Injectable Silicone

[toemeister]

I have been impressed with the research done on injectable medical grade silicone for intractable plantar keratoses. Does anyone know where I can purchase some?
Dr. Douglas Flegal

[Admin]

There is this website that has some info on the current legal status of injectable silicone for cosmetic uses:
http://www.orentreich.com/silicone_injections.htm

Not sure where to purchase, but guess from medical suppliers to cosmetic surgeons :confused:

The most recent key references were:
The Histologic Host Response to Liquid Silicone Injections for Prevention of Pressure-Related Ulcers of the Foot (http://www.japmaonline.org/cgi/content/abstract/94/6/550)This study analyzed the histologic effects of and host response to subdermally injected liquid silicone to augment soft-tissue cushioning of the bony prominences of the foot. A total of 148 postmortem and surgical specimens of pedal skin with attached soft tissue were obtained from 49 patients between July 1, 1974, and November 30, 2002. The longest period that silicone was in vivo was 38 years. The specimens were then processed into paraffin blocks and examined for specific findings. The variables considered included distribution of silicone within the tissue, host response, migration to regional lymph nodes, and viability of the host tissue after treatment. The host response to silicone therapy consisted primarily of delicate-to-robust fibrous deposition and histiocytic phagocytosis, with eventual formation of well-formed elliptic fibrous pads. The response in the foot appears different from that in the breast and other areas of the body previously studied. No examples of granulomas, chronic lymphoplasmacytic inflammation, or granulation tissue formation were seen, with only rare foreign-body giant cells present. Silicone injections in fat pads for the treatment of atrophy and loss of viable tissue show a histologically stable and biologically tolerated host response that is effective, with no evidence of any systemic changes. (J Am Podiatr Med Assoc 94(6): 550–557, 2004)
Efficacy of injected liquid silicone in the diabetic foot to reduce risk factors for ulceration: a randomized double-blind placebo-controlled trial (http://care.diabetesjournals.org/cgi/content/abstract/23/5/634)OBJECTIVE: To investigate the effectiveness of injecting liquid silicone in the diabetic foot to reduce risk factors for ulceration in a randomized double-blind placebo-controlled trial. RESEARCH DESIGN AND METHODS: A total of 28 diabetic neuropathic patients without peripheral vascular disease were randomized to active treatment with 6 injections of 0.2 ml liquid silicone in the plantar surface of the foot or to treatment with an equal volume of saline (placebo). No significant differences were evident regarding age or neuropathy status between the 2 groups. All injections were under the metatarsal heads at sites of calluses or high pressures. Barefoot plantar pressures (pedobarography) and plantar tissue thickness under the metatarsal heads (Planscan ultrasound device) were measured at baseline and at 3, 6, and 12 months after the first injection. Injection sites were photographed at all stages, and callus formation was scored as a change from baseline. Throughout the study, patients were treated by the same podiatrist for all podiatry treatment. RESULTS: Patients who received silicone treatment had significantly increased plantar tissue thickness at injection sites compared with the placebo group (1.8 vs. 0.1 mm) (P < 0.0001) and correspondingly significantly decreased plantar pressures (-232 vs. -25 kPa) (P < 0.05) at 3 months, with similar results at 6 and 12 months. A trend was noted toward a reduction of callus formation in the silicone-treated group compared with no change in the placebo group. CONCLUSIONS: The results confirm the efficacy of plantar silicone injections in reducing recognized risk factors associated with diabetic foot ulceration. Diabetes Care, Vol 23, Issue 5 634-638

[toemeister]

I have spoken a couple of times to Dr. Balkin who did the studies and he has much evidence as to it's safety.
I have tried to obtain the silicone but evidently it is not available in the U.S. I would probably need to get it from another country. I understand it is approved for use in Canada, England and Norway but I don't know where to buy it. I would plan on using it "off label", as we do with many other medications.

[NewsBot]

The characterization and optimization of injectable silicone resin particles in conjunction with dermal fibroblasts and growth factors: An in vitro study.
Crews RM, Jennings JA, McCanless J, Cole JA, Bumgardner JD, Haggard WO.
J Biomed Mater Res B Appl Biomater. 2010 Jan 20. (http://www.ncbi.nlm.nih.gov/pubmed/20091922?dopt=Abstract)
Minimally invasive subdermal injection of liquid silicone has been used clinically to augment the soft tissue of the foot to mitigate high pressures that cause diabetic foot ulcers. However, implant migration has been a clinical issue. The objective of this study was to assess the effects of three specific concentrations of silicone resin particles (12 mum average diameter) in conjunction with either platelet-derived growth factor (PDGF-BB) or basic fibroblast growth factor (bFGF) on fibroblast cell proliferation, collagen synthesis, cell morphology, and migration through in vitro assays and a monolayer scratch wound model. PDGF and bFGF enhanced the proliferation of fibroblasts 5.7-fold and fivefold, respectively, while the addition of silicone particles had no significant effect on proliferation. Collagen production was increased approximately twofold with the addition of bFGF and the medium concentration of particles over bFGF without particles and the PDGF groups. The addition of silicone particles had no significant effect on collagen production compared with control groups without particles. Fibroblast migration was enhanced by the addition of both PDGF and bFGF compared to controls, although slower scratch wound closure rates were observed in the presence of particles compared to controls without particles. Cell morphology suggested that particles induced cellular aggregation encircling silicone particles postwounding as well as migration into the wound area. These results suggest that silicone particles in combination with a growth factor might enhance fibroblast aggregation and implant stability, and could promote connective tissue ingrowth and implant encapsulation in the soft tissue of the diabetic foot

[ezlington]

I have spoken a couple of times to Dr. Balkin who did the studies and he has much evidence as to it's safety.
I have tried to obtain the silicone but evidently it is not available in the U.S. I would probably need to get it from another country. I understand it is approved for use in Canada, England and Norway but I don't know where to buy it. I would plan on using it "off label", as we do with many other medications.

As I understand the situation in the USA, It is a "misdemeanor" in many States to inject Silicone fluid without a containment medium.

I quote from my (under construction) website

"Injecting tiny volumes of Silicone fluid between bony prominences and the skin DrBalkin assumed that the fluid behaved like a half inflated baloon and formed a cushion. His early technique involved implanting 0.5 – 1.0 ml directly under the lesion, however, at that time many plastic surgeons and non-qualified practitioners were injecting 500 – 1000ml (often of poor quality or industrial grade) directly into breasts. As there was no containment volumes of this silicone migrated under the influence of gravity, forming unsightly tags. .In an attempt to prevent this, many practitioners adulterated the silicone with scarring agents in an attempt to wall in the silicone. The very poor results of the silicone injections on both men and women led to lawsuits. Most of the legal actions failed as the patients had signed “experimental procedure waivers”. Unfortunately for Dow Corning, the manufacturers of the silicone products used, the USA had “Product Liability” Laws in place and they were held accountable for the misuse of their product. There was a settlement for almost $80,000,000 : a lot of “bread” in the 70’s .

At the time the regulation of "medicines" in the USA was very lax, basically anything that was not "banned" could be used on people, compared with the UK where medicines had to be licensed fro use.

To prevent a repetition, in 1975 Dow Corning had it "banned" which made it a misdemeanour to inject Silicone without a containment medium as the company was unable to devise a workable system of control that would prevent the misuse of of the highly purified medical grade silicone. "

http://www.siliconeinjections.co.uk/index.html

Cheers,

€z