Fw: Letter to the FDA's Dr. Whalen from Dr. Melmed, plastic surgeon

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----- Original Message ----- From: *~Patty~*

EMelmed@...

Sent: Sunday, November 09, 2003 11:23 AM

Subject: Fw: Letter to the FDA's Dr. Whalen from Dr. Melmed, plastic surgeon

Dear Dr. Melmed,

I wanted to respond to this letter, (below) as I have some concern about your implication that saline implants are a safer alternative to silicone gel implants.

I understand and respect that you are a knowledgeable plastic surgeon and have done a tremendous job to bring awareness to this issue and in helping women with proper explant procedures. Indeed, on my saline support group, we have often recommended you for explant for our women.

However, the concept of saline implants as being a "safer" alternative to silicone gel is dangerous. Perhaps you mean this in a relative way, but it has been the experience of many, many women that saline implants have been tremendously damaging to their body. I myself suffered serious immune system damage to my body after having McGhan textured saline implants for only 9 months. I presented with an eleveted rheumatoid factor, lowered C3 complement, and eventually was diagnosed with Hashimoto's autoimmune thyroid disease. This was a result of my "safe" saline implants. I suffered all of the same constellation of symptoms that women who were sick from silicone gel suffered. Upon explant, almost all of these symptoms have resolved, and I now live a normal life with treatment for my Hashimoto's. It is my hope that someday these abnormal blood tests can return to normal values.

I want to point out to you that a recent Canadian report on the amount of health care resources used by breast implanted women made no distinction between the amount of health care resources used by women implanted with silicone gel vs. saline. I will supply the link to this article with this letter, and would like to emphasize this statement:

Types of implants (saline or silicone gel) did not significantly affect hospitalization or medical utilization.

Here is this statement, in context:

A new study by researchers at the Centre of Excellence for Women’s Health in British Columbia finds relatively high complication rates for breast implantation in Canada as well. Data collected from a study group of 147 women who had undergone breast implant surgery were compared to data from a non-implant comparison group (583 women). The study reported that women who have or have had breast implants:

Ø visited doctors and specialists significantly more often

Ø were more than four times as likely to be hospitalized, and

Ø experienced more hospitalizations over the study period than women without implants.

All these differences were significant when age, marital status, education level, exercise, use of alcohol, and geographic region were statistically controlled. Types of implants (saline or silicone gel) did not significantly affect hospitalization or medical utilization.

You can see this entire report on Dr. Zuckerman's informative website:

http://www.breastimplantinfo.org/what_know/bihlthcomp.html

I founded a support group for women harmed by saline implants. There are hundreds and thousands of women in this category. Please don't offend our sensitivities by stating that saline implants are a safer alternative to silicone gel. That is what we believed when we chose saline implants, and yet we all paid a very dear price for this deception.

Sincerely,

Faussett

Founder of Saline Support on

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----- Original Message ----- From: Rogene S

Sent: Saturday, November 08, 2003 7:21 AM

Subject: Letter to the FDA's Dr. Whalen from Dr. Melmed, plastic surgeon

Dear Dr. Whalen:I am the only Plastic Surgeon who testified at the Gaithersburg hearingsagainst the reissue of Silicone Gel Implants.I am also a Plastic Surgeon who performs a significant number implantremovals. As such, I consult with and hear from hundreds of women withproblems. Almost all the women have had their complaints brushed off by their plasticsurgeons who claim "there is absolutely nothing wrong with silicone".I had drafted a letter to you as panel chairperson imploring that, eventhough the vote was 9-6, this be reconsidered. Your public voicing of yourconcerns pre-empted me sending my letter. So this e-mail is to tell you how relievedI am that someone is expressing concerns about the unanswered long termquestions regarding this medical device.My concerns and worries centered on the three major problems associated withimplants.#1: Failure rate. How can the FDA accept a device that fai ls 50-70% of thetime after being implanted for 10 years on? If reissued, use in 16-18 yearolds who get a "boob-job for graduation" will mean a generation of 30-35 yearolds with ruptured implants.#2: Severe local complications. These are trivialized by surgeons whodismiss this as "minor" or "insignificant." There are some grotesque deformitieswith multiple surgeries for these complications. A procedure that guaranteesmultiple operations should be unacceptable.#3: The yet unanswered question of symptoms. There is no doubt that a groupof women all have the same symptom complex. Yes, this is not "classicalautoimmune disease." But something is going on. At the hearings, some womenwere very emotional. But there are sane, intelligent women who have the same symptomcomplex. The truth lies somewhere in the middle.Just because there is a demand from plastic surgeons and the manufacturer,this product should not be release d to be used in very young women untilsafety and low failure rates can be proven. Silicone gel may be considered inreconstruction after cancer. But why allow use in 1-18 year old women whenthere is a safer alternative - saline filled implants -- available?I congratulate you on your courageous stand. I would have liked more than 3-5min to have been able to talk about the 'other side' of the issue. If I can be of any help, please feel free to contact me.Sincerely, P. Melmed, MD,Medical City Hospital Dallas