Re: Testimony- Helman_Ed Brent_ Hickey_ Schultz

[Guest guest]

-

Everytime I read PJ's story it makes me cry. It is just so sad.

And I so respect her husband for trying to make a difference too.

kathy

-- In , Rogene S <saxony01@y...> wrote:

> >

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

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

> > Subject: POST: Testimony- Helman_Ed Brent_

> > Hickey_ Schultz

> > Kathynye@a...

> >

> > Subj: Helman Testimony - FDA Panel Hearings -

> > April 2005

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

> > From: myrlj@j...

> >

> > 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.

> >

> >

> ===========================================================

> > Subj: Ed Brent Testimony - FDA Panel Hearings -

> > April 2005

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

> > From: myrlj@j...

> >

> > 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.

> >

> =============================================================

> > Subj: Hickey Testimony - FDA Panel Hearings -

> > April 2005

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

> > From: myrlj@j...

> >

> > 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@j...

> >

> > 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.

> >

> >

> >

> >

> >

> >

> >