Wednesday, May 14, 2008

EXCELLENT NEWS: Silicone gel implants may lose approval in Canada!

Key chemicals could be declared toxic.

Health Canada may have to reverse its controversial 2006 decision to allow women to get silicone gel-filled breast implants if it proceeds with a plan to declare key chemicals found in them to be toxic, experts say.

Health Canada is expected to announce Friday its plans for synthetic chemicals found in silicone fluids as part of a risk assessment of 200 chemical substances, identified as top priorities for action because they are potentially harmful to human health or the environment.

It has already written to industry, explaining that "in the absence of additional relevant information," the government is "predisposed to conclude, based on a screening assessment, that this substance
satisfies the definition of toxic (under the) Canadian Environmental Protection Act."

A toxic declaration about the Cyclohexasiloxane family, also known as D4, D5, D6, would start a process that could lead to a ban in certain products, as with bisphenol A in baby bottles.

"The different departments at Health Canada have been a bit of a dysfunctional family that don't listen to one another. If the environmental assessment decides this should be toxic, there should be a duty of the medical devices branches to study whether it should be taken off the market," said Dr. Kapil Khatter, scientific adviser for Environmental Defence.

Silicone implants were pulled from the market in 1992 amid concerns they were unsafe for women. Fourteen years later, Health Canada changed course and made them freely available to women with the caveat that "no medical device is 100 per cent safe."

Health Canada said it reviewed more than 65,000 pages of evidence submitted by manufacturers and more than 2,500 scientific articles in reaching its decision to grant licences to two companies to market silicone implants. Full story from Ottawa Citizen:
http://www.canada.com/ottawacitizen/news/story.html?id=e8e8a978-f360-47f2-98bf-35b8ff6a42f4.

Friday, April 18, 2008

Bravo to Krista & Beauty & The Breast ... Made it to Google News Search Engines!

Are Breast Implants Going out of Style?

Beauty and the Breast - 12 hours ago
On this note, I wonder if it is inevitable that our beloved breast implants that came into style in the 1980's will eventually go out of style as well?

Meet Krista

Wednesday, April 09, 2008

Teens Dying to Look Beautiful

National Enquirer, April 14, 2008

The national epidemic of teen breast surgery is completely unnecessary and totally wrong.
Dr. Diana Zuckerman

Dangerous & unwarranted procedures need to stop, say experts.

This beautiful teenager wanted the perfect body ... and her Plastic Surgeon used the loophole of assymmetry to go around the FDA mandate that women must be at least 22 years old before getting implants.

This tragedy should never have happened ... plastic surgeons to this day, are denying the very real risks of this surgery.

Thanks to Kathy Nye for this info ... read her story here.


Sunday, March 30, 2008

LOOPHOLES ALLOW PLASTIC SURGEONS TO CIRCUMVENT RULES ABOUT BREAST IMPLANTS

Excellent article and a follow-up to the tragedy of this beautiful young cheerleader here.

I concur with Dr. Zuckerman's comments:

I had a young woman tell me her plastic surgeon called an acne scar a deformity so she could get a silicone implant," said Diana Zuckerman, president of the National Research Center for Women & Families.

Similarly, I know plastic surgeons who placed saline implants for a few months, to circumvent the mandate that women under 22 could receive saline ... and then re-operated to replace them with silicone gel. This loophole I have heard about many times. (Gel replacements are allowed for women under 22 ... not first time implants.)

Monday, March 24, 2008

Florida High School Varsity Cheerleader Dies after Breast Implant Surgery

A West Boca Raton High School Senior died from complications after undergoing a breast augmentation, friends say.
Stephanie was a Senior at West Boca Raton High School

Stephanie was a Senior at West Boca Raton High School

Note from Ilena Rosenthal: The FDA mandates that women must be at least 22 years old to get breast implants. How & why did this Plastic Surgeon circumvent this? Full story here.

Sunday, March 16, 2008

Birmingham, the world is watching. ~ Federal Breast Implant Judge, Samuel C. Pointer Dies


Banner courtesy of Judith Patience, Photo by Kathy Nye

Judge Pointer is dead. Here is a Birmingham article on his passing.

As his loved ones mourn his loss, we also mourn the loss of justice for hundreds of thousands of women harmed by faulty breast implants who received little or no compensation, much based on his ill fated, so called, science panel.

His rulings that gave, in our opinion, almost a free ride to the manufacturers, made sense when upon his retirement as a judge.

Pointer went to work for Lightfoot, Franklin, & White ... a veritable Who's Who of Corporate America, whose clients include Bristol Myers Squibb and Baxter (both former implant makers) as well as tobacco and pharmaceutical and oil giants (to name but a few).

After several of us made a peaceful protest on the courthouse lawn and attended hearings of his Science Panel in 1999, Sally Kirkland and I published this piece to him.

~~~~~~~~~~~~~~~~~~~~~~~~~~~

U.S. District Judge Sam C. Pointer, Jr., Federal Courthouse,
Birmingham, Alabama
May 5, 1999

Birmingham, the world is watching.


To The Honorable Judge Pointer,

After witnessing Dr. Hulka under cross examination in your courtroom April 21st, the Birmingham Civil Rights Institute right around the corner was a fresh breath of hope.

In the early 60's, equality for our black citizens also seemed but a dream. Equally, justice for breast implant victims presently appears to be anything but imminent. You, Judge Pointer, can change that and protect millions of medical consumers from faulty medical devices.

As the sign in that historical museum read, "Birmingham, the world is watching."

Judge Pointer, the world is watching you, your courtroom and your National Science Panel. Regrettably though, Benjamin Franklin's words ring loudly,

"It's such a pity that our legal system has so little to do
with justice."


After reading much of the testimony revealing manufacturer influence at so many turns, and the basic lack of curiosity of the researchers to even look in medline beyond "breast implants" to "silicone," we can't help but paraphrase:

"It's such a pity that our science panel has so little to do with science."

The responsibility you have to the health of millions of women and their offspring is awesome. In the bookstore of this Martin Luther King Museum, we had a conversation with the 20 year old clerk. He shared that at 18, his former girlfriend had gotten implants as a graduation gift from her surgeon father. Her little sister is receiving this same "gift" this year.

Judge Pointer, undoubtedly, this surgeon ~ as scores of thousands of other physicians around the world ~ has been mislead into believing that silicone and breast implants are "safe." Your Panel is continuing to disseminate this rumor to the world. Do you not feel your personal responsibility in issuing false assurances to the millions with disintegrating and leaking implants in place and those who purchase their first implants from now on?

At a FDA / Medical Devices meeting last week, the FDA could not designate what they felt an "acceptable rupture rate 3 was. You did not even instruct your NSP to investigate this serious, usually inevitable event that often results in multiple invasive surgeries. How could this have been ignored?

While widely accepted that early detection is one of the key factors in limiting the devastation of breast cancer, nowhere was the definite obstruction of good mammography by all implants even addressed. This consequence of breast implants alone, makes their presence highly unsafe.

Judge Pointer, please tell us, what can the women do to get your attention off these worn manufacturer bought, teeny, skewed, short, lopsided "studies" whose purpose was to obfuscate litigation, and onto their serious health problems?

When we heard Dr. Hulka defend the design of the Mayo study as "excellent" when she couldn't even say whether any of the control group of Mayo patients (might that bias alone not tell volumes?) had implants, or why women with one month old implants were included in a "study" investigating systemic disease, I realized that your courtroom was just very expensive
theatre. She seemed to find the concept of "latency" almost trivial.

Women spent thousands of their own dollars to have their medical records included in their cases, yet, to date, this staggering evidence of autoimmune diseases and infections and multiple surgeries is under lock and key while the Mayo and Harvard studies are yet again being presented as Commandments 11 and 12.

Millions of women with leaking and disintegrating and ruptured implants are being lulled into false assurances by your panel. Plastic surgeons are implanting between 500-750 new sets of implants every day.

What if only 10% of the women were to become ill from these never FDA approved devices? Or 25%? Or 40%?

Judge Pointer, when we conducted our peaceful Rally in from of your courtroom April 21st, we had mounted police surrounding us for our protection and your Court's.

Where is the protection for the implanted women past, present and future?

And their offspring?

What science has ever said that it is safe to gestate and nurse babies born of implanted women?

We all know that answer is sadly, "none."

Please study the records of the nearly half a million women involved in these lawsuits. And please, recognize the bias of your Panel, and re-consider the Plaintiff's Motion for their dismissal.

Judge Pointer, the world is watching.

Respectfully,

Ilena Rosenthal
Director, Humantics Foundation for Women
San Diego, CA

Sally Kirkland
Kirkland Institute for Implant Survival Syndrome
West Hollywood, CA

Saturday, March 15, 2008

Silicone Wars ~ Ides of March, Important Repost from 1999

by Ilena Rosenthal, March 15, 1999

Beware The Ides of March.

This historical date of classic betrayal and traitorism ~ March 15th ~ appears to be living up to it's reputation. Caeser and Brutus move over.

Here come The Dows!

On this date, Dow Corning's bankruptcy division, in yet another public relations blitz regarding their previously profitable breast implant division, will begin mailing a couple hundred thousand implant recipients a settlement offer for their vote.


They will continue their very expensive PR campaign to make the forgiving public believe that there is zilch ~ zero ~ nada ~ none ~ no evidence whatsoever ~ that their previous cash cow of silicone, causes harm. They will hit the media through their intricate and expansive network with "Poor Dow" and "Generous Dow" articles. They won't reveal however, that Baby Dow Corning has earned over $200 million in profit each and every year. Bankruptcy has served them well.


Nor will they remind the public that Papa Dow Chemical recently lost $4 million in Reno and an as yet unknown amount in a class action suit in Louisiana they have managed to stall. They are guilty of not only manufacturing, but for years, concealing the known dangers and risks of breast implants. Mighty Dow, in spite of the Nevada verdict Halloween, 1995, is still appealing at the federal level. They have lost all state appeals but with clever legal strategies and stonewalling, that four million dollars is still in the coffers of Dow, and the very ill plaintiff, Marianne Hopkins, is left broke with a debilitating disease similar to Multple Sclerosis.


They will fail to mention, that although marketed as "lasting a lifetime," recent studies, including one in the prestigious British Lancet (11/22/97), report a rupture rate up to 95% over 20 years. Nor will the press releases mention hidden studies done by Dow as early in the 50's and 60's whose results were buried for years. They did not want their customers to know that silicone migrated throughout the body and crossed the placental barrier. They exclude the fact that implants were once designed as a "drug delivery system," or that cockroaches dropped dead from the silicone fluid.


They will try to convince you, that it is out of their generosity, not scientific evidence, that they are paying out $3.2 billion. They prefer to be seen as the benevolent, unfairly maligned corporation, who, with no fault of their own, offer this money out of pure concern for fairness.


They will utilize their long running campaign of defaming all doctors who dare to report their findings on the damage to women's bodies and immune systems by calling them "junk scientists." They will imply that hundreds of thousands of implanted women are faking serious autoimmune symptoms and removing their ruptured implants at the whim of plantiff attorneys.

Preposterous.


Rarely admitted is the fact that no breast implant has ever been approved by the FDA for safety. Or why, as of 9/10/98, 127,500 women with silicone gel implants and an additional 49,661 with saline filled implants had reported serious adverse reactions to the FDA.


In 1995, my phone started ringing with women sharing their implant stories and I began my internet newsgroup and email list. The horrors continue to unfold today as hundreds more ill women come forward every month. Women literally and figuratively disintegrating ~ at least one whose tortured chest is being held together by mesh. Silicone in their brains, their uteri, their livers, their spinal fluid, their children.

The manufacturers have engaged implanted women as distractors causing confusion and paranoia throughout the support system, knowing that dividing the injured women disempowers them. It's as if Brutus himself taught them well to spread rumors like viruses.


What about the women?


With the pittance offered the majority of them, will they even be able to afford to remove their ruptured or disintegrating implants?

And if they vote "no," will a better offer ever come their way?

Who will cover their mounting medical bills as their immune systems break down from chemicals and known carcinogens like silica, toluene, and platinum? Health insurers are already routinely refusing coverage for implanted women.


The Silicone Issue is the slippery slope of Big Bu$ine$$. It brings attention to other dangerous devices and drugs, other toxins whose real dangers are still being minimized.


If the wealthy silicone manufacturers don't take real responsibility for their failed products, this is a public health catastrophe in the making.


Ilena Rosenthal, is Director of The Humantics Foundation for Women and author of Breast Implants, The Myths, The Facts the Women. Daily she communicates with thousands of implanted women and their families via her email lists.

Wednesday, February 27, 2008

Congressional Democrats To Draft Bill To Overturn Supreme Court Decision On Medical Devices

Regarding this ill advised, virtual “get out of jail free card” ruling, to benefit mightily the Med Device Industry, I was thrilled to see others equally as upset.


Senator Ted Kennedy sums it up well:


“In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.” He said that without congressional action “FDA approval will become a green light for shoddy practices by manufacturers” of medical devices. Full article here.

Tuesday, February 26, 2008

HUGE NEWS: Government Concedes Vaccine-Autism Link in Federal Court!

Note from Ilena: This is a landmark case and one to make the enormous Vaccination Public Relations Teams go wild!

I highly doubt it was the 'plaintiff's' identity that sealed this case. In the breast implant debacle, one of the ways the manufacturers keep their cover up going, is with gag orders silencing the women (after paying mere pittances for their damages).


The Vaccination and Breast Implant Industries have used identical strategies (and PR people) for several years. I fully believe that breast implants (and all the chemicals and metals present), can and often do trigger disease responses much like described here ... some which may have forever remained dormant.

By David Kirby

After years of insisting there is no evidence to link vaccines with the onset of autism spectrum disorder (ASD), the US government has quietly conceded a vaccine-autism case in the Court of Federal Claims.

The unprecedented concession was filed on November 9, and sealed to protect the plaintiff's identify. It was obtained through individuals unrelated to the case.

In its written concession, the government said the child had a pre-existing mitochondrial disorder that was "aggravated" by her shots, and which ultimately resulted in an ASD diagnosis. More at Huffington Post.

Friday, February 22, 2008

Bravo and thank you to Mary McDonough from the Waltons ... Attributes lupus to her silicone breast implants

Excerpt from American Profile Magazine, February 22, 2008
Visit Mary's website, In the Know.

Erin
Mary McDonough, 46, is an actress, filmmaker and inspirational speaker. The mother of a 15-year-old daughter, she is engaged and lives in Orange County, Calif. She has a recurring part on the CBS series The New Adventures of Old Christine. Diagnosed with lupus several years ago, McDonough attributes the disease to her now-removed silicone breast implants. As a result, she has become an activist to educate women about the possible dangers of implants.


Wednesday, February 20, 2008

Dangerous Precedent ~ Supreme Court Gives Med Device Industry a Free Ride Because FDA Claims Device is "Safe"

Note from Ilena: Even at a time when the FDA has admitted many of it's failings ... the Supreme Court gives the industry a free ride because this product, (like breast implants)  is considered 'safe' by the FDA.

"The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak." Read FDA report here (opens pdf). Full index here.


The Supreme Court is making it harder for consumers to sue manufacturers of federally approved medical devices.

In an 8-1 decision, the court ruled against the estate of a patient who suffered serious injuries when a catheter burst during a medical procedure.  More here.

Tuesday, February 12, 2008

Britney Spears Had Breast Implants As A Teen

Rolling Stone magazine delves into Britney Spears' troubled adolescence in their new issue – and, among other surprising revelations, claims that the singer's mother allowed her to get breast implants as a teen.

Though it was widely speculated at the time that Brit had gone under the knife, the singer denied having a boob job.

The friend adds: "When other girls did their boobs [they admitted it] and moved on, but Britney was brought up to lie about herself."

Click here for more.




Monday, February 11, 2008

Surgical Site Infections More Common Than Expected Following Breast Procedures

Infections at the incision site occurred in more than 5 percent of patients following breast surgery and cost them more than $4,000 each in hospital-related expenses, according to a new article.

Infections were more common in patients undergoing cancer-related procedures, and occurred following 12.4 percent of mastectomies with immediate breast reconstruction using an implant ... click here for more.

Monday, January 21, 2008

NYTIMES: Do My Breast Implants Have a Warranty? BRAVO & Thank You to all who contributed!

SKIN DEEP
Amaranth Productions

BE PREPARED Dr. Edward Melmed, in a scene from "Absolutely Safe," removes an older-model silicone implant that failed.




By NATASHA SINGER
Published: January 17, 2008

A NAKED woman, her left arm strategically draped over her nipples, grins beatifically at readers in an advertisement for cosmetic surgery that equates breast implants with a more durable commodity: jewels.

Amaranth Productions

NOTHING LASTS FOREVER A patient in the anti-implant documentary film "Absolutely Safe."

Krista Schell needed two follow-up implant operations within five years of her first.
Jamie Schwaberow for The New York Times

Dr. Linda Huang tells patients that implants should be removed within 10 to 15 years.

"My plastic surgeon told me that my saline implants should last forever," said Krista Schell.

Ms. Schell, 29, who lives in Thornton, Colo., and works for the State of Colorado, said she first spent $6,500 in 2003 on breast enhancement surgery with a doctor in California. She had a second operation with that doctor last April to replace a deflated saline implant whose collapse made her left breast look "hollow"; her implants were still under warranty, but she did have to pay for the trip to California and lost a week's pay, she said.

Last November, Ms. Schell had a third operation, which cost $6,000, this time with a surgeon in Denver who removed both implants as well as extensive scar tissue, she said. She also lost two weeks' wages because she had to take time off, she said. The implants had also caused rippling, a lump around one nipple and pain. "If you look at the negatives, you would talk yourself out of getting implants," Ms. Schell said.

"If the envelope has broken down and the silicone has leaked out, you are trying to get out all of that goo," said Dr. Susan E. Kolb, a plastic surgeon in Atlanta who performs three to five explantation surgeries a week. To remove scar tissue, which can adhere to muscles and to the fibrous tissue covering the ribs, some doctors mistakenly remove too much muscle or breast tissue, which can cause chest deformities, she said. Click here for full article.

Sunday, December 30, 2007

Ilena quoted in RedWood Age: Resolutions That Go Beyond Losing Weight

Excerpt from Redwood Age:

#6 Become a better health advocate

Ilena Rosenthal, a women's health advocate, cautioned boomers not to be swayed by advertising, and to be mindful of subsequent perks some physicians receive to tout products.

"Learning to follow the money behind the massive number of medical messages we receive daily may well lead us to realize that modern medicine has little to do with health and everything to do with business," Rosenthal said."

… full article here

Visit Ilena's Blog

Friday, December 14, 2007

Halliburton Employee Violently Raped ... Breast Implant Trauma ... How She Was Further Mistreated

The last few days I've been made aware of this horrific story ... of the brutal rape, imprisionment, and other mistreatment by a woman employed by Halliburton.


I just found a website she made relating her horrors ... and read this:

I awoke the next morning in the barracks to find my naked body battered and bruised. I was still groggy from whatever had been put in my drink. I was bleeding from between my legs and my breast implants were severely disfigured. (I found out later that my attackers tore my pectoral muscles due to the brutality of the attack).

The rest of Jamie's story is here.

http://www.jamiesfoundation.org/Jamie.htm

~~~~~~~~~~~~~~~~~
Breast Implant Awareness Blog

Wednesday, December 12, 2007

For women of a certain age ...


Women of a certain age will fully appreciate this true story.

If you don't, ask your Mom ... for sure she will.

A Michigan woman and her family were vacationing in a small new England town where Paul Newman and his family often visited.

One Sunday morning, the woman got up early to take a long walk. After a brisk five-mile hike, she decided to treat herself to a double-dip chocolate ice cream cone.

She hopped in the car, drove to the center of the village and went straight to the combination bakery/ice cream parlor.

There was only one other patron in the store.
Paul Newman, sitting at the counter having a doughnut and coffee.

The woman's heart skipped a beat as her eyes made contact with those famous baby-blue eyes.

The actor nodded graciously and the star struck woman smiled demurely.

Pull yourself together! She chides herself. You're a happily married woman with three children, you're forty-five years old, not a teenager!

The clerk filled her order and she took the double-dip chocolate ice cream cone in one hand and her change in the other. Then she went out the door, avoiding even a glance in Paul Newman's direction.

When she reached her car, she realized that she had a handful of change but her other hand was empty.
Where's my ice cream cone? Did I leave it in the store? Back into the shop she went, expecting to see the cone still in the clerk's hand or in a holder on the counter or something. No ice cream cone was in sight.

With that, she happened to look over at Paul Newman.
His face broke into his familiar warm friendly grin and he said to the woman,


'You put it in your purse.'



--

Wednesday, December 05, 2007

Why the breast implant issue is never boring ...


To read lots of stories of women post implants ... please visit:

Humantics Foundation Website
Breast Implant Awareness Blog

Wed Dec 5, 2007 



By Dan Whitcomb
http://today.reuters.com/news/articlenews.aspx?type=oddlyEnoughNews&storyid=2007-12-05T141823Z_01_N05581766_RTRUKOC_0_US-IMPLANTS.xml

LOS ANGELES, Dec 4 (Reuters) - Porn star Mary Carey, who shot to fame by running for California governor against Arnold Schwarzenegger, unveiled plans on Tuesday to auction off her autographed, recently removed breast implants for charity.

Carey said the size 36-D implants were taken out two weeks ago and replaced with larger 36-DDDs and while under anesthesia she realized they could be used to raise money for breast cancer research.

"The doctors asked me what I wanted to do with them and I said, 'You know what, I'm going to keep them and try to sell them. Because my grandmother had breast cancer," Carey told Reuters in an interview.


The 27-year-old star of such adult films as "Boobsville Sorority Girls" and "Big Breasted Beauties" will be seen in the upcoming VH1 reality show "Celebrity Rehab with Dr. Drew" and said that during taping she kicked addictions to the anti-anxiety drug Xanax and alcohol.

"Now that I'm sober I wanted a new physical state to go along with my new mental state," Carey said. "I thought the auction would be a great way to spread some holiday cheer and make sure someone out there would have a Mary Mary Christmas."

The autographed implants have been placed on eBay and Carey, whose real name is Mary Cook, said she planned to donate some 90 percent of the proceeds to the Susan G. Komen Breast Cancer Foundation.

She intends to use the rest of the money on medical bills for her mother, who suffered major injuries after jumping off a four-story building in 2006.

"I'm actually overall very anti-plastic surgery," Carey said. "I watched my mom go through 11 surgeries (for her injuries) and it's like, for me to voluntarily put myself through that, the only right thing to do is make money and donate it to charity."

Carey gained international fame in 2003 with her quixotic gubernatorial campaign against eventual winner Schwarzenegger. She abandoned a second run for governor against Schwarzenegger to be with her ailing mother and said it was then that she turned to Xanax, taking three times the prescribed dose.

Saturday, December 01, 2007

Shocking document: FDA Science and Mission at Risk ... " The FDA cannot fulfill its mission because its scientific base has eroded ..."


Thanks to Louise Kosta for the heads up on this.

Watching the FDA cave in to the breast implant industry pressure and claim that their very often very dangerous medical device is 'safe' was certainly one of many recent low points. We believe women put their health at risk believing breast implants are 'safe.'
www.BreastImplantAwareness.org/

Visit our blog and read about the real 'after' stories


Ilena's Blog

~~~~~~~~~~~~~~



EXCERPT:
1.2.1 The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

Complete report here (opens pdf file)
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
Full index

New York Times December 1, 2007

http://www.nytimes.com/2007/12/01/washington/01fda.html?_r=2&th=&adxnnl=1&oref=slogin&emc=th&adxnnlx=1196514155-yrpd2FxUV18JPLsHEtnRIg&oref=slogin

Advisers Say F.D.A.'s Flaws Put Lives at Risk
By GARDINER HARRIS

"WASHINGTON, Nov. 30 — The nation's food supply is at risk, its drugs are potentially dangerous and its citizens' lives are at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to an alarming report by agency advisers."
....

From Associated Press coverage:
http://www.nj.com/newsflash/washington/index.ssf?/base/politics-14/119648218241120.xml&storylist=washington
....
"The Science Board subcommittee given the task was blunt: 'In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events and our findings indicate that some of those crises are now realities and American lives are at risk.'"
....
The report itself is linked at
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html


Tuesday, November 27, 2007

We Welcome Diana Leighland and read her new Book: Big Breasts to Die For: The Silicone Survivors Handbook




Click here for Webpage

The Humantics Foundation, with open hearts, welcomes the very loving Diana Leighland to our Support System



and recommends her incredible new book ...

Big Breasts to Die For: The Silicone Survivors Handbook




Thankfulness & Support Group Messages for 11 26 2007


Dearest Group,

I spent a lot of time focusing on my blessings during this Thanksgiving Holiday ... I've long believed that what we focus on expands.

I am very, very grateful that new women are finding our support group and sharing their stories and providing loving energy to our growing numbers. I'd like to introduce you all to one of our newest members, Tammy from Florida, and invite you to read her story and especially her intelligent comments on dental concerns post implants. Click here for her new page.

Some things I read make me want to scream ... such as the plastic surgeon, whose patient, Donda West, died post surgery,  denying any possible wrongdoing. I found this revealing article on him,  Dr. Adams Blames Malpractice on Bad Patients.

Here's Pamela & the Human Adjuvant Disease Corp's latest newsletter.

This article promoting implants after being diagnosed with the breast cancer gene is particularly upsetting.

Breast Implants as Health Options, Not Cosmetic

http://www.wral.com/lifestyles/healthteam/story/2075974/

Dr. Zuckerman wrote an excellent piece on Unnecessary Mastectomies, click here and another on Prophylactic Mastectomies here.

Another of our blessings is support group leader Kathy Nye.

For our newcomers who haven't had the pleasure yet of meeting Kathy, please read her story here, and how her breasts and how the promises made her 40 years ago, are almost mirrored in the article from this week.

http://kathynyebreastimplants.homestead.com/MyNightmare.html


I was very happy to hear from another long term friend of our support group, Linda B ...a very beloved sister. Please join me in sending her much love and healing energy.

~~~~~~~~~

From:  Linda B.

Ilena please let all of the women that you can get in touch with, know, that I have just gotten out of the hospital after a 25 day stay.

I have Lymph node Cancer. I had my first treatment in the hospital last week. Have it in all nodes. They found it behind the Left breast.

I started with fevers of 104. Hard chills, sweats, etc. I am still very week. The Dr's think I've had it anywhere from 3 to 2 years.

That's why I haven't been online lately. When I feel better, I'll email you more details. If any of the other women have it, ask them to email me. I have such low blood counts ....... Just hope they didn't catch it to late. mine is T Cell.

Much love for now.


Linda B (Silicone suckered)

~~~~~~~~~~~~~

Hungarian women with implants petition non-existent bill

There's lots and lots more but that's all I have time for at this moment.

If any of you knows anyone who could help our small non profit, The Humantics Foundation, with a tax deductible donation in any amount, it would greatly help us keep our message of cautions with breast implants on the internet. It is an extremely time consuming undertaking, to say the least.

The breast implant industry has merged their own vast public relations budgets with the chemical industry denial of MCS and the vaccination / pharmaceutical / anti-alternative industry  (to name a few.) They google bomb and attempt to drown out any non industry voices such as Mine ... and perhaps yours.


Love & Blessings from Ilena

Breast ImplantAwareness. org

Breast ImplantAwareness Blog


Monday, November 12, 2007

Breast Implant Plaintiffs Lawyers in 'Blood Feud' Over Fees From $2 Billion Settlement

Nate Raymond    The American Lawyer
 
There's a brawl raging in the Lone Star state among some of America's
richest plaintiffs lawyers.

These three men have been fighting for years. The latest round
involves legal fees won by O'Quinn in a $2 billion settlement in a
breast implant class action. O'Quinn collected $263 million of that
money as legal fees, according to arbitrators. for more click
here.

Death of Rapper's Mom Shines Light on Liposuction & Breast Surgery ... Bravo to Dr. Zuckerman for being quoted

Dondawest Cosmetic surgery is so common in this town, you could forget it carries some risks.

Until someone famous dies while having a "procedure". That's what appears to have happened to Donda West, the mother of rap star Kanye West.

According to her publicist, Donda West underwent some kind of cosmetic operation (reportedly liposuction and breast reduction) at a facility in the L.A. area. Something went wrong, and she was taken by paramedics to the ER at Centinela Freeman hospital. Doctors could not revive her, and she was pronounced dead about a half an hour after she arrived.

Now, coroner's investigators will perform an autopsy to determine if she died from "complications of surgery." Donda West was 58 years old.

The fact that people can and do die from cosmetic procedures will shock many folks here. After all, plastic surgeons advertise their services on billboards and in glossy magazines. Sometimes you see them on TV news programs touting their work with "before" and "after" photos. They don't tell you that as with all surgery, there are no guarantees when it comes to safety.

Here's an excerpt from the Ethics Journal of the American Medical Association, March 2005, written by Dr. Diana Zuckerman:

Primary risks (of liposuction) include infection, damage to skin, nerves, or vital organs, fat or blood clots (that can migrate to the lungs, leading to death), and excessive fluid loss that can lead to shock or death. In addition, the different techniques are associated with complications such as skin or deep tissue damage, lidocaine toxicity, and fluid accumulation in the lungs. Despite the documented risks, the general public has an inflated sense of the benefits and a minimized sense of the risks of plastic surgery.

Wednesday, October 24, 2007

Breast Cancer Sells * Support Group Greetings * Raising Awareness

Dearest Friends ... near & far.

I've been so relieved to reconnect and learn many of our support group members and family members in Southern California are safe from the fires ... although breathing is proving to be hazardous to the health of many in this vast area.

How in the world did so many fires start simultaneously?

Our group  has many relatives and loved ones whose property is still in danger and the challenges are rising ... Interstate 5 is now closed ... the implications of which are more than concerning. The good news is the winds are slowing down.

Our dearest friend Joanie, long time Support Group Leader Extraordinaire in La Jolla had this soothing advice:

Thank you. I have a house full of refuges. I keep lots of boiling water with a gob of Vicks or Mentholatum on the stove boiling at all times. It keeps the air moist and helps with keeping the ash from entering your nose. If you have a chance let people here know as the air is so dry and the ash is very bad for us. Also, Zicam for allergies ( the gel) is excellent. It is homeopathic and works wonders.

 
Love you Ilena  Thanks for your prayers. Much appreciated.

I am using this stressful time to update our Website & Blog  with more & more of your stories ... we are finding it quite effective in combating some of the vast and limitless advertising / public relations volumes churned out daily by the Breast Implant Industry.

Here are a couple of newer entries ... please meet these wonderful people.

Lyn's Story
Anthony's Story
Dede's Story
Sue in England's Story

Note from Ilena:
The quote below shows the depths the breast implant / breast cancer industry goes down to, to market their highly profitable product.


AlterNet
Breast Cancer Sells By Lucinda Marshall, AlterNet Posted on October 24, 2007

EXCERPT:
This year there is even called Beyond Breast Cancer that cheerfully proclaims that there are "10 Good Things About Breast Cancer."

According to the bubblegum-colored magazine,
one perk is a pair of new boobs that "will face the horizon, not the South Pole.' Better yet, they will be paid for by insurance.



  Whole article here:

~~~~~~~~~~~~~~~~~~~~~~~~

Wednesday, October 17, 2007

FDA Allowing Mentor to Drop Women From Study & DeLauro Letter To FDA

This is very, very serious information. Mentor is trying hard to be released from the conditions that were put in to the FDA 'approval'. Thanks to all who are circulating this and acting on it. Thanks to Sandra and her dad for putting this together.

www.BreastImplantAwareness.org/



FOR IMMEDIATE RELEASE
Contact: Adriana Surfas

Thursday, October 11, 2007
(202) 225-3661


FDA Ignoring Requirement for
Post-Market Surveillance of Breast Implants

Less than one year after approval, FDA allows company to change study requirement Washington , D.C. – Congresswoman Rosa L. DeLauro (Conn. – 3), as part of an on-going effort to ensure that science – and not corporate interests – informs decisions within the Food and Drug Administration, sent a letter to Dr. Andrew von Eschenbach, FDA Commissioner, seeking information regarding a change in a mandatory post-market requirement for silicone breast implants.

Earlier this year, Mentor , a manufacturer of silicone breast
implants, announced that the FDA approved an amendment to the company's Post Approval Study Protocol that eliminated a mandatory requirement that each patient receiving silicone breast implants be enrolled into a study.


The FDA approval of silicone breast implants
last November was based on a number of conditions that the manufacturers were to follow, and those conditions already appear to be changing less than on year after their approval.

"If true, this raises serious policy questions regarding the FDA's
post marketing approval process," DeLauro stated. "This also raises serious questions about the FDA's ability and willingness to conduct the new post-market safety measures that were recently enacted in the new Prescription Drug User Fee Act.

If industry will be able to
dictate the terms and conditions of the post-market studies required under PDUFA, it will be rendered useless."

In May of this year, Rep. DeLauro introduced The FDA Scientific
Fairness for Women Act, which would rescind the approval of silicone breast implants if their safety has not been conclusively demonstrated for the life of the implant.

This bill has been
endorsed by the National Research Center for Women and Families, Breast Cancer Fund, National Women's Health Network, NOW, Reproductive Technologies Project, Our Bodies Ourselves, In the Know and Command Trust Network.

Additionally, the legislation would
require the FDA to convene a scientific workshop on the use of emergency contraception by young women under the age of 18 and elevate the Office of Women's Health within the FDA so that it reports directly to the Commissioner. Below is the full text of the letter:

October 11, 2007


The Honorable Andrew von Eschenbach, M.D.

Commissioner
Food and Drug Administration
5600 Fishers Lane
Room 14-71 Rockville, MD 20857

Dear Dr. von Eschenbach:


I am writing to express concern about the potential
amendments to Mentor's MemoryGel Breast Implants Post Approval Study (PAS) Protocol. Silicone breast implants were approved based on a number of conditions that Mentor and Allergen were to follow, and less than one year after their approval, the conditions appear to be changing. If true, this raises serious policy questions regarding the FDA's post marketing approval process.

Mentor announced on May 2 that the FDA approved an amendment to the PAS protocol, which removed a mandatory requirement that each patient receiving silicone breast implants be enrolled into a study. The announcement claimed that the amendment was a response to feedback from Institutional Review Boards and physicians who were concerned about the restriction of patient access to silicone breast implants. What specific data was provided to the FDA to justify this request?

Was an advisory board called or asked
about the change? In addition, please provide a status report of the post- approval studies for saline breast implants made by Mentor and McGhan (now Allergan). As a condition for approval in 2000, both companies were required to continue their 3-year safety studies for an additional 7 years, so these 10-year studies should be completed this year.

However, when the FDA held a public meeting to discuss
the 5-year data in July 2002, Mentor did not have follow-up health data on most of their patients. Since the same companies are also responsible for 10-year post-market studies of silicone gel breast implants, the quality of their 10-year studies of saline breast implants, and the rigor of FDA's monitoring of those studies, is an important indication of whether the FDA will exercise its regulatory authority on the silicone gel breast implant studies or any other required post-market studies. As part of this request, please include information about the number of women initially enrolled in each study, the number of women for whom data regarding health and complications were collected at 3 years, 5 years, 7 years, and 10 years, the results of the studies, and the FDA's assessment of the quality of the studies and the implications for patients.

Please also include all appropriate information
pertaining to Mentor's request, such as information about FDA's internal process for considering it, and the current status of post- marketing studies and conditions. All documents (electronic or hard copies), internal memoranda, communications, data, public input, and notes pertinent to this consideration also would be appreciated.

I
look forward to your timely response.

Sincerely,
ROSA L. DeLAURO
Chairwoman
House Appropriations Subcommittee on Agriculture Rural Development, Food and Drug Administration, and Related Agencies

Bravo & Welcome to Gretchen's Beautiful New Site ... My Implant Story

My Implant Story

Wednesday, October 03, 2007

'I had the world's first breast job - and endured years of misery ...'

Thank you so much to Kathy Nye ... click here for her website.
Dawn Beaven mentioned in this article has long been a part of our support group and heads a British support group. See her Silicone Survivors UK website here.

Hi Ilena, Kathy of Toxic Discovery and I were on the Leeza show with Timmie ... the first woman to have silicone gel implants.

'I had the world's first breast job - and endured years of misery ...Daily Mail - UK

...As the first woman to receive silicone breast implants, she has paved the way for more than two million women to undergo surgical enhancements


Here's the story in the Daily Mail.

Thursday, July 19, 2007

O'Quinn Lawyer Ordered to Pay Clients $35.7M for more than 3,000 clients

 
Lawyer Ordered to Pay Clients $35.7M
Associated Press 07.19.07, 8:05 PM