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Audio: Breast Implants -The Smoking Gun
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PostPosted: Mon Nov 27, 2006 6:43 pm    Post subject: Audio: Breast Implants -The Smoking Gun Reply with quote

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

Dialup Mp3 Audio



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

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.


Sidney M. Wolfe, MD
Director, Public Citizen’s Health Research Group

See Also -Original Letter by Whistleblower

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.

Ban on Silicone Breast Implants Lifted

Improved Implants (Sort Of)
Yes, they're back, but they still require a heck of a lot of scrutiny

Breast Implant Study Results Reflect Funding

The Silicone Breast Implant Controversy
by: Susan E. Kolb, M.D., F.A.C.S.

Is silicone or saline right for you?

If you're considering breast augmentation...

Mentor Breast Implant Safety Information

Allergan Breast Implant Promotional Website

FDA Backgrounder on Platinum in Silicone Breast Implants

[b]Citizen Petition to the FDA on Breast Implants


Confidence Game: Burson-Marsteller's PR Plan for Silicone Breast Implants

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.....


Last edited by Fintan on Fri Aug 08, 2008 9:54 am; edited 11 times in total
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PostPosted: Tue Nov 28, 2006 5:25 am    Post subject: Reply with quote

Do people actually get turned on by silicone (or salene) tits?

Just asking.
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PostPosted: Tue Nov 28, 2006 5:34 pm    Post subject: Reply with quote

MichaelC wrote:
Do people actually get turned on by silicone (or salene) tits?

Just asking.

Apparently so ... they drive the porn industry.

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PostPosted: Tue Nov 28, 2006 7:19 pm    Post subject: Reply with quote

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.


just cos things are fucked up doesn't mean it isn't progress...
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PostPosted: Tue Nov 28, 2006 7:54 pm    Post subject: Reply with quote

MichaelC wrote:
Do people actually get turned on by silicone (or salene) tits?

Just asking.

They're real on the outside. Wink

"No matter what happens, ever... there's ALWAYS at least one reason. And the top reason is ALWAYS money."
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PostPosted: Tue Nov 28, 2006 8:30 pm    Post subject: Reply with quote

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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PostPosted: Tue Nov 28, 2006 8:59 pm    Post subject: Reply with quote

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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PostPosted: Wed Nov 29, 2006 3:06 am    Post subject: Reply with quote

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. Shocked

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.

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Damian Flynn

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PostPosted: Wed Nov 29, 2006 3:18 am    Post subject: Reply with quote

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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PostPosted: Wed Nov 29, 2006 3:42 am    Post subject: Reply with quote

Why don't they just implant Bono and Bobby Shriver -- they're fake tits, really fake tits.


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 Idea Confused
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PostPosted: Wed Nov 29, 2006 8:14 am    Post subject: Reply with quote

Just for the record, I don't wear padded bra's with "chicken fillets" in them Razz "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 Embarassed 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? Confused
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PostPosted: Wed Nov 29, 2006 8:59 am    Post subject: Reply with quote

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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