Testimony- Helman_Ed Brent_ Hickey_ Schultz

[Guest guest]

>

> Kathynye@... wrote:From: Kathynye@...

> Date: Sun, 1 May 2005 12:12:24 EDT

> Subject: POST: Testimony- Helman_Ed Brent_

> Hickey_ Schultz

> Kathynye@...

>

> Subj: Helman Testimony - FDA Panel Hearings -

> April 2005

> Date: 4/29/2005 8:16:10 PM Eastern Standard Time

> From: myrlj@...

>

> DR. HELMAN: Hi. Good morning. I'm Helman

> from Florida. I have paid

> my own way here because I feel that this panel needs

> to hear from women like

> me.

>

> I had breast implants for 15 years and suffered

> greatly. My implants

> ruptured. And after numerous surgeries to remove

> silicone from my body, the

> last surgeon stated, " There is no way to remove it

> all, . It's

> migrated to all your tissues, your organs. It's

> everywhere. " Silicone as

> well as platinum was found in my cheek cells, bone

> marrow, and lymph nodes,

> also in my urine and in my blood.

>

> My urine platinum levels when measured eight years

> after explantation were

> 25 parts per billion, which is within the range of

> patients receiving

> chemotherapy agent cisplatin. The urine platinum

> level in the general

> population is .04 parts per billion. So mine was

> more than 500 times

> greater.

>

> The platinum ion in my urine and in my tissues I

> found was the exact match

> to my implants that they studied as well. My body

> is full of ionized

> platinum with no known way to remove it.

>

> As you know, the CDC has identified platinum as a

> suspected toxin. Because

> of my ruptured implants and the resulting exposure

> to silicone and platinum,

> I have been diagnosed with MS and lupus and

> fibromyalgia and scleroderma

> among many other things.

>

> And I'm sick. And I can't get health insurance.

> When I need it the most, I

> can't get it. I don't want anybody else to suffer

> this way. I get severe

> disabling headaches and nausea when I am exposed to

> exhaust fumes or unusual

> odors of any kind, and I never had this problem

> before ever.

>

> I'm also concerned about young women of childbearing

> age and their children.

> I've heard that platinum can be transmitted in milk.

> And I have platinum in

> my urine. So, you know, I see no reason why it

> couldn't be in breast milk.

>

> Any mother would be heartbroken to find out that

> during a cosmetic surgery,

> unbeknownst to her, it caused her breast milk to be

> adulterated and cause

> injury to her newborn child.

>

> I just ask that before implants are considered safe,

> platinum testing be

> done on a random sample of women with silicone gel

> breast implants and on

> women with implants, the breast milk of women with

> implants.

>

> And, in closing, please, please, please vote against

> the gel?filled breast

> implants until you're sure that the benefits far

> outweigh the risks. The

> first oath a doctor learns is do no harm.

>

> Thank you.

>

>

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> Subj: Ed Brent Testimony - FDA Panel Hearings -

> April 2005

> Date: 4/29/2005 8:12:07 PM Eastern Standard Time

> From: myrlj@...

>

> MR. BRENT: Good morning. My name is Ed Brent. And

> I am representing my

> wife, P. J. Brent, and our children.

>

> My wife had silicone breast implants for ten years.

> She had no problems at

> first but became increasingly ill. On May 29th,

> 2000, my wife committed

> suicide. She left behind seven children. On behalf

> of my wife and my seven

> children, I urge this panel and the FDA not to

> approve silicone breast

> implants unless there is clear evidence that the

> implants being sold now are

> safe for long?term use, meaning ten years or more.

>

> Several studies have shown higher rates of suicide

> among breast implant

> patients. And a National Cancer Institute study

> found that women with

> implants were four times as likely to kill

> themselves as other plastic

> surgery patients.

>

> The implant makers think the explanation is that

> women with breast implants

> had lower self-esteem before they got their

> implants, but there is no reason

> to think that women who decide to get implants have

> lower self-esteem than

> women who decide to get liposuction, nose jobs, or

> any other plastic

> surgery.

>

> My wife was not a woman with low self-esteem. She

> was a vibrant, loving

> wife and mother. P. J. loved the way she looked the

> first few years after

> her implants. Then she began to get sick, and her

> joints hurt, her fingers

> would swell. She had lupus-like symptoms and was

> diagnosed with

> fibromyalgia.

>

> P. J. breast-fed two of our daughters after getting

> implants. Both are

> seriously ill. My daughter , who is with

> me now, was diagnosed

> with chronic inflammatory demyelinating

> polyneuropathy as well as esophageal

> motility disorder. She spent years in leg braces,

> and now the leg braces

> have been replaced with a wheelchair.

>

> Our daughter also has esophageal motility

> disorder and leg

> weakness as well. In contrast, our five children

> born before my wife got

> breast implants are perfectly healthy.

>

> After P. J. committed suicide, an autopsy was

> performed. Large amounts of

> platinum were found in her body. And a doctor at

> the CDC after seeing the

> amount of platinum in P. J.'s body said she could

> not have been in her right

> mind.

>

> Tissue samples from our daughters who had breast-fed

> found that they, too,

> had elevated platinum levels. These findings were

> presented at a meeting of

> the American Chemical Society last year.

>

> P. J. felt terrible guilt that her two daughters had

> been so seriously

> harmed by her decision to get breast implants. It

> was not her fault. She

> had no way of knowing what would happen. Most

> doctors did not know that

> there had not been any long-term studies on the

> breast implants.

>

> Just two months before my wife's death, she

> testified at a previously FDA

> meeting on breast implants. She felt the panel

> ignored testimony given by

> women with implants.

>

> And I am here today to ask you to listen to these

> patients and their loved

> ones and do not endorse a product not proven safe

> for long-term use. Women

> and their yet unborn children may be forever

> affected. This is a scientific

> issue and a moral issue.

>

> Thank you.

>

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> Subj: Hickey Testimony - FDA Panel Hearings -

> April 2005

> Date: 4/29/2005 8:16:16 PM Eastern Standard Time

> From: myrlj@...

>

> MS. HICKEY: Good morning. I am Hickey, and I

> am from Phoenix. I have

> no conflicts of interest.

>

> I am here to tell you I experienced four surgeries

> in four years due to

> complications with implants. My experience involved

> three manufacturers and

> new and improved products. Two of the surgeries

> were back to back after a

> rupture occurred.

>

> Concurrent with the implant exposures, I experienced

> serious systemic

> illness and visual and motor impairment, which

> improved considerably after

> the implants and capsules were removed.

>

> After the rupture diagnosis, I was required to sign

> a Mentor informed

> consent document in order to receive replacements.

> That occurred after a

> moratorium had been placed on the implants that I

> knew nothing about.

>

> During prep for the rupture removal, I was sedated

> and negotiated with for

> my rupture evidence. My baseline mammogram and

> evidence were taken away

> from me around the same time as that surgery.

>

> If implants are so safe, why are there gag orders

> and sealed documents

> regarding silicone implants from an historical

> perspective? Now I

> understand that the Justice Department has entered a

> settlement agreement

> with manufacturers for recovery of enormous expenses

> paid out to Health and

> Human Services claims for breast implant

> complications.

>

> Aren't Social Security and Medicare in enough

> trouble already? How is it

> that the Justice Department can recover its losses

> with the Daubert rule in

> place, not allowing important evidence from

> expensive medical testing, while

> at the same time there is a law in place requiring

> insurance to cover breast

> cancer reconstruction with implants?

>

> And I have been told the Navy Department is

> conducting a large breast cancer

> study. I am a furloughed flight attendant for a

> struggling airline that is

> required to pay for products with high complication

> rates for

> reconstructions when the Justice Department is

> trying to recover U.S. losses

> incurred by enormous claims from complication.

>

> Now, I do not have a fancy degree or knowledge about

> rocket science, but my

> grandparents were educators. And they taught me to

> read the road signs on

> the highway of life. I can read that things just

> don't add up to safety

> when it comes to silicone gel.

>

> Many of my fellow flight attendant friends and

> acquaintances with implant

> exposures have been ill. And some have passed on in

> the prime of their

> lives.

>

> Is silicone research taking place in the morgue? In

> your approval process,

> please consider what this research does not tell

> you. Breast implant

> exposures altered my health forever. Believe me,

> experiencing illness

> serious enough to have my implants cut out in hopes

> of feeling better did

> not improve my self-esteem.

>

> I implore you to help ensure that what happened to

> me and my friends with

> silicone exposures never happens to anyone else,

> especially young women in

> childbearing years, single mothers with limited

> financial resources, and

> vulnerable cancer patients.

>

> Thank you.

>

==========================================================

> Subj: Schultz Testimony - FDA Panel Hearings

> - April 2005

> Date: 4/29/2005 8:15:37 PM Eastern Standard Time

> From: myrlj@...

>

> MR. SCHULTZ: Good morning. My name is

> Schultz. I am representing a group of women's

> organizations led by Command Trust. I appreciate

> being given five minutes. Thank you.

>

> Thank you for the opportunity to address this

> Committee on the very important question of whether

> FDA should approve the applications for silicone gel

> breast implants. For the record, I have no

> financial ties to either of the applicants.

>

> Congress enacted the medical device amendments in

> 1976 in the wake of several tragedies, including the

> Dalkon shield IUD, which killed 16 women and injured

> countless others. Congress sought to remedy the

> defect by a new law, the defect being that medical

> devices were being marketed without any

> demonstration of their safety or any adequate

> testing.

>

> Congress was particularly concerned about the safety

> of implantable devices. The basic showing that it

> required manufacturers of these devices to make was

> that there was a reasonable assurance that the

> device was safe and effective. In the case of

> breast implants, efficacy is obviously not the

> issue. Instead, the issue is safety.

>

> If you think about it, for a therapeutic product,

> such as a heart valve, the safety standard entails a

> weighing of risk versus benefits to health. And so

> FDA may approve a product with substantial risks if

> it finds the benefits are even greater.

>

> But for a cosmetic product, which is what we have

> before us today, there are no therapeutic benefits.

> For these products, the law does not allow approval

> if the product is associated with significant risk

> or even if there is significant uncertainty about

> safety. And I think that is a very important

> principle to keep in mind as we go through the next

> three days.

>

> It is also relevant that the manufacturer has the

> burden of proof. Where there are doubts or

> uncertainties, then the product may not be approved

> because the manufacturer has not carried its burden.

> The law does not contemplate that the patients or

> consumers should bear the risk of unanswered

> questions.

>

> At the October 2003 Advisory Committee meeting,

> there was discussion of various approval conditions

> and post?market studies. First, the Committee

> should understand that any approval conditions are

> not enforceable by FDA. Once the agency approves a

> product, then physicians are allowed to deviate from

> restrictions on the use of the product. And FDA has

> no authority to enforce those restrictions.

>

> Second, while post?market studies may be useful,

> they cannot substitute for the basic safety standard

> in the statute. The statute does not provide that

> the agency may approve a product now and allow the

> demonstration of safety at a later date.

>

> At the last Advisor Committee meeting, there was

> also discussion about whether women should have the

> option or the choice of using breast implants as

> long as they were fully informed.

>

> Although Congress has adopted the buyer beware

> approach for dietary supplements and in other areas,

> this was not the approach that it adopted for

> medical devices. Instead, for these products, it

> has declared in law that medical devices are not to

> be available until the manufacturer has demonstrated

> safety. It is this Committee's charge to do its

> best to apply that law.

>

> Congress' approach has two important benefits.

> First, it means that patients and consumers can be

> confident of the safety of device products that they

> use. It also creates an important incentive to the

> manufacturers to design their products to meet the

> high standard that Congress established.

>

> Significant questions have been raised about the

> safety of breast implants. I'm not going to address

> those. But it's important, of course. These

> products are going to be in the body for many years.

> Even though the manufacturers have known about the

> standards of the statute for more than 25 years, we

> don't really have long?term data. And given the

> extremely high breakage rate of these products, lack

> of long?term data raises serious problems.

>

> In January 2004, FDA determined that the evidence

> was not adequate. And the question that this

> Committee must look at is whether the companies have

> produced additional data that is sufficient to

> justify approval.

>

> In conclusion, approval of silicone gel breast

> implants without an adequate demonstration of safety

> would have two very unfortunate consequences.

> First, we would have lost the opportunity to require

> First, we would have lost the opportunity to require

> that these products be adequately tested.

>

> And, perhaps even more important, such a decision

> would send a message to other product manufacturers

> that the door has been open for approval of medical

> devices that do not meet the safety requirements

> established by law and that patients will suffer.

>

> Thank you very much. And good luck.

>

>

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