some more FAQ's? can any one please answer these things..its urjent.

[mybody]

9. What are my implant type choices? What about Soy, Hydrogel, and Cohesive Silicone?

Saline-filled: The U.S. F.D.A. recently approved only two manufacturers' saline filled implants for general, cosmetic use in the USA. Those two companies are McGhan Medical and Mentor Corp. According to one sales rep for Poly Implants Prostheses (PIP) in June of 2000, they have an extended 2 year study program for their saline pre-filled implants. However, the "test subjects" must agree to participate in follow up studies for two years. Two other such saline filled implant companies which still are allowed to "test" only are Hutchinson International and Silimed L.L.C.

The Trilucent Implant with Soy Triglyceride Oils (Trilipid Z6) for implant filler is, in fact, not approved. LipoMatrix Inc., owned by Collagen Aesthetics (who make injectable collagen). Almost 5000 subjects, approximately 200 of them U.S. citizens, participated in clinical study regarding the safety of the Triclucent Implant. However, no new test subjects have been implanted although the subjects are still being evaluated. It is unknown if the Trilucent implant will ever be approved although no new studies have been scheduled for this implant.

It was rumored that studies in Europe had suggested carcinogenic properties related to Soy Triglyceride however it has not been proven. A recent Study in the U.S. suggested with a higher percentage of sterility in pubescent children after long term consumption of Soy products. This has not been proven and even though this study was for products consumed I would think the odds are that if it is remotely bad for you, don't try it. At least not for now. Besides, studies suggest that the Soy Triglyceride filler turns rancid after prolonged exposure at high body temperatures. And even this has yet to be proven.

PIP Hydrogel implants: The Hydrogel mammary prosthesis has a filler which is made from biologically inert hyaluronic acid fluid inside the silicone elastomer shell. This filler is the same substance as the injectable filler, Restylane, for use in lips and wrinkles. These were taken off of the market. Not because of its filler but the implant manufacturer was unable to present evidence in time, proving the safety of the medical device -- as a whole.

Silicone gel-filled implants are available in the U.S. but only to a select few. Those being subjects who have or have had cancer and are undergoing reconstructive surgery or other reconstructive patients who agree to be a part of the study. It is unclear why these individuals are allowed access to silicone gel filled implants. Silicone has gotten a lot of negative publicity in the last 10 years and it is still unknown whether or not the long term* effects of silicone are negative. Although on May 10, 2000 the FDA granted approval for saline-filled silicone elastomer shelled implants by McGhan & Mentor Corp. and the shells (bags) of these implants are constructed of a silicone elastomer. All studies based on Silicone and Connective Tissue Disorders were shown to be inconclusive in regards to Silicone actually causing these diseases.

However, it is proven that liquid silicone injections or deposits can cause granulomas and sometimes chronic inflammatory responses

Cohesive Silicone-filled (silicone elastomer shell): This French implant's filler is a thicker silicone gel that enables the patient to be "free" of silicone seepage even in the unlikely event that a rupture should occur. This implant is now available in the US for clinical trials. Australia has access to this implant as well.

*long term being in excess of 50 years

[mybody]

Well what about Silicone Gel-filled implants? Are they safe? Why aren't they "legal* in the United States?

Silicone products, in their solid form, have been used within the body 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). Solid Silicone is used to augment or reconstruct the cheeks, the chin, the brow bone, calves, pectoral areas for men, joints, fingers, rotary cuffs, testicles and buttocks, as well as a multitude of other medical uses. 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 silicone injections. It must be said as far as the issue of cell suffocation, migration, granulomas...

granuloma
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)

...macrophages and other inflammatory responses (including chronic) is absolutely true when it comes to injected or free liquid silicone within the body. Read on...
"Liquid Silicone Injections

* 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"

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, but even the elastomer shell degrades - they don't last forever. 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).

The FDA recognizes and warns of the fact of granulomatous, inflammatory responses, migration and discoloration of tissue after having had silicone injections. Unfortunately, silicone injection is still being practiced on the black market. Remember, it 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.

So what does all that have to do with silicone gel-filled breast implants for that matter? 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, contained or removed they can cause problems.

Regarding silicone-filled implants experiencing gel bleed: Silicone-filled implants do bleed. The silicone gel or oil filler is unstable and therefore contain a range of higher and lower molecular weighted silicones. 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). Read below:

"There is some debate as to what degree the silicone materials used to fill implants are crosslinked. 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

Which accounts for the migration properties 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.

*Silicone-gel breast implants are available to reconstruction patients or to those who previously had silicone implants if they are willing to sign a waiver and be a part of a study. They are also available to persons with slight asymmetries and thin skin. The silicone gel filled implants do offer a women the choice of a softer, more natural breast.

[mybody]

11. How many cc's make a cup size?

The below excerpt is an approximate cc amount vs. cup size range study:

"Results of the study showed that an average of 189cc of saline was needed to change one bra cup size. Increasing an A cup to a C cup required a total of 391cc, or 196cc per cup. Moving from a B cup to a D cup required a total of 448cc, or 224cc per cup. The largest change, an A cup increasing to a D, cup required 437cc, or 145cc per cup."

"...while these amounts help achieve the desired size, they are not exact and that differences may occur because of other variables, such as chest wall size, breast tissue and the tissue envelope size." (source: Breast Augmentation Patients Try Implants on for Size - ASPS)

Interestingly, Brava, LLC claims that 10 weeks of their device stimulates 50cc of tissue growth which is what they consider to be 1/2 bra cup size. Just food for thought.

[mybody]

12. What is overfilling and how much can implants be overfilled?

This is a controversial subject for two reasons:

1. If it should be done in the first place and
2. definition of overfill

Essentially, I am not overfilled, per se. I am filled on one side (510cc) at optimum according to McGhan's recommendations for my implant size. However, many women will say they are overfilled when the cc amount is over the bag volume/size number. Because there is underfilling too. I know this is REALLY confusing. But a lot of women will say, "I have such-and -such implants, size 450, o/f 40cc to 490cc" when in fact they are overfilled only 10cc because up to 480cc is the maximum for that size implant. So when you discuss overfill with someone just find out the implant size and the full cc amount and then do your calculations. Or quite frankly, don't worry yourself sick over it because you may not be able to tell the difference in increments.

Be advised that the manufacturer has an advised optimum fill and that many a woman is walking around right this very minute with an overfill that surpasses the recommended or max amount. Now, don't be alarmed, there is no need to be. I have been told by many surgeons that the implant manufacturers recommend this amount because these were the specifications at the time of approval with this low amount. Many, Many surgeons overfill a certain amount to prohibit rippling, or wrinkling of the implant. If you don't fill it up enough, rippling, if you fill it up too much, rippling. GEEZ!! Well the best way to avoid rippling is to inquire at the consult if the surgeon overfills above the manufacturer-recommended amount. And remember that your needs will be different than the last or next patient's. Afterall, this is just a rundown of facts presented to you, not a definite for your own individual case.

Remember the repetitive 30,000 breaths, well this in fact will weaken the implant's elastomer shell by creasing it over and over, if it is not at least optimally filled. The extra volume does help with resistance of the crushing breaths, thereby eliminating much of the natural wrinkling while the implant is in vivo (in the body). This is the general consensus from the many, many surgeons I have spoken with as well as the patients of those I have not spoken with so listen to your surgeon - plus it makes sense!

[mybody]

13. Which is better - McGhan or Mentor?

There is no better, there is only what is best for your own needs, but more than likely, which your surgeon uses because many do not offer both. Many of you will also find surgeons who believe one IS better than the other and will give you their reasons for it. Some like that Mentor Shells are thinner than McGhan implant shells. Having felt both out of the body and while optimally filled and within someone's body, I don't feel there is much of a difference. I happen to prefer McGhan (although I am biased on that one because I have McGhans). Mentor once had a better warranty and were the first to come out with High Profile implants -- but now McGhan has a very similar warranty and both High and Low Profile implants.

Although they are basically about the same, there are slight differences so please go over this with your surgeon if you really want to get picky.

[mybody]

14. What are Expandable Implants?

This implant was designed by Dr. Hilton Becker under Mentor Corp. in 1984 for use primarily in breast reconstructive (mastectomy) patients, to gradually expand the tissues with out severe trauma to the tissues. By the late 1980's. the Becker expandable implant gradually wound its way into the cosmetic breast augmentation market. A decade later the Becker expandable implant was replaced by the Spectrum breast implant (sometimes referred to as the Spectrum-Becker). The Spectrum implant is a permanent solution to expansion breast augmentation with the the Becker-designed valve, filling tube and reservoir system.

The original Becker saline-expandable implant (gel also available) is still available although highly restricted by the FDA. But it's not the restriction that makes it inappropriate as an expansion breast augmentation device, it's the expensive price. Hence, the reason why the Spectrum implant has taken over the market of expansion breast augmentation.

The Spectrum expandable implant comes in ranges, or different sizes, like standard implants. The implants cannot be filled up indefinitely. You must have a general idea of what size you would like to be post-operatively, then build on this size. They come in textured and smooth models and can be placed either sub-glandular or sub-pectoral.

When they are first implanted, especially if you are small breasted in comparison to your size goal, your surgeon may not fill them to their starting volume. The gradual filling will give your tissues and muscles, if applicable, time to adjust and not traumatize or over exert the tissues to the point of fissures, tears or excessive stretch marks. Just remember with augmentation, stretch marks are always possible. There is a dime-sized filler port in each implant, that is left in near your incision (crease, peri-areolar) for ease of injection until after it is determined that you are at your volume goal.

You will probably have another fill (usually in 50cc increments) about 1 week post-operatively then on to 2 weeks, then perhaps a few weeks later. Most patients report that the fill-ups do cause them minor discomfort and that after all the settling and dropping you have accomplished over the weeks is for naught. You see, you become rounder, fuller, higher and tighter after each fill up so your body has to get back to work to accommodate the implant all over again. You should expect to pay about $400US more for a Spectrum and remember, until the filler port is removed (through your original incisions) you will be able to feel them and the area may become chafed if your bra or support garment rubs up against this area during natural body movement. It is reported that the extrusion rate for the filler ports is about .76% -- very rare.

Although a saline filler is the most popular regardless of either implant shell, there are other options. If some women meet certain criteria (reconstruction, thin skin, asymmetry, congenital deformities, replacing an already existing silicone-filled implant, etc.), they may be eligible for silicone filled implants, which brings us to the next option...

[mybody]

15. My surgeon has offered me silicone and I meet none of the criteria, is this illegal?

Actually, it is illegal. You must meet certain criteria (such as being thin skinned, have had problems with CC, need them for reconstruction purposes, be asymmetrical, have had silicone before, problems with rippling that cannot be corrected with optimum fill amounts, etc.) to be eligible for silicone breast implants. However, many surgeons are handing out silicone implants like so much candy, or because the patient *hears* they ripple less or feel more natural. If you do not meet the criteria for the study, you are legally not eligible and your surgeon is being unethical. The study is being conducted for a reason and altering reports or being untruthful in these clinical trials may significantly alter the statistics.

[mybody]

15. Can I get Cohesive Silicone implants in the United States if I meet the criteria?

Yes you may, if you are eligible and they are available to you. The Cohesive Silicone Implant trials should now be under way -- please ask your surgeon if he/she is involved in the trials and determine if you meet the criteria. being involve din clinical trials carries with it, responsibility, You must continue to be faithful in follow up appointments and may be asked to keep a journal for reflection.

[mybody]

16. Will the implant burst when I get my next mammogram?

Although it is possible, more than likely, not. Your mammogram technician may be experienced (hopefully) in the Eklund technique for patients with implants.

[mybody]

17. What size should I choose? How do I know which is best for me?

This question is probably one of the most often-asked. This is totally up to you! If you are asking what is the average size - C and D's are pretty common. If you are asking what size would help balance YOUR figure -- try determining your hip-to-bust ratio. Say for instance if your hips are 36 inches, your breasts can be 34 to 36 inches and up (around the breasts, not your bra band size) and you will look more like an hourglass as opposed to a pear. However, like I said, it is entirely up to you. You don't have to look like an hourglass if you don't want to. Just choose a size that you would be comfortable with, both emotionally and physically. You will have to wear them from here on out. Just remember that most women say "I wish I would have gone bigger."