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.