LINKS

ACTION ALERT

Please click here to send a message to Andrew von Eschenbach, Acting FDA Commissioner to NOT 'approve' silicone gel implants while Mentor's criminal investigation continues.

Click here for Petition reminding the FDA and other Government Officials that Mentor's data is NOT complete.

New electronic newsletter regarding upcoming meetings on Dow Bankruptcy 2.24.2006

Also important info from 1.6.2006

EBAY Auction - novel & brilliant way to learn about the true dangers of breast implants    DON'T MISS!

MUST READ    "Decisions in the Dark" ... click here to open pdf file.

To read what Dr. Whalen told the FDA Panel just 2 short years ago, and his 180 degree spinaround, click here.

Click here for EBAY auctions of Beth's ... brilliant way to get the information to the public on the dangers of breast implants.

Dr. Zuckerman's site on the science of breast implants

National Cancer Institute Spells Out Risks of Breast Implants            Data Show Increased Risks Of Death From Cancers and Suicide

Read about Kim Hoffman's upcoming book on her Mentor breast implant experiences ... and more!

Meet Karen Curry and read about her life after silicone gel breast implants.

Dr. Vasey's "Where There is Smoke There is Fire."     Rheumatologist who has researched extensively the immune system and breast implants.

Mary McDonough, formerly of The Waltons, now speaks out on her Lupus and Breast Implant Connection.

Founder of the Saline Support Group, Patty Faussett shares her story of healing.

Meet Lea and read about her life after silicone gel breast implants

Read Redbook article on the effects on children after implants from 1995. (opens pdf file)

Meet Cindy Morrisey and her daughter Hilary, both affected from Cindy's breast implants. Hilary is helping others with her "Small Hands, Big Hearts" hair drive. Hilary says people who wish to donate their hair have until February 14, 2006!

Shari Halverson interviewed on MTV about her saline implant problems

FDA Rupture Study #1

Our Jewell's story on a Scleroderma Forum

Canadian Study from 2003 on breast implants

Toxic Discovery Network -good links and information

Breast Augmentation: A Younger Generation Seeks Perfection

Colleen's Story ... she is also appearing on MTV

Meet Kacey Long and read her story after saline breast implants

Sally Kirkland ~ Oscar Nominated Actress, talks about her 5 sets of breast implants

Memoirs of a Junk Scientist by Dr. Bernard Patten

Breast Implants: America's Silent Epidemic by Ilena Rosenthal

Keeping Abreast of Parasitic Implants

Command Trust Network

Human Adjuvant Disease Corporation

Great photos from the FDA Hearings by Kathy Nye ... meet many of the wonderful people who gave testimony and support at the Hearings in April, 2005

Sherrill Sellman, author of Hormone Heresy, Interviews Ilena on breast implants

Fibromyalgia and Ruptured Silicone Gel Breast Implants

Silicone Cover Up and Political Manipulations by Ilena in 1996

 

Note from Ilena:

If you find any typos, busted links etc. and want to let me know ... I very much appreciate it! Our staff is only me, right now with all my heart and soul, wanting to keep our message in front of the public. It was 10 years last August, and I've seen so many support groups and activists in this issue die ... or get too ill to fight Goliath anymore ... and these powerful women fade underground to protect their health and family life.

Corporate America and the Plastic Surgeon's Lobbies are no match for sick and dying women. the Their combined PR campaigns are legendary, orchestrated by the PR giant, Burson Marsteller.

One longtime support group leader, with no shortage of her own serious implant related health challenges put it this way to me:

"You on the other hand, just battling a world of multi-billion dollar corps, a world of murderously insane lunatics, and prepping for Court."

The Court she is referring to is the Supreme Court of California. Click here for the Quackbusters vs me.

The newsgroup I created in the Fall of 1995 is one medium that the Junk Science Campaign can not totally control as they have all others.

The Wild West of the Internet ... a visit there now will reveal a Corporate Lobbyist (Andrew M. Langer)  totally embedded with and leading a small, vocal group of those who call themselves "legitimate"support group leaders who have tried to push me out of their mutual way since Autumn, 2001.

They have worked hand in hand with my Plaintiffs above and Inamed's former President.. to create a Smear Campaign against me ... so vicious ... it appears they have no boundaries. Since I began the newsgroup, their twisted version of my personal life has been broadcast wide & far. That it bears no relationship to reality doesn't faze nor slow them now in their defamation against me.

Together in what they named the "SBIPrivateClub" ... this group and and former Inamed President Patrick O'leary (currently head of Eurosilicone in France) have hired a Private Investigator to hunt me down ... stalked friends of mine in their search, and attempted to access my bank accounts.

They are, in my opinion, the embodiment of the PR Plan describing the cover up of damning Dow Corning information ... and the creation of "networks."

These are typical tactics used for years by the "quackbusters" in their attempts to destroy chiropractors, holistic and alternative healers, naturopaths, fluoride activists, critics, radio show hosts, homeopaths and doctors working to uncover the mystery of Multiple Chemical Sensitivities -- to name but a few.

Check back for links and more details soon ... as this is being updated as their Campaign is spreading. Click here.

 

 

NEWS ... May, 2007

YOUR MONEY  EDITED BY WARREN BERRY  May 6, 2007

Excerpt:

Breast implants. They're foreign objects. "That's why every decade or
two, depending on the patient, most implants need to be replaced.
While 300,000 women receive implants annually, 25,000 have them
removed," according to smartmoney. "It's strictly a function of time,"
adds UCLA surgeon Stanley Frileck.

Note from Ilena Rosenthal:  We appreciate this PS mentioning that breast implants will need
replacement and agree that most do break ... within weeks, years, or
decades.

~~~~~~~

FDA allows Mentor Corp to remove "follow up" requirement

Note from Ilena Rosenthal:  This is scandalous! Mentor Corporation is being allowed, after the FDA gave them "safety approval" for their 'memory gel' implants based on follow up studies ... to no longer require them! In their so called 'studies' ... they had to report as low as a 5% follow up rate.

~~~~~~~

FDA hoodwinks public over CAM Guidelines comment period, slams door shut on public comments one month early

~~~~~~~

Breast implant contest doc on probation

~~~~~~~

23 Year Old, Former Miss Great Britian, Danielle Lloyd, to lose breast implant

~~~~~~~

Stevie Nicks Interview About Her removed implants being kept in Freezer!

~~~~~~~

CONFESSIONS OF A ROCK CHICK by Stevie Nicks

EXCERPT:   They made me very, very sick," says Stevie gravely. "I had them done in December 1976. I'd only been in Fleetwood Mac one year
and I was getting a lot of attention. I had always thought my hips were too big and that I had no chest.

I reckoned it would look better onstage, but I would advise every woman against having them.

~~~~~~~

NEW STUDIES

Metals are known to produce complex biological actions with immunological, mutagenic, and toxic effects" from a study entitled: Metallic debris from orthopaedic implants.

This  is especially upsetting as there was a recent advertisement that Australian women by the thousands are being used as  experimentation guinea pigs yet again with titanium covered implants.

~~~~~~~

STUDY: Mammography with Implants Increases Radiation Induced Breast Cancer to Unacceptable Level

 

 

February 26, 2006:

Midland News article on ongoing Dow Bankruptcy Saga

NOTES FROM ILENA: After over 10 years in bankruptcy protection, Dow has paid less than a quarter of the claims, and these average under $10,000 each. In most cases, this does not even cover the cost of explantation ... borne for the most part out of the pockets of the women.

EXCERPTS:

Claims administrator David Austern said the facility has paid around 57,000 claims, amounting to $565.5 million.     more here ....

Vicki Lawrence of Florida is among those frustrated awaiting her settlement check from Dow Corning. Lawrence had two sets of Dow Corning implants; the first was removed in the mid-1980s and the second in 1992. She received $5,000 for implant removal a little more than a year ago and she's fighting for a $20,000 settlement for rupture.

    "What the women do is, you hurry up and you wait," she said. "It makes you crazy."   more here ....

Our greatest wish is that as we begin this new year, that our prayers are heard and sanity prevails ... on God's Green Earth & in the Breast Implant Awareness Cause ... more here

  • ... that the 'powers that be' at the FDA refuse to yield to silicone makers and the plastic surgeons and their lobbyists and their front groups ... all in abundance.
  • We pray that the FDA will not lie to the public that silicone gel breast implants have been proven to be 'safe' based on flawed, short, controversial, and inconclusive studies.
  • This is true by no definition of what safety means.
  • The problems with serious and often life threatening infections are common. Just this week, a study admitting the high complication and re-surgery rates in women post mastectomy was published.
  • Click here to read the San Francisco Chronicle article entitled, Implants, Mastectomies Linked to Problems.
  • Even this study, in part funded by the silicone industry, gave a far rosier picture than reality. Please read the statement of Dr. Diana Zuckerman, Ph.D. President, National Research Center for Women & Families by clicking here for a powerful response to this complex issue.
  • The mighty"Junk Science" (aka "Quackery") propaganda machine with vast pooled funds from the Silicone, Vaccination, Tobacco, and other Industries have new "Spokes Doctors" making false claims of the dangers of several highly politicized and funded products. The Boston Globe Magazine's recent "The Secret Truth" by Darshak Sanghavi subtlely disinformed readers that the "notion" of breast implants and autoimmune diseases had been "discarded." Far from it. Check back for our response to Dr. Sanghavi.

Women pursuing claims over breast implants to see further delays

February 13, 2006: 

MyDNA:  Implants: Safe? 

EXCERPTS are also published here.

Breast Cancer Survivors Making Surgery Decisions With Limited Information, Says New Report
Former Director of FDA Office on Women's Health Speaks at Release of  'Decisions in the Dark',

WASHINGTON, Feb. 3 /PRNewswire/ -- EXCERPT:  Breast cancer survivors who undergo reconstructive surgery using silicone implants have access to very little research-based information about the likely risks, according to a report released today by the National Research Center (NRC) for Women & Families. Dr. Susan Wood, former director of the U.S. Food and Drug Administration's (FDA) Office of Women, was a speaker at a National Press Club Newsmakers' event where the report was released.

MUST READ    "Decisions in the Dark" ... click here to open pdf file.

Criminal Investigation of Mentor  ~ breast implant manufacturer.   

Please click here to send a message to Andrew von Eschenbach, Acting FDA Commissioner to NOT 'approve' silicone gel implants while this criminal investigation continues.

     

RECENT PRESS (updated December 12, 2005)

Snowe, Feinstein urge breast-implant probe

12.12.05 WASHINGTON, D.C. - U.S. Sens. Olympia J. Snowe, R-Maine, and Dianne Feinstein, D-Calif., sent a letter to Food and Drug Administration acting Commissioner Andrew von Eschenbach urging him to investigate safety concerns raised by a whistleblower about Mentor’s silicone breast implants.

"The FDA must fully investigate these very serious allegations," Snowe said. "The critical concerns - how many implants rupture, why they do, and what the consequences could be - still remain in doubt."

As reported in The Washington Post. a former employee of Mentor has gone public with two key allegations against the company. The first is that Mentor’s implants used in surgery leak more than the ones used in demonstrations to doctors and patients. The second allegation is that there is a design flaw in Mentor’s implants, which has resulted in a higher rupture rate and that the higher rupture rate has not been accurately reported to the FDA.

MPs call for removal of Health Canada's breast-implant
panel members

Former Miss Russia's Breast Implant Horror

Scarred! A Plastic Surgery Nightmare

Applauding Crawford Resignation, NOW Asks for Reversal on Implants

Inamed Breast Implant Research Shortchanges Breast Cancer Patients by Dr. Diana Zuckerman

Excellent Canadian Press, Video on Breast Implant Decisions

NYTIMES: Guidant Case May Involve Crime Inquiry (another medical device with cover-up of dangers) (need subscription to open)

Comments of Sybil Goldrich, Executive Director of the Command Trust Network, on the FDA's 'Approvable Letter' to Inamed on Silicone Gel Breast Implants

FRENCH STUDY SHOWS 60% RUPURE IN SILICONE GEL IMPLANTS AFTER ONLY 10 YEARS

Statement by Sidney M. Wolfe, MD, Public Citizen’s Health Research Group Regarding Petitions to Block FDA Approval of Silicone Gel Breast Implants

Breast implant class action settlement approved by B.C. Supreme Court   Women to receive only around $5,000 for illnesses and injuries.

Updates on Dow Bankruptcy from TCC with dates for upcoming meetings in Europe

Latest news from the Settlement Committee for Dow Bankruptcy

Link to FDA site announcement

Press Release Source: National Research Center for Women & Families

EXCERPT:

The FDA letter is a stumbling step in the wrong direction, amid mounting questions about FDA decision-making. Approval would be an embarrassment unless the Senate and the FDA give Mentor a "clean bill of health" after thoroughly investigating allegations that Mentor misrepresented the rupture rate of its implants.

A Senate investigation of the Mentor safety data and the FDA approval process is currently underway, and concerns are growing.

Enormous loss of our beautiful sister, Jewell Tara.

Sally Kirkland Press Release to FDA on implant dangers

Is breastfeeding with breast implants a real concern?

Breast Surgery Likely to Cause Breastfeeding Problems

New Studies Reveal High Platinum Levels in Children and Mothers with breast implants.

 A New York Daily News article included a misquote from a"wee hours" interview given by Sally Kirkland.

In it she expressed her very deep and real concerns for women with breast implants who breastfeed their babies.

New York Daily News

Kirkland keeps abreast of Brit's pregnancy

The unfortunate (mis)quote from the New York Daily News article:

"I happen to know Britney Spears' breast-implant doctor,"

No, Sally never said that.

She is extremely grateful however, to Baird Jones and to Lloyd Grove and the New York Daily News for opening up this topic!

"and I just hope she does not breastfeed. Because if she does, she could give her baby so many future [health] problems."

Yes ... she did express this very real concern for all women with breast implants and their offspring.

 

The real issue here ... are breast implants "safe" for women and their offspring?

For information on extremely high platinum levels being found in implanted women and their offspring, please click here.

Sally Kirkland and The Humantics Foundation firmly believe that it would be a travesty if the FDA declares Mentor {or Inamed} silicone gel implants "safe."

The Mentor "studies" done to date have removed the data from women who took their explants out. One "study" of theirs had only 5% follow-up.

 

 

Visit Sally's Website

National Enquirer on Sally's Explant

Sally Kirkland and Mary McDonough In the Know.org

Sally interviewed in Soap Digest

Sally & Kathy Nye at Rally in front of Judge Pointer's Court in April, 1999 at SOBB Rally

Candid Interview on Sally in Moxie Magazine

Some recent Sally Kirkland News

LA Femme Film

The “Lifetime Achievement Award” will be presented to award winning actress, Sally Kirkland.

It's All About Jack

Sally interviewed for "Jack Nicholson: The E! True Hollywood Story"

Sally Kirkland at the Coffeehouse Chronicles

 

We invite you to read this Petition which mirrors our beliefs and notify the FDA and your Congressmen of your concern.

 

NOW asks Freedom of Information Act for Mentor Records

Giving Breast Implants As Birthday Gifts Makes 16 Less Sweet

HEALTH CANADA STORY

EXCERPT:

"I'm very afraid for young women who don't know about the problems we had in the '80s with those implants," Bloc Quebecois MP Nicole Demers said in an interview Thursday.

Researchers have found a high rate of complications and hospitalization associated with the implants, which can rupture and break down, and frequently must be replaced or removed.

Pierre Blais, a former Health Canada employee who was among the first to raise questions about breast implants, says the products currently being promoted aren't significantly different from those of the 1980s.

Blais said the special release program is "being abused to the point of ridicule."

He said implant surgery is a major drain on the health system because complications are generally dealt with in the public system, even though the original implant procedure is not covered by medicare.

Blais said if the devices are approved they will be promoted aggressively rather than merely being made available on request.

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

May 15th was the 10th anniversary of Dow Corning going into bankruptcy "protection."

But who is protecting the women????????

Business Week (and others) reported on falsification of data by Mentor Corp.

EXCERPT: 

He said packaging for the implants was sometimes infested with fleas, and workers on the factory floor would stash defective parts above ceiling tiles to hide them from superiors.

RALLY IN WASHINGTON, DC

MAY 17 & 18

See photos of   IN THE KNOW Rally here  &   here.

A huge thank-you to all the brave women who participated.

The Humantics Foundation mourns the loss of Dr. Marc Lappe ... Scientist & Hero

EXCERPT: Between 1984 and 1998, he worked extensively as a consultant on the high stakes litigation that had erupted over silicone-gel breast implants.

Dow Corning sent a private detective to the small northern California town of Gualala where my father lived to investigate his non-profit organization in an effort to discredit his testimony.

Latest Dow Bankruptcy Newsletter ... click here.

Average claim now paid after 10 years of bankruptcy ... $8,744.

Limiting options for breast implants 5.12.2005

EXCERPTS: Do women have the "right to choose" to have these devices surgically implanted in their bodies? One woman after another stood up to claim this right, and the plastic surgeons were out in droves to assert the right of choice on behalf of women. In 1991, the American Society of Plastic Surgeons assessed $1,050 from each of its members. The money was allocated to finance a public-relations campaign to counteract negative publicity about silicone breast implants. One of the main features of the campaign was to appropriate the feminist slogan "women have the right to choose." The plastic-surgery industry brought women to the nation's capital for the heavily publicized 1992 FDA meeting considering the safety and efficacy of silicone breast implants. These women used the phrase in various forms in their testimonies.

In the October 2003 FDA advisory panel meeting to reconsider silicone breast implants, 25 women with silicone implants testified in favor of the manufacturer's application. Virtually all of them employed the notion of "choice" in their argument. One woman used the word "choice," "choose," "chose" or "option" eight times in her 3-minute testimony. Pro-approval surgeons also used this language.

The right to choose requires an understanding of the risks and benefits of those choices, and it is those risks and benefits that the FDA is addressing.

EDITORIAL   SFGATE

When secrets can be deadly

Tuesday, May 10, 2005

EXCERPT:There is a long and shameful list of secret settlements that left the public unaware of serious danger -- and resulted in more victims. For example:

-- Firestone tires. One of the most infamous examples of secret settlements, the problems with defective Firestone tires were kept quiet for years, even as the casualty count reached 150 deaths and 500 injuries. Some 6. 5 million tires were ultimately recalled in 2000.

The list goes on. Health problems associated with silicon breast implants. Defective heart valves. Ford Pinto gas tanks that exploded on impact. Drugs that have deadly side effects.

BREAST IMPLANTS: More information needed before any FDA approval  

JEERS from Womensenews.org

EXCERPT: The only two "expert witnesses" advising Health Canada, the country's federal health department, on whether to allow silicone, gel-filled breast implants back on the market are paid consultants to implant makers Inamed and Mentor Corp., reports the Montreal Gazette on Thursday.

Transcripts from the FDA Meeting

EXCERPT: Dr. Barbara Manno is a Toxicologist and Professor of Psychiatry at Louisiana State University. She is explaining why she voted "yes" and recommended that Mentor silicone gel breast implants be deemed "safe."


DR. MANNO: ... I think we have got enough to approve this and that the recipients of the device will have a choice. And it isn't to have a choice, they can make a choice and it's tough luck if it doesn't work.

Click here to read her complete comments in context ... go to Find and type in "tough luck."

Probe of FDA Breast Implant Review Sought

BRAVO DR. ZUCKERMAN!

FoxNews

Breast Implants: A Women's Choice, But a Safe Choice?

EXCERPT: The bottom line: men and women have a right to choose safe medical products, and it is the FDA’s job to determine if a medical product is safe. Whether the product is a painkiller, an anti-depressant, or a breast implant, FDA approval should be made on science, not wishful thinking or philosophical musings about choice.

click here

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

US Groups Seek Probe of FDA Breast Implant Review

(Note from Ilena: Last I looked, there were 160 papers that published this piece!)

EXCERPT:

WASHINGTON - Six women's groups on Thursday called for a congressional probe into the U.S. government's review of silicone breast implants, citing an e-mail they said showed U.S. regulators planned to approve the products regardless of any advice from outside experts.

click here

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

Madness in the breast implant controversy continues to bubble

editorial comment by Ilena Rosenthal

The {plastic surgeon heavy} Med Device Panel recommended on 4.13.05 that Mentor silicone gel implants be approved by the FDA as 'safe' ... albeit with many very expensive, redundant and unenforceable 'conditions.'

One day earlier, the Panel recommended 'non-approval' for Inamed implants.

That I fully support.

This bizarre split decision has now placed the two Silicone Makers from Santa Barbara, California back into a rival situation ... as one's stocks and dreams rose ... and the other, newly 'wedded' Inamed, dumped.

The 'conditions' for Mentor are listed here.

One of them tells much about the 'studies' so far.

EXCERPT:  Those studies must include analysis of patients who have their implant removed and not replaced. Currently, how those women fare is not being tracked.

The industry 'science' that is being heralded on all medium as "sound science" ... was able to selective ignore the many women who,  for whatever reasons, chose to remove their implants entirely.

Yes, you read that correctly ... the women with rupture and/or illnesses who chose not to keep their implants had their data DROPPED from all previous studies!

In fact, in a 'study' by Mentor {before their saline implants were given the 'safe enough' green light in 2000} ... the follow-up had been a pathetic and unscientific 5%!

To read Dr. Zuckerman's findings on this matter, please click here.

Not only have the two main silicone manufacturers now been pitted against each other, but one of the conditions was that only Board Certified Plastic Surgeons would be able to benefit from selling and installing silicone gel breast implants.

The Cosmetic Surgeons and others who have been reaping the rewards of the silicone shuffle are outraged. Click here for one of their Press Releases.

For more on the FDA process as it unfolds, please visit our Daily Page with lots of links to newspaper articles and quotes and comments.

This San Francisco Chronicle Editorial says it so well:

EXCERPT:

EXCERPT: The women's health over the next seven years is apparently not as important as getting these money-makers on the market.

An excellent Letter to the Editor in the San Francisco Chronicle:

Excerpt: The women's health over the next seven years is apparently not as important as getting these money-makers on the market.

Breast-implant statistics are like a bikini

For more on the FDA silicone breast implant hearings, see photos of those who spoke and attended, and lots, lots, more ... please click here.

Here is a photo of one of our beloved support group member's explanted "new & improved" silicone gel implants of the time. To read her story, click the photo.

 

 

June 3, 2005

With heavy hearts, we must share the saddest of news ... our beautiful Jewell Tara passed away June 1st in the late evening in Canada.

There was no sweeter woman than Jewell.

Jewell suffered from scleroderma, among other things, a debillitating autoimmune disease shared by too many other breast implant recipients.

Here is her story written on a Schleroderma Forum in 2003. Jewell's words: 

"Lastly, I would like to state very firmly that it is my belief after a good deal of research that the scleroderma I have has been caused by silicone implants."

To send a note to Jewell's family, please click here.

And to send messages of loving support to Jewell's beloved friend, Rachel, another of our sweetest of sisters, please click here.

 

May 2, 2005

 

"The return of silicone?"

Article quotes Dawn Miller and Susan Kolb, M.D., plastic surgeon. It discusses platinum now being found in the urine of breast implanted women and that implants leak chemicals that may be toxic to the nerves and may be carcinogens.

(thanks to Marlene Keeling)

 

While we are recovering & re-grouping from the madness of the split decision FDA hearings ... one of our sweetest and most beloved sisters, Jewell from Vancouver, Canada, is not doing well at all ... after more than seven weeks in hospital. We fear her organs are shutting down.

Jewell suffers from scleroderma, among other things, a debillitating autoimmune disease shared by too many other breast implant recipients.

Here is her story written on a Schleroderma Forum in 2003. Jewell's words: 

"Lastly, I would like to state very firmly that it is my belief after a good deal of research that the scleroderma I have has been caused by silicone implants."

Please join us in sending Jewell healing energy and prayers.

To send her a note, click here:

 

 

BRAVO DR. ZUCKERMAN

FoxNews

Breast Implants: A Women's Choice, But a Safe Choice?

EXCERPT: The bottom line: men and women have a right to choose safe medical products, and it is the FDA’s job to determine if a medical product is safe. Whether the product is a painkiller, an anti-depressant, or a breast implant, FDA approval should be made on science, not wishful thinking or philosophical musings about choice.

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

Some beautiful photos taken and published by longtime advocate, Kathy Nye. You'll meet several of the brave men and women quoted below. Bravo Kathy! Click here.

San Francisco Chronicle, Editorial

Excerpt: The women's health over the next seven years is apparently not as important as getting these money-makers on the market.

FORBES: FDA Panel's Breast Implant Ruling Puzzles, Pleases

Excerpt: "It's a very illogical and conflicting message to the FDA, and a confusing message to women across the country who might have breast implants," said Diana Zuckerman, president of the National Research Center for Women and Families.

Noting that both companies provided different kinds of data, Zuckerman added, "The company that provided more research information was the one that didn't get approved. The company that provided less information got recommended for approval. That sends a really bad message. That's just silly."

In turnaround, FDA panel backs Mentor silicone implants

Excerpt:  "These conditions are unenforceable," said Sybil Goldrich, a breast cancer survivor who went through four sets of broken implants in the 1980s. "Who's going to pay for that MRI?"

FDA Advisers Recommend Approving Mentor Implants with 10 Conditions

FDA Advised to Keep Silicone Implant Ban on Inamed Gel Implants

Excerpt:

Excerpt: "Science has won the day today," said Diana Zuckerman, president of the National Research Center for Women and Families.

Some quotes:

Implants' critics not swayed by studies, Star Tribune

EXCERPT:

Suzanne McLain of Minneapolis is amazed that the federal government is even thinking of lifting the ban on silicone breast implants. After all, she believes they made her and thousands of other women chronically ill.

For some, the new debate has reopened old wounds.

"It surprises me that anyone would do it again," said McLain, 70, who had silicone implants following a double mastectomy at age 50. At the time, "Safety wasn't even discussed. They said this was for life."

But the implants leaked, and when she had them removed in 1993, she learned that silicone had spread like "silly putty" throughout her body, she said. She developed several disorders, including Graves' disease, anemia and numbness, all of which she blames on the implants.

New York Times

EXCERPT:

Ed Brent of Atlanta told the panel that his wife, P. J. Brent, committed suicide in 2000, two months after testifying at a previous hearing on implants. Ms. Brent believed that her silicone implants had seeped into her breast milk and sickened her two children, Mr. Brent said. The five children she had before the implants are healthy, he added.

"P. J. felt terrible guilt that her two daughters had been so seriously harmed by her decision to get breast implants," Mr. Brent said.

WUSA-TV Channel 9

Excerpt:

Thirty-seven year old Cindy Marshall got her silicone gel implants as a birthday present when she turned 21. They ruptured and her life has never been the same.

Marshall had her implants removed last year after she was diagnosed with silicone poisoning.

 

FDA Panel Rejects Inamed Breast Implants
April 12, 2005 6:09:00 PM ET

Excerpt:

GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel on Tuesday narrowly rejected U.S. sales of Inamed Corp.'s-(IMDC) silicone gel-filled breast implants by a 5-4 vote.

WEBMD: FDA Reviews Ban on Silicone Breast Implants

Excerpt:

Ilena Rosenthal, director of the Humantics Foundation, a group opposed to breast implants, says that "thousands" of women in her organization have serious health problems that they attribute to their breast implants and to silicone. The group is urging the FDA to keep silicone implants off the market for most women.

"These are not recallable items, at least without more surgery to get them out. It's not like taking Vioxx or Bextra off the shelves," Rosenthal says in an interview, referring to the two painkillers recently pulled from the market due to an elevated risk of heart attacks and strokes.

Mercury News (need subscription)

FDA HEARING: WOMEN EXPRESS PROS, CONS OF COSMETIC SURGERY

Excerpt:

Carolyn Wolfe, 74, of Manassas, Va., told the panel that after her silicone implants had ruptured, strings of silicone started coming out of her eyes and ears. Her nipples seeped silicone, she said, and she developed rheumatoid arthritis and a goiter.

``I do not want young women to have to go through what I have gone through and risk the health of their children,'' Wolfe said.

ABC 7 Medical: Are Silicone Implants Safe Now?

Excerpts:

Mary McDonough, actress:  "For me, it was one of the biggest mistake I made in my life."

Mary:  "They finally diagnosed me with lupus and then I had my implants out, and it's made a huge difference."

SOME WOMEN BROKE DOWN IN TEARS, SAYING SILICONE BREAST IMPLANTS RUINED THEIR LIVES.

Diana Zuckerman, National Research Center for Women & Families:  "I agree the evidence isn't there. But what I say is that the evidence isn't there for safety."

Women Speak at FDA Breast-Implant Hearing

Excerpt:

My plan to be more beautiful was ironic," said Rebecca Smith-Miles of Michigan, describing how rocklike scar-tissue formed around her gel implants within two years. "I was uglier by the day."

Click here for full article.

Silicone Breast Implants Aren't Safe, Patients Say (Update4)

Bloomberg News

Excerpt:

April 11 (Bloomberg) -- Mentor Corp. and Inamed Corp.'s silicone breast implants aren't any safer than when U.S. regulators banned earlier devices 13 years ago, patients and doctors told government advisers today.

`Toxic Secret'

Health insurers refuse to cover women who have had breast implants, said Pam Dowd of Boise, Idaho. She and her 22-year-old daughter Brenna said they drove almost 2,500 miles in a 1984 Southwind motor home to the hearing at their own expense. Dowd attributed years of health problems, including pain in her bones, to three ruptured silicone implants.

``What is the toxic secret that the insurance companies know but are not sharing?'' Dowd said. ``I am 57, uninsured and uninsurable.''

Click here for full article.

FDA Opens Breast Implant Review

Consumer Affairs

Excerpt:

Specifically, these data estimate that 93% of breast cancer reconstruction patients should expect at least one broken implant, 38% of augmentation patients, and 66% of women who replace previous breast implants with new ones.

Click here for full article.

FDA Hearings on Silicone Breast Implants: Analysis of FDA & Industry Data

Excerpt:

FDA scientists studied women who had silicone breast implants for at least six years, and found that women with extracapsular silicone leakage were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia.(ii) Extracapsular leakage was evaluated using an MRI.

Click here for full article.

Canada ... Secret talks held on lifting implant ban

Health Canada has held private meetings with plastic surgeons and other experts to discuss ending a 13-year-old voluntary ban on controversial silicone gel-filled breast implants, CanWest News Services has learned.

"I want to know, why is it private? If there is nothing to hide, then why did Health Canada keep those meetings hidden?" asks Joyce Attis, president of Breast Implant Line of Canada, a support group for women who have had breast implants.

Click here for full article.

Ilena Rosenthal

Director, Humantics Foundation

~~~~~

VIDEO
  CLIPS

Shari Halverson interviewed on Florida News about her saline implant problems

Dr. E. Melmed debates Dr. Rey during Hearings

CBS News ...
"It makes me very uneasy. I don't feel secure about the safety."
FDA adviser Dr. Amy
Newburger

 

We need your help!

Thank you for any tax deductible donation that will help The Humantics Foundation keep the message of the dangers of breast implants before the public.

We have spent 12 years on this Mission ... providing free information on this highly charged, controversial topic.

Today more than ever ... the breast implant industry and their very connected public relations teams have a lot of power to keep their corporate backed message before the public.

Please click paypal below ... credit cards are now accepted.

Thank you very much.

 

 

 

WEBMD: FDA Reviews Ban on Silicone Breast Implants

Excerpt:

Ilena Rosenthal, director of the Humantics Foundation, a group opposed to breast implants, says that "thousands" of women in her organization have serious health problems that they attribute to their breast implants and to silicone. The group is urging the FDA to keep silicone implants off the market for most women.

"These are not recallable items, at least without more surgery to get them out. It's not like taking Vioxx or Bextra off the shelves," Rosenthal says in an interview, referring to the two painkillers recently pulled from the market due to an elevated risk of heart attacks and strokes.

 

 

 

 

 

 

 

 

     

 


   

 

Hallelujah!

Sanity Prevails at the FDA ... Happenings from the October 2003 Inamed Silicone Gel Hearings

FDA Panel Head, Dr. Thomas Whalen advises FDA to "ignore the vote."

His letter to FDA head, Dr. McClelland

Citizen Petition from many groups to urge FDA to disapprove Inamed's petition

(Unfortunately, the FDA denied this petition even though the information and recommendations in it are excellent and should be implemented.)

To view the transcripts of this monumental October FDA meeting, click here.

LA TIMES (article needs registration)

Excerpt:

"Long-term safety, the concern that prompted the removal from the market 11
years ago, was clearly not demonstrated."

Important Links regarding the FDA Panel's decision to recommend "safety approval" to Inamed silicone gel implants on October 15, 2003.

Outspoken Panelist took money from Inamed

Dr. Zuckerman's Press Release

PBS: Silicone Breast Implants and the FDA Panel's Decision

USA Today: Women kept in dark about safety of silicone implants

Public Citizen: FDA panel's recommendation on silicone gel breast implants is reckless

Tort Claimant Committee Statement

WASHINGTON POST: No Clearer Than It Was Before

Unsafe at Any Size

Outstanding article by Kim Gandy of NOW

Washington Times: A Split Decision on Breast Implants Excellent OP-ED by Dr. Zuckerman

Canadian Study on Health Complications of Breast Implants

Day One Transcripts of FDA Silicone Gel Implant Hearings (October 14, 2003)

Day Two Transcripts of FDA Silicone Gel Implant Hearings (October 15, 2003)

To sign up to receive updates from the FDA listserve

 

 

Note from Ilena end of August, 2004.

I apologize for not keeping this page up ... I'm going to be remedying that soon.

As we know ... the FDA forunately did NOT approve Inamed's silicone breast implants in January of this year ... largely due to the courageous letter from Dr. Whalen, who was heading the panel. His letter is here ... and says so much.

 

Currently (early October, 2003) silicone manufacturer, Inamed, is pushing both the FDA and Health Canada to give safety approval on their latest version of their "new & improved" silicone gel breast implant. They wish them to base this "approval" on only two years of medical trials. The FDA has scheduled October 14 & 15th for these trials.

"Implant Imbroglio" in Time Magazine 9/29/03

"FDA Is Reconsidering Use of Silicone Implants" in Wall Street Journal 10/02/03

Click here for 3 recent articles on this.

Click here for USA article on this of 9/30/03.

Our silicone support group is filled with thousands of women ... now ill and scarred ... who got the earlier "new & improved" implants.

Women in Entertainment Rally Against FDA's Lifting of Restrictions on Sale of Silicone Gel Breast Implants

Click here for Public Citizen's viewpoint.

Here is a link to Public Citizen's website, where you can write the FDA requesting longterm "trials" before safety disapproval or approval is evaluated.

To give input to the FDA directly, here are their addresses.

Long time Dutch advocate, Marlou Boots

with a small part of her collection of "explants."

9/1 Safety measures on breast implants introduced in Britian

9/2 Propaganda to the max ... Junk Journalism Mike Fumento on Inamed's quest

Pathologist removes breast implants without permission of
family

 

2.25.03 With much sadness, we announce the loss of another beloved sister,

Addie Dee Parks. Our heart goes out to her beloved husband, Mark and all her friends and family who love her.


January 1, 2003

Dear Friends ...

The end of 2002 brought some of the most outrageous and deceitful propaganda that we had seen for years in the breast implant controversy.

From Good Morning America pushing the potentially very dangerous "cohesive" gel implants ... to Junk Journalist and corporate flack Steve Milloy's attempt to deny the indisputable science against his Sponsors, the year ended with a thud for the women harmed by breast implants.

You might want to bookmark this page ... I'll be doing frequent updates, but am unable to continue my support lists at the present time.

I'm currently in Latin America ... where silicone implants are being pushed as if there were safe ...

Love from Ilena

 

 


Sherrill Sellman, author of Hormone Heresy, Interviews Ilena Rosenthal

2/4/2003 Happy Birthday, Rosa Parks! by Ilena on Womensenews.com

Dow Bankruptcy Information

 

LATEST UPDATE on Dow Bankruptcy from the Tort Claimaints Committee.

LATEST UPDATE on Dow Bankruptcy from the Settlement facility.

 

February 25, 2003 Click here for Annex A ... a 115 page pdf file entitled Dow Corning Settlement Program and Claims Resolution Procedures: Settlement Facility and Fund Distribution Agreement

February 25, 2003 - Settlement Facility and Fund Distribution Agreement (39 pages)

Click here for explanation of Judge Hood's 1/9/2003 Order regarding early mailing of forms in February, 2003.

Click here for pdf file of Judge Hood's 36 page Order of 12/11/2002 on Dow Bankruptcy (must have Adobe Reader)

 

1/20/2003 Parliament to adopt position on breast implants

European Parliament resolution on the Commission (opens pdf file)

Toronto PS charged with using banned silicon injections

Beware the witch's chin, excerpt:

"Some illegal practitioners use silicone instead of Botox because it is cheaper," Prawit said.

"The silicone will later cause the skin to look uneven and bumpy and in some cases will gather at the chin (creating a point) like a witch's chin."

1/7/2003 Taking beauty standards to extremes by Dr. Zuckerman

1/7/2003 U.S. Seeks Share of Breast Implant Payout

1/7/2003 Dow Corning's Counsel Faces Deposition in Shareholder Suit

1/5/2003 NYTimes ... silicone lies

Quote from NYTimes article:

. In the case of silicone breast implants, for instance, the science is quite definitive: these implants do not cause any major diseases. Yet that made no difference in the lawsuits, which took off on the wings of sympathetic female plaintiffs, a product fallen into social disrepute and a highly evolved, well-finance

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