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.

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

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.

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.

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.

look forward to your timely response.

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.