Breast Implants: Recovery & Discovery
May 13, 2005
Dearest Dr. Whalen,
In a world where corporations truly rule and ethics seems but a concept ... you, Thomas Whalen, were once my hero beyond measure.
When you took your powerful stand and put sense up against billions of dollars of breast implant money on the table in October, 2003, you gave me faith in humankind again.
After decades of lies and broken implants and promises from the manufacturers, you, Thomas Whalen, stood up to them.
Let's together look at what you said 19 short months ago ...
Please dear Dr. Whalen ... heed your own sage words of warning above. The women in this world need an honest, brave, educated, ethical man like yourself to stand up against the mighty silicone manufacturers again.
With hope, prayers and belief that sanity can still prevail.
Director, Humantics Foundation for Women
To write Dr. Whalen, click here:
Here is what beautiful Kacey Long wrote to him ... and our Ginny.
This is not a negative email. I don't like getting those, so I don't send them either. I just wanted to say that I was so happy when you decided to recommend that the FDA not approve silicone-gel implants....you were a hero to the people that needed you most. Life is hard, and the tough decisions are often the best ones. It was difficult for you, I'm sure, to make such a stand...to put your credibility on the line (as our credibility is always on the line) and to say something that your colleagues did not want to hear. You had so many people praying for you, it does not surprise me that you had the courage to speak out.
We have to always question why we choose to do something, why we say a certain thing or think a certain way. We can get caught up in the things of this world...its easy in more ways than one. It is easy to join the majority, but it takes a strong person to speak up for what is right. I know that person is in you. And I thank you for letting him speak out at the last hearings.
Kacey Long age 22, Texas
Sick from saline breast implants since 2001...when they were put in.
(To see Kacey's wonderful website, click here.)
Dear Dr. Whalen,
If you'd like for me to post your letter to him, click here and send me a copy.
Here is what our Poetess, Vicki Lawrence has to say now:
|Nothing surprises me anymore
It's getting really difficult to keep the score
It's just more proof that our System is failin'
We'll still win our fight without DR. WHALEN!
Who is he, anyway?
Soon our thoughts of him will fade
Gee, I wonder...
Do you think he got paid?
Whoops! I shouldn't think like that
He's probably a decent enough chap
We all need to write him or "tan his hide"
And remind him why he was once on our side!!
Bye bye, Dr. Whalen
You've made poor choices
You'll never be heard
Over a million women's voices
We will never, never give up the fight
We must research and educate and never lose sight
For we are the women who are in the "know"
And shall overcome and survive the Silicone Fiasco!
I personally know of the tactics the silicone manufacturers use to attempt to have their 'image' upgraded ... and how infiltrated they are within the breast implant support system.
Below was written in November, 2003 ... obviously, it no longer remains true.
Check out the "red" areas ... what could have made him forget his own words?
This is the bravest act I have ever witnessed in the breast implant controversy since Dr. David Kessler approved the original partial ban in 1992.
Thank you to Dr. Whalen ... may he be protected always for exerting such courage.
Vicki from our Support Group, said it best:
voices being heard
Our implants are "failin"
Thank the Universe and the Lord
For Dr. Whalen!!!!
Click here to view Dr. Whalen's University Website.
October 31, 2003
Mark B. McClellan, M.D., PhD
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Dear Doctor McClellan,
On October 14 and 15 of this year, I chaired the General and Plastic
Surgery Devices Advisory Panel in Gaithersburg, MD for consideration
of a PMA by Inamed Corporation for silicone gel breast implants. As I
am sure you are aware, the panel voted 9 to 6 that this PMA was
approvable and the matter is now under consideration for action at the
CDRH. I write to express as the Panel Chair my very strong
reservations concerning this vote having thoroughly reviewed the PMA,
heard my scientific colleagues on the panel as well as the
presentations of Inamed and the FDA, and having intently listened to
all of the over 100 individuals who gave public testimony.
At its essence, and as is mandated by federal code, the mission of an
FDA panel and then the FDA itself acting upon the panel recommendation
is really elegantly simple: to judge that the company bringing the PMA
before them has demonstrated with reasonable assurance that the
product under consideration is both safe and effective. Effectiveness
was demonstrated (and is almost self-evident). Long-term safety, the
concern that prompted the removal from the market eleven years ago,
was clearly not demonstrated and to approve this device poses threats
to women that are clearly unknown. In my opinion there is at least
one facet of long-term danger that was established during the panel
specifically the obscuration of surrounding normal breast tissue to
mammographic detection of breast cancer. The re-operation rates and
other local complications from silicone leaking outside the breast
area have also been established by FDA scientists and are not minor
considerations for a cosmetic device. Moreover, despite the
sophistication of the Institute of Medicine's report, all of what was
considered by them reflected low-quality data in the age of
It is incumbent upon the FDA to demand that the manufacturer establish
in a rigorous prospective, controlled study that these devices,
despite their established breakage and leakage rates, are safe in the
long term. If that is deemed to be not feasible for the company, then
they should abandon pursuit of approval. However, the company's track
record suggests that they are capable of such research but have not
been sufficiently motivated to complete it.
The plethora of approval conditions that had my head spinning during
panel deliberations is proof that even those who voted the PMA as
approvable are deeply concerned about the lack of long-term safety
data on this product. What will motivate the company to follow these
FDA requirements? Most upsetting was when an FDA official admitted,
at my pressing, that there is little if any remedy for the FDA if
demands to demonstrate long-term safety are not carried out by the
I need not point out to you in your position what the term "FDA
Approved" represents to our citizenry. Once this horse is out of the
barn, indeed for a second time, there will be no recourse.
I have the utmost respect for my colleagues on the panel, one and all.
This most assuredly includes the four well-respected and
knowledgeable plastic surgeons. Certainly, it was essential to
include board certified plastic and reconstructive surgeons when
considering a PMA on breast implants. On the other hand, it serves
the reputation of the FDA in general, and the standing of the panel
process in particular, exceedingly poorly to have had all of the
plastic surgeons vote the PMA as approvable on such a close vote.
Even in academic settings, plastic surgeons may stand to increase
their own income with the use of these devices. To cite a worn
aphorism, it just does not play well in Peoria.
In closing, I must add that the issue of medical care of women who
suffer complications from these implants is extraordinarily troubling.
Costs for removal of these implants and for extra-capsular silicone
can be enormous and are very rarely covered by a health plan. This is
a public health issue of no small import that must be addressed should
the FDA second this misguided panel decision.
I have been honored to be a part of the General and Plastic Surgery
Devices Advisory Panel these past few years, and have been extremely
impressed by the devotion and professionalism of those in your agency.
I regret that the final chapter of my FDA experience was this one and
implore you and Doctors Feigal and Witten to not approve this PMA. I
would be delighted to provide any further information if you desire
Thomas V. Whalen, MD
Professor of Surgery and
cc: David W. Feigal Jr., MD
Celia Witten, MD, PhD
Senator Jon Corzine
Senator Edward Kennedy
Senator Frank Lautenberg
Representative Roy Blunt
Representative James Greenwood
FastCounter by bCentral