POST: News & S. Ayers & Ilena & Dr. Zuckerman and more...

[Guest guest]

Long message with lots of info . . . I'm sending it as an attachment . . . For those who read their mail from the list, the links won't work . . . Let me know and I'll mail you directly. - RogeneNote: forwarded message attached.

breast implants news

All Breast Implants Not Created Equal, Research Says

PR Web (press release) - Ferndale,WA,USA

According to new plastic surgery research, all breast implants are not created equal when it comes to long-term durability. Marina ...

Universal ID Systems Urged for Medical Devices

New York Times - United States

.... being considered were impractical for their far more diversified industry, which makes everything from disposable bandages and needles to implants meant to ...

Breast implants with own flesh

Toronto Star - Ontario, Canada

.... he says. "Surgeons doing breast implants got together and decided to eliminate the possibility of fat injections to the breast.". ...

Let your voice be heard on breast implants

Elmira Star-Gazette - Elmira,NY,USA

By a McCulloch-Dews. Silicone breast implants have long been the subject of debate regarding their impact on a woman's health. ...

History of the breast

Health24.com - Cape Town,South Africa

.... In 1994, an American "exotic dancer", Hess, applied successfully to the American tax authorities to have her size 56FF breast implants accepted as a tax ...

How to Spot a Boob Job

Chosun Ilbo - Seoul,South Korea

.... Plastic surgery clinic BARAM in Gangnam, Seoul says the size of breast implants has doubled from 135 cc on average in 1994 to 265 cc in 2003. ...

The permanency of cosmetic surgery

Toronto Star - Ontario, Canada

.... But not everything is as difficult to reverse. Breast implants can quite easily be adjusted to be smaller or larger or removed altogether without much concern. ...

Sternbach: Making a clean breast of just how shallow I can ...

Santa Cruz Sentinel - Santa Cruz,CA,USA

Attracted by the title of the article, "How Men Really Feel About Breast Implants," I picked up a copy of the July "O" magazine while standing in the checkout ...

THE PUEBLO CHIEFTAIN

Pueblo Chieftain - Pueblo,CO,USA

.... She's also been a patient. Her first procedure was rhinoplasty (nose job), then eyelid work and finally, in 1985, breast implants. ...

Trials of silicone breast implants raise concerns

Newark Star Ledger - NJ, USA

.... expressed for years by women's health advocates and consumer groups about missteps and problems associated with clinical studies of silicone breast implants. ...

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Subj: Fw: Important Message from Ayers ... Please visit this site and write to Judge Hood ASAP

Date: 8/4/2006 10:54:06 PM Eastern Standard Time

THIS IS PERTINENT TO ANYONE ELIGIBLE FOR THE DOW CORNING LAWSUIT SETTLEMENT --- most people know if they had the early implants manufactured by Dow Corning, or implants filled with Dow Corning manufactured silicone... I have no way of knowing who is eligible, and who is not, so am forwarding this message to everybody on my list... I'm not sure of the years covered?? but I think if your implants were manufactured after 1995 you are probably not eligible??? Does anybody know the dates covered?? Please inform me of the dates, if you know..

I am forwarding, from Ilena, a message from Ayers, who many of us have met at FDA hearings. Dr. Ayers (PHD) is the author of several books, and has a greater knowledge of the law and has "cut to the chase" on the the changing of the wording of the settlement. She has included a copy of her letter to Judge Hood, so we can print it out, and using it as a model, in our own words, express our thoughts on the matter!!!

IT IS MOST IMPORTANT THAT EACH AND EVERY ELIGIBLE PERSON WRITE THIS LETTER ASAP!!!

Carolyn

http://www.BreastImplantAwareness.org/JudgeHood.htm

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

Subj: Question from our Lany on hearing loss ...

Date: 8/5/2006 10:39:54 AM Eastern Standard Time

From: ilena.rose@...

Sent from the Internet (Details)

(Posted by Lany on her SBIPrayer Forum ... please write her directly and send me a copy of any responses ... thanks from Ilena)

"lany" <lany25@...>

Dear Members,

I wrote you not long ago, letting you know that I had lost nearly all of

the hearing in my left ear, and that I had severe tinnitus.

I don't have Meniere's Disease.

Day before yesterday, I went completely deaf in my left ear. I saw an

audiologist today who dx'd me as have "moderate to severe hearing loss

with tinnitus" She said I would be a candidate for a hearing aid, but

not for about ten years or so.

I've not been able to hear at all since Wednesday afternoon, and I'm

afraid I will lose my hearing completely, or bilaterally.

Has anyone had this problem, or know of a SBI Patient who has? It could

be from a dozen different things, but from the very baffled looks on the

doctor's faces, and the fact that my ENT wrote me a hand-writtten letter

encouraging me to go to the audiologist for further evaluation, I have

to wonder why this has happened, how serious it is, and why they are so

baffled, like most doctors get when they are presented with one of our

'weird' illnesses.

I can't believe all of this . . . I think I'm still dealing with shock

and denial.

Lany

http://community-2.webtv.net/lany25/LifeAfterBreast0/

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

Subj: Reporter looking for women with medical stories

Date: 8/15/2006 12:50:46 AM Eastern Standard Time

From: dz@...

ifriends@...

Sent from the Internet (Details)

For an article for a woman's magazine, a writer is looking for women in their 20s, 30s, or 40s who had a doctor blow off their symptoms as just stress when they actually had a serious illness. Examples of health problems that might be confused with stress include heart disease, hepatitis C, and fibromyalgia. She is also interested in hearing about any other serious conditions with symptoms similar to those of stress.

If any of you are in that age range and are interested in talking to this reporter, let me know and I'll put you in touch. Please do not express your anger to me about the age limitations the writer has specified. Magazines aim for an audience of particular ages because of their advertisers. It's very frustrating because it feels like many of us get too old to be listened to.

However, this is a good opportunity to try to include some of the experiences that women with implants have had, so let me know if this fits for you.

Zuckerman, Ph.D.

President

National Research Center for Women & Families

1701 K Street, NW, Suite 700

Washington, DC 20006

(202) 223-4000

www.center4research.org

We're Combined Federal Campaign # 1988

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

Subj: Our needs some good support ...

Date: 8/14/2006 12:13:35 PM Eastern Standard Time

From: ilena.rose@...

Sent from the Internet (Details)

... you are definitely not alone.

I'm going to share your very important request with our group ... we have many, many women who have gotten much, much better after explant and know your very real concerns. I believe you've found a good doctor to do your explant en bloc ... that's a very important part of the process. Please stay in good touch.

Love from Ilena

www.BreastImplantAwareness.org

---------- Forwarded message ----------

From: Platte <deniseplatte@...>

Date: Aug 14, 2006 9:04 AM

Ilena Rose <ilena.rose@...>

Dear Ilena~

I am having a really hard time. I feel like walking

death. Poisoned and unable to detox appropriately. My

fiance and I are breaking up. I have to move out of

our big beautiful house today and tomorrow. He can't

handle me being sick anymore and I can't handle his

misery anymore. He can't understand my sickness and

thinks it is all in my head. I feel like I should have

stayed and I got my explantation first, but there was

too much pressure.

I am suppossed to get explanted on September 7th. I

am afraid because I already feel so sick and

"unstable." It's ridiculous. 2 years ago I would have

never have said this. exactly 1 year ago I tried to

take my life because of the crazy things that were

going on with my body.

Is there hope for me? I'm 38,unable to work, and

tired of being an inconvenience to my family. I

wanted children. I was a Marriage and Family

Counselor. Can I make something out of my life after

explantation?

Will I be alone? All these questions race through my

mind.

Any input?

I had saline for 6, switched to silicone for 1 year,

and went back to saline. I total of 9 years.

lv,

> From : Platte <deniseplatte@...>

> Sent : Sunday, June 25, 2006 11:04 PM

> To : ilena2000@...

> Subject : support group

>

>

> *Ileana~`

>

> I live in San Diego and put in Saline implants in

> 1995. I had them for 7

> years and my doctor convinced me to switch to

> Silicone. After a year with

> silicone I became very ill and opted to remove them

> and replace them with

> saline. My health has still deteriorated. I have

> multiple chemical

> sensitivities. I am scheduled to have my implants

> out in Septemeber and am

> really scared. Do you have Saline Implant ladies in

> your support groups?

> And, do you believe saline implants can also make

> someone ill? Most people

> think I am crazy. I believe I have 2 choices, my

> boobs or my health. They

> are so much a part of my self-image it's scary.

>

> Thank you for all your help.

>

> Best,

>

> *La Jolla, CA

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

Subj: Trials of silicone breast implants raise concerns

Date: 8/14/2006 9:08:17 AM Eastern Standard Time

From: ilena.rose@...

Sent from the Internet (Details)

Thanks Rogene!

http://www.nj.com/printer/printer.ssf?/base/news-8/11554444054100.xml & coll=1

Trials of silicone breast implants raise concerns

Essex surgeon warned on protocol

Sunday, August 13, 2006

BY ROBERT COHEN

STAR-LEDGER WASHINGTON BUREAU WASHINGTON -- Lori Apgar faced the nightmare of breast cancer last

year. She underwent a double mastectomy, then turned to plastic

surgeon Spiro of West Orange for breast reconstruction using

silicone gel implants. "He is the one who made me feel there was hope and who put me back

together," said the 48-year old Long Valley resident. "I would

describe him as an unbelievable, caring and considerate doctor who

leaves no stone unturned. He was there for me." Apgar received the silicone implants -- which have been the subject of

a raging controversy for almost two decades and are not still not

approved by the Food and Drug Administration -- through a

government-sanctioned clinical trial designed in part to gather data

about medical complications women may experience after breast

reconstruction. But in a lengthy warning letter made public last month, the FDA said

Spiro failed to strictly follow the study protocol -- rules designed

to protect patients and ensure the data collected is scientifically

reliable. The FDA said Spiro did not report all medical complications; had

inaccurate and incomplete medical records for some patients; did not

return for inspection implants that were surgically removed; and used

an unapproved version of the informed consent form. The case of the New Jersey surgeon highlights concerns expressed for

years by women's health advocates and consumer groups about missteps

and problems associated with clinical studies of silicone breast

implants. "This is not a question of the doctor's skills but about the

importance of collecting the data on patient outcomes both in the

short term and long term in a rigorous fashion so we will have better

information on the safety, effectiveness and complications of these

still experimental devices," said Wood, a former assistant FDA

commissioner for women's health. "Unfortunately it appears that these studies are not being carried out

properly and it is women who suffer in the long run," Wood said. While the FDA called the violations "serious," Spiro, described by

colleagues as a meticulous surgeon, said the findings had "nothing to

do with the implants or the medical outcomes." "It's all about dotting all the i's and crossing all t's. How many

nit-picky inconsequential things could they find? It's very unfair,

unfounded and unjust," Spiro said. "They came in here looking for

something negative, and the only things they could find were clerical

things and that is sad." Spiro faulted Mentor Corp. the implant maker and study sponsor, for

"letting me down" by not providing the proper support regarding the

reporting requirements, and said there were disputes between the

company and the FDA on interpreting the protocol. A Mentor spokesman would not comment on Spiro or even confirm that he

was part of their clinical trial known as the Adjunct Study. But a

company statement said "Mentor has been very proactive in our approach

to working with and supporting physicians," and has "an entire staff

dedicated to the Adjunct Study."

CONCERNS PROMPTED BAN Silicone gel implants went on the market in the early 1960s, before

the FDA had authority to approve medical devices for safety and

effectiveness. In 1992, the silicone implants were banned amid

concerns about health problems caused by ruptures and leakage of

fluids into the body, and an FDA conclusion that manufacturers could

not prove they were safe. Saline-filled implants, considered less natural in appearance and feel

to silicone, have remained on the market and are widely used for

cosmetic purposes. While women testified last year before an FDA advisory panel about

serious health problems stemming from silicone implants, including

connective-tissue and autoimmune diseases, medical research to date

has not verified these claims. Despite the 14-year ban, thousands of women have received silicone

implants through FDA-approved clinical trials like the one involving

Spiro. The studies have included breast cancer patients needing

reconstruction after mastectomy, women with congenital deformities and

those who have had trouble with saline or older silicone implants. Spiro was part of Mentor's national Adjunct Study, which has included

70,000 women since 1992. The data from the Adjunct Study has been used to supplement a smaller,

separate clinical trial involving 1,000 women that was submitted to

the FDA in 2005 as the basis for seeking approval to market its

silicone implants. Mentor was faulted by members of an FDA advisory panel and health

groups last year for losing track of patients enrolled between 1992

and 2002 in its Adjunct Study, with the company able to follow up on

only about 19 percent of the women three years after surgery, and

about 11 percent at five years.

STUDY'S DATA CRITICIZED Amy Newburger, a New York dermatologist who sat on the FDA's expert

advisory panel that reviewed Mentor's silicone breast implant

application in April 2005, said the company's Adjunct Study data was

"sloppy." "We panelists were very disappointed and dismayed by that," said

Newburger, who voted against approving the implants. Mentor said it has "confidence in the body of scientific information

presented to the FDA panel about the safety and efficacy" of its

silicone gel implants. Mentor's competitor, Inamed Corp., had the same types of problems with

a similar long-running study, and like Mentor submitted data from a

separate 1,000-woman clinical trial as the basis for seeking FDA

approval. In July and September of last year, the FDA first told Mentor and then

Inamed (now part of Allergan Inc.) that it would let them begin

selling silicone implants once the companies met certain medical and

marketing safeguards that have not been publicly disclosed. The FDA

has yet to grant final marketing approval to either California-based

company. Mentor has continued to enroll patients in its Adjunct Study and

collect data at sites throughout the country. In the warning letter, the FDA said an inspection of Spiro's clinical

site in March and April found that five of 56 women patients suffered

medical problems requiring surgical interventions that had not been

reported to Mentor or to Saint Barnabas Medical Center's Institutional

Review Board in Livingston overseeing the clinical trial. The FDA said implants removed in two cases because of complications

were not returned to the manufacturer for analysis as required; that

38 of 56 subjects in the study signed "unapproved versions" of the

informed consent forms; and that some medical information regarding

the implant operations and patient case histories was not documented

for a number of patients. It found records designed to track the use and disposition of the

breast implants were inaccurate or incomplete, and that three breast

implant operations took place after Spiro's clinical trial

certification had expired. Spiro said Mentor told him in several instances he did not have to

return the removed implants or report adverse reactions because they

did not involve any problem with the product itself. Mentor's statement said the study protocol states that "any implant

removed as a result of an adverse event must be returned to the

company."

VIOLATIONS WERE 'MINOR' Spiro said inventory control was not part of his responsibility, and

that his patients, despite the paperwork citations, were all fully

informed at great length about all their rights and the risks. The West Orange doctor said he received permission from

Goodman, a radiation oncologist and head of the St. Barnabas

Institutional Review Board, to conduct the three operations after his

clinical trial certification lapsed. Goodman confirmed he made an exception to allow the three surgeries

because the review board did not have a scheduled meeting, and he said

Spiro's certification was later renewed. But the FDA said this still

represented a violation of study protocol. Goodman said Spiro had a responsibility to "report all data in a

timely fashion on every correct form" and to ensure the information

was accurate and reliable. But he said there is no FDA claim of harm to any patients, and that

looking at the bigger picture, the violations are "minor" even though

there is a need to "follow the rules all of the time." " is an extraordinarily compassionate plastic surgeon," said

Goodman. Wood, the former FDA head of women's health, said Spiro had

obligations to his patients and as a clinical researcher. "The

information is no good if we don't have quality studies. It is

critical that doctors who engage in this research are held accountable

along with the medical review boards and the companies," she said.

~~~~~~~~~

www.BreastImplantAwareness.org

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Subj: Join Us This Monday Morning on Internet Radio Show with Sally Kirkland

Date: 8/13/2006 7:46:38 PM Eastern Standard Time

From: ilena.rose@...

Sent from the Internet (Details)

To listen online, please follow links on our webpage ... 10am Pacific time, Sally and I will be discussing breast implants!

You need Windows Media Player ... and if you miss the broadcast, it will be archived at the www.Healthylife.net website.

www.BreastImplantAwareness.org

www.SallyKirkland.com

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

Subj: Very Bad Advice from Dear Abby Today ... let's educate her!!!

Date: 8/14/2006 4:50:01 PM Eastern Standard Time

From: ilena.rose@...

Sent from the Internet (Details)

http://www.uexpress.com/dearabby/

To write "Dear Abby"

http://www.uexpress.com/dearabby/dearabby_form.html

WOMAN SHRINKS FROM STARES THAT BIGGER BREASTS MAY BRING

DEAR ABBY: Due to childbirth, menopause and various surgeries, my breasts aren't what they used to be, so at 54 years of age, I and my husband agree that it's time for me to have breast augmentation. I'm not looking to be another Pamela ; I just want to replace what I've lost so my clothes will fit better. I'm a bit self-conscious about this and fear the stares, comments and questions from family or friends who think it's their right to ask me about it. What is a tactful response to the comments? -- DIANE IN KESWICK, VA. DEAR DIANE: You might say, "Why, thank you for noticing," and change the subject. But you should be aware that many women consider breast augmentation to be such an uplifting experience that they feel compelled to share every detail, including "show-and-tell." So don't be shocked if your attitude changes after you have it done. Dear Abby

is written by

Abigail Van Buren,

also known as

Jeanne ,

and was founded

by her mother,

ine .

It is the most

popular and widely

syndicated column

in the world --

known for its

uncommon

common sense

and youthful

perspective