Re: Re: ready to repair my face and butt- Bioalcamid update

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From facialwasting.org about BioAlcamid and other acrylamide products, written by Al Benson

Polyacrylamide Hydrogels

The other well known non-absorbable (and hence permanent) implants, the polyacrylamide hydrogels (known variously as Aquamid, Bio-Alcamid, Bio-Formacril) have been available for 3 decades. Initially used mainly in Eastern Europe and Russia, these gels have several well documented complications including infection, migration, and release of toxic acrylimide monomers. All of these complications become aggravated over time.

“The use of polyacrylamide as an injectable filler material was initiated in 1983 clinically in Russia 1990 as Formacryl (Interfall Ltd, Kiev, Ukraine, now relocated to Bulgaria) and in China as Interfall or â€Amazing Gel†(FuHua Aesthetics Ltd, Shenzhen, China). Since Interfall's European patent expired, at least five European companies are marketing polyacrylamides as dermal filler substances: Formacryl, Interfall, Argiform (contains antibacterial silver ions), OutLine (absorbable), Aquamid, Evolution (contains non-resorbable microspheres in fast absorbing polyacrylamide, and Bio-Alcamid. They may differ in the number of free ends; Aquamid has more [free ends] because it is less cross-linked.†(Lemperle, Gauthier-Hazan) 2

Some years ago, an Italian company, Polymekon, bought the rights to an existing acrylimide gel and reformulated it with the claims that the new product -- named Bio-Alcamid -- did not release toxic acrylimide monomers, did not degrade and did not migrate. They also ‘changed’ the chemical name from acrylimide to alkylimide. The chemistry however remains the same, only with tighter molecular bonds, a process the manufacturer calls ‘reticulation’.

This product gained a fast acceptance in the HIV community in 2001 when no other permanent options were available. Many traveled to Mexico to get their faces reconstructed in only one or two sessions. The apparent safety and permanence of this product was extolled by patients who had been treated with it for facial lipoatrophy, in the past six years.

Bio-Alcamid was widely used in Italy, the UK, Mexico and Canada. Best known for the use of the product was a Mexican clinic during the time it was led by Dr. Casavantes who was its medical director. Dr. Casavantes developed many of the injection techniques which became standard in the use of Bio-Alcamid, lecturing and demonstrating his new techniques at international dermatological gatherings.

After a few years of use, it became apparent from reports coming from medical practices around the world including from Italy where the product was developed, that many physicians and patients were suffering higher than expected complication rates, infections, indurations (hardening) and also dislocation of the implant. Many patients are still happy with the results after 5 years, however.

In an interview, Dr. Casavantes, who has performed many Bio-Alcamid implants, he expressed his view that the high complication rate for these implants, in his opinion, perhaps 10% or more, stem from two main causes: a not-fully sterile field on the skin surface with the concomitant capture and injection at the time of the procedure of pathogenic skin bacteria (staphylococcus aureus, micrococcus luteus, staphylococcus epidermis and methicilin resistant staph aureus) and bad placement of the implant by poorly trained practitioners. Late onset complications can sometimes be traced to disruption of the encapsulation pocket, while some late complications have not been able to be traced to any identifiable cause at all.

Very large volume buttock implants, he elaborated, “are more prone to deformation and migration from sitting pressureâ€. This remains true with all polyacrylamide hydrogels including Bio-Alcamid, and became apparent after Bio-Alcamid became extensively used in HIV facial and buttock wasting restoration’

“Its [polyacrylamide gel] clinical and histological behavior is very similar to that of silicone fluid. In patients with very loose connective tissue, larger quantities can “migrate†or more accurately dislocate from the face to the neck, from the breast to the groin, and from the buttock to the hollow of the knee. The reason for its ease in dislocation is due to its good biocompatibility, which does not stimulate much capsule formation and even less cellular ingrowth. It would be the ideal filler (like silicone fluid) if it were not followed by a rather high rate of late complications.†(Lemperle et al.) 1

Many dermatologists throughout the world were sold on its use by patient demand for a permanent solution to facial and buttock wasting. Unfortunately, training was not provided with the product and so unacceptable levels of complications developed. Notable were patient reports from Italy, the UK and Canada reporting complications arising from poor placement.

Abstracts on Polyacrylamide Hydrogel complications can be found on the Blackwell Synergy website:

H. MD, Alastair Carruthers MD, Fitzgerald MD, G. Sarantopoulos MD, Binder MD (2007) Late-Appearing Abscesses after Injections of Nonabsorbable Hydrogel Polymer for HIV-Associated Facial Lipoatrophy Dermatologic Surgery 33 (s2) , S193–S198 doi:10.1111/j.1524-4725.2007.33360.x

Another abstract from the Science Direct website discusses a study of 18 cases of Bio-Alcamid complications: Complications of polyalkylimide 4% injections (Bio-Alcamidâ„¢): a report of 18 cases . Journal of Plastic, Reconstructive & Aesthetic Surgery , Volume 59 , Issue 12 , Pages 1409 - 1414 R . Karim , J . Hage , L . van Rozelaar , C . Lange , J . Raaijmakers.

Four years ago when the above paper was written, the incidence of Bio-Alcamid complications were documented at 4%. Since then Dr. Casavantes has reported in communications with us a 7% complication for faces and a 20% rate for large volume Bio-Alcamid implants of the buttocks.

This has not been confirmed by any other sources, and when questioned, Dr. Casavantes commented that when complications arise among the client base of the Mexican clinic which pioneered the use of Bio-Alcamid, he is often sought out for consultations as the former medical director of that clinic.

Bio-Alcamid has since been removed from the Mexican market by the owners of its distribution rights, but this was done for financial reasons rather than medical concerns. Bio-Alcamid remains available in Canada. A recent news release from Polymekon announced a partnership with an American firm, Ascente Medical Corporation to market Bio-Alcamid.

Pricing is not available for this product from Canada where it’s still used because it is heavily subsidized, but a Mexican clinic which was the first in North America would charge upwards of $10,000.00, for buttock reconstruction. The owners of the Mexican clinic confirmed to me 3 years ago that their inability to get better pricing for Bio-Alcamid from the manufacturer led them to eventually abandon its use on buttocks.

Regards, VergelDirectorProgram for Wellness Restorationpowerusa dot org

In a message dated 8/25/2008 6:21:23 P.M. Central Daylight Time, markboothan@... writes:

Al, could you please explain? If you are reffering to PMMA it is approved in the USA as well as in Brazil.

I went to Brazing to do PMMA the first time and it is the same Dr Casavantes has

used on me.

Are you saying they are not using the real thing?

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