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Fintan
Site Admin
Joined: 18 Jan 2006
Posts: 5202
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 Posted: Mon Nov 27, 2006 6:43 pm Post subject: Audio: Breast Implants -The Smoking Gun |
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Breast Implants: The Smoking Gun
Even as we are still dealing with the consequences of the last silicone
implants disaster, the FDA has for the first time ever, assured the public
that silicone breast implants are safe. Now it's likely that we are on target
for half a million Americans a year getting implants!
But are they safe? Or will they harm your health as you age?
We speak to three people leading the debate, and discuss smoking gun
revelations by a whistleblowing scientist who worked for one of the
implant manufacturerers. Evidence that points to a potential health
catastrophe lying in wait.
Kim Gandy, President National Organization for Women
Dr. Scot Glasberg, Practicing Plastic Surgeon
Ilena Rosenthal, BreastImplantAwareness.org
"The Next Level" Internet Radio Show
DSL Mp3 Audio 
http://www.mylonglife.com/audio/MyLongLife061128a.mp3
Dialup Mp3 Audio
http://www.mylonglife.com/audio/MyLongLife061128.mp3
| Quote: | 
REFERENCES & LINKS
Kim Gandy, NOW website http://www.now.org/
Ilena Rosenthal's Website http://www.BreastImplantAwareness.org
Dr. Glasberg's Website http://www.drglasberg.com
Silicone Gel Breast Implants: Most Defective Medical Device Ever Approved by the FDA
http://www.citizen.org/pressroom/release.cfm?ID=2320
| Quote: | Public Citizen Calls for Criminal Investigation of Breast
Implant Manufacturer for Withholding Safety Data from FDA
Public Citizen's letter to the FDA written by Sidney M. Wolfe, MD.
Whistleblower's letter to the FDA highlighting
dangers associated with silicone gel implants.
October 12, 2006
Andrew von Eschenbach, M.D., Acting Commissioner
U.S. Food and Drug Administration
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. von Eschenbach:
I have recently obtained a copy (below) of a June 22, 2006 letter sent to the FDA by a former senior scientist from Mentor—one of the two companies seeking FDA approval of silicone gel breast implants—accusing the company of withholding from the FDA important new safety information concerning dangerous physical and chemical properties of their implants. Prior to sending the letter, the scientist had raised all of the serious concerns mentioned in the letter within the company; he had urged Mentor to submit the withheld data, but they had refused. The scientist sent the information to the FDA only after his employment was terminated after 15 years with the company.
Several weeks ago, the former Mentor scientist was called by the FDA staff member to whom the letter was sent. The scientist was told that because:
(1) the withheld test data demonstrating dangers of the implants referred to in the letter were not required in FDA’s request to Mentor (and Inamed, the other breast implant manufacturer) for more studies (referred to as the “deficiency response”); and (2) since the submitted data from both Mentor and Inamed (the other silicone gel breast implant manufacturer) were similar, that he had no other comment on the new information, implying that the agency would take no action.
This new information is compelling enough to warrant a reassessment of FDA’s position. At the very least it should clearly stop any FDA final approval of either device until the withheld data has been submitted, evaluated by the FDA staff, and made available to the public. This new evidence that information has been illegally withheld from the FDA should prompt a new criminal investigation into the Mentor’s failure to promptly send the agency all new information bearing on the safety of silicone gel implants.
In discussions with the scientist, he has explained to me the details and significance of the information. This is summarized below, under five subheadings that correspond to the five points made in the letter to the FDA:
Tests/data concerning gel leakage, composition
Diffusion Testing Validation: The gel bleed (diffusion out of the implant and into the body) chemical test data submitted to the FDA is invalid and has been fraudulently represented. A new procedure to correct this problem was successfully tested but the data from this more valid method was never submitted to the FDA. The importance of this is that the submitted data might understate the amount of low molecular weight siloxanes (the more toxic component of silicone gel) that is seeping out from the implant into the body.
Explant Semivolatile Extractable Testing: In tests of explanted silicone gel implants, the company found that there were very large amounts of the above-mentioned low molecular weight siloxanes compared to the amounts in devices that had not yet been implanted, implying that the larger molecular weight siloxanes were continually being degraded in the body to low molecular weight siloxanes. This suggests that a continual degradation of higher molecular weight gel to lower molecular weight siloxanes and bleeding of this may subject women to a constant source of the more dangerous low molecular weight siloxanes. These data were not submitted to the FDA.
Tests related to mechanical properties of the implant
Explant Mechanical Testing: The company found a significant decrease in some of the mechanical properties of explanted devices in comparison to unimplanted control devices from the same manufacturing lot. In their submission to the FDA, however, these comparisons with unimplanted devices were not explicitly made, thus obscuring as much as a 50% decrease in some of these mechanical properties. This magnitude of weakening of the implant shell is extremely relevant to the issue of implant rupture.
Device Projection Fatigue Testing: Device projection refers to the distance from the front of the implant to the back (the anterior-posterior distance). A Mentor investigation of the relationship between device projection and fatigue lifetime (the time until the implant ruptures) found an inverse relationship, i.e., as the device projection increased, the estimated lifetime of the device decreased. This information was also not sent to the FDA.
More toxic form of platinum in the implant shell
Platinum Valence: As noted in the letter, Mentor studies showed that in the silicone rubber envelope of the implant, Platinum existed in the +2 oxidation state (Pt (II). This previously unknown finding is of potential importance since this oxidation state is thought to be more toxic than the Pt (0) oxidation state of the metal. Again, this information was not sent to the FDA.
In summary, this former Mentor scientist has made the FDA aware of previously undisclosed information based on company files. These include considerable test data showing safety problems with silicone gel breast implants. Although some of these studies were not “required “ to be done in the Guidance among the studies the FDA asked Mentor to do, their results directly address important issues of safety that are of relevance and concern. The fact that they were done and that they found some serious problems with the safety of the implants is reason enough for the FDA to take them into account and demand that Mentor provide the actual data from the studies.
As mentioned above, no approval decision on either the Mentor or Inamed implants can be made until the FDA is in possession of and has evaluated these new studies. Unless the FDA opens a criminal investigation into Mentor’s failure to submit the studies, it will encourage Mentor and other device manufacturers to selectively send the agency only those studies that put their products in the most favorable light. Please note that in his letter to the FDA, the former employee identified the specific Mentor staff files containing the withheld information.
I look forward to a prompt response concerning this serious matter.
Sincerely,
Sidney M. Wolfe, MD
Director, Public Citizen’s Health Research Group
See Also -Original Letter by Whistleblower
http://www.citizen.org/publications/release.cfm?ID=7476
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| Quote: | Take Action on NEW Implant Safety Risks
by National Organiztion of Women, Friday Nov 3rd, 2006 12:05 AM
FDA Ignores New Allegations -- This month new allegations by a scientist formerly employed by Mentor Corp. accused the company of withholding unfavorable safety data about silicone gel breast implants from the Food and Drug Administration (FDA), which is currently deciding whether to approve these implants for unrestricted use. NOW has concluded that silicone gel breast implants pose unacceptable health risks to women.
It is the responsibility of the FDA to make sure that information provided by industry about medical products is accurate, and that the products are safe, before an approval decision is made. This is not always possible, but when whistleblowers come forward, the allegations must be scrutinized immediately.
http://www.now.org/press/11-06/11-17.html |
Ban on Silicone Breast Implants Lifted
http://www.forbes.com/business/energy/feeds/ap/2006/11/17/ap3186546.html
Improved Implants (Sort Of)
Yes, they're back, but they still require a heck of a lot of scrutiny
http://www.usnews.com/usnews/health/articles/061126/4implant.htm
Breast Implant Study Results Reflect Funding
LINK
The Silicone Breast Implant Controversy
by: Susan E. Kolb, M.D., F.A.C.S.
http://www.plastikos.com/art-silicone.htm
TYPICAL SLOPPY CORPORATE JOURNALISM ARTICLE:
Is silicone or saline right for you?
http://www.thedesertsun.com/apps/pbcs.dll/article?AID=/20061126/LIFESTYLES03/611260315/1006
TYPICAL PLASTIC SURGERY PROMO ARTICLE ON RISKS:
If you're considering breast augmentation...
http://www.plasticsurgery.org/public_education/procedures/AugmentationMammoplasty.cfm
Mentor Breast Implant Safety Information
http://www.mentorcorp.com/global/breast-augmentation/breast-implant-study.htm
Allergan Breast Implant Promotional Website
http://www.breastimplantstoday.com/silicone/silicone_safety.ht
FDA Backgrounder on Platinum in Silicone Breast Implants
http://www.fda.gov/cdrh/breastimplants/platinum.html
[b]Citizen Petition to the FDA on Breast Implants
LINK
[/b]
Confidence Game: Burson-Marsteller's PR Plan for Silicone Breast Implants
http://www.prwatch.org/prwissues/1996Q1/silicone10.html
| Quote: | Keeping Abreast of
Parasitic Implants!
Featuring an audio interview with Ilena Rosenthal
BreakForNews.com, 8 Feb, 2006 by Fintan Dunne, Editor
When an advisory panel to the Food and Drug Administration recommended that silicone gel-filled breast implants be reinstated after having been banned years ago on health concerns, the membership of that panel got little mention.
That panel was made up of plastic-surgery experts including practicing plastic surgeons. Are alarm bells ringing for you? One of those so-called experts was University of Texas plastic surgeon Michael Miller, who said afterwards: "The risks are well-defined and small. The patient can decide."
But what if the patient is deciding based on false medical risk evaluations? Implant manufacturer Inamed told the panel that the rupture rate of its implants was 1.2% for women who had breast augmentation. Is that true?
Where can you get the truth about breast implants and their impact on the human body? Not from the manufacturers that make billions of dollars selling these toxic bags of ego gratification. Not from the US congress, and definitely not from the mainstream media.....
http://www.breakfornews.com/articles/Breast-Implants.htm
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Last edited by Fintan on Fri Aug 08, 2008 9:54 am; edited 11 times in total |
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MichaelC
Joined: 06 Jul 2006
Posts: 1973
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| Posted: Tue Nov 28, 2006 5:25 am Post subject: |
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Do people actually get turned on by silicone (or salene) tits?
Just asking. |
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elfis
Joined: 07 Mar 2006
Posts: 74
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| Posted: Tue Nov 28, 2006 5:34 pm Post subject: |
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| MichaelC wrote: | Do people actually get turned on by silicone (or salene) tits?
Just asking. |
Apparently so ... they drive the porn industry.
sMiles |
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RedMahna
Joined: 07 Sep 2006
Posts: 909
Location: On or near a computer
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| Posted: Tue Nov 28, 2006 7:19 pm Post subject: |
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imo, they are disgusting and feel like shit, too.
sorry for the TMO (too much info) but i prefer "natural" porn models, myself.
(yes, i'm an old fart who doesn't get laid much...)
in the USA, the customary thing in the past 30-40 years had been getting a new car for the girls' 18th birthday or graduation present.
they are now getting implants instead - you can observe this at any shopping mall across the country.
what a waste.. not to mention an extreme hazard to their health.
i had seen documentaries about the leakage problems, and about how these implants begin rotting one's flesh from the outside areas that enclose the foreign material.
i'll check out the audio a little later after work. but i'm sure it'll have the same info i've already known.
one thing, tho... no matter what is made legal & available, buyer beware. it's not the same as pushing bad meds on a poor country that has little power. here you have mega-marketing under the pretense that a procedure or drug is safe to a consumer who can afford it or can charge it on credit. it's not the same, tho it's still wrong to make it sound okay to do.
after all, cigarettes are bad, too, and i choose to smoke. i cannot understand why people sue the tobacco industry. just because booze is legal doesn't mean it's dewer's fault if i kill someone on the road. and kids still put bolts in their tongue, even tho it's the worst place to get a piercing.
peer pressure, body image, laziness & convenience are easy targets for marketers.
red
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speechless for once. |
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Rumpl4skn
Joined: 11 Feb 2006
Posts: 2654
Location: 36° 3'N x 86°40'W
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| Posted: Tue Nov 28, 2006 7:54 pm Post subject: |
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| MichaelC wrote: | Do people actually get turned on by silicone (or salene) tits?
Just asking. |
They're real on the outside. 
_________________
I stand for truth and justice. I used to add "American Way" to that, before I realized that latter has nothing to do with the previous two. |
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maverick
Joined: 09 Aug 2006
Posts: 271
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| Posted: Tue Nov 28, 2006 8:30 pm Post subject: |
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Dr.Scott Glasberg.........
..."these silicon implants are the single most researched devices in the history of the FDA"
Does this guy think we are stupid...........
How does he expect anyone to believe that BS.............. |
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maverick
Joined: 09 Aug 2006
Posts: 271
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| Posted: Tue Nov 28, 2006 8:59 pm Post subject: |
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Isnt it funny how we make such a big deal over the use of steriods but the use of these breast implants is not hardly even mentioned.............
Now I am not saying steriods are risk free but I would rather have testosterone floating around in my body rather than silicon or platinum in my system............. |
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rustyh
Joined: 17 Sep 2006
Posts: 418
Location: A Wonderful World
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| Posted: Wed Nov 29, 2006 3:06 am Post subject: |
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Fake tits are like CIA fakes.
They look good at first, but on closer inspection you have your doubts and then once you get the feel of them? Cheated. Bloody fakes. 
Just goes to show that half a million chicks have either low self esteem or they want to look like some 'big boobed' celebrity.
Sign of the times."Boobs like Brittany, this weeks special".
I bet they do more research into 'who' they want to look like ,rather than checking out if silicone is harmful.
Plus, they wouldnt want to know if it is harmful!
They want the good looking titties.
Rusty |
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Damian Flynn
Joined: 29 Jan 2006
Posts: 220
Location: Australia
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| Posted: Wed Nov 29, 2006 3:18 am Post subject: |
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| What about women's rights? I read somewhere that breast implants are the greatest thing for women's liberation since the pill. In the case of Africa, it would of course have to be the life saving female condoms. I heard that African women are dying for female condoms. |
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atm
Joined: 16 Apr 2006
Posts: 3131
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| Posted: Wed Nov 29, 2006 3:42 am Post subject: |
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Why don't they just implant Bono and Bobby Shriver -- they're fake tits, really fake tits.
http://www.youtube.com/watch?v=noNe4_NlBuk
Bono could be the right tit (because he is one). Shriver could be the left tit (because he's a Democrap).
Or Alex Jones and Paul Joseph Watson? They could do that left-right paradigm tit thing.
Or how about Victor Thorn and George Noory?
Or...[That's enough. Ed.]
atm  
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"“If only God would give me some clear sign! Like making a large deposit in my name in a BitCoin wallet.dat.file.”
[Apologies to Woody Allen.] |
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kathy
Site Admin
Joined: 20 Jan 2006
Posts: 672
Location: Surfing The Waves
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| Posted: Wed Nov 29, 2006 8:14 am Post subject: |
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Just for the record, I don't wear padded bra's with "chicken fillets" in them  "God" be with the days when a sock or tissue was what expanded the breast :roll: I say that a bit of hand rearing is what's needed instead of silicone.
My eldest sister was at a disco many years ago and had an ankle sock stuffed in her bra to make her boobs look bigger what embarrassment when it slipped out on the dance floor  Mine were so tiny when I was a teenager a guy who eventually asked me to dance said he had wondered if I was a boy or a girl :roll:
All joking aside though, do women get implants to feel good themselves, to make other women jealous or to live up to the "perfect image" portrayed on TV and magazines? And where are the women's voices in this discussion, are there only men posting here? |
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Nat
Joined: 15 Sep 2006
Posts: 851
Location: minime-rica
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| Posted: Wed Nov 29, 2006 8:59 am Post subject: |
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you've hit on some important points there, Kathy
it's sheer fear driving many of these women surely ? if everyone has artificially oversized boobs, then the 'norm' shifts
Last edited by Nat on Sat Apr 17, 2010 5:44 am; edited 4 times in total |
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MichaelC
Joined: 06 Jul 2006
Posts: 1973
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| Posted: Wed Nov 29, 2006 12:55 pm Post subject: |
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| Quote: | heard that African women are dying for female condoms.
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Please learn the facts about this NWO/BigPharma horse-shit:
http://www.lewrockwell.com/orig7/culshaw1.html |
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kathy
Site Admin
Joined: 20 Jan 2006
Posts: 672
Location: Surfing The Waves
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| Posted: Wed Nov 29, 2006 2:24 pm Post subject: |
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titanium tit's, now there's an idea, now I was joking when I wrote that a few hours ago and it sat here on my desktop waiting for me to finish it. Meanwhile I did a search for "titanium breast" and look what I found:
| Quote: | What a lovely pair of titaniums!
June 24 2004 at 01:41PM
By Thea Jordan
A doctor in Germany has invented the world's first titanium bra - and it's meant to be worn under the skin.
Dr Ziya Saylan, president of the European Academy of Cosmetic Surgery, has developed a technique to implant cups of titanium mesh under the breasts.
They are then attached to the patient's ribs and muscle. The effect is claimed to be instant, youthful-looking boobs with invisible lift.
'A woman with these implants will never have to wear a bra again'
In the past four months, more than two dozen women have undergone the procedure, which costs the equivalent of R47 000.
"The advantage is that a woman with these implants will never have to wear a bra again," says Saylan. The surgical technique is unique to Germany at the moment, but is expected to become available elsewhere in due course.
Titanium is flexible, but extremely strong. It is completely inert, so will not cause an allergic reaction in the body, and Saylan claims it will never sag.
The procedure, which can be done at the same time as a silicone implant to increase the size of the breast, is performed under general anaesthetic. Saylan, 55, says most patients are women between 30 and 45 who have developed sagging breasts after childbirth or weight loss.
Older patients are less suited for the procedure because their skin might have lost some of its elasticity.
'After a short while you will not even know it is there'
At the start of the 90-minute operation, the patient is placed in a sitting position so the breasts hang down over the chest.
A semicircular cut is made around each nipple and space is made for the implants between the glandular tissue of the breast and the fat just under the skin.
Dr Saylan says it is important not to damage the fat layer, because otherwise the implant may show through.
The titanium mesh, which weighs just 35g and is as thin as net curtains, is cut to size and moulded into a cup shape. It is flexible enough to be rolled up and inserted through the small incision round the nipple and then manoeuvred gently into place.
The implant is held in place by stitches that attach it to the breastbone and the pectoral muscles.
These dissolve after 10 weeks, when it has already fused with surrounding tissue. Patients stay in hospital over-night but can be back at work after a week.
"At first, the breast is tender to touch," says Saylan, "but after a short while you will not even know it is there".
Scarring is minimal because it is disguised around the nipple.
Afterwards, the breasts are higher and firmer, because the tissue is compacted into the titanium cup.
Apart from the cos-metic effect, patients who go bra-less could get health benefits, too.
An American survey of almost 5 000 women showed the odds of getting breast cancer increased dramatically the longer women wore bras.
The study concluded that the constricting effect of bras suppressed the lymphatic system below the armpits, blocking a network of vessels supposed to flush toxic wastes from the body.
Saylan's patients have all been happy with their surgery, but some experts advise caution.
Mike Bowen, a gynaecologist in London, believes the implants could lead to less attractive breasts in the long run.
"It is well known that titanium meshes can lead to fibrosis in the tissue - unsightly lumps and bumps," he says.
Another potential problem is called erosion - the mesh works its way through the fat and starts poking through the skin.
More seriously, all implants increase the risk of infection.
Breast tissue can die if the blood supply is interrupted, leaving scarring.
Says Bowen: "Titanium is not biodegradable and stays in place permanently. It will be difficult to remove if things go wrong. Women may gain weight or change body shape as they get older. With a conventional bra, you can just buy a different size. A titanium implant cannot be swopped for a D cup".
He also dismisses the idea that conventional bras could lead to back problems and even cancer.
"I've never heard of a well-fitting bra causing health problems and they are actually quite attractive items of clothing".
Selma S, 38, is a beauty therapist in Dusseldorf. She is divorced and was one of the first women to have the procedure.
"I was unhappy with the shape of my breasts.
"They used to be quite firm, but I went on a diet and lost weight.
"I was very happy with my new trim figure, but I noticed my breasts were hanging down. I had a boyfriend who made a jokey comment, which really hurt.
I was so self-conscious I would hide my breasts under baggy clothes. It got to a point that I would take my clothes off only in a darkened room. Wearing a bikini on the beach was out of the question.
"When I went to see Dr Saylan he showed me a computer reconstruction of my new breasts, to make sure they were what I wanted.
"Before I decided to go ahead, he warned me the titanium bra can make it difficult to feel small breast tumours, so it's really important that I have regular mammograms and ultrasound examinations at least twice a year.
"The operation itself went really well.
"There were no complications and no pain. I was back at work in a week, although I had to wear a special sports bra with lots of support for 10 weeks until the swelling was gone.
"I work in the beauty industry and I know that it is natural for someone to desire a better body. The operation has changed my life and I feel a lot better about myself".
LINK
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I had titanium nails put into my right and left legs following RTA and swore I did not want to see x-ray's, it actually took me a long time to accept my titanium nails, even though without them I may not have been able to walk again (?). Can't imagine having silicone or titanium tit's (Ughhhhhh) Can imagine they would leave dents, if ya know what I mean, no disrespect to anyone suffering as a result of leakages or anything.
The way I see it is regarding "me" is what you see is what you get and a beautiful mind is worth ten silicone tit's or penis extensions 
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atm
Joined: 16 Apr 2006
Posts: 3131
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| Posted: Fri Dec 01, 2006 4:09 am Post subject: |
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Suggested reading:
Naomi Wolf's "The Beauty Myth."
http://en.wikipedia.org/wiki/The_Beauty_Myth
http://www.synaptic.bc.ca/Contact/viewforum.php?f=17
Suggested viewing:
Jean Kilbourne's "Killing Us Softly" and "Still Killing Us Softly."
http://www.jeankilbourne.com/video.html
On the flip side (this is how screwed up women have become due to advertising and hard-sell Hollywoodesque marketing):
http://www.mediaed.org/videos/MediaGenderAndDiversity/SlimHopes
Gawd, you should see what katoey's [lady boys] do to themslves in SE Asia: It's a freak show.
Advertisers tell us what is masculine and what is feminine. What they don't tell you (why would they?) is the costs to individuals and society at large.
It's a type of biological / chemical / psychological warfare, IMHO.
atm 
_________________
"“If only God would give me some clear sign! Like making a large deposit in my name in a BitCoin wallet.dat.file.”
[Apologies to Woody Allen.] |
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