(includes Adatosil 5000, Silikon 1000, SilSkin, etc. when implanted subdermally)

Silicone: Just the Facts Ma'am, Just the Facts
I am sure you are aware of the controversy in the past regarding silicone and breast implants and free silicone injections.  The explosion of the Internet and free web hosting now makes it possible for everyone in the world to have a website -- or two or more! -- of their own to display whatever it is they feel, believe in or would like to convey to the world.  Even if this means to misinform the universe, whether on purpose or not -- it can be accomplished more easily through the Internet.  In this section we will discuss silica, silicon and silicone.  We will ultimately discuss how silicone is made and what its impacts on the body are.

Silica is silicon dioxide SiO₂, it occurs in a crystalline state, an amorphous (shapeless) state and in impure forms such as quartz, opal and sand, respectively. "In the form of silicates it is present in most natural water supplies. Typical concentrations lie between 1 and 30 mg/L.  Higher concentrations may exist in brackish waters and brines. " (3) 

Silicon is a "nonmetallic element that occurs combined as the most abundant element next to oxygen in the earth's crust and is used especially in alloys and electronic device" (Merriam-Webster).  It may not BE a metal but it is considered semi-metallic. In other words, "Silicon doesn't occur in the free, elemental state, but is found in the form of silicon dioxide and complex silicates".  It was discovered in 1824 by Jöns Jacob Berzelius. "Silicon is important in plant and animal life. Diatoms in both fresh and salt water extract silica from the water to use as a component of their cell walls". (1) Silicon is used in many household items such as transistors, micro chips and electronics. Hence, Silicon Valley - the computer capital. 

Silicone is any of the "various polymeric organic silicon compounds obtained as oils, greases, or plastics and used especially for water-resistant and heat-resistant lubricants, varnishes, binders, and electric insulators" (Merriam-Webster)  It is also found in processed foods, cosmetics, medications and all sorts of products that you are exposed to and ingest on a daily basis.  It is also used to lubricate medical devices such as tubing, hypodermic needles and is found in the food industry as being used to lubricate blenders, frozen drink machines, piping, cooking utensils, and machines.

Silicones are synthetic polymers and are made by combining oxygen and silicon and in high temperatures and pressures can produce polydimethylsiloxane (PDMS).  The fluids are made from linear chains of PDMS whereas the gels are lightly crosslinked to give it a thicker cohesive-ness.  Although without a container such as a highly cross-linked silicone elastomer breast prosthesis the silicone gel takes on no shape of its own and is very vulnerable to gravity and momentum, if applicable.  The elastomer implant shells contain very little free PDMS so that it remains a solid.  However since like can not hold like for long, the lower-weighted molecular silicones bleed through the elastomer shells -- even with the presence of "protective" inner barriers.

Silicone & Its Uses In the Body
Silicone products, in their solid form, have been used within the body for cosmetic applications for years and years without incident other than occasional sensitivity and encapsulation (which happens with all foreign bodies inserted into the human body as this is its way of sealing off the foreign object from the body).  Encapsulation is when the body forms a fibrous tissue capsule around a foreign body as it does not recognize it as its own -- why would it? 

Solid silicone is used to augment or reconstruct the cheeks, the chin, the brow bone, calves, pectoral areas for men, as a replacement for lost digits, testicles and for buttock augmentation.  It is also used for joint replacements, rotary cuffs, and sockets -- as well as a multitude of other medical uses.  

Liquid silicone is not approved for injection into the body for cosmetic applications but is approved for intra-ocular use for retinal tamponades.  Detached retinas can cause bleeding and blindness and silicone oil injections are used to help this.  It is, however, not approved to sculpt the lips, cheeks, buttocks, face, etc.  However since the oils (i.e. Silikon 1000 & Adatosil 5000) are approved in general, an amendment makes it so physicians are allowed to use approved drugs and devices off label as they see fit.

Unfortunately, silicone oil injections can cause granulomas, inflammatory nidus, macrophage activity and migration.  

gran*u*lo*ma (noun), plural -mas or -ma*ta
First appeared 1861
: a mass or nodule of chronically inflamed tissue with
granulations that is usu. associated with an infective process
-- gran*u*lo*ma*tous (adjective)

mac*ro*phage (noun)
[International Scientific Vocabulary]
First appeared 1890
: a phagocytic tissue cell of the reticuloendothelial system that may 
be fixed or freely motile, is derived from a monocyte, and functions 
in the protection of the body against infection and noxious substances -- called also histiocyte
-- mac*ro*phag*ic (adjective)

...macrophages and other inflammatory responses (including chronic) is absolutely true when it comes to injected or free liquid silicone within the body.  Autoimmune disorders however have not been proven to be caused by silicone -- either liquid or solid.

Regarding liquid silicone or (LIS), the infiltration of foreign substances of a certain molecular size/weight, can cause problems on a cellular level if they can not be successfully excreted or contained.  Many may argue that the goal should be not to inject or otherwise implant mobile substances of this size such as silicone oils and gels is something and that ideally it should be avoided.  

You may have heard Silicone referred to as inert.  Inert literally means static or immobile.  Although in the scientific world 'inert' is usually referring to chemically inert, or chemically non-reactive.  Silicone may be chemically inert, but it may not be biochemically inert. Biochemically inert would mean that these substances wouldn't change composition in the body, but even the elastomer shell of breast implants degrade -- they don't last forever, nor would they cause reactions in the body.  It's a fact, sorry.   

Inert, by definition, the material should not be able to migrate in a way that they may infiltrate a cellular structure, the surrounding subcutaneous tissue or an organ tissue, thereby smothering cells, and causing cell necrosis (death) nor would it inflame the surrounding tissues or cause sensitivity reactions. 

Personally, I don't believe that silicone-based oils or gels or many synthetic substances can be classified as inert, by definition.  Reason being I have seen many cases of free silicone lip injection where the silicone has migrated to the chin region or even further down the neck, and has not stayed where it was supposed to -- in the lip.  The fact is free silicone is known to migrate, therefore it is not completely inert, by definition, when injected into the lips, breasts, subcutaneous tissue, wherever. 

The FDA recognizes and warns of the fact of granulomatous, inflammatory responses, migration and discoloration of tissue after having had silicone injections -- period.  Silicone injection is still being practiced on the black market and in plastic surgeons' offices.  As liquid injectable silicone (LIS) was approved for ophthalmic use only.  Although some doctors are using LIS off-label for wrinkles, augmentation of lips, etc. advertising for such is illegal.  I even spoke to the FDA myself; I have the letter to prove it.  There is a loophole regarding the use of any product a physician deems suitable -- as we will discuss further below -- but the advertisement of off label use of any approved drug or device is illegal.  

Just remember that silicone can be problematic if in it's migrating, liquid or gelatinous form if it enters a cell and suffocates it or you suffer from a chronic inflammatory response.  In fact, It is supposed to form granulomas so that it does not migrate -- they rely on that granulomatous response to impede migration.

Auto Immune Disorders & Breast Implants or Silicone Implants 
Siliconosis
This is an unofficial name that has been given to patients by other anti-breast implant activists who have 1 or more of 14 key disorders thought to be caused by silicone -- including silicone injections, solid implants and breast implant shells and their silicone fillers, when applicable.

I know several people who had these disorders before they ever had any type of operation and the disorder never got any worse after breast augmentation or other types of surgeries involving silicone.   We routinely are exposed to silicone in our foods, eye drops. cosmetics, injections or any puncture by a hypodermic needle (which is lubricated by silicone).  Some may argue that yes, this is all true but we are not routinely exposed to such large amounts of silicone.  Well, yes you have a point.  And I never said that mass injections or intra tissue deposits of silicone were a good thing, did I? 

But we aren't talking about cellular level problems and giant cell granulomas -- we are talking about an immune response disease that are blamed for things such as:

• alopecia (I had that from anesthesia before and still have it, non-implant related)
• arthralgia (which I had before and STILL have, it's called wear and tear and too many motorcycle accidents)
• carpal tunnel syndrome (which I had before my augmentation and do NOT know how this can be caused by silicone)
• chest wall erythema (also a sympton of Empyema, whic is defined as "is defined as accumulation of pus or fluid with demonstrable bacteria in pleural space" and "Erythema is an abnormal redness of the skin due to dialation of the superficial capillaries of the skin causing inflammation.  It can result from many different causes, diseases of the skin and some systemic diseases." www.erythema.com)
• cognitive dysfunction (which is a symptom of chronic fatigue syndrome, also called "yuppie flu" (I swear that's true!) which affects those from 20-40 who apparently don't get enough sleep and live on fast food. This disorder is often seen in canines which I assure you do NOT have breast implants.)
• dry eye (also a symptom of hormonal imbalance and menopause, not to mention dehydration, and dry or warm/cold climates)
• dry mouth (I get this, it's called dehydration, 75% of Americans are chronically dehydrated)
• dysphagia (difficulty in swallowing; caused by all sorts of things, from structural disorders like tumors or bone spurs to functional disorders such as primary motor disorders, achalasia, to secondary motor disorders like scleroderma
• chronic fatigue (see "cognitive dysfunction", above) Although this is a real problem with those who have fibromyalgia (which happens regardless if one has silicone in their body) or Multiple Sclerosis as well.)
• lacrimal gland enlargement (various causes)
• parotid enlargement (various causes)
• petechiae (a minute reddish or purplish spot containing blood that appears in skin or mucous membrane esp. in some infectious diseases; Merriam-Webster. Common causes are (credit: The Library of Medicine, HealthAnswers.com)
  • injury or trauma
  • allergic reactions to medications
  • autoimmune disorders, which are conditions in which the person's body creates antibodies to its own tissues for unknown reasons (these happen without ever having a silicone anything in the body)
  • liver disorders, such as cirrhosis
  • infections, such as mononucleosis and endocarditis
  • bone marrow disorders, such as leukemia
  • thrombocytopenia, a deficiency of platelets
  • nutritional deficiencies, such as a deficiency in vitamins C, K, or B12, or folic acid
  • medications, such as blood thinners
  • recent blood transfusions
  • medical treatment, such as radiation therapy and chemotherapy for cancer
  • birth, due to the pressure changes caused by vaginal delivery
  • aging skin
  • sepsis, or blood infection
  • violent vomiting or coughing
• photosensitive dermatitis (can be caused by medications as well as metabolic disorders)
• telangiectasia (Telangiectasias form after anything that causes the face to flush or blush. Heredity, sun damage, acne rosacea (an adult form of acne), hot and spicy food, exercise, emotions, hormones, cortisone medications and some other rare skin diseases can cause telangiectasia.) Gateway Aesthetic Institute and Laser Center of Salt Lake City, Utah.

All of the above happens often without any type of silicone implant. I have 4 out of 14 -- do I have an immune response disorder?  No, I had this all before I ever had implants.  Is it worse now?  No, it has its good days and bad days. Getting older stinks.  I also want to add that I know several people with Fibromyalgia, Multiple Sclerosis and other disorders which have gotten implants since finding out of their conditions and report no changes either way of their condition.  If you'd like to speak with them, post on the message board and they will respond.

Am I sympathetic to those who believe they have siliconosis -- yes, of course I am.  But I do NOT think that their disorders were caused solely because of their breast implants.  I think that for some the operation (and ANY trauma) can trigger sickness in those who are prone to it.  I believe there are those who are allergic to silicone as well as there are t hose allergic to latex. 

There is NO certifiable proof that breast implants cause immune response disorders -- period.  But there IS proof that liquid, gel and/or lower-weighted molecular silicone cause granulomas, cysts, and fibroids in response to inflammation of the tissues on a cellular level.  Which of course opens up the possibility for infection of the thick, avascular, fibrous capsules which surround the silicone droplets.  So until it is proven other wise, think about it before making a choice.

Silicone Injections (Silicone Oil): (technically: purified, medical grade polydimethylsiloxane oil) Often referred to as Liquid Injectable Silicone  or simply, LIS.  Silicone, in general, has met much controversy over the last few decades.  Some issues, with good reasons and others due to junk science.  I could write pages upon pages about the issues which have revolved around the use of all forms of silicones and more pages still on how much it is found and used in many products we use on a daily basis.  But since this isn't about the controversy of the compound itself, I won't.  If you are interested just type in silicone in Google and thousands websites will be returned.  Just be sure what you read is backed by real science.  I will, however, cover the intended uses of silicone oil and the off-label uses, as well.  I will cover the glory and cover the not so bright and shiny side of liquid silicone injections.

Firstly, injections of silicone oil are not approved for cosmetic use in the United States, no matter what anyone tells you.  The off-label use of an approved medical device is, however, allowed because of the 1997 amendment to the Federal Food, Drug & Cosmetic Act 6, which states:

"Nothing in (FD&C Act) shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship." 

This means a physician can legally use any FDA approved drug or device, as he sees fit, if he believes it can effectively treat or cure your complaint.  Both Silikon 1000 and Adato Sil-ol 5000 (originally approved under the name "Adatomed Silicone Oil 0P5000") -- also called simply Adatosil -- are approved, but for injection into the vitreous cavity of the eye in the event of retinal detachment and/or hemorrhage.  It is intended to help save a person's eyesight.  And it is also intended to be aspirated at a later date and not kept inside the body indefinitely.

Re: Adatosil 5000: "AdatoSil 5000™ was approved by FDA through the Premarket Approval process (PMA) on November 4, 1994, pursuant to section 5 15(d)( 1)(B) (ii) of the Act. It is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitroretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. AdatoSil 5000™ is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) -related CMV retinitis, and other viral infections." --credit: Larry D. Spears Acting Director, Office of Compliance Center for Devices and Radiological Health (FDA)

Re: SILIKON 1000: "This device is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating in injuries. SILIKON 1000 is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) related CMV retinitis and other viral infections affecting the retina." --credit: PMA Final Decisions Rendered for September 1997

Re: SILISKIN: "SilSkin™ is a purified 1000cs silicone oil manufactured by RJ Development [a subsidiary of Richard-James, Inc.] and currently under investigation for facial soft tissue augmentation. At present, SilSkin is an investigational device limited by Federal law to investigational use." --credit: http://richard-james.com/page0005.htm 

"Liquid Silicone Injections

1. Has liquid silicone been approved by FDA for injection?
   No. FDA has not approved the marketing of liquid silicone for injection for any cosmetic purpose, including the treatment of facial defects or wrinkles, or enlarging the breasts. The adverse effects of liquid silicone injections have included movement of the silicone to other parts of the body, inflammation and discoloration of surrounding tissues, and the formation of granulomas (nodules of granulated, inflamed tissue).

2. Can FDA prohibit doctors from promoting the injection of liquid silicone, since its marketing has not been approved?
   Yes. FDA prohibits manufacturers or doctors from marketing or promoting unapproved products such as liquid silicone. This means that a doctor cannot legally advertise or sell this material." --credit: http://www.fda.gov 

"Silicone injection into facial tissues was popularized in the 1960s and 1970s with the introduction of medical grade silicone (MDX 4-4011) by Dow Corning. Microdroplets of silicone are dispersed within the dermal tissues. Fibrosis around these droplets localizes the material, and it is seemingly well tolerated in small amounts in the face. Silicone oil has many advocates among those who used it prior to Food and Drug Administration (FDA) withdrawal of approval. However, silicone, although chemically well tolerated, becomes encapsulated as a foreign body by a chronic inflammatory reaction. Giant cells surround the material and cannot process any ingested material, establishing a low-grade inflammatory nidus. Fibrous tissue surrounds and encapsulates the silicone; this capsule is avascular and is a potential site of infection. A number of late infections, granulomas, and palpable masses have been reported following silicone use." --credit: Emedicine.com - Soft Tissue Implants

The Method of Augmentation By Silicone Oil Injections
The injection of silicone oil, and many injectable tissue augmentation fillers, triggers a foreign body response by the accumulation of phagocytes, macrophages, lymphocytes, etc.  This low grade inflammation causes your body to respond by trying to either break it down, by engulfing the product and by moving it to other organs for excretion.  Silicone oil cannot be broken down by the body so the lower molecular silicones are either engulfed and moved and the higher viscosities remain behind when they are encapsulated.  The macrophage accumulation triggers fibroblasts to begin encapsulating the silicone oil, to wall it off from the rest of the body.  Imagine the silicone as a grain of sand, and your body as the oyster.  The body forms collagen layers around the silicone and eventually augmentation is gained in the form of fibrous tissue.  If the body cannot find relief after encapsulating the silicone, it will continue to form more and more collagen around the product, eventually causing a firm nodule.  The good thing about encapsulation is that it can help keep the majority of the liquid silicone where it was injected and hinder its migration into the surrounding tissues.

So remember, the augmentation isn't due to the product itself, large amounts of silicone oil should not be injected for volume augmentation.  It is the body's inflammatory response which triggers the formation of collagen that is the method of augmentation.  The amount of collagen formed is dependent upon your own body's sensitivity to the silicone, and the purity of the product.

Questions To Ask Your Physician When Getting Silicone Injections: (Printer-friendly Version)

Approved Silicone Oils

• ADATO SIL-ol 5000 - Bausch & Lomb

• SILIKON 1000 Product Sheet (Alcon Labs) (PDF)

• SILIKON 1000 - Alcon Labs (PDF)

• SILIKON 1000 PMA Approval (PDF) 

Silicone Not Intended For Injection

• Dow-Corning 360 Medical Fluid Frequently Asked Questions (PDF) NOT FOR HUMAN INJECTION

• Dow-Corning MDX4-4159, 50% Medical Grade Dispersion NOT FOR HUMAN INJECTION

Silicone Removal Information:

• Silicone Granuloma Management: TNFinhibitors may be effective as intervention

Update! 04/09/02: I spoke with Diane Richard, vice president for the company which manufactures SilSkin today.  Mrs. Richard advised that although a silicone product, SilSkin is "different" than Adatosil or Dow-Corning silicone and that trials are beginning for their product for cosmetic applications.  Only time will tell if there will be problems associated with this new product as in the past with other silicone products.  If anyone has personal experience or knowledge of this product, please contact me.
Update! 03/25/03: I met with Diane Richard at the American Academy of Dermatology Meeting in San Francisco (Mar. 21-25, 2003) and viewed some before and after photos and was given some clinical data of their progress so far.  I would still like to speak to any patients who are participating in the clinicals.

References:
(1) Institute of Medicine (IOM) - Information for Women about the Safety of Silicone, Nat'l Academy Press
(2) Independent Review Group, UK - Silicone Gel Breast Implants Home Page
(3) APHA Standard Methods, 19th ed., p. 4-118, method 4500-Si D (1995).
ASTM D 859-94, Silica in Water.
EPA Methods for Chemical Analysis of Water and Wastes, method 370.1 (1983).
(4) Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants in a population of women in Birmingham, Alabama. American Journal of Roentgenology 2000;175:1-8.

*Both Adatosil and Silikon liquid injectable silicone (LIS) were approved for ophthalmic use only.
** SilSkin injectable silicone product was approved for clinical trials in January of 2001

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