as Published in TGForum
and Transgender Community News

It seems like every year the most significant side effect of Silicone injections, death, makes the headlines with a new death and prosecution for homicide.  Recently a death in Brooklyn 12 years after the injection of Silicone and in 2002 a homicide prosecution in Miramar, Florida for a fatal pulmonary embolus always brings a more serious problem to our attention. The deaths while tragic and rare are not the bulk of the problems now being seen 15 to 20 years after the initial injection of Silicone. Previously our attention was turned to the disfiguring effects of large breast and buttock injections, but now we are seeing more late facial disfigurement for smaller amounts injected into the lips and cheeks. Fortunately the practice of injecting large amounts does not appear to be a major problem in this country expect for a few illicit practitioners, who move from town to town, but you still can obtain facial injections from some dermatologists and general practitioners, who are using an off label Liquid silicone (LS) approved by the FDA. But you must realize that the approval is for temporary use in the eye to correct retinal detachment. The liquid silicone is then removed from the liquid portion of the eye without migration. When LS is injected into your lips, it cannot be removed except by excising the affected tissue and using other facial skin as a covering flap. The complications to which I am referring are now being seen 5-7 years after injection. They include increased swelling and inflammation with tenderness of the vermilion border of the lips which persists and is occasionally eased with the injection of steroids into the lips. Attempts to remove these granulomas, as described below, have been unsuccessful. When CO2 laser was used, small flames and explosions under the skin caused additional disfigurement and is now contraindicated. Attempts to use liposuction with small cannulas was unsuccessful because the silicone was trapped in scar tissue below the skin. These complications are something you must live without incurring additional surgery. The physicians who are still using Medical LS claim that by using a very fine syringe and injecting microdroplets of one/one hundredth milliliter, they can safely fill facial wrinkles and scars, but these small amounts can never fill lips. So to fully understand what we are dealing with please read on.

''You would think that with all the publicity and the warnings about the dangers of silicone injections, that it would raise a red flag,'' said Enrique Torres, chief investigator for the Florida Department of Health's unlicensed activity office. "But what I'm finding is quite the opposite. It still goes on. More than ever."

For the past half century physicians have been trying to reshape
the human body to conform to the aesthetic contours of the times.
We do not hesitate to have our bodies cut, noses broken, faces
sculpted and injected with whatever will achieve the desired look.
Enter, in the early Sixties, the Dow-Corning Chemical (DCC)
company, the major manufacturer of Silicone, an industrial
lubricant. What exactly is Silicone?

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.You can't
say we didn't warn you.

Best of Luck in Your New Future,
Cerise Richards, M.D.