Open Letters to Dr. Whalen

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 ...

Wisdom from Dr. Whalen October 31, 2003	Ilena's comments 5.13.2005
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.	You were so right. The short term studies that Mentor was given conditional 'approval' on ... have changed nothing. Dr. Whalen, Mentor had but a 5% follow-up rate in an earlier study. Women were tossed from these studies and the revealing data which included their illnesses and their ruptures evaporated. The threats you mentioned are definitely still there.
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.	Dr. Whalen, this remains true ... and perhaps even worse with the thicker breast implants. What is making them thicker, by the way? What ingredients have been added to make these "new & improved" silicone gel implants, Dr. Whalen. I was at a party recently in Central America. A new friend shared that her 42 year old sister had breast implants for 9 years. For the last 3 or so she felt very ill. She had more than one mammogram which revealed nothing. She just recently had her implants removed, and a mastectomy which included 9 tumors hidden behind those implants. Please Dr. Whalen ... tell us how what your concern is no longer valid.
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 evidence-based medicine.	Yes, Dr. Whalen. Very low quality data. Do you remember the turn around the IOM had to do regarding Agent Orange? Their "good news" about breast implants may well not prove to be true in the long run. My opinion is exactly what you expressed so well.
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.	You are so right here Dr. Whalen. I recently received court records where a woman was dropped from a Mentor study after their her surgeon had an affair with her. Others were dropped when they became ill. How in the world will this be monitored?
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 company.	Words of wisdom ... every bit as true now as in October, 2003.
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.	Silicone breast implants can't just be taken off the shelves. There's no "ooops factor" here Dr. Whalen. Do you recall how thousands of British women had to have their "latest & greatest" soy oil implants removed with no good options thereafter. That was just a handful of years ago.
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.	Not in October 2003. Not in May 2005.
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.	This is no less true for now. Fewer insurance companies are offering coverage to implanted women, Dr. Whalen. Where will they turn for their failing health?

Washington Post article of May 11, 2005 "Much of my change in philosophy over this difficult issue arises from a newfound perspective that to not allow these devices for women who knowingly make the choice to have them is sexist,"	This is not about "choice" ... it's about safety. There is still time for you to be that independent, ethical man who stood up to Inamed in 2003. Please do the right thing again. Safety is not 'sexist.' It's the only question on the table.

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.

Ilena Rosenthal

Director, Humantics Foundation for Women

www.BreastImplantAwareness.org

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.

Dear Dr. Whalen,

Is there no one we can trust or turn to in our terrible pain and suffering. Everyone seems to be turning against us as we grow sicker and sicker. We can't get insurance. Our doctors won't treat us. We hoped you would continue to support our cause.

We are sorry to see you leave as our hero.

Sincerely,
Virginia L. Saxe

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
evidence-based medicine.

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
company.

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
it.

Sincerely yours,

Thomas V. Whalen, MD

Professor of Surgery and
Pediatrics

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