October 31, 2003

 

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