Re: PMMA injections with Dr. Serra in Brazil

[Guest guest]

OK this sounds great. But can you please bring me up to speed what is PMMA and what is the cost of the service. I am excited for you and can't wait to hear all about it.

from facialwasting.org (I wonder how many people read my web site)

Microspheres of polymers. Microspheres of polymethylmethacrylate (PMMA), hydroxyethylmethacrylate (HEMA) and ethylmethacrylate (EMA), with diameters in the ranges 20 µ to 40 µ or 40 to 60 µ, placed in a gelatin suspension or solution, a collagen solution or a hyaluronate gel. HEMA and EMA are not used as much anymore. PMMA has 10 years of research in humans. In addition, in some cases the vector used is once again a collagen of bovine origin (in Brazil, the vehicle used is a cellulose solution- hydroxyethylcellulose.)The desired material is an implant allowing controlled resorption. The aim would be first to find a type of implant offering a resorption period of one year in order to allow possible cosmetic adjustments. PMMA has been used successfully by Dr. Marcio Serra in Rio de Janeiro- Brazil (mserra@... or mserra@... ) with over 223 HIV positive patients for over 3 years. The cost for the entire procedure in Brazil is $500 (two sessions needed.) Dr Serra does the implants in the subcutaneous (sub-dermal) area to avoid granuloma formation. No long-term safety data are available. The trademark in Canada (and soon in the US) for PMMA is Artecoll. Another PMMA product is Metrex. Anecdotal reports from patients who obtained one session of Artecoll in Canada are not very encouraging (Artecoll may need more than one session.)After an interview with Dr. Gottfried Lemperle, one of the researchers of Artecoll, it was informed to me that some doctors are very conservative about injecting too much product since it can not be removed after its application, so one session is not enough is most cases.More information about Artecoll can be found at www.artecollusa.com or by emailing glemperle@....Doctors using Artecoll in Canada for HIV lipoatrophy: Dr. Alastair Carruthers in Vancouver and Dr. Kent Remington in in Calgary, Dr. Beninger, Dr. Sheldon Pollack and Dr. Middleton in Toronto, and Dr. Schwartz in Montreal ·Polylactic Acid (New Fill) Sculptra in the US – or PLA – (http://www.new-fill.com/Page/Anglais ) www.Sculptra.com is a biocompatible, bioabsorbable synthetic polymer belonging to the family of aliphatic polyesters. Its safety is an acknowledged reality, as is shown by the toxicology studies and a range of medical and surgical applications over a number of years (rheumatology, reconstructive traumatology). Its bioabsorbability is well established, and its resorption is controllable, verifiable, open to modulation to satisfy various criteria, and reproducible. After several months of experience since the product was first mentioned at the 2000 Lipodystrophy Conference in Toronto, it seems that it takes 3-5 sessions for moderate facial wasting, and 6-7 for severe facial wasting. Touch ups are needed after a year. For a list of US doctors using this product, go to http://www.thebody.com/tpan/septoct_01/new_fill.html (prices in this web site are no longer valid.) Dr Doug Mest in Los Angeles is one of the top US doctors using Sculptra. His ocntact information is: Blue Pacific Aesthetic Medical Group 1301 Manhattan Ave #201 Hermosa Beach, CA 90254 www.bpacific.com R Mest (drmest@...

Sculptra is now approved for HIV facial lipoatrophy in the US. For more information, visit www.Sculptra.com

Dermik, the company that owns the rights to Sculptra in the US, is setting up a patient assistance program. Read more in their www.Sculptra.com

If your doctor is trying to get your insurance company to pay for Sculptra, you can use this letter of medical necessity to be sent to the insurance company : http://health.groups.yahoo.com/group/PozHealth/message/8047

.. Polyalkylamide gel (Bio-Alcamid): This product has been used in Italy for 6 years as gel type prosthesis in plastic surgery without major complications. I started hearing about it at the beginning of 2001 from patients in Los Angeles and San Diego, who were reporting great and durable results with only 1-3 sessions, so I decided to investigate it. Everyone had gone to Clinic’estetica in Tijuana to get the procedure done by Love, who has been in that business for 9 years and had trained cosmetic surgeons from the US. A presentation at the ECLMS conference in Marbella, Spain (April 2002) made by Dr. Arevalo showed good and lasting results in over 100 patients in the past 3 years. One to two sessions were needed to correct most cases. No “touch ups†are needed unless lipoatrophy continues. It seems that two of the advantages of Bio-Alcamid is that it can be removed easily if too much product is injected (just like a "pimple") and large quantities can be injected (ideal for buttocks also)without an immune response. The manufacturer sent me an email to ensure that I did not confuse this product with polyacrylamide gel since they believe polyalkylimide is a lot more stable than polyacrylamide gel (there have been reports of bacterial contamination of polyacrylamide gels from Russia.) Presently, the only source of this product in North America is Love at http://www.clinicestetica.com/ . The average price for a full restoration job is $3500-$4500 plus travel expenses (two to three trips). Pictures of different applications (implants in different body parts like buttocks, face, chin, nose, biceps, etc) can be found in the Italian web site http://www.bioalcamid.com/index2.htm . You can also find information at www.polymekonresearch.com and www.polymekon.it

__________________________________________________________________________ The following information was provided by Nuovo Sciences, Corp., representatives of Polymekon in the US :What is BIO-ALCAMID®

BIO-ALCAMID® is an injectable endoprosthesis. The innovation lies not only in the fact that it is a synthetic biopolymer (comprising 97% apyrogenous water; the remaining 3% is polyalkylimide based), but above all in its unique features it combines all the requisites necessary to obtain an optimum implant, i.e.: 1. The implant is biocompatible with the tissues. 2. It is non-mutagenic. 3. It is non-allergenic (does not require any test). 4. It is radio-transparent (a necessary and fundamental requisite for making a differential diagnosis between the implant and the various types of tissues). 5. It is permanent (it is not re-absorbed and is therefore classified as a Class IIb Medical Device). 6. It is easy to remove (absolutely new for an injectable implant). 7. It does not migrate. 8. It remains chemically and physically stable (does not release monomeric units). 9. Its consistency is similar to that of the tissue into which it is implanted (it is almost imperceptible to the touch as it comprises 97% apyrogenous water). 10. Considerable quantities can be implanted (even more than 500 ml! A unique feature for any type of implant). These features make BIO-ALCAMID® the first injectable water endoprosthesis for soft tissues.INDICATIONSBIO-ALCAMID® is an injectable medical substance specially created for filling soft tissues; it must therefore be used for correcting congenital or acquired deficits of such tissues. Due to its high degree of biocompatibility and its permanent effect, BIO-ALCAMID® is recommended also in cases of significant deficits: such as facial hemiatrophy, severe tissue deficits as in the case of Poland syndrome, Pectus Excavatum, etc. However, it is not recommended for correcting fine wrinkles and for filling the mucosa (lips) area. HISTOLOGICAL DATAIn order to evaluate the biocompatibility of BIO-ALCAMID® biopsies were done on mammalian tissues for over five years, with controls carried out from the third day for up to more than a year following the implant. The results showed a high degree of biocompatibility, with minimum inflammatory response, only slight edema, and regular neutrophyl response in the period immediately following the implant. Macrophagic migration begins later and, after about fifteen days, a very thin connective tissue capsule is formed. There is no infiltration of cells into the prosthesis. Subsequently, the connective tissue capsule is replaced by fine collagen fibers, together with a few macrophages and fibroblasts without either fibroplastic activity or the presence of lymphocytes, thus becoming a stable and permanent, although very thin (less than 0.2 mm), fibrocellular capsule. The implant is thus transformed into a "natural" prosthesis (endoprosthesis) containing only BIO-ALCAMID® (and thus comprising 97% water) which, if perforated, allows the implant to be completely removed if necessary (using an appropriate technique). The effect obtained will correspond to that actually seen immediately after the substance is injected.____________________________________________________________________________ Conclusion:

The impact of facial lipoatrophy on self-image and self-esteem is devastating for the HIV surviving community. Several non-FDA approved options for lipoatrophy related facial reconstruction are emerging to deal with this problem that may be induced by HIV medications. Patients can access these products in Mexico, France, Brazil or through FDA approved IDE protocols in the US. In all instances, including US protocols, the patient has to pay amounts that exceed $3000 (some companies are trying to set up their research protocols to provide free or discounted access.) No reimbursement is currently available for these options. Furthermore, no long-term HIV specific data are available, so it is difficult to assess safety of any of these options. Current information is limited to small studies with no clinical data besides before and after pictures. Some options may require frequent touch ups and others tend to be more permanent. A comprehensive and effective advocacy campaign is needed from the HIV community to stress all important issues at the FDA level for safe protocols and access to those who may want to make an informed decision based on risks and benefits. Additional advocacy in the area of reimbursement is also needed since these are corrective measures that treat a drug induced side effect, and like any other side effect corrective measures available, it should be reimbursed by third party payers. Hopefully, we will see a lot of activity on this issue in the near future.Please address any comments or concerns to powertx@...For more information about facial wasting and to keep current on the subject, subscribe to the free Internet newsgroup lipodystrophy . Subscribe by sending an email to lipodystrophy-subscribe . The author and facialwasting.org do not assume any responsibility on the decision a person makes after reading this information. This information is to be shared with your physician for further discussion. All of these procedures lack long term safety data in HIV positive patients.BIBLIOGRAPHY:ï‚· Dewan PA, Byard RW: Histological response to injected Polytef and Bioplastique in a rat model. Br J Urol 1994 Apr; 73(4): 370-6[Medline]. ï‚· Ersek RA, Beisang AA 3d: Bioplastique: a new biphasic polymer for minimally invasive injection implantation. Aesthetic Plast Surg 1992 Winter; 16(1): 59-65[Medline]. ï‚· Ersek RA, SR, Salisbury AV: Bioplastique at 6 years: clinical outcome studies. Plast Reconstr Surg 1997 Nov; 100(6): 1570-4[Medline]. ï‚· Gold MH: Fibrel. Dermatol Clin 1995 Apr; 13(2): 353-61[Medline]. ï‚· Jost G: Experience with collagen injection for the correction of contour deficiencies. Aesthetic Plast Surg 1985; 9(2): 163-5[Medline]. ï‚· Klein AW, Wexler P, Carruthers A: Treatment of facial furrows and rhytides. Dermatol Clin 1997 Oct; 15(4): 595-607[Medline]. ï‚· Lemperle G, Ott H, Charrier U: PMMA microspheres for intradermal implantation: Part I. Animal research. Ann Plast Surg 1991 Jan; 26(1): 57-63[Medline]. ï‚· Lemperle G, Gauthier-Hazan N, Lemperle M: PMMA-Microspheres (Artecoll) for long-lasting correction of wrinkles: refinements and statistical results [see comments]. Aesthetic Plast Surg 1998 Sep-Oct; 22(5): 356-65[Medline]. ï‚· Mladick RA: Twelve months of experience with Bioplastique. Aesthetic Plast Surg 1992 Winter; 16(1): 69-76[Medline]. ï‚· Piacquadio D, Jarcho M, Goltz R: Evaluation of hylan b gel as a soft-tissue augmentation implant material. J Am Acad Dermatol 1997 Apr; 36(4): 544-9[Medline]. ï‚· Pieyre JM: Collagen injections: two years' experience. Aesthetic Plast Surg 1985; 9(2): 153-4[Medline]. ï‚· Simons G, Mazaleyrat P, Masurel T: Utilization of injectable microimplants in aesthetic facial surgery. Aesthetic Plast Surg 1992 Winter; 16(1): 77-82[Medline]. ï‚· West TB, Alster TS: Autologous human collagen and dermal fibroblasts for soft tissue augmentation. Dermatol Surg 1998 May; 24(5): 510-2[Medline]. MORE INFORMATION ON FACIAL FILLERS, CLICK HERE

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