Fw: Letter to FDA head by Dr. Whalen on silicone gel breast implant safety concerns

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Yes, Yes and Amen! (Keep praying!) Luke 18:1

The Parable of the Persistent Widow 1Then Jesus told his disciples a parable to show them that they should always pray and not give up. 2He said: "In a certain town there was a judge who neither feared God nor cared about men. 3And there was a widow in that town who kept coming to him with the plea, 'Grant me justice against my adversary.' 4"For some time he refused. But finally he said to himself, 'Even though I don't fear God or care about men, 5yet because this widow keeps bothering me, I will see that she gets justice, so that she won't eventually wear me out with her coming!' " 6And the Lord said, "Listen to what the unjust judge says. 7And will not God bring about justice for his chosen ones, who cry out to him day and night? Will he keep putting them off? 8I tell you, he will see that they get justice, and quickly.....

----- Original Message ----- From: ilena rose

ilena@...

Sent: Wednesday, November 05, 2003 7:17 PM

Subject: Letter to FDA head by Dr. Whalen on silicone gel breast implant safety concerns

Bravo, Bravo, Bravo, Bravo to Dr. Whalen!!!!

October 31, 2003 Mark B. McClellan, M.D., PhDFood and Drug Administration5600 Fishers LaneRockville, land 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 al and Witten to not approve this PMA. I would be delighted to provide any further information if you desire it. ; Sincerely yours, & nbsp; V. Whalen, MD Professor of Surgery and Pediatrics cc: W. al Jr., MD Celia Witten, MD, PhD Senator Jon Corzine Senator Kennedy ; Senator Lautenberg Representative Roy Blunt Representative Greenwood~~~~~~~~~~~~~~~~~~~~~

For information and links, please visit:

www.BreastImplantAwareness.org

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