Silicone: What Price Beauty?
Published in TGForum and Transgender
Community News by
Cerise Richards, M.D.

Silicone is a synthetic polymer derived from the second most common element on earth, Silicon (Si). Silicon is found in its natural state as Silicon Dioxide (SiO2) in sand, quartz and natural silica. When Silica is fused with other elements they become Silicates in the form of gemstones, clays, etc. With the abundance of this element is easy to see how so many commercial products have been produced in Silicon Valley. But Dow-Corning has created Silicone a very complicated polydimethylsiloxane, (PDMS). It has wonderful physical properties. It is a very stable, chemically inert, compound. It does not deteriorate, has a very slippery surface and has very low reactivity when implanted in animals. By increasing the cross-linking between the Si-O-Si backbones, it can be transformed from a liquid with multiple viscosities to a gel to a solid elastomer, which can be molded into any shape with the properties of natural rubber but a fraction of its reactivity in the human body. Not quite a miracle, but a biomaterial that revolutionized medicine in the form of tubing for cardiac surgery, catheters, implantable shunts and prosthetics for all surgical specialties. DCC’s contributions to health care are immeasurable.

In the early Sixties they supplied the first implantable breast prostheses for breast reconstruction in mastectomy patients. The formation of an elastomer shell with a central gel to simulate breast tissue came to fruition in the Seventies after extensive monkey implantations and tissue examinations. The problem the chemists knew they had was that as they decreased the cross-linkings in the gel it became softer and began to diffuse through the shell. Initially the diffusion was so small, less than a thimble and the surrounding reactivity so little that they called it acceptable.

In the mid Sixties they also produced a Medical grade of Liquid Silicone (LS) which was supplied to physicians as part of a Research Protocol. By the Seventies, the first complications were observed because there seemed to be a latent period of approximately 3 years before they became obvious.

The most obvious was the formation of fibrous marble-sized nodules below the skin known as “siliconomas”. These were named for the inflammatory cells that develop around any foreign body that the human body encounters, small granulomas as in TB or larger as the lung’s reaction to talc, a silicate. In the case of larger solid elastomers an inflammatory reaction would develop in joint replacements and stopped when the prostheses were removed. One irrefutable fact is that silicone in any form is not biologically inert. It produces an inflammatory reaction which differs in its severity according to each person’s reaction to the material. It has been shown to migrate in small sphericals to the lymph nodes, kidneys, lungs, brain and liver though the lymphatics and veins. By the mid Seventies, Plastic surgeons were calling for the limited use of LS to 1 - 3 ounces because of the side effects. In the Seventies, LS was removed from the Dow-Corning Research protocols and no longer distributed for human injection.

A Medical grade LS is still sold as a lubricant for surgical tubing, surfaces and syringes. But world wide physicians and others were using large amounts, quarts to a gallon, in breasts, hips and buttocks. What became obvious as these large amounts were injected was that they would migrate to the abdomen, legs and feet by sheer gravity. Remembering that this is a liquid, these doctors would add other oils and irritants in hopes of creating a larger fibrous reaction which would keep the LS in place. It didn’t work, but only made things worse as they added mineral oil, flax seed oil and fatty acids to LS. While most doctors in this country stopped the injection of LS in the Eighties, two medical groups on each coast persisted with their own reformulations of LS until they signed a consent decree with the FDA in 1992 to stop promoting and using LS.

By this time they were using LS only to fill wrinkles and acne scars. They would say that any complications of LS were from impure materials and poor injections methods. The truth of the matter is that the complications are devastating, disfiguring and associated with death in two cases of pneumonia and respiratory failure following injection. The DCC company has clearly stated over the years that Silicone Fluid is not approved by the FDA for tissue augmentation and Dow-Corning does not support this use. But the same Docs are back in business using a legal LS preparation sold for intraocular eye surgery. After obtaining a legal opinion from the FDA in 1997 that any legally marketed preparation may be used for “off-label” use within a doctor-patient relationship, they are injecting any facial depression with microdroplets in order to produce scarring and elevation of the skin. They deny that all the complications I am describing will occur with the amounts injected, less than .5 ccs total, and their technique. You have to be crazy to accept their pseudoscience when the latency period for increased scarring may be up to 10 years. Enough said!

The noxious effects on the breast are well documented. A painful swelling occurs which returns repeatedly year after year. Large silicone cysts develop which can be aspirated. The skin thickens, hardens and can rarely ulcerate resulting in bilateral mastectomies. The silicone shifts downward through the tissues causing the “Bowling ball in the Gunny Sac” look. I can attest to this result as I watched the Queen of Silicone, Carol Doda, perform at the San Fran Condor Club with her sagging fortunes in the Mid-Sixties.

The complications of the buttocks injections are more disfiguring as the LS settles into the legs producing irreparable swelling of the leg similar to lymph edema in the arm. Cystic erosion of the bones of the foot have been demonstrated. The skin of the leg macerates and must be removed surgically en block causing disability and nerve palsy. Attempts to remove LS by liposuction have been unsuccessful resulting in the removal of only healthy fat, not the fibrotic trapped LS. The pictures are quite dramatic and saddening. Deformities of the nose, face and eyelids are easier to correct surgically since the amounts used are smaller.

Fortunately using Magnetic Resonance Imaging (MRI) we can pinpoint the location of LS which cannot be seen on conventional X-Ray. What we note is that LS moves freely though fat below the skin and into muscle on occasion until it is trapped by fibrous tissue which can continue to expand and disfigure. Let us now return to the issue of breast implants which have been associated with autoimmune responses and maybe Connective Tissue diseases (CTD) such as Lupus, Scleroderma and Fibromyalgia. In 1992 the FDA stopped the insertion of Gel filled implants, except under research protocols, because of the possible association. Although increased antinuclear antibodies have increased in these patients, there are an equal number of papers showing no association with CTD. It is sort of like Lung Cancer and tobacco. The patients are there, but the evidence and causality is lacking for the cigarette companies. I actually published a paper in 1960 detailing the deleterious effects of tobacco, but some are still arguing about cause and effect forty years later. The cause and effect argument over Silicone will continue for the near future.

What is clear is that most all implants will develop a fibrous capsule around the implant as a reaction to the elastomer and silicone filler and that MRI can detect the gel which has leaked out beyond the capsule in approximately 50% to 70% of the implants over 10 years of age. Women with leakage are 2.8 times more likely to report symptoms of fibromyalgia or CTD than women without documented leakage. There does not appear to be any relationship to Breast Cancer except that LS can obscure cancer on standard Mammography and therefore is best detected with MRI. Therefore the FDA has required the manufacturers to list the above information in their brochure as Dow-Corning continues to modify the implant and gel viscosity.

A focus group of twenty Drag Queens in the U.S. reports passing around a syringe with LS for a facial fix before a pageant and a group of Brazilian Drag Queens reports a 50% HIV rate from similar uses with a single needle. Now that’s frightening. Many Thanks to my lovely collaborator, Morgan, whose personal experience in this arena far exceeds my own. You can’t say we didn’t warn you.

Best of Luck in Your New Future,