MEDIBOLICS™

 

Silicon Caution


by JB, Florida

Here in South Florida, there has recently been a series of arrests following the death of a woman who had clandestine silicone injections to enhance her buttocks, and this has renewed discussion of use of silicone to correct lipoatrophy.

While I have seen improvements in men who have used this material,  I am also aware of risks and complications.  I think anyone thinking of using silicone oil should educate themselves about it before
doing it.

Silicone oil is a clear, gooey fluid that has been around for decades.  It is widely used as an industrial lubricant.  While medical-grade silicone has been used cosmetically, the complications  are  frequent enough  that very few  dermatologists will touch it, especially with the current controversy surrounding silicone breast implants. 

There are licensed dermatologists who use medical-grade silicone, and with experience, perhaps the risk of complications may be lower.  Those dermatologists who use silicone seem to go for a series of widely spaced injections over weeks to months, slowly building up the tissues. These practitioners feel that by using medical-grade silicone (as opposed to repackaged industrial lubricants used by some fly-by night types), and allowing time for the body to form collagen around the oil droplets between shots, silicone can be safe and effective.  This is a minority opinion, though.  Prior to the approval of silicone oil for retinal surgery, the FDA would shut down offices that advertised the use of silicone.

What are the dangers?  First, liquid silicone oil may follow gravity or local pressure  and ooze to other locations.  This is especially true when the material is injected in large quantity, to fix the problem in one brief sitting.  The tendency of silicone to flow "downhill" is well known  (that's the reason for those "bags" they use for breast implants).  I have seen this occur in men who have used silicone, only to wind up with "wattles."  When silicone shifts, it may be impossible to remove. Despite the claims of some unscrupulous vendors, there is no "antidote;" though injections of corticosteroids may temporarily reduce swelling.

A larger problem is the unpredictable occurrence of bizarre, unpredictable immune  reactions.  Patients may have severe swelling, with the skin over the injected area becoming red and swollen.  The surrounding skin  may become hard, lumpy, and fibrous.  The body may reject the silicone like a liver transplant, leading to an uncontrollable inflammatory reaction.   Sometimes, chemotherapy drugs must be injected to try to control inflammation, as again, it is next to impossible to remove silicone oil completely by surgery.  In very severe cases, the body may try to expel the oil and surrounding tissues like a giant splinter.  It isn't pretty.   

At one point, I spoke with an underground contact for "Biopolymere III" treatments, a mystery product used by many illegal providers. The contact told me it was a mixture of "all natural ingredients, approved in Europe, and pending approval in the USA.  I was given "literature" about the product in
Spanish and badly translated English, which elaborately introduced the material as the newest generation "biological polymer," and then went on to describe it chemically as silicone oil. 

Supposedly, this wonder product is manufactured in Geneva, Switzerland, by"Biocell."  I haven't been able to find a  phone listing for the company there, and friends working in the pharmacy industry in Switzerland have looked, too. The address given is actually in Vaduz, Liechtenstein, at a mail
drop.  There is no web site.  If the company has offices in Geneva, they are hidden like a CIA branch office.  You have to ask why a company with a miracle drug would be so hard to find.

Physician contacts in Europe assure me that Biopolymere III is not approved there, and that silicone, as in the US, is only approved for retinal surgery. I called the division of the FDA that investigates medical devices, and was told that there is no new drug application pending for this material, and
that any silicone-based implant would be rejected immediately due to safety concerns.  Having a janitor inject anything into your body doesn't sound wise to me!  The woman who died here recently died as a direct result of injection of a foreign substance by an unlicensed and unqualified practitioner, and this is the nature of these "clinics" and "silicone parties."

I will admit this:   I have seen  HIV positive men who have had biopolymere III injections, and, at least in the short term, many do show dramatic improvement.  Unfortunately, I have at this point also seen some pretty unpleasant complications, including shifting of the material, inflammation, and formation of hard, lumpy nodules.  I know of three men locally who have had operations to try to scrape out silicone.  Local dermatologists report seeing various complications, and disfiguring fibrosis, and complications of silicone injections have been a subject of conferences at the University of
Miami's Dermatology Department.

While I do know of dermatologists who have used medical-grade silicone in patients, apparently without problems, and I have seen some impressive improvements following "unapproved" products, the rate of complications is unacceptably high and information provided about the products is fragmentary, false, and misleading.   I would urge anyone considering these treatments to
think very carefully about it.  They could wind up worse off than they are now.

JB

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