Bio-Alcamid Complication rate

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List,

I received the following letter from Dr. Casavantes in response

to the recent discussion/exchanges on Bio-Alcamid complications

-al

From: Dr Casavantes

[mailto:dr.casavantes@...]

Sent: Saturday, May 10, 2008 3:44 PM

Al Benson; Vergel; Gottfried Lemperle; Gerald Pierone

Subject: BioAlcamid - Dr. Casavantes experience

Hello everyone:

The 7% [bio-Alcamid Complication

rate] data was observed by me. I documented it after 3 years of use

of Bioalcamid.

Most patients did very good for a couple of years, but

tragedy struck with or without associated factors.

The rate of complications is even higher in those that had

buttock augmentation with the product (20%), being migration the main deal.

Unfortunately, I was working on this results when I left the

Clinic that introduced the product in Mexico. Part of the agreement when I left

was to continue and finish the investigation / publication, but the

communication with the owners was no longer possible and all the information

belong to them.

However, after almost two years since I left that Clinic, I

have seen more patients, like this one presented here:

Image of left hemisphere, facial

Bio-Alcamid complication of unknown etiology

Sept 04, 2007

He had BioAlcamid injected (by me) in the left cheek to

correct his congenital facial hemiatrophy; results were excellent, with no

complications, and every one was more than pleased and happy. However, around

three years later, one morning he waked up to a swollen face that was treated

by his local physician (a fiend and colleague of mine) in Mexico City. The only

thing that the physician found and that could be associated with this infection

was chronic gingivitis.

Since this patient was treated during my time with the BA

franchisers, I am contacting him directly for authorization to use his before

and after BioAlcamid Pictures. The attached picture was sent directly to me,

back in September 2007.

My anecdotal consideration is that the original 7% has

actually gone up, since new complicated patients have continued to appear even

though BA has not been used for several years now. The Clinic where I use to

collaborate stopped using it before I left, and I will never use (under any

circumstance) it in my new practice.

Warm Regards,

L Casavantes.

---------------------------------------

DR. LUIS CASAVANTES

RECONSTRUCTIVE

& COSMETIC DERMATOLOGIST

WebSite: www.DrCasavantes.com

E-Mail: drc@...

On May 10, 2008, at 10:21 AM, Al wrote:

Regarding the posting from bjncarlsbad who had an exchange with

Dr. Pierone at the Body.Com; there were some questions raised about the

complication rate for Bio-Alcamid and the source of the 7% reported rate.

Dr. Pierone explanation has relied on the Bio-Alcamid

manufacturer’s published materials for the behavior of polyacrylamide

gels. In past years I used the same sources to explain how Bio-Alcamid

worked.

I think manufacturers always put the best face on their products

and so unless we look critically at their materials we risk following the

manufacturers train of thought and arriving at their same conclusions. This is

not always warranted.

I was unaware of the nature of polyacrylamide gels, other than the

materials from the manufacturer. I think this was a mistake on my part. In fact

there were others on this list who are trained medical doctors who immediately

saw the possible complications from a material like Bio-Alcamid and spoke up

about it, but the desperation if people like me and others for a real and

permanent fix to their faces, their voices were drowned out and there were a

great many people who sought this treatment. Having said that, it is important

to note that the majority of those who have used Bio-Alcamid are doing well and

are expected to do well. The 7% reported complication rate was an estimate from the owners of the clinic which

started using Bio-Alcamid in Mexico. Not the most credible source, but I have

no reason to suspect that it was an that far off.

Dr. Lemperle and several other doctors, in several peer reviewed

papers presented, have written extensively on implanted tissue fillers. When I

read his papers recently for an update to the Buttock Wasting page, it was like

a light bulb had turned on in my head. He is one very smart man! I will reprint

a few passages here from my new additions which quotes from Dr. Lempel’s

and also show the references. Dr. Lempel’s comments are in italics.

--------------------------------------------------------------------

(From the new additions to the Buttock Page)

Polyacrylamide Hydrogels

“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 ”Amazing

Gel<image002.png>(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)

In an interview, Dr. Casavantes, who has performed many

Bio-Alcamid implants, he expressed his view that the high complication rate for

these implants, stem from 2 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 … and bad placement of the implant by poorly

trained practitioners.

Very large volume implants, he elaborated, “are more prone

to deformation and migration from sitting pressure”. 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 treatment in the early part of this century.

“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.)

What I thought was fascinating was the comment that the complications

with Bio-Alcamid come precisely because of its good bio-compatibility. If the

body does not have a strong immune response to it because it sees it a

harmless, it will not encapsulate it very strongly and it will have a greater

tendency to dislocate.

One might speculate that in people with an underlying immune

problem, there might be even less of an immune response to Bio-Alcamid and

therefore it might have a greater tendency to dislocate.

The entire article will be up and available later next week.

Al

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"The 7% [bio-Alcamid Complication rate] data was observed by me. I documentedit after 3 years of use of Bioalcamid. "I think that it is safe to say that there is a complication rate for bioalcamid that was predictable from the day it first appeared in Mexico.Exactly what that rate is not clear, as the experience of a single clinic may or may not be representative of the experience of other doctors. It is interesting that we are not hearing about problems in list members who had their injections performed in Canada. I am aware of problems in France and Italy.JB