Date: Fri, 21 Apr 2000 11:39:35 -0700

Ilena:

PLEASE POST...........Lea

Dearest Ilena:

These women will never speak up. I know, because I have been calling them and they do not want to talk to me. I could write for these women, but why should I? Most have just given up, and after what the lawyers have done to them, I'm not surprised. The FDA is not going to listen to us because they are there for the powermongers. We need intervention by the attorney general, but she is too busy fighting for some SPOILED CHILD WHO IS BECOMING A POINTLESS PUBLIC SPECTACLE. I wrote to Janet Reno in 1994 and asked for help and she never responded! What does this tell you??? Women who are sick and dying are of no interest to her, because we made the choice to have these deadly devices. In her opinion we deserve to suffer; this is the way I see it. On the other hand, it could be that manufacturer money is being placed in the hands of those who are able to prevent this issue from showing up on Reno's desk. Either way, I think that this woman should be replaced.

I am an American citizen and a Canadian citizen, so I have the right to speak up. We need new governments in the US and Canada if we want changes. Women have been fighting this issue for years, wonderful and powerful women. What makes you think that we can make a difference?? I love and admire all of you for trying, and I will help if you want me to, but my head hurts from beating it against a ''BRICK WALL OF IGNORANCE''.

The legal system is horrific. In the US, I have been tossed from every law firm you can think of, from darling Melvin Belli's in San Francisco to Michael Hugo's in Boston. After Mr. Belli died--he was a very compassionate man and I had numerous conversations with him, as well as correspondence--I wrote to his son, Caesar, to appeal to him to continue with my case. He never responded to my letter! Filing my case in the US was difficult because of forum non conveniens. Now my medical files are floating somewhere in the US; who knows where they are. I do have some sympathy for the lawyers, because they do get beaten up. We know of one Houston lawyer who was sitting in his car here at the UNIVERSITY OF ALBERTA farm trying to have a nervous breakdown, but he had a squirrel from Montana stuck under his dashboard. I guess the squirrel saved his life!!! Where he is now, I don't know...the lawyer either! I now have wonderful lawyers here in Canada who will nail these b#$%*%$s soon.

Much love......................Lea

----- Original Message -----

Sent: Friday, April 21, 2000 2:07 AM

Subject: Another Reminder.....

If you haven't sent a letter to your legislator's, NOW is the time to do so.....

Did you have implants?

Did you know they were NOT approved by the FDA?

Would you like to see Saline Implants APPROVED, by the FDA in May?

If you don't care....do nothing and read no further.

If you DO care, you can help, and there is not much time.....

Below are sample letters which you can fax, email, mail to your Congressmen and Senators to voice your point of view. Do it now! Follow the samples and create your own letter.

May 10th will be the date the FDA will approve or disapprove!

To locate your Congressman and Senators:

Or

For more information:

Diana Zuckerman, Ph.D.

Executive Director

National Center for Policy Research

for Women and Families

1444 Eye Street, NW

Suite 900

Washington, DC 20005

202 216-9507

DIANA REQUESTS THAT YOU DO A BCC: TO HER AT:

OR AT LEAST LET HER KNOW YOU'VE WRITTEN YOUR LEGISLATORS, SO SHE WILL HAVE RESEARCH STATISTICS TO USE ON OUR BEHALF!

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

April , 2000

The Honorable _______

U.S. House of Representatives

Washington, DC 20515

Dear Congressman ________________,

As one of your constituents and a breast implant victim, I am very concerned about the recent activity regarding our FDA. As a consumer of food, medications, and medical devices, it is my understanding that the Purpose of the FDA is to insure that all of these items are safe and effective for their intended use. With this in mind, I beg you to look into this situation with the FDA and answer some very pressing, simple questions for all of your constituents.

1) Why did it take so long for the FDA to remove Rezulin and other dangerous medications from public consumption after they had been linked to several untimely deaths?

2) Why did the FDA accept safety data testimony from Mentor Corporation in March of this year while it currently has a criminal investigation in progress about Mentor's collection and reporting of safety data?

3) Why did the Medical Devices Advisory Committee recommend conditional approval of Mentors pre-market application (PMA) when these 'questionable data' reflected a 73% complication rate for breast cancer patients after only 3 years?

4) Why did this Committee recommend conditional approval for McGhan's PMA when their safety data reflected an 84% complication rate for breast cancer patients after only 4 years?

5) What does our current FDA consider to be an unacceptable complication rate for a medical device to have it's PMA denied?

6) Breast Implants have been in general use for more than 35 years without ever being found safe and effective. What analysis has the FDA conducted of the more than 100,000 adverse reaction reports regarding breast implants received through MedWatch to date?

7) How much weight do these 100,000 adverse reaction reports carry (vs. the 2,862 patients enrolled in the manufacturer's studies) relative to the FDA's PMA approval criteria? There were only 2,862 patients enrolled in the manufacturers' studies, and they had implants for between 1-4 years. Shouldn't the adverse reaction reports be considered before any decision is made about approving saline breast implants?

8) What authority and resources does the FDA have to conduct post-market surveillance on saline breast implants if they are approved? It is my understanding that they will not conduct such surveillance, and if not, how can they approve products with such a high rate of complications and adverse reactions?

9) Since the primary bodily function of the female breast is breast feeding, why didn't the FDA require data on the impact of implants on breast feeding? It is my understanding that there is very little research on this topic, but it is well known that breast implants can interfere with the pain associated with breast feeding, as well as the ability to breast feed.

What effects could breast feeding with implants have on the children? Have there been any adverse reports filed about this?

10) If the FDA continues to allow breast implants to be sold in the U.S., what enforceable steps does the FDA plan to implement which insure that all surgeons performing breast augmentation have provided the necessary informed consent to their patients? How does the FDA intend to monitor compliance?

11) Since approximately 80 percent of breast implants are used to augment healthy breasts rather than for reconstruction after mastectomy, why can't the FDA suspend the use of breast implants for augmentation until they are found to be safe and effective for long-term use (i.e. at least 5-7 years)?

12) Dr. Norman Anderson, previous chairman of the General and Plastic Surgery Advisory Panel, recommended in a letter on December 12, 1991 that the FDA study existing patients rather than perform new studies. He also recommended that the FDA establish a testing facility for explanted breast prostheses. Why has this never happened?

Based on the current publicly available information, it appears that the FDA is just bowing to industry pressure to keep implants on the market rather than seriously attempting to protect the consumer.

I believe that young women and cancer victims have been used as human guinea pigs for far too long in assessing the safety of these devices. A conditional approval is not an acceptable means of allowing this sham to continue.

The FDA is planning to issue a final approval on these PMA applications by mid-May. It is therefore imperative that we (your constituents) have official answers to these simple questions by 5/1/2000. I am seeking your help in getting truthful answers from the FDA.

Sincerely,

Your Name

Address

City, State

Phone

CC: Senators

Local Media

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

[Date]

The Honorable [Jane Doe]

United States House of Representatives

Washington, DC 20510

Dear Rep. [Doe]:

I am writing to you as a constituent to ask for your help. On March 1-3, the Food and Drug Administration (FDA) held an Advisory Committee meeting on the safety of saline breast implants. During the meeting, panel members expressed serious doubts about the safety of the implants. However, the panel was overtly pressured by FDA officials to recommend approval.

It made me wonder if "FDA approval" really means anything.

HERE IS WHERE YOU either describe your experiences with saline breast implants, or your friends' experiences with saline implants. An example follows in brackets.]

[In 1984, I had breast augmentation surgery out of a desire to enhance my appearance as a model. At that time, silicone-gel implants were used. However, I began to suffer severe breast pain and implant rupture, which required 4 surgeries to attempt to rectify. In 1992, I received saline implants after my doctor assured me that they were the safest ones available. He was wrong.

My worst problems started after I received saline breast implants. Each day, I face chronic fatigue, excruciating chest pain, and problems with my immune system. Although I wish to have my implants emoved, I cannot afford to do so.

The surgeries and treatment that I have endured over the years have cost me more than $50,000 in medical expenses, and even more in lost wages. Unfortunately, because of my serious health problems, I am also uninsurable and Medicaid will not pay for the removal of my implants unless they rupture.]

At the meeting, the FDA advisory panel was instructed to ignore the experiences of consumers. That should never happen. No human being should suffer as I have suffered - especially not from products which our government has allowed on the market.

Since the FDA did not listen to consumers like me, I hope they will listen to you. I am writing to ask you to write to the FDA Commissioner, Jane Henney, M.D., to express your concern about their apparent reluctance to fulfill their role as a "watchdog" protecting consumers. FDA approval must be based on sound science, but when the science is limited, they also need to listen to the experiences of consumers so that what happened to me won't happen to others. For example, they should not even considering saline breast implants until they analyze all the thousands of adverse reactions that have been reported through the Medical Device Reports (MDRs).

Thank you very much for your time and attention to this urgent matter.

Sincerely,

Name

Address

Phone

e-mail