Please also visit Ilena's Blog and QuackWatchWatch and Terry Polevoy vs Ilena Rosenthal

Breast Implant Study Results Reflect Funding

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Public Citizen Petition's the FDA

Petition to halt FDA's decision on allowing silicone gel breast
implants back on the market (HRG Publication #1682)

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Independent Studies Raise Serious Safety Concerns for Implant Recipients

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Fibromyalgia and Ruptured Silicone gel implants

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Dr. Vasey's Where There's Smoke There's Fire: The Silicone Breast Implant Controversy Continues to Flicker: A New Disease That Needs To Be Defined, Journal of Rheumatology

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Breast Implant Surveillance Reports to the U.S. Food and Drug Administration: Maternal-Child Health Problems

EXCERPTS: We identified 339 reports that described maternal-child adverse events.

Nearly half of these reports (46%) described actual problems with breastfeeding or expressed concern that implants would be unsafe or interfere with breastfeeding.

Forty-four percent of reports (n = 149) described either nonspecific or specific signs, symptoms, or illnesses in children.

An additional 3.5% of reports (n = 12) detailed a congenital anomaly believed by the reporter to be caused by breast implants.

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July 2002 Update On Saline Breast Implants: New 5-Year Studies
Available

By Diana Zuckerman, Ph. D.


EXCERPT:  However, of the more than 1200 women in the Mentor study of breast augmentation patients, only 60 (5 percent!) were analyzed at the five-year follow-up. Physicians, researchers, and the ethicist and consumer representative on the Advisory Panel said an informed choice was impossible for Mentor patients because of the low response rate.

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JAMA refuses to exclude authors who hide financial ties to drug
companies

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How Bill Frist and the Drug Lobby Covertly
Bagged a Liability Shield

 

 

 

 
   
Ilena Rosenthal was recently cyber-interviewed by WIRED Senior Editor

Kristen Philipkoski 

full article here

 

The surgeons I have spoken to say that the dangers of silicone implants have been proven to be false.

KP

 

Plastic Surgeons have very selective memories. I spoke to one here in San Diego once who claimed he had "never had a problem" with breast implants. Some months later, I was at a breast implant support group meeting with several of his breast implant patients. He had assured all of them that their myriad of health problems had nothing to do with their implants.

If a Plastic Surgeon inserts just 2 pair of implants a week ... that's over a half a million dollars annually coming in to their coffers in implant revenue alone.

Multiply that many times for income from dozens of sets of implants, not to mention all the other surgeries they do, and it's easily a multi-million dollar business if they believe they are 'safe.'

Further, when women finally decide to remove their implants all together, the "warranty" from the manufacturer is useless. Women must cover this operation, often nearing $10,000 themselves.

Also, can you
cite some studies that show the implants are unsafe?

KP

 

  • A just released study mirrors the concerns many of us have with the offspring of implanted women. See sidebar at left for excerpts.
  • This study clearly illustrates the link between ruptured implants and the very painful fibromyalgia.
  • The high rupture rate has now been well documented by the FDA. Ruptures mean dangerous re-surgeries and complications.
  • The high suicide rates have been documented by several studies. I differ in why I believe this is true. When a woman loses so much: her implants, her natural breast tissue, often her health, her job, her mate and her insurance ... and has the medical professionals telling her she's "crazy" when she knows she is sick ... she may feel desperate, with no healing in sight.
  • Dr. Vasey's article illustrates the health problems of the majority of the women who contact us.
  • A National Cancer Institute Study had even more dire indications.

Excerpt:

When the NCI researchers compared the risks for the implant patients with the general population, they found that the implant patients were two to three times more likely to develop stomach cancer, leukemia, and cancers of the cervix, vulva and brain.

Previous breast implant studies also reported an increased risk of cancers of the cervix and vulva compared to the general population.

Eleven cases of brain tumors among the implant patients were identified on death certificates as the cause of death compared to one case in the plastic surgery control group. Most of the tumors were classified as glioblastoma multiforme.

This research does not get the airplay the 'positive' industsy funded studies do.

One surgeon said that breast implants have been studied more than any other medical device and have been found to be safe.

KP

 

Recently, many, many reports have been coming out about industry paying supposively unbiased scientists who then write positive outcomes for the so-called studies. This has definitely been integral in the breast implant researchers.

There is so much at stake ... future implant sales as well as ongoing and future litigation.

Many of the studies have been utterly useless. One Mentor Corporation study had a dismal 5% follow up! Click here. Women have been systematically removed from implant studies when they removed their implants for any reason. There is no incentive to follow up on the women by the plastic surgeons.

True scientists and doctors uncovering the problems have been put under intense scrutiny and fired or harassed out of business. Click here to read Dr. Bernard M Patten's Memoirs of a Junk Scientist. There are many other such histories. Dr. Pierre Blais in Canada lost his high position at Health Canada because of exposing the dangers of implants.

Dr. Diana Zuckerman clearly explains here:

The company (Dow) has funded almost four dozen research articles in the last decade, all of which conclude that breast implants are safe. However, studies funded by scientists who do not have ties to implant manufacturers have consistently found implant problems that the Dow-funded studies have not.

 

Further, the breast implant industry merges their vast Public Relations Budgets with those of the oil, tobacco, cell phone, vaccination and food industries (to name but a few) fill all medium with their Industry point of view. Junkscience.com and ACSH.org and all their frontgroups are very well represented in the Wired World Wide Web.

These tactics have been honed to perfection by the largest PR corporation in the world, Burson Marsteller. Several documents have surfaced revealing their PR Campaign in the early 90's when all the silicone related injuries began to surface. Click here for this one:

Confidence Game: Burson-Marsteller's PR Plan for Silicone Breast Implants

  • There have been well over 250,000 adverse reports to the FDA on implants, and these usually represent a fraction of the real complications.
  • Re-surgery rates are very high, each with it's own risks of infections and complications.
  • Clean, clear mammography is virtually impossible with implants in place. I believe the latest "new & improved" Gummy Bear implants will make tumor detection even more difficult. I know several women who have discovered 3 - 7 tumors hidden behind their implants.
  • ~~~~~~~~~~~~~~~~~~~

Judging by your web site, you still believe they are not safe.

Are you communicating with the FDA to try to prevent the approval?

KP

 

The Humantics Foundation and our international support group have spent years sending in petitions and providing links for our members and readers. I attended an FDA Teleconference La Jolla some years ago along with Marlene Keeling of CANDO, who has been researching the platinum issue about implanted women and their offspring.

We keep a link for women to report to the FDA their complications and surgeries and re-surgeries and regularly encourage them to do so. Check box below. To date, there have been well over a quarter of a million adverse reports sent to the FDA and we are aghast that these device could still be considered safe. On our website homepage and email support lists, we regularly provide links to various petitions to the FDA and various government officials.

 

If you have not yet updated or ever sent in a Med-Watch form telling the FDA of your breast implant related illnesses or complications, please click here and let your voice be known.

By early 2001, 234,187 had filed serious adverse reactions with the FDA.

 

ACTION ALERT

Please click here to send a message to your Member of Congress ... the FDA MUST Thoroughly Examine Safety Evidence & Must Stop Ignoring Evidence of the dangers of silicone breast implants.

 

Please click here to ask the FDA not to Approve Silicone Breast Implants While Mentor is Under a Criminal Investigation

The Humantics Foundation thanks WIRED!

If you would like more information about The Humantics Foundation or would like to financially support the continuance of our work, please visit here. Without it, our message will be silenced.

 

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