answer for your Q. in regard of the possibility about the usage of e-beam for pmma sterilization) :-

Ethylene Oxide gas is the only method which can effectively eliminate oxidation so it won\'t modify the physico-chemical properties of the product. (as far as I know pmma is a degradative oxidation).

They have found e.g. that gamma and e-beam irradiation can further produce oxidation, even when conducted in the absence of oxygen . and some of these oxidized radicals can activate the macrophages in our body--->the possibility of Foreign Body Granulomas formations.

E-beam can cause crosslinking , chain scission and long term oxidative degradation of polyethylene (many of the chemical and physical properties of the polymer begin to worsen).

And if oxidation process has been initiated, it cannot be interrupted and its rate increases continuously (i.e. during the period of storage and also during the implantation in our body).

So e-beam sterilization of polyethylene is a \"degradation process\".


So the idea of the irradiation during the sterilization of pmma is not only to (the viruses, fungi and the bacteria) but it is also important to avoid oxygen during this procedure and during the storage period of pmma ; thats why the E.O.gas has this property but in the other hand the e-beam has not.

For that reason some orthopedic surgeon introduced Vit.E (an anti-oxidant)for arthroplasty (joint replacement-pmma) to prevent oxidation. (Actually it will reduce it, but it will never prevent it), they also prefer Ethylene Oxide gas (with no oxidation) for the sterilization of joint prosthesis (which contains pmma) more than the gamma or e-beam irradiation (with high possibilities of oxidation to the product ---> modifying its physico-chemical properties)

Ok I see and understand now the surface area being greater with the 40% beads, you explained very well thank you.
Next, about the bio burden question, Ive shot Underground lab steroids many many times, Ive injected my legs \"quads\" hundred of times with needles deeply over a decade and never came close to having the slightest infection, of course i use an alcohol swab as precaution. but i know some of my underground steroids labs gear isn\'t the most sterile and have yet to get an infection after a decade, which now i know is the phagocytes you mention.

2 new questions
Why did you say this? what do you mean by it? \" I am sure nobody would like to have e.g. a piece of a bone-like graft (i.e. from the 40-45% PMMA) in his biceps, lol.
\"
i know Dr. Luis Casavantes and Dr. Morales inject PMMA 30% into muscles for tens of guys every Tuesday in Tijuana Mexico, are you stating that PMMA in the bicep would not feel like a squishy gummy bear covered in collagen and that it would feel like a hard piece of bone graft? I several people who say that the PMMA in thier muslces doesnt bother them and it feels fine,

2, when i get my specially made PMMA back from Nutek Corporation, are you suggesting i wait 2 weeks before having my PMMA injected into my muscles because ethylene-oxide gas left over will tissue and or bacteria and anything else nearby just as it does in the e-beam chamber? this i have not heard of, or at least the man at Nutek didn\'t warn me about a waiting period.
i wish i could find a cheaper place tho to have my PMMA beads and pharmacy grade cmc ebeamed at cause Nutek charges 410$ for 20minutes in the chamber and i Think but am not sure that its 15-20 kilogray, they have a smaller machines that can only fit 14inch wide packages of material in its chamber.

Hi 4johnybravo,

Sorry for the delay and thanks for the nice words.


I will try my best to answer your Q.s as much as I can :-

The most important thing we should know that for an example if you increase the total body\'s surface area of an implant in our body ---> you will increase its strength.

E.g A fenestrated alloplastic sheet implant (e.g. for hernial repair) will be initially softer than the solid sheet implant but later on due to fibro-vascular infiltration through the fenestrations (i.e. which has an increase in the total surface area) will be stronger than the solid one :-

(( [0020]In one embodiment, the biocompatible alloplastic mesh implant is a solid sheet. Woven structures are advantageous, as well as microporous materials. The implant may be fenestrated to allow additional fibrovascular infiltration through the mesh scaffold. The fenestrations may be formed in a variety of geometric shapes and sizes. Initially, a fenestrated mesh implant may not be as strong as a solid sheet implant. However, because of the increased surface area and the potential for fibrovascular infiltration through the fenestrations, a fenestrated implant will ultimately be stronger than a solid sheet implant. The fenestrations may also be used to more securely anchor the mesh implant to the host.))

www.faqs.org/patents/app/20080299172#b

1- First of all we have to know how many pmma beads (e.g.a diam. of 40 microns) are in 10%, 20% and 30% conc. in 1 cc. :-

10% ---> around 3 millions pmma beads / 1cc.
20% ---> around 6 millions pmma beads / 1cc.
30% ---> around 9 millions pmma beads / 1cc.

So that means 1% pmma conc. contains 300,000 pmma beads.

So now to answer your 1st Q. :-

Let us take the 20% conc. as for an example with the 40 micron and 100 micron beads and to have a comparison between these two different sizes :-

First of all we should know that the 20% conc. means it contains :- 20% pmma beads and 80% collagen (or CMC) and it will be the same for either the 40 micron or for the 100 micron bead ( i.e. in volume) so :-

1 cc. of 40 micron @ 20% will have 6000,000 beads, but
1 cc. of 100 micron @ 20% will have 384,000 beads only :-

I will try to explain it much better :- each 40 micron (radius 20) has a volume of (33,510.322 micron3) and in 1 cc (i.e. 6 millions beads) a total volume of (201,061,932,780 micron3) and this total volume of the beads in 1 cc. will be also the same for the100 micron diam. beads @ 20% ; but the volume of a single 100 micron bead (the radius of 50 micron) is (523,598.78 micron3) so when you divide the total volume of the 100 micron beads @20% in 1cc. over the volume of a single 100 micron bead ---> will give you 384,000 beads .

So now the TOTAL surface area of the whole pmma beads all together (and not for a single bead) is the most important point for the amount (the volume) of the new collagen formation .

You have mentioned a single 100 micron bead is more than double the size of a 40 micron bead and it is true also in regard of the surface area :-

A single 40 micron bead ---> has a surface area of (125.664 micron2)
A single 100 micron bead ---> has a surface area of (314.159 micron2)

But the number of the beads as we mentioned before is different in 1cc. ( 6 millions beads of 40 micron @20%) + ( only 384,000 beads of 100 micron @20%).

So the total surface area of :-

1- 6000,000 beads of 40 micron =753,984,000 micron2
2- 384,000 beads of 100 micron =120,637,056 micron2

In summary :-

40 micron beads will give you around 6.25 X MORE total surface area than the 100 micron beads do.

So thats why the smaller micron beads will give you more volume of the new collagen formation and also much firmer than the bigger micron beads.

E.g. if we have two pieces of plexiglas (pmma) with exactly the same size (volume) :- one is divided into 100 of spheres and the other one into 1000,000 microspheres (sure they will be smaller in size than the 1st one) and both implanted into the body after few weeks the 2nd one will give you more volume gain (i.e. the newly formed collagen) and also much firmer.

As you know Metacrill\'s conc.s:-

2% ---> suitable for skin wrinkles.
10% ---> suitable for fat augmentation, i.e. nearly the same texture of fat.
30% ---> suitable for muscle augmentation, i.e. nearly the same texture of muscle.
40-45% ---> for bone reconstruction, i.e. its texture will be the same as bone (it is used for skull bone defect reconstruction e.g. frontal bone defect).

So as you increase the number of the beads / 1 cc.(i.e. as you bring the beads close to each other) ---> it will increase the firmness of the new collagen.

I am sure nobody would like to have e.g. a piece of a bone-like graft (i.e. from the 40-45% pmma) in his biceps, lol.


2- With every transdermal needle stitch through the skin, one will introduce 100s of bacteria, mostly Staph. epidermidis, which are sitting on the undersurface of the skin dandruffs and are never reached by disinfectants .

Furthermore, any injectable is surrounded by macrophages on day 2, e.g. if you introduce bacteria, which you do, they are phagocytosed right away. However, that does not interest the FDA : they want to know black or white : zero or any amount of bacteria.

Because they have read that the UV-light may make cracks in Plexiglas, they forbid UV-sterilization but asked for ethylene-oxide gas, which takes weeks to evaporate from the microspheres.

one question thoe, is 1 100 micron bead is more than double the size of a 40um bead, and the 100um bead make 56% collogen, and the 40um bead makes 80%collogen, wouldnt the equation be

40um+80%=72um cuase 80% of 40 is 32.
100+56%= 156um total in width 56% of 100 is 156.
isnt the 100mcron bead still bigger? it seems kinda so,
I could see that the 80% collogen that the 40um bead produces would make a PMMA injected muscle more squishy and soft and not as rock hard were the filler was placed, but still overall the larger bead is still larger just with mor fibrous tissue growth around it than collogen?

So \"smartman\" i have another Q, what is the safest microbial limit not to be exceeded in a substance meant for bodily injection? i know of a lab that is gunna sterilize this powder ill be injecting, they are using e-beam which sosts 400$, and after they sterilize this powder, and have the lab analyse the powder to do a bioburden count, whats the microbial limit? i know USP <71> states that absoloutly zero, but thats if its an FDA product, but medically speaking you can get away with some microbe and bacteria in a very small number per gram of material, is it somthing like 4 or 5 per gram of powder?

holly cow dude. i couldnt have gotten a more precise answer, i greatly greatly thank you smartman!!!!!!!!!!!!!!! im accualy copying and pasting your answers in a notpad file to save on my pc. DANG GLAD I CAME HERE!

I did find it for you it was written by Prof. Lemperle :-

The smaller the microspheres (to the threshold of phagocytosis),the larger the combined surface area in a given volume and the greater the total amount of new collagen formation.

E.g. :- A microsphere size 100 microns will give you only 56% new collagen.
In the other hand 40 microns will give you 80% new collagen.

escholarship.org/uc/item/45b4s0jb#page-4

Hi 4johnybravo,

Actually the larger the diam. of the pmma microspheres (i.e. >60 microns) is in the opposite will give you a less collagen gain than the smaler ones (i.e.30-50 microns) per surface area.

And I am 100% sure about that and I have read it in an article I will try to find it for you.

A size <20 microns can be phagocytosed by the macrophages ---> migration and also foreign body granuloma formation.

So they found that the optimal pmma bead\'s diam. which can form the maximum amount of collagen formation and cannot be phagocytosed by macrophages was between 30-50 (and never larger than 60 microns) i.e. these pmma beads are 4-5x bigger than the red blood cells and white blood cells.

And also the reason for choosing this size of the pmma bead is their diam. are bigger than the diam. of the subcutaneous blood vessels so to avoid implanting these beads into blood vessels---> emboli.

Thats why Prof. Gottfried Lemperle found :-

1- As mentioned above for sub-dermal and subcutaneous space he chooses the diam. (e.g. 30-50 microns) because this size will be bigger than the diam. of the blood vessels and the lymphatic channels in this area.

2- For the treatment of reflux esophagitis, urinary incontinence and fecal incontinence he found that he has to form a bigger size of the pmma bead\'s diam. i.e. bigger than the diam. of the sub-mucosal vessel in these parts of the body and he found the diam. of 125 microns is the safest and the best to avoid any implantation of pmma beads into these vessels (G125, I125 and F125):-

www.ascentxmedical.com/technology-platform/technology-overview/

In summary:-

The 30-50 microns beads will give you more collagen formation than the larger (>60 microns) beads per surface area.

The volume of the new collagen formation will depend on the volume of the injected pmma\'s product into our body.

The firmness of the new collagen will depend on the concentration of the pmma.

yes dr. c uses metacrill which under microscope and not going by what the metacrill website say has a micron bead ranging in size from 30 to 60um. i know metacril VERY. but if anyone can chime in on collogen and larger diameter spheres it would be appreciated, ive messaged dr gotfried lamperle on facebook but i doubt he ever checks his face book, i know he could answer my question,

According to Dr C, he used 30% PMMA on his arms and for his patient\'s muscles...He never mentioned to me if the size of the spheres were any larger than other concentrations that he uses for the penis...Not much help, but FYI...