TOPIC: Infections, Complications, Risks of PMMA?

@skatezy - I rounded up the 1.4% (2/145) from the initial Artefill FDA presentation. I agree that the evidence suggests that the Newplastic numbers are likely much higher I don\'t want to get hung up on a debate on the exact number.

The important point is that if all 200 members on this forum had Newplastic PMMA, 4 of us are likely to get granulomas. Now maybe it is 10 to 20 like Arteplast or maybe only 2 or 3. It is important that the 2 or 3 or 10 or 20 brothers on this forum understand what they may be up against if their number is called!

@eqstudent
I noticed you referenced in one of your earlier posts the Caldellas study:http://www.ncbi.nlm.nih.gov/pubmed/20601571
In that study, ALL 21 of the patients had granulomatous formations with PMMA.
I am wondering why you pegged the risk of granuloma formation then, in an earlier post, at about 2 in 100? What am I missing? That is indeed a discouraging study.

smartman wrote: ... why is he using another permanent product which can cause the same serious complication?? ...

This is the kind of question which you clutter this and other thread with which leads me to question your motives or understanding of this subject matter. Ask him not me! Quite frankly the answers are just not germane to this discussion, but pick one of the following:1) He believes that Silikon has a much lower complication rate for some procedures2) He believes that Silikon is an appropriate risk/reward solution for HIV wasting3) He believes that Silikon is overall safer than Artefill/Artesense for HIV patients4) Silikon is more cost effective for the volume required for HIV Wasting.How does this help with understanding the issues in this thread?If you don't believe that granulomas is a serious complication just say so and move on.

skatezy777 wrote: Sorry, eqstudent, is the attached paper in support of your argument that Carruthers has done a 180 and is now against Artecoll? It seems in the paper to suggest that the method is safe, and that the late onset granulomas have responded successfully to treatment.

That was one of his initial reports in 2005 when he was one of the biggest proponents of Artecoll and one who suggested that the granulomas were rare and easily managed with steroid therapy. Compare with his more recent statements including ones here:http://www.entrepreneur.com/tradejournals/article/135215598.htmlAlthough a 2003 publication cited just 15 cases of delayed granulomatous reactions worldwide, he has seen at least 8 cases in Vancouver alone, including one in a patient he personally injected with the permanent filler.Another patient injected 3 years ago by another physician has not responded to numerous therapies, said Dr. Carruthers.\"I\'ve spent a year and a half treating her with everything I can think of to throw at her,\" he said.A Vancouver colleague has spent a similar length of time treating a patient with a delayed granulomatous reaction, \"and she is not responding well.\"

@eq
In this study he mentioned :-
Practitioners will need to learn how to use this exacting agent and will obtain excellent results with careful use.
Background. Polymethylmethacrylate microspheres/collagen has been used in Canada since 1998. A closely related product will probably be approved in the United States shortly. Concerns have been expressed about the use of permanent fillers such as this.Objective. This retrospective study of the authors\' clinical practice is designed to reflect their experience with this agent. In particular, the authors describe some of the problems they have seen.Results. Polymethylmethacrylate microspheres/collagen has behaved as a satisfactory long-term tissue augmenting agent in the authors\' practice. They have had the opportunity of managing any number of patients with Artecoll granulomas and describe these patients.Conclusion. When polymethylmethacrylate microspheres/collagen is introduced to the United States, practitioners will need to learn how to use this exacting agent and will obtain excellent results with careful use.
So he emphasized the doctors should be well trained for any permanent filler (e.g.PMMA) ---> to reduce the risk of any complication. As far as I remember he mentioned also PMMA granulomas disappear after 3-5 years by itself ! (Carruthers)
BTW he was talking in this study about Artecoll and not about Artefill
About what I have mentioned \"Silicon oil injection\"(a permanent product) that he is using in HIV-patients with facial lipodystrophy and also the chance of FBG formation from it , I think it is important point because he mentioned as you said FBG is a serious complication from any permanent filler.
So we know FBG can happen with any fillers (including pmma) so I am only wondering if FBG is a serious complication?? why is he using a permanent product which (not FDA approved for HIV-Patients as a facial filler) can also cause this serious complication as he stated.
I have never said there is no chance of FBG formation from PMMA injection , but the thing I and also most of us here want to know if FBG is a serious complication from a permanent filler (as you have mentioned before:-It's very clear that the medical community certainly considers granulomas a very serious complication of permanent fillers (PMMA). Even the staunchest proponents of Artefill considers granulomas a serious complication, some like Alastair Carruters who were amongst the leaders in championing Artefill have since done a 180 based on the number, severity, and treatment efficacy of real world granulomas. www.entrepreneur.com/tradejournals/article/135215598.html why is he using another permanent product which can cause the same serious complication?? Do you still think I should not bring the topic about Silicon oil injection he is using ??
And I think it is a great idea what you have mentioned :-\"I think it is a good idea to start a new thread comparing the risks and complications of the different enlargement methods if that is your goal. I would certainly be interested in reading any real data posted in such a thread.\"
I will do my search and I need your help and the others too --> to find a product (for penile girth enhancement) which has:-1-The lowest risk of any complication.2-Permanency.3-The best aesthetic result.4-Lower cost.

Sorry, eqstudent, is the attached paper in support of your argument that Carruthers has done a 180 and is now against Artecoll? It seems in the paper to suggest that the method is safe, and that the late onset granulomas have responded successfully to treatment.

@smartman ' most of your questions posed to me are either rhetorical or need to be addressed to Dr Carruthers. I have no idea why his info on Silikon usage for HIV wasting has any bearing on this discussion of PMMA granuloma complication. The key point on Carruthers is that he was a huge Artefill supporter and now years later after the real patient experiences with late onset granulomas he seems to have done a 180.I think it is a good idea to start a new thread comparing the risks and complications of the different enlargement methods if that is your goal. I would certainly be interested in reading any real data posted in such a thread.

@smartman

Well done! An apples to apples comparison is what we are all after! Being aware of possible or foreseeable complications is always to our benefit as well as potential remedies. Thanks for the contribution!!!

There are no data on patients under chemotherapy. And as far as I know encapsulation is no immune reaction but wound healing ! Mikehok you are right , the only theoretical risk I think, would be a little less granulation tissue formation in these patients, e.g. a little harder implant. Encapsulation of microspheres is fibroblast activity - and this maybe slightly delayed under chemotherapy

With regard to my chemotherapy question, I wasn\'t really thinking it could cause FBG, quite the opposite. As I understand it the PMMA is mostly held in place by fibroblasts/collagen but there are also some macrophages at the scene ? I wonder if perhaps the fibroblasts would remain unaffected but not sure about the macrophages ?

I read a paper from Germany where they have successfully treated FBG after Artecoll injection in a 61 lady\'s forehead with Allopurinol (which is used to treat hyperuricemia i.e. gout disease and cutaneous sarcoidosis) so this drug eliminates the need for painful intralesional corticosteroid suspension injections and avoids disfiguration due to excision.
archderm.ama-assn.org/cgi/content/full/139/1/17
@eq
Also they have mentioned about the relationship between injecting PMMA superficially and FBG formation :-
Some authors interpret foreign body granulomas as a low-grade chronic inflammation in the sense of a usual second response to implantation, which would be clinically invisible after strictly subdermal injection and only accidentally diagnosed by histologic examination.12-13 In addition, superficial intradermal implantation itself may lead to granulomas.2-3 Furthermore, undesired dislocation of the subdermally localized implant to more superficial skin parts'especially of the forehead because of its frequent muscle movement (my Q. is could it happen also in the penis \"frequent muscle movement\" ???) 'should be discussed.Investigations of intradermal models of guinea pigs demonstrated transepidermal elimination that began as a movement of the PMMA beads toward the epidermis.
Also they have mentioned in regard of FBG formation :-
- some of the PMMA particles were smaller than 35 'm in diameter.
- presumption that degradation of the microspheres due to local enzymatic activity or aggressive metabolites causes foreign body granulomas requires further, predominantly long-term, investigations.
- a correlation between the quantity of the implanted material and the incidence of foreign body granulomas.
As I have said before we should have all the information about PMMA (the good and the bad) but we have to compare its complication with other penile girth procedures ????

@eq,
www.facialwasting.org/products.htm

They mentioned :-
- We also have noted from the clinical experience that NewPlastic' does not seem to produce granuloma formation when grafted sub-facially in the Nacul/Casavantes technique.

- We were unable to trace any reported complications or adverse reactions from Dr. Serra's approach or PMMA products. However the clinical and preclinical research of Dr. Gottfried Lemperle, an expert on PMMA formulations and professor at the Universityof California in San Diego, suggests that there are greater incidents of palpable nodules and granulomas when PMMA is injected too superficially. One correspondent, a physician from Miami has reported minor and non-troublesome granulomas as a result of treatment with the subcutaneous approach. In general, people This email address is being protected from spambots. You need JavaScript enabled to view it. who have traveled to Rio de Janeiro to use his services are generally pleased with the results.
I will try to get you more information about that.
Also you have mentioned :-
\"Even the staunchest proponents of Artefill considers granulomas a serious complication, some like Alastair Carruters who were amongst the leaders in championing Artefill have since done a 180 based on the number, severity, and treatment efficacy of real world granulomas.\"
www.entrepreneur.com/tradejournals/article/135215598.html
Dr. Alastair Carruthers mentioned about the chance of FBG in the permanent filler \"Artecoll\" . In Dr. Alastair Carruthers\'s web-site :-
www.carruthers.net/services/soft-tissue-fillers/silicone-oil/
He mentioned that he used silicon oil injection (silikon 1000) in volume enhancement for HIV-patients in Vancouver. Silicon oil injection (Silikon 1000) is FDA approved only for eye procedure and not for soft tissues enhancement in HIV-patients ( it is like Artefill it is FDA approved for e.g. Naso-labial fold injection and not for HIV-patients.
So if he is worried about FBG from Artecoll so why he is using Silicon oil injection (permanent) which can also cause FBG???
As he mentioned he is worried from the serious complication of FBG ???
Silicon oil injection :- has a potential site of infection. A number of late infections, granulomas, and palpable masses have been reported following silicone use.
So why he is using something (like silicon oil) which can cause also FBG like Artefill or Artecoll ? strange ??
Is it because that Artecoll is more expensive than silicon oil in Canada??
Or is it because he is using silicon oil injection in deeper injection (volume enhancement in HIV-patients facial lipoatrophy) and Artecoll for wrinkles treatments ???

@mikehok - that is a really great question. Since we know that antimitotics like 5FU are used to treat PMMA granulomas and reduce lumps it is reasonable to assume that the newer more powerful chemo antimotic products delivered systemically could deteriorate the encapsulating tissue.

eq just read the interferon report. Coincidentally I was wondering the other day whether chemotherapy could have any effect on the tissue encapsulating the PMMA. Any thoughts ?

@smartman ' I have seen that idea that the granuloma frequency will be lower in deep injection sites such as the penis or butt posted on this site. Could you post any data or study which supports that conclusion?Note in the full Salles Case Review pdf I attached above showed granulomas in the Gluteus and Abdomen of 3 of the 10 cases reviewed.Interestingly the other 'Artecoll Inteferon' pdf I attached showed the microspheres having distinctive changes in their smooth surfaces and infiltration into surrounding tissues which is something I had not seen before (Fig 2, B and C)!