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

[Guest guest]

EEEGADS! This was great until I got to the paragraph where he said saline implants are a safer alternative!!! Does he know how sick we are Rogene?

I love Dr. Melmed, and I know he is helping us. But wow, do I get offended when saline implants are promoted as safer! That's why I got salines, because they were "safer" and that is just bullcrap! They ruined my health! Argh!

----- 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

[Guest guest]

And remember that Canadian report about health care costs that Zuckerman posted? Be sure to show him that, and especially the part that says this:

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

Which, of course, means that both are experiencing the same problems. Saline are NOT safer, and somehow they need to understand that.

I agree, he was probably writing that to placate the reader, and not to seem extreme in his views, but I think there could have been a better way to get his point across than to make any reference to saline implants as safer.m OH well. Let's continue to educate!

If they could just find a way to use our own tissue, like cloning or something...we could be rid of all this nonsense...

Thanks Rogene.

Patty

----- Original Message -----

From: Rogene S

Sent: Saturday, November 08, 2003 10:03 AM

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

I don't understand Dr. Melmed's reference to salines either . .. I've told him that. I know that he believes that the PIP (prefilled) saline implants are preferrable to the others. However, PIP's aren't FDA approved either. They've been distributed illegally by Silimed.

In the meantime, I'm bombarding him with information about how sick saline implanted women get. Everyone is welcome to do so too . . emelmed@....

Personally, I suspect that sentence was to placate Dr.Whalen. I'm convinced that Dr. Melmed doesn't like using breast implants at all.

As a small concession to saline implants, I think it's possible that, if a surgeon maintains absolute sterility and uses prefilled implants, the incidence of complication is signficantly reduced. At least some studies show that.

However, that still doesn't account for hyper-sensitivity to silicone, and long term deterioration of the envelope that eventually cause health problems.

Rogene

[Guest guest]

Patty, and Rogene,

I don’t want to make anybody upset, but if Dr Melmed is the one in Texas, I emailed him personally when looking for an explant doc last year, and he told me he didn’t believe that saline smooth were making me ill. That "happens with silicone" And that silicone toxicity wasn’t an issue for me either. He was a kind man to email me back and forth, but he just wasn’t what I wanted after that.

He did add that textured salines could be a problem, but not smooth. I chose not to go to him. I also felt that some other explanting doctors didnt think that saline were making me ill.

----- Original Message -----

From: *~Patty~*

Sent: Saturday, November 08, 2003 2:09 PM

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

And remember that Canadian report about health care costs that Zuckerman posted? Be sure to show him that, and especially the part that says this:

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

Which, of course, means that both are experiencing the same problems. Saline are NOT safer, and somehow they need to understand that.

I agree, he was probably writing that to placate the reader, and not to seem extreme in his views, but I think there could have been a better way to get his point across than to make any reference to saline implants as safer.m OH well. Let's continue to educate!

If they could just find a way to use our own tissue, like cloning or something...we could be rid of all this nonsense...

Thanks Rogene.

Patty

----- Original Message -----

From: Rogene S

Sent: Saturday, November 08, 2003 10:03 AM

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

I don't understand Dr. Melmed's reference to salines either . .. I've told him that. I know that he believes that the PIP (prefilled) saline implants are preferrable to the others. However, PIP's aren't FDA approved either. They've been distributed illegally by Silimed.

In the meantime, I'm bombarding him with information about how sick saline implanted women get. Everyone is welcome to do so too . . emelmed@....

Personally, I suspect that sentence was to placate Dr.Whalen. I'm convinced that Dr. Melmed doesn't like using breast implants at all.

As a small concession to saline implants, I think it's possible that, if a surgeon maintains absolute sterility and uses prefilled implants, the incidence of complication is signficantly reduced. At least some studies show that.

However, that still doesn't account for hyper-sensitivity to silicone, and long term deterioration of the envelope that eventually cause health problems.

Rogene

[Guest guest]

Oh my Lord. I have on the contrary, heard some PS's tell me that saline can be worse than silicone in their opinion as they create not only silicone poisoning in the long run, but platinum, tin and also infectious contaminated issues that wouldn’t dare grow (or could) in silicone gel. I'm not saying they are worse myself, just that they both present different problems.

Come on People they are in silicone envelopes deteriorating away beneath our chest muscles!

Maybe put it easier" Silicone anything=illness

----- Original Message -----

From: *~Patty~*

Sent: Saturday, November 08, 2003 10:20 AM

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

EEEGADS! This was great until I got to the paragraph where he said saline implants are a safer alternative!!! Does he know how sick we are Rogene?

I love Dr. Melmed, and I know he is helping us. But wow, do I get offended when saline implants are promoted as safer! That's why I got salines, because they were "safer" and that is just bullcrap! They ruined my health! Argh!

----- 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

[Guest guest]

I'll be writing Dr. Melmed to give him my perspective, too.

----- Original Message -----

From: JOSEPH PALANCA

Sent: Saturday, November 08, 2003 9:15 PM

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

Oh my Lord. I have on the contrary, heard some PS's tell me that saline can be worse than silicone in their opinion as they create not only silicone poisoning in the long run, but platinum, tin and also infectious contaminated issues that wouldn’t dare grow (or could) in silicone gel. I'm not saying they are worse myself, just that they both present different problems.

Come on People they are in silicone envelopes deteriorating away beneath our chest muscles!

Maybe put it easier" Silicone anything=illness

[Guest guest]

I definitely think you should, especially if you have consulted with him.

----- Original Message -----

From: JOSEPH PALANCA

Sent: Saturday, November 08, 2003 8:27 PM

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

Rogene, your welcome. Although I think he is off in the right direction, he def needs more info on salines. Do you think I should email him what my explanting doc went through to remove them, and what a mess it was? And the improvement in my health? Or no?

[Guest guest]

Thanks for letting us know . This is important info, since he is on our list of doctors who supposedly "know". I, for one, thought he understood that salines were just as dangerous.

----- Original Message -----

From: JOSEPH PALANCA

Sent: Saturday, November 08, 2003 7:57 PM

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

Patty, and Rogene,

I don’t want to make anybody upset, but if Dr Melmed is the one in Texas, I emailed him personally when looking for an explant doc last year, and he told me he didn’t believe that saline smooth were making me ill. That "happens with silicone" And that silicone toxicity wasn’t an issue for me either. He was a kind man to email me back and forth, but he just wasn’t what I wanted after that.

He did add that textured salines could be a problem, but not smooth. I chose not to go to him. I also felt that some other explanting doctors didnt think that saline were making me ill.

[Guest guest]

Thanks Rogene. I hope I didn't sound too extreme, because I do appreciate all his work to help educate about the dangers of implants.

Patty

----- Original Message -----

From: Rogene S

Sent: Sunday, November 09, 2003 3:10 PM

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

Dr. Melmed gave me permission to post his letter . . . so your comments won't be coming as a surprise!

Rogene

[Guest guest]

RIGHT ON a PS who does not believe in putting in implants YEAH!

In , " *~Patty~* " <fdp@l...> wrote:

> Dr Melmed has written me again...he is completely amazing, and

wonderful! He has my utmost respect. He confirmed that he

understands what saline implants can do (not mentioning any names,

but told me about a case that sounds like yours Kacey!), and stated

that they should only be used for reconstruction. He is definitely a

rare jewel...if only all doctors could be like him, a true doctor who

practices with a heart of compassion, concern and a desire to do the

right thing. God bless him. He is walking a very lonely road, like

all of us do who know the truth about implants.

> Patty

> ----- Original Message -----

> From: kaceybu02

>

> Sent: Monday, November 10, 2003 9:20 PM

> Subject: Re: Letter to the FDA's Dr. Whalen from

Dr. Melmed, plastic surgeon

>

>

> ,

>

> As you can tell, I think Dr. Melmed is completely amazing! I

think

> he goes about things in a very diplomatic manner; which is

precisely

> what we need....to have educated, well-respected, competent

speakers

> on our side! I remember saying a prayer for his life before I

had

> my surgery.....I just wanted to make sure God would take care of

him

> and bless him, so he would be able to " save " me. It's so sad

that

> there are so few doctors like him.

>

> Silicone is a bigger issue than anyone wants to admit right now.

> The medical community depends on it, as there seems to be no

other

> current alternative. Silicone is used so abundantly (hip/joint

> replacements, chin implants, etc.) that the medical community

almost

> CANNOT speak out against it. They have to think about the

lawsuits.

>

> I am with the opinion that saline implants can very well be more

> harmful than silicone (at first, that is, before the silicone gel

> ruptures everywhere). I do think that storehousing fugus, mold,

and

> bacteria is not good at all....just think of all the " Black Mold "

> house lawsuits. I do also believe that Dr. Melmed is well aware

of

> the effects of smooth saline implants; thus, he does not implant

> women anymore. If he thought they were " harmless " he'd be

offering

> them as a " safe " alternative....and that just isn't the case.

>

> Thanks for your message and take care,

> Kacey