extra! extra! #41, vol. 1

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. 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 "like can not hold like" so 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 capsulization (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). Capsulization 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. Obviously, I am for the use of solid silicone and silicone elastomer shelled, saline-filled implants for use in the body. The United States FDA released a Clean Bill of Health for the use of medical grade silicone elastomer-shelled, saline-filled Mammary Prostheses for breast augmentation and reconstruction. 

They did not, however, approve the use of liquid- or gelatinous silicone-filled mammary prostheses nor did they approve the injection of these materials into the human body in any form*. In fact, it is illegal, as a doctor or manufacturer, to even promote or advertise the use of liquid silicone injections for other than its approved use (ophthalmic)! It must be said as far as the issue of cell suffocation, migration, granulomas...

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. Don't believe me? Read on... 

• 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).
• 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." FDA and Collagen and Liquid Silicone Injections"

Also from Emedicine:

"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 [without vascularity; or blood vessels] and is a potential site of infection. A number of late infections, granulomas, and palpable masses have been reported following silicone use." Emedicine.com - Soft Tissue Implants

Need more unbiased, independent scientific information?  Please visit the Independent Review Group's Website regarding Silicone Gel. This IRG website is UK government-run, containing evidential findings, studies, and reports by hundreds of scientists and their staff from several countries, including the US. They are unbiased and, to my knowledge, have no monetary interest in the breast implant industry.

You see, 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. 

The goal of not injecting or otherwise implanting mobile substances of this size such as silicone oils and gels is something that should ideally 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 degrades - they don't last forever, nor would they cause reactions in the body. It's a fact, sorry. But, I am prepared to take on the responsibility should I need a replacement surgery. 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 think that silicone-based oils or gels or many synthetic substances can be classified as inert, by definition. Reason being I have seen cases of free silicone lip injection where the silicone has migrated to the mentum (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. You may say I have a lot of nerve since almost every BA site says the opposite. Just know the difference. The FDA recognizes and warns of the fact of granulomatous, inflammatory responses, migration and discoloration of tissue after having had silicone injections - period. Unfortunately, silicone injection is still being practiced on the black market and unfortunately 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. This is illegal. I even spoke to the FDA myself; I have the letter to prove it. Regrettably, there is a loophole regarding the use of any product a physician deems suitable - as we will discuss further below. 

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. Like that's a good thing?! 

Okay, so now you ask, "Well what does that have to do with silicone gel-filled breast implants?" Well, common sense would tell you that if a rupture or massive "bleed" of a silicone oil- or gel-filled implant should occur, it is basically "injected" or rather deposited into your breasts and surrounding tissue. Thereby causing the exact same problems as the silicone injections. If these silicones cannot be secreted or contained they can cause problems. These are all facts, concluded and reported by United States FDA, Institute of Medicine (IOM) and Independent Review Group (IRG) themselves, not to mention many independent studies, the Mayo clinic and more. 

Silicone-Filled Implants & "Gel Bleed"? 
Silicone-filled implants do bleed. I didn't even think it bled as much as it did until I read up on the issue. Remember I am not saying that the bleeding silicone itself causes sickness I am just saying that the silicone gel or oil filler is unstable and therefore contain a range of higher and lower molecular weighted silicones and does seep through the implant. The lower molecular silicones, which is reported to possibly be upwards of 85% of the silicone filler in the implants, bleed through the higher crosslinked silicone elastomer barrier in situ and in vivo (outside and inside the body, respectively). Read below:

"There is some debate as to what degree the silicone materials used to fill implants are cross linked. Some authors propose that the implant filler consists of only 5 to 15% chemically crosslinked silicone gel, leaving 85 to 95% of the low molecular mass filling material with a fairly low viscosity." IRG website - Rupture (2)

Which accounts for the migration capabilities of lower molecular weighted silicone variances. These lower molecular weight silicone molecules are also more likely to stimulate biological activity in vivo as well as in suspended serum.  

 
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"FDA completed a retrospective study on rupture of silicone gel-filled breast implants.⁽⁴⁾ This study was performed in Birmingham, Alabama and included women who had their first breast implant before 1988. Women with silicone gel-filled breast implants had a MRI examination of their breasts to determine the status of their current breast implants. The 344 women who received a MRI examination had a total of 687 implants. Of the 687 implants in the study, at least two of the three study radiologists agreed that 378 implants were ruptured (55%). This means that 69% of the 344 women had at least one ruptured breast implant. Of the 344 women, 73 (21%) had extracapsular silicone gel in one or both breasts. Factors that were associated with rupture included increasing age of the implant, the implant manufacturer, and submuscular rather than subglandular location of the implant. A summary of the findings of this study is also available on FDA’s website at http://www.fda.gov/cdrh/breastimplants/studies/biinterview.pdf and http://www.fda.gov/cdrh/breastimplants/studies/birupture.pdf."

(credit: http://www.fda.gov/cdrh/breastimplants/birisk.html)

I am obviously NOT an anti implant advocate and I only pay attention to scientific fact not speculation (well not too much speculation, hey it pays to listen) - I also site my sources. I can back every statement in this entire website if need be. Am I against silicone filled implants? No. Do I know people who are perfectly healthy and without problems who have silicone-filled implants? Yes, many. I just provide the facts, so you can make an informed choice. 

Now, when I wake up I am prepared to have many emails. But perhaps by saying this I will not receive threats and angry emails.

Well, it's "hump day" everyone that means were half way through the work week! Have a pleasant day and don't forget CHAT is tonight at a NEW TIME! 6:00 PM Pacific, 9:00 PM Eastern. Hope to see you there tonight. Open topic in the General channel and Revision Rhinoplasty in Channel 1 or 2.