Re: Silikon 1000 vs SilSkin..what is the difference?

December 26, 2002

I would suggest that what has seen is not the results of trained physicians.

You are 100 % right.

I apologize for the use "most of them" but certainly, as you know, there are doctors who are using Silikon 1000 who do not use the microdropplet procedure that you promote with SilSkin,as you are aware. I think that it is a true statement to say that your company can not control or monitor (or is responsible for) what is happening out there with all practicioners who use the off label Silikon 1000. May be you can explain to this list the difference between following the SilSkin protocol and what is happenning with unmonitored use of Silikon 1000 (it would also be nice to explain the difference between these two products and why your company is seeking a FDA approval for SilSkin even though Silikon 1000 is currently being used freely "off label")

It would also be nice to list the doctors who you think are the most responsible and trained on the microdropplet procedure. This will help me not have to be the one always educating the community when someone else can do a better job!

This is my original statement:

"I think Bio-Alcamid, Artecoll and Silicone microdroplets (SilSkin) are probably more durable options. Bio-Alcamid requires 1-2 sessions and SikSkin anywhere from 6 to 8. Artecoll requires around 4 for most but it is very hard to correct if the doctor screws up. Artecoll will be the first product approved in the US for general cosmetic applications for facial filling. There is an off label use of silicone (Silikon 1000) that is being used right now by many doctors. Most of them inject too much silicone and the results are less than appealing (I have seen some really freaky "droopy faces")"

I should not have used "most of them" but "some of them" ( i know of three but will not disclose unless the patients do). I have also seen bad results from work done by non doctors with silicone from unknown origin.

Vergel

Program for Wellness Restoration, PoWeR

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December 26, 2002

.....as you know, there are doctors who are using Silikon 1000 who do not use the microdropplet procedure that you promote with SilSkin, as you are aware.

It would also be nice to list the doctors who you think are the most responsible and trained on the microdropplet procedure. This will help me not have to be the one always educating the community when someone else can do a better job!

It would also be great if we lipoatrophy guys had some names of doctors who are misusing this product. Can you help us out with some names, anyone? Thanks, Joe

January 2, 2003

You are absolutely right, , I can't control what happens with physicians who incorrectly use an off-label product, especially when someone else now owns that product. The medico-legal system and physicians' fear of off-label use without malpractice insurance can to some degree keep these doctors in line. My company does, however, support articles in medical journals and lectures at the annual meetings that these physicians attend, pointing out that there is only one technique that is proving to be safe and effective in the use of liquid silicone, the serial puncture microdroplet technique. Anything else can cause avoidable problems. Any dermatologist or plastic surgeon who uses silicone in their practice need only look in textbooks to see chapters written on this subject that explain how it should be done in great detail. We also intend to sponsor formal training courses for physicians to learn the technique with hands on treatment of patients with instructors. There is also a long history of use with silicone (some of it negative) that clearly shows that it must be injected in small volumes, spaced at least a month apart. Currently the average lipoatrophy patient needs 5/6 visits. A mild case is 2/3 and a very severe case may take 8/9. Like anything, the way to great results is to follow the directions.

There are differences in significant properties that make SilSkin a superior product when compared to Silikon 1000, which I would prefer not to discuss publicly right now because of proprietary reasons, but the most important thing is that Silikon 1000 will never be studied for facial lipoatrophy by the manufacturer, Alcon, nor be FDA approved for that use. However SilSkin is presently being studied for lipoatrophy under FDA approved studies by - and will, therefore, be freely available to physicians who treat this condition as an approved product for lipoatrophy. Most physicians do not like to use a product off-label and in this case, most are doing so out of desperation to help their patients. Another significant difference between the two products is that SilSkin can hopefully be covered by patients' insurance because it is being studied for facial lipoatrophy whereas in most cases Silikon 1000, which is approved for detached retinas, can not. This is why we are doing a separate study

In the future, we will have site information for the trials on our website which is undergoing reconstruction. We may also have a list of recommended physicians, based on their training. In the interim, I would be happy to communicate with anyone by e-mail regarding a physician in their geographic location at djr2rji@... or drichard@....

I totally agree with Ellen's suggestion about a place where individuals can go to hear what patients' experiences have been with their physicians, especially if they have been bad. In this case, a dermatologist, plastic surgeon or ENT surgeon are the three who would have the necessary knowledge of the face and skin to treat lipoatrophy. I have heard of some general practitioners who are being trained to inject New-Fill but I don't know enough to comment. In any case, only a trained physician should be injecting any of these treatments, not unlicensed practitioners. I would personally like to speak with the patients who have had a less than desired result with Silikon 1000 because I do speak with a lot of patients who contact me and I would then have a better knowledge of who not to refer them to when SilSkin is approved. We follow this very closely because we would rather risk a physician's ire than bad patient results with the use of our products. Our seven clinical investigators have all been trained and while the study is underway, we will be training other physicians in formal programs with hands on clinical experience. There are also many physicians whose long term record of injecting silicone is well known and considered succcessful by their colleagues who are using Silikon 1000 until SilSkin is approved for lipoatrophy. I would be very interested in weeding out physicians who do not follow the microdroplet technique because they harm patients as well as a product's reputation and that does concern me.

I'm sorry for the long e-mail but I hope that I've answered all your questions.

Best regards,

Diane

Vice President

-, Inc.

January 3, 2003

Hello, I live in New York City and I am desperately looking for an ongoing trial for SilSkin. Do you know of any? I am a long term survivor 15yrs., and fortunately never been sick a day, however now I am plagued with the dreaded lipodystrophy. I have the large belly, and now the facial wasting. I am very self-consious to the point that it is ruining my quality of life, I do not want to go out for fear of being seen by anyone I know. Please if you know of any trails in my area would you be so kind to let me know where to go. I will be eternally grateful. Sincerely, niobx198

January 3, 2003

Drop an e-mail to Diane at djr2rji@.... She can tell you what you need to know. She's a very nice lady and won't run you around in circles.