Testimony_M. McDonough_J. Norsigian_G. Howe_Diane _P. Noonan-Saraceni

[Guest guest]

>

> Note: forwarded message attached.

> > From: Kathynye@...

> Date: Mon, 2 May 2005 22:02:34 EDT

> Subject: POST:Testimony_M. McDonough_J. Norsigian_G.

> Howe_Diane _P. Noonan-Saraceni

> Kathynye@...

>

> Subj: McDonough Testimony - FDA Panel

> Hearings - April 2005

> From: myrlj@...

>

> MS. McDONOUGH: Good afternoon. My name is

> McDonough. I am an

> actress, a mom, and a founder of In the Know, a

> supportive and caring

> community created by women in the entertainment

> industry to share

> information about health, body image, and plastic

> surgery. I have no

> conflicts.

>

> Several of the plastic surgeons here today

> testifying have attempted to

> differentiate between the older generation and the

> new third generation of

> breast implants. It's important to point out to you

> that the new, " new, "

> generation implants start in 1981. In October of

> 2003, Inamed stated that

> there had been no changes in this product since

> 1991. Mentor stated in

> their PMA that they have not changed their product

> since 1987. So we're

> talking about a product that has virtually gone

> unchanged for 25 years.

>

> I was only 23 when I got my silicone gel breast

> implants. Because after my

> years of playing on " The Waltons, " I really

> wanted to continue my

> acting career, it was suggested to me that if I had

> larger breasts, that

> might do the trick.

>

> Within 24 hours of my implant surgery, I broke out

> in a rash. Then for the

> first couple of years, my implants seemed like they

> were okay. Then by year

> seven, I got more and more symptoms that have led to

> a diagnosis of lupus.

>

> Over the course of those ten years, I became more

> ill. And I felt like I

> was dying. When I asked my doctor about removing

> the implants, he told me

> that I would probably become too depressed. He also

> said that there was no

> link between the implants and everything that I had.

>

> Another plastic surgeon told me, " Well, your breasts

> look and feel great.

> You know, I wouldn't touch them, at least not with a

> knife. "

>

> I had a mammogram at 31 to see if my implants were

> ruptured, but the

> mammogram came out clear. And then I had a breast

> MRI because it was

> supposed to be more conclusive. And, according to

> the MRI, the implants had

> not ruptured.

>

> Inamed has said that if its PMA is approved, they

> will recommend an MRI

> every one or two years to monitor the rupture, but

> no one tells you what the

> physical experience of that MRI is like. It's long,

> and it's uncomfortable.

> Basically you lie face down in a dark enclosed tube

> with your breasts in

> these holes. And if you're in pain, like I was,

> it's even worse.

>

> The other thing that Inamed doesn't mention is that

> MRIs are very expensive;

> on an average, $1,890 according to Blue Cross.

> That's $1,890 of your own

> money because they are not covered by insurance.

> Most women can't afford

> one MRI, let alone one every year or two.

>

> Now, while Inamed has recommended the MRI, I don't

> see a plan that is set up

> or fund to pay for these MRIs. Also, not all MRIs

> or facilities are

> equipped to conduct the necessary procedures.

>

> In clinical trials, the industry has been using very

> specific centers with

> experienced radiologists. And even those centers

> don't always detect

> rupture. And many women don't even find out they

> have a rupture until their

> implants are removed.

>

> The industry's own data shows a high false positive

> rate for rupture

> detection through MRI. In the past, we have heard a

> 95 percent accuracy

> rate with MRI. Yet, according to Inamed's core

> study, more than a third of

> MRIs, 36 percent, falsely detect rupture. And such

> high rupture rates and

> false positives of those high rates create

> unnecessary anxiety for women and

> potentially unnecessary surgery.

>

> In my experience, despite the fact that my MRI did

> not detect that my

> implants had ruptured, I still decided to have them

> out. But when they were

> removed, both of my implants were ruptured. And the

> outer shell had

> completely disintegrated. And now, while I still

> suffer from lupus, the

> farther I get away from my implant surgery, the

> better I feel.

>

> I am not the only one with this experience. Other

> members of In the Know

> have had similar MRI experiences where a rupture was

> present but not

> detected.

>

> MRIs are unreliable, expensive, and unpleasant.

> Inamed's recommendation for

> yearly MRIs is both unrealistic and disingenuous for

> the women who actually

> have to go through them.

>

> Thank you very much for listening and for your time

> tonight. Thank you.

>

>

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

> Subj: Judy Norsigian Testimony - FDA Panel

> Hearings - April 2005

>

> From: myrlj@...

>

> DR. NORSIGIAN: Good afternoon. My name is Judy

> Norsigian. I am the

> Executive Director of Our Bodies, Ourselves, also

> known as the Boston

> Women's Health Book Collective, a nonprofit public

> interest, women's health,

> education, and advocacy organization. For 35 years,

> we have advocated for

> women's health from an evidence?based and consumer

> perspective, most notably

> through our major publication, Our Bodies,

> Ourselves. We have no financial

> ties to either of the manufacturers or their

> competitors.

>

> Our organization's interest in breast implants goes

> back to the mid 1980s,

> when the late Esther Rome, my coworker, began to

> work with hundreds of

> women, both locally and nationally, who believed

> that breast implants caused

> some serious problems. Many of these women were

> initially happy with their

> implants but later developed debilitating conditions

> after five or ten years

> or more. Even today, many women continue to have

> problems with more recent

> models. And we still do not have adequate data that

> would allow women to

> make informed choices about using these devices.

>

> As we and others have said before, we do want

> choices, but we want safe

> choices. Since the October 2003 panel that

> addressed the safety of silicone

> gel implants, studies in mammography and platinum

> suggest new challenges for

> women with silicone gel implants.

>

> A study published in the January 2004 JAMA issue

> found that breast implants

> interfere with mammography, missing 55 percent of

> breast cancers in women

> with breast implants, compared to 33 percent in

> women without implants.

> This fact alone provides a compelling reason for the

> FDA to weigh carefully

> the risk?benefit issues regarding these products.

>

> Silicone breast implants have also been found to

> contain platinum. A study

> published in the July 2004 issue of Analytical and

> Bioanalytical Chemistry

> found very high levels of platinum in silicone gel

> as well as the encasing

> materials, implant elastomer, double lumen, and

> foam, materials that are in

> direct contact with the chest wall of patients.

>

> Much media coverage has suggested that there are

> many studies showing that

> breast implants are safe, but the largest, best

> designed studies do show

> increased risks. Even the Breiting, et al., study

> of Danish women noted

> substantial problems that call for further research.

> When read carefully,

> this study is anything but a stamp of approval for

> silicone breast implants.

>

> Scientists at the FDA and NIH are among those who

> have called for more

> research to answer many of the key questions that

> have been raised

> repeatedly at FDA hearings. You should be joining

> them.

>

> All assertions to the contrary, we simply do not

> have adequate data on such

> conditions as fibromyalgia. Our recent experiences

> with premature drug and

> device approval underscore how critical it is to

> take a cautious approach.

>

> Although saline implants are less ideal for many

> women, they do provide a

> reasonable alternative while we await the findings

> of further research. And

> such research must include women with implants for a

> minimum of ten years,

> not an average of ten years.

>

> Women's health and lives depend upon a careful

> assessment of these devices.

> We urge the panel to require adequate safety data to

> be collected before any

> decision to approve their use, especially in light

> of industry's current

> marketing strategy of targeting younger women, whose

> long-term health status

> may depend upon your recommendation.

>

> Thank you very much.

>

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

> Subj: Genevieve Howe Testimony - FDA Panel

> Hearings - April 2005

> Date: 5/1/2005 7:50:15 PM Eastern Standard Time

> From: myrlj@...

> myrlj@...

> Sent from the Internet (Details)

>

>

>

>

> MS. HOWE: You've got two Massachusetts people

> together here. Thank you for

> this opportunity to testify. My name is Genevieve

> Howe, and I am a member

> of the board of Massachusetts Breast Cancer

> Coalition.

>

> The coalition defines breast cancer as a political

> issue and challenges all

> obstacles to eradication of the disease. All board

> members are volunteers

> for the coalition, and it does not accept financial

> or any kind of support

> from pharmaceutical companies or any sources that

> profit from cancer or

> contribute to environmental pollution. I have no

> financial conflict of

> interest in this issue.

>

> Although reconstruction after mastectomy represents

> only about 20 percent of

> breast implant surgeries, the devices play a

> significant role in the lives

> of the 215,000 women diagnosed with breast cancer

> each year.

>

> I would like to address three concerns about

> silicone gel?filled breast

> implants: one, health risks due to lower

> sensitivity of screening

> mammography; two, the very high rate of resurgeries

> and other complications,

> especially in reconstruction patients; and, three,

> the reluctance of

> organized plastic surgery and breast implant

> manufacturers to accurately

> inform women about the nature and magnitude of the

> risks involved in

> reconstruction with silicone implants.

>

> Researchers generally agree that augmentation

> implants significantly reduce

> the ability of radiologists to analyze breast tissue

> in mammography, even

> when using special techniques.

>

> Two sound studies, Miglioretti, et al.; and Brinton,

> et al., found that

> women with implants who were later diagnosed with

> breast tumors did not

> present with higher stage cancers. However, as

> Brinton accurately points

> out, there are major differences between women who

> undergo breast

> augmentation and those who don't.

>

> Women who choose augmentation tend to be younger, to

> have a smaller breast

> size, and less glandular tissue mass, and to have

> their first child at a

> younger age than the adult female population as a

> whole. Each of these

> factors associated with lower breast cancer risk,

> particularly younger age.

>

> In my written testimony, I have included a statement

> on conflicts of

> interest by researchers making the improbable claim

> that silicone breast

> implants can lower women's risk of developing breast

> cancer.

>

> In their own data, both Inamed and Mentor find very

> high rates of moderate,

> severe, or very severe complications within three

> years. These

> complications are much more frequent in

> reconstruction patients than

> augmentation patients.

>

> Inamed reports one or more resurgeries in 21 percent

> of augmentation

> patients and 39 percent of post?mastectomy patients.

> That seems very high

> to me. Four out of ten have one or more repeat

> surgeries within three

> years.

>

> Mentor's application shows resurgeries within 3

> years on 15 percent of

> augmentation patients and on 26 percent of

> post-mastectomy patients. Other

> local complications are also frequent. And many

> patients have more than one

> type of complication. Inamed lists 21 types of

> moderate, severe, or very

> severe complications, 6 of which were each

> experienced by 20 percent or more

> of reconstruction patients.

>

> In both of the pending applications, the

> manufacturers tend to minimize the

> risks in patient information. For example, Inamed

> projects rupture risk as

> linear without acknowledging deterioration in device

> materials over time.

> And the company underestimates the decline in MRI

> sensitivity and

> specificity. Mentor's glowing measures of

> satisfaction include fewer than

> half of their original 251 reconstruction patients.

>

> Organized plastic surgery has opened up a new

> dot.org Web site,

> breastcancersafety.org, claiming we place patient

> safety above all else.

> The site's overview page links to a letter sent to

> this panel by 12 breast

> cancer advocacy groups, at least several of which

> have received

> contributions from plastic surgery organizations

> and/or breast implant

> manufacturers.

>

> Given the plethora of biased information and

> research and the lack of

> long?term prospective studies, it is difficult to

> imagine women being able

> to make truly informed decisions on silicone

> implants.

>

> Judith Brady is a 67-year-old cancer activist in San

> Francisco. Both of her

> breasts were reconstructed with silicone implants

> following a double

> mastectomy nearly 25 years ago. She has been living

> with these implants

> ever since and considers them to be " a ticking time

> bomb, " to quote her, in

> her body.

>

> When I asked her what advice she would offer to

> women considering silicone

> implants, she said that, as far as reconstruction

> goes, " choose a plastic

> surgeon with great care. "

>

> As for women considering breast augmentation, she

> said, " That I think should

> be clearly avoided. In fact, I think doctors who do

> this surgery should be

> strung up. " That is not a response we advocate, but

> my point is that our

> male-dominated culture too often pressures women to

> risk pain, suffering,

> and great expense simply to fit in.

>

> We urge the FDA to deny the pending applications for

> widespread use of

> silicone implants. We fear that a lack of caution

> by FDA in this matter

> could lead to further unnecessary pain and suffering

> on the part of women

> and additional years of costly litigation.

>

> Thank you very much.

>

>

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

> Subj: Diane Testimony - FDA Panel Hearings -

> April 2005

> Date: 5/1/2005 8:00:04 PM Eastern Standard Time

> From: myrlj@...

> myrlj@...

> Sent from the Internet (Details)

>

>

>

>

> MS. JAMES: Good afternoon. My name is Diane .

> And I am here today on

> behalf of the s Institute of Women's Health.

> We are not supported by

> anyone with a financial interest in this matter.

>

> The s mission is to promote excellence in

> women's health by studying

> the interaction of medical and social systems,

> facilitating informed

> dialogue and awareness among consumer and health

> providers and promoting

> problem resolution and information dissemination of

> key issues. It is from

> this perspective that the questions surrounding

> availability of silicone

> breast implants are important to the institute.

>

> The regulation history of breast implants is long

> and complex. Following

> decisions made in the 1990s, use of silicone gel

> implants has only been

> permitted among women who have been part of adjunct

> studies. The limitation

> on use of these implants has been the result of

> numerous unanswered

> questions; in particular, questions regarding

> long-term safety. These

> questions mandate carefully executed studies to

> acquire the data needed for

> approval.

>

> Now in 2005, this distinguished panel has been

> assembled to determine once

> again whether questions related to the safety and

> effectiveness of silicone

> gel implants from Inamed and Mentor have been

> adequately investigated and if

> the accumulated data answer the safety questions

> sufficiently.

>

> The panel must determine whether the current data

> available for review are

> sufficient to provide practicing physicians with the

> information they need

> in order to recommend these breast implants and have

> confidence that their

> use will not cause harm to their patients.

>

> Physicians and other health care providers must know

> that the benefits far

> outweigh the risks for an elective procedure

> requested by women who often

> are young and in good physical health. The data

> must also be sufficient to

> provide women contemplating breast implants with the

> information they need

> in order to make a truly informed decision.

>

> What are the key questions for which a physician

> must have answers? These

> have been outlined in the guidance document issued

> by FDA on January 13th,

> 2004. But clearly of prime importance is the

> question regarding

> complication rates. Has the longstanding issue of

> implant rupture during

> the lifetime of these devices been adequately

> addressed in the core study?

>

> Preliminary estimates from reviewers released to the

> public late last week

> suggest that the rate of rupture of silicone

> implants within 10 years for

> women having reconstructive surgery may be as high

> as 93 percent. Among

> women undergoing breast implant surgery for other

> cosmetic reasons, the rate

> may be as high as 74 percent.

>

> This ten-year estimate obviously includes women

> whose implants will rupture

> long before ten years and raises questions about

> appropriate ongoing

> surveillance and diagnostic testing that will be

> required at regular

> intervals.

>

> It also raises questions about who will pay for this

> surveillance. What

> percentage of women will be able to afford

> appropriate diagnostic tests and

> even further surgeries should health care coverage

> be unavailable for what

> is generally categorized as an elective cosmetic

> procedure.

>

> Imbedded in this critical safety issue is the

> persistent question of what

> happens to the silicone when the silicone implants

> from Inamed and Mentor

> rupture. Are there adverse health effects from the

> ruptures, either local

> or systemic?

>

> While an IOM committee in 1999 determined that there

> was little evidence

> that silicone implants caused connective tissue

> disease, we must keep in

> mind that this conclusion was based largely on

> retrospective data from the

> nurses' health study and from a case-controlled

> database from the Mayo

> Clinic.

>

> Because of the study limitations related to the size

> and types of studies

> used, the true risk of these conditions cannot be

> precisely estimated.

> There may still be a small but significant increased

> risk of some forms of

> connective tissue disease associated with the

> silicone implants under

> review.

>

> From the patient's perspective, it will be vital for

> physicians to have

> these answers in order to openly and honestly

> discuss the risks and benefits

> of this procedure.

>

> Women must be informed regarding the expected

> incidence of rupture and what

> rupture may mean in terms of the need for repeat

> surgeries. They need to

> know about the process for removing gel-filled

> implants following rupture,

> discomfort they may experience, and the potential

> long-term health

> consequences should silicone gel leak. Women must

> also have this

> information presented to them in a clear and concise

> fashion that is part of

> the informed consent process itself.

>

> The s Institute is concerned about the existing

> process and urges the

> Committee to consider this in their deliberations.

> These concerns arise

> from examining current saline breast implant patient

> brochures provided by

> industry.

>

> Subjected to a Fry analysis used by reading experts

> and those committed to

> following clear health communication principles, as

> advocated by the Surgeon

> General and the DHHS, this written information

> cannot be easily understood

> by the majority of audiences in the United States.

>

> According to the Fry analysis, the 42-page brochure

> reviewed is clearly

> written for college-level individuals. This means

> women who are not able to

> read health information at the college level will

> not be able to fully

> comprehend the information provided.

>

> We urge the Committee and the FDA to be certain that

> educational materials

> describing risks and benefits are written at a level

> that most women will

> understand.

>

> In closing, we urge you, the Committee, to consider

> carefully the safety and

> effectiveness requirement that Congress has mandated

> to the FDA in

> determining whether devices should be permitted on

> the market.

>

> Thank you for this opportunity.

>

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

> Subj: Pamela Noonan-Saraceni Testimony - FDA Panel

> Hearings - April 2005

> Date: 5/1/2005 8:08:36 PM Eastern Standard Time

> From: myrlj@...

> myrlj@...

> Sent from the Internet (Details)

>

>

>

>

> MS. NOONAN-SARACENI: Hello. My name is Pamela

> Noonan-Saraceni. I have no

> conflicts of interest.

>

> On July 5th of this year, I will be celebrating my

> 27th year as a breast

> cancer survivor. However, I continue to live with

> the ramifications of

> silicone gel implants.

>

> In 1978, when I was only 25 years old, I was

> diagnosed with breast cancer

> and had a modified radical mastectomy. I waited

> five years before I decided

> to have silicone implant reconstructive surgery. I

> led an active lifestyle,

> and I played tennis, jogged, and I taught aerobics.

> And I had grown tired

> of the inconvenience and embarrassment caused by my

> external prosthesis

> shifting and falling out of my bra.

>

> I am a well-educated woman. And I thought I had

> done my homework on breast

> implants prior to my reconstructive surgery, but I

> was never advised of any

> health risks associated with silicone breast

> implants or the fact that there

> was a chance for additional surgeries. In fact, I

> was told they would last

> a lifetime and complications were few, if ever.

>

> Within three months of my initial reconstructive

> surgery, I was back on the

> operating table. My body has formed a capsule

> around my implant, and it had

> moved up to my collarbone.

>

> The searing pain at the time caused my shoulder to

> freeze and become

> immobile. The surgery seemed to help, but symptoms

> of physical illness

> began to develop after that. At first, I attributed

> the fatigue, muscle

> aches, and pain to just getting older. However, I

> was only 36 years old at

> that time.

>

> Before I had the implant permanently removed in

> 1994, ten years after my

> initial reconstruction, I had to again wear a

> partial prosthesis. Capsular

> contracture had again become a problem. And my

> breasts had become lopsided

> and misshapen. The explanation was the fifth

> surgery at my breast site.

>

> I know that almost half of breast cancer patients

> with implants will need

> one additional surgery due to serious problems that

> occur within three

> years. And that is from Mentor's own data.

>

> To date, my out-of-pocket medical expenses are

> approaching $50,000. My

> husband and I are self-insured. And the insurance

> policy that we took out

> carries an exclusion that I would not be covered for

> any illness or

> disability related to my reconstructive surgery.

> The insurance company

> understands that there are health risks associated

> with the breast implants,

> and they are not willing to bear the financial cost.

>

> Apparently the government also knows this. Last

> year the Department of

> Health and Human Services settled with silicone

> breast implant companies to

> recuperate the cost of caring for women made ill by

> silicone breast

> implants. How can the FDA even consider approving

> these devices while at

> the same time a sister agency sought financial

> compensation for harm that

> they caused hundred of thousands of women?

>

> Please do not recommend approval of this product

> until the companies provide

> the long?term data needed to prove their safety.

> Women across America are

> counting on you, the FDA, to protect them.

>

> Thank you.

>

>

>

>

>

>

>

>

Subj: McDonough Testimony - FDA Panel Hearings - April 2005

From: myrlj@...

MS. McDONOUGH: Good afternoon. My name is McDonough. I am an

actress, a mom, and a founder of In the Know, a supportive and caring

community created by women in the entertainment industry to share

information about health, body image, and plastic surgery. I have no

conflicts.

Several of the plastic surgeons here today testifying have attempted to

differentiate between the older generation and the new third generation of

breast implants. It's important to point out to you that the new, " new, "

generation implants start in 1981. In October of 2003, Inamed stated that

there had been no changes in this product since 1991. Mentor stated in

their PMA that they have not changed their product since 1987. So we're

talking about a product that has virtually gone unchanged for 25 years.

I was only 23 when I got my silicone gel breast implants. Because after my

years of playing on " The Waltons, " I really wanted to continue my

acting career, it was suggested to me that if I had larger breasts, that

might do the trick.

Within 24 hours of my implant surgery, I broke out in a rash. Then for the

first couple of years, my implants seemed like they were okay. Then by year

seven, I got more and more symptoms that have led to a diagnosis of lupus.

Over the course of those ten years, I became more ill. And I felt like I

was dying. When I asked my doctor about removing the implants, he told me

that I would probably become too depressed. He also said that there was no

link between the implants and everything that I had.

Another plastic surgeon told me, " Well, your breasts look and feel great.

You know, I wouldn't touch them, at least not with a knife. "

I had a mammogram at 31 to see if my implants were ruptured, but the

mammogram came out clear. And then I had a breast MRI because it was

supposed to be more conclusive. And, according to the MRI, the implants had

not ruptured.

Inamed has said that if its PMA is approved, they will recommend an MRI

every one or two years to monitor the rupture, but no one tells you what the

physical experience of that MRI is like. It's long, and it's uncomfortable.

Basically you lie face down in a dark enclosed tube with your breasts in

these holes. And if you're in pain, like I was, it's even worse.

The other thing that Inamed doesn't mention is that MRIs are very expensive;

on an average, $1,890 according to Blue Cross. That's $1,890 of your own

money because they are not covered by insurance. Most women can't afford

one MRI, let alone one every year or two.

Now, while Inamed has recommended the MRI, I don't see a plan that is set up

or fund to pay for these MRIs. Also, not all MRIs or facilities are

equipped to conduct the necessary procedures.

In clinical trials, the industry has been using very specific centers with

experienced radiologists. And even those centers don't always detect

rupture. And many women don't even find out they have a rupture until their

implants are removed.

The industry's own data shows a high false positive rate for rupture

detection through MRI. In the past, we have heard a 95 percent accuracy

rate with MRI. Yet, according to Inamed's core study, more than a third of

MRIs, 36 percent, falsely detect rupture. And such high rupture rates and

false positives of those high rates create unnecessary anxiety for women and

potentially unnecessary surgery.

In my experience, despite the fact that my MRI did not detect that my

implants had ruptured, I still decided to have them out. But when they were

removed, both of my implants were ruptured. And the outer shell had

completely disintegrated. And now, while I still suffer from lupus, the

farther I get away from my implant surgery, the better I feel.

I am not the only one with this experience. Other members of In the Know

have had similar MRI experiences where a rupture was present but not

detected.

MRIs are unreliable, expensive, and unpleasant. Inamed's recommendation for

yearly MRIs is both unrealistic and disingenuous for the women who actually

have to go through them.

Thank you very much for listening and for your time tonight. Thank you.

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

Subj: Judy Norsigian Testimony - FDA Panel Hearings - April 2005

From: myrlj@...

DR. NORSIGIAN: Good afternoon. My name is Judy Norsigian. I am the

Executive Director of Our Bodies, Ourselves, also known as the Boston

Women's Health Book Collective, a nonprofit public interest, women's health,

education, and advocacy organization. For 35 years, we have advocated for

women's health from an evidence?based and consumer perspective, most notably

through our major publication, Our Bodies, Ourselves. We have no financial

ties to either of the manufacturers or their competitors.

Our organization's interest in breast implants goes back to the mid 1980s,

when the late Esther Rome, my coworker, began to work with hundreds of

women, both locally and nationally, who believed that breast implants caused

some serious problems. Many of these women were initially happy with their

implants but later developed debilitating conditions after five or ten years

or more. Even today, many women continue to have problems with more recent

models. And we still do not have adequate data that would allow women to

make informed choices about using these devices.

As we and others have said before, we do want choices, but we want safe

choices. Since the October 2003 panel that addressed the safety of silicone

gel implants, studies in mammography and platinum suggest new challenges for

women with silicone gel implants.

A study published in the January 2004 JAMA issue found that breast implants

interfere with mammography, missing 55 percent of breast cancers in women

with breast implants, compared to 33 percent in women without implants.

This fact alone provides a compelling reason for the FDA to weigh carefully

the risk?benefit issues regarding these products.

Silicone breast implants have also been found to contain platinum. A study

published in the July 2004 issue of Analytical and Bioanalytical Chemistry

found very high levels of platinum in silicone gel as well as the encasing

materials, implant elastomer, double lumen, and foam, materials that are in

direct contact with the chest wall of patients.

Much media coverage has suggested that there are many studies showing that

breast implants are safe, but the largest, best designed studies do show

increased risks. Even the Breiting, et al., study of Danish women noted

substantial problems that call for further research. When read carefully,

this study is anything but a stamp of approval for silicone breast implants.

Scientists at the FDA and NIH are among those who have called for more

research to answer many of the key questions that have been raised

repeatedly at FDA hearings. You should be joining them.

All assertions to the contrary, we simply do not have adequate data on such

conditions as fibromyalgia. Our recent experiences with premature drug and

device approval underscore how critical it is to take a cautious approach.

Although saline implants are less ideal for many women, they do provide a

reasonable alternative while we await the findings of further research. And

such research must include women with implants for a minimum of ten years,

not an average of ten years.

Women's health and lives depend upon a careful assessment of these devices.

We urge the panel to require adequate safety data to be collected before any

decision to approve their use, especially in light of industry's current

marketing strategy of targeting younger women, whose long-term health status

may depend upon your recommendation.

Thank you very much.

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

Subj: Genevieve Howe Testimony - FDA Panel Hearings - April 2005

Date: 5/1/2005 7:50:15 PM Eastern Standard Time

From: myrlj@...

myrlj@...

Sent from the Internet (Details)

MS. HOWE: You've got two Massachusetts people together here. Thank you for

this opportunity to testify. My name is Genevieve Howe, and I am a member

of the board of Massachusetts Breast Cancer Coalition.

The coalition defines breast cancer as a political issue and challenges all

obstacles to eradication of the disease. All board members are volunteers

for the coalition, and it does not accept financial or any kind of support

from pharmaceutical companies or any sources that profit from cancer or

contribute to environmental pollution. I have no financial conflict of

interest in this issue.

Although reconstruction after mastectomy represents only about 20 percent of

breast implant surgeries, the devices play a significant role in the lives

of the 215,000 women diagnosed with breast cancer each year.

I would like to address three concerns about silicone gel?filled breast

implants: one, health risks due to lower sensitivity of screening

mammography; two, the very high rate of resurgeries and other complications,

especially in reconstruction patients; and, three, the reluctance of

organized plastic surgery and breast implant manufacturers to accurately

inform women about the nature and magnitude of the risks involved in

reconstruction with silicone implants.

Researchers generally agree that augmentation implants significantly reduce

the ability of radiologists to analyze breast tissue in mammography, even

when using special techniques.

Two sound studies, Miglioretti, et al.; and Brinton, et al., found that

women with implants who were later diagnosed with breast tumors did not

present with higher stage cancers. However, as Brinton accurately points

out, there are major differences between women who undergo breast

augmentation and those who don't.

Women who choose augmentation tend to be younger, to have a smaller breast

size, and less glandular tissue mass, and to have their first child at a

younger age than the adult female population as a whole. Each of these

factors associated with lower breast cancer risk, particularly younger age.

In my written testimony, I have included a statement on conflicts of

interest by researchers making the improbable claim that silicone breast

implants can lower women's risk of developing breast cancer.

In their own data, both Inamed and Mentor find very high rates of moderate,

severe, or very severe complications within three years. These

complications are much more frequent in reconstruction patients than

augmentation patients.

Inamed reports one or more resurgeries in 21 percent of augmentation

patients and 39 percent of post?mastectomy patients. That seems very high

to me. Four out of ten have one or more repeat surgeries within three

years.

Mentor's application shows resurgeries within 3 years on 15 percent of

augmentation patients and on 26 percent of post-mastectomy patients. Other

local complications are also frequent. And many patients have more than one

type of complication. Inamed lists 21 types of moderate, severe, or very

severe complications, 6 of which were each experienced by 20 percent or more

of reconstruction patients.

In both of the pending applications, the manufacturers tend to minimize the

risks in patient information. For example, Inamed projects rupture risk as

linear without acknowledging deterioration in device materials over time.

And the company underestimates the decline in MRI sensitivity and

specificity. Mentor's glowing measures of satisfaction include fewer than

half of their original 251 reconstruction patients.

Organized plastic surgery has opened up a new dot.org Web site,

breastcancersafety.org, claiming we place patient safety above all else.

The site's overview page links to a letter sent to this panel by 12 breast

cancer advocacy groups, at least several of which have received

contributions from plastic surgery organizations and/or breast implant

manufacturers.

Given the plethora of biased information and research and the lack of

long?term prospective studies, it is difficult to imagine women being able

to make truly informed decisions on silicone implants.

Judith Brady is a 67-year-old cancer activist in San Francisco. Both of her

breasts were reconstructed with silicone implants following a double

mastectomy nearly 25 years ago. She has been living with these implants

ever since and considers them to be " a ticking time bomb, " to quote her, in

her body.

When I asked her what advice she would offer to women considering silicone

implants, she said that, as far as reconstruction goes, " choose a plastic

surgeon with great care. "

As for women considering breast augmentation, she said, " That I think should

be clearly avoided. In fact, I think doctors who do this surgery should be

strung up. " That is not a response we advocate, but my point is that our

male-dominated culture too often pressures women to risk pain, suffering,

and great expense simply to fit in.

We urge the FDA to deny the pending applications for widespread use of

silicone implants. We fear that a lack of caution by FDA in this matter

could lead to further unnecessary pain and suffering on the part of women

and additional years of costly litigation.

Thank you very much.

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

Subj: Diane Testimony - FDA Panel Hearings - April 2005

Date: 5/1/2005 8:00:04 PM Eastern Standard Time

From: myrlj@...

myrlj@...

Sent from the Internet (Details)

MS. JAMES: Good afternoon. My name is Diane . And I am here today on

behalf of the s Institute of Women's Health. We are not supported by

anyone with a financial interest in this matter.

The s mission is to promote excellence in women's health by studying

the interaction of medical and social systems, facilitating informed

dialogue and awareness among consumer and health providers and promoting

problem resolution and information dissemination of key issues. It is from

this perspective that the questions surrounding availability of silicone

breast implants are important to the institute.

The regulation history of breast implants is long and complex. Following

decisions made in the 1990s, use of silicone gel implants has only been

permitted among women who have been part of adjunct studies. The limitation

on use of these implants has been the result of numerous unanswered

questions; in particular, questions regarding long-term safety. These

questions mandate carefully executed studies to acquire the data needed for

approval.

Now in 2005, this distinguished panel has been assembled to determine once

again whether questions related to the safety and effectiveness of silicone

gel implants from Inamed and Mentor have been adequately investigated and if

the accumulated data answer the safety questions sufficiently.

The panel must determine whether the current data available for review are

sufficient to provide practicing physicians with the information they need

in order to recommend these breast implants and have confidence that their

use will not cause harm to their patients.

Physicians and other health care providers must know that the benefits far

outweigh the risks for an elective procedure requested by women who often

are young and in good physical health. The data must also be sufficient to

provide women contemplating breast implants with the information they need

in order to make a truly informed decision.

What are the key questions for which a physician must have answers? These

have been outlined in the guidance document issued by FDA on January 13th,

2004. But clearly of prime importance is the question regarding

complication rates. Has the longstanding issue of implant rupture during

the lifetime of these devices been adequately addressed in the core study?

Preliminary estimates from reviewers released to the public late last week

suggest that the rate of rupture of silicone implants within 10 years for

women having reconstructive surgery may be as high as 93 percent. Among

women undergoing breast implant surgery for other cosmetic reasons, the rate

may be as high as 74 percent.

This ten-year estimate obviously includes women whose implants will rupture

long before ten years and raises questions about appropriate ongoing

surveillance and diagnostic testing that will be required at regular

intervals.

It also raises questions about who will pay for this surveillance. What

percentage of women will be able to afford appropriate diagnostic tests and

even further surgeries should health care coverage be unavailable for what

is generally categorized as an elective cosmetic procedure.

Imbedded in this critical safety issue is the persistent question of what

happens to the silicone when the silicone implants from Inamed and Mentor

rupture. Are there adverse health effects from the ruptures, either local

or systemic?

While an IOM committee in 1999 determined that there was little evidence

that silicone implants caused connective tissue disease, we must keep in

mind that this conclusion was based largely on retrospective data from the

nurses' health study and from a case-controlled database from the Mayo

Clinic.

Because of the study limitations related to the size and types of studies

used, the true risk of these conditions cannot be precisely estimated.

There may still be a small but significant increased risk of some forms of

connective tissue disease associated with the silicone implants under

review.

From the patient's perspective, it will be vital for physicians to have

these answers in order to openly and honestly discuss the risks and benefits

of this procedure.

Women must be informed regarding the expected incidence of rupture and what

rupture may mean in terms of the need for repeat surgeries. They need to

know about the process for removing gel-filled implants following rupture,

discomfort they may experience, and the potential long-term health

consequences should silicone gel leak. Women must also have this

information presented to them in a clear and concise fashion that is part of

the informed consent process itself.

The s Institute is concerned about the existing process and urges the

Committee to consider this in their deliberations. These concerns arise

from examining current saline breast implant patient brochures provided by

industry.

Subjected to a Fry analysis used by reading experts and those committed to

following clear health communication principles, as advocated by the Surgeon

General and the DHHS, this written information cannot be easily understood

by the majority of audiences in the United States.

According to the Fry analysis, the 42-page brochure reviewed is clearly

written for college-level individuals. This means women who are not able to

read health information at the college level will not be able to fully

comprehend the information provided.

We urge the Committee and the FDA to be certain that educational materials

describing risks and benefits are written at a level that most women will

understand.

In closing, we urge you, the Committee, to consider carefully the safety and

effectiveness requirement that Congress has mandated to the FDA in

determining whether devices should be permitted on the market.

Thank you for this opportunity.

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

Subj: Pamela Noonan-Saraceni Testimony - FDA Panel Hearings - April 2005

Date: 5/1/2005 8:08:36 PM Eastern Standard Time

From: myrlj@...

myrlj@...

Sent from the Internet (Details)

MS. NOONAN-SARACENI: Hello. My name is Pamela Noonan-Saraceni. I have no

conflicts of interest.

On July 5th of this year, I will be celebrating my 27th year as a breast

cancer survivor. However, I continue to live with the ramifications of

silicone gel implants.

In 1978, when I was only 25 years old, I was diagnosed with breast cancer

and had a modified radical mastectomy. I waited five years before I decided

to have silicone implant reconstructive surgery. I led an active lifestyle,

and I played tennis, jogged, and I taught aerobics. And I had grown tired

of the inconvenience and embarrassment caused by my external prosthesis

shifting and falling out of my bra.

I am a well-educated woman. And I thought I had done my homework on breast

implants prior to my reconstructive surgery, but I was never advised of any

health risks associated with silicone breast implants or the fact that there

was a chance for additional surgeries. In fact, I was told they would last

a lifetime and complications were few, if ever.

Within three months of my initial reconstructive surgery, I was back on the

operating table. My body has formed a capsule around my implant, and it had

moved up to my collarbone.

The searing pain at the time caused my shoulder to freeze and become

immobile. The surgery seemed to help, but symptoms of physical illness

began to develop after that. At first, I attributed the fatigue, muscle

aches, and pain to just getting older. However, I was only 36 years old at

that time.

Before I had the implant permanently removed in 1994, ten years after my

initial reconstruction, I had to again wear a partial prosthesis. Capsular

contracture had again become a problem. And my breasts had become lopsided

and misshapen. The explanation was the fifth surgery at my breast site.

I know that almost half of breast cancer patients with implants will need

one additional surgery due to serious problems that occur within three

years. And that is from Mentor's own data.

To date, my out-of-pocket medical expenses are approaching $50,000. My

husband and I are self-insured. And the insurance policy that we took out

carries an exclusion that I would not be covered for any illness or

disability related to my reconstructive surgery. The insurance company

understands that there are health risks associated with the breast implants,

and they are not willing to bear the financial cost.

Apparently the government also knows this. Last year the Department of

Health and Human Services settled with silicone breast implant companies to

recuperate the cost of caring for women made ill by silicone breast

implants. How can the FDA even consider approving these devices while at

the same time a sister agency sought financial compensation for harm that

they caused hundred of thousands of women?

Please do not recommend approval of this product until the companies provide

the long?term data needed to prove their safety. Women across America are

counting on you, the FDA, to protect them.

Thank you.