Date: Mon, 24 Apr 2000 19:23:30 -0700

To: Recipient List Suppressed:;

Hi ilena

Could you please post the following:

The following is the letter I have written and mailed to my United State Senators and Congressman. I did use several of the statements that were suggested, but the rest came from me. I hope they will read it and perhaps reply or help. I really feel that we "all" need to write our State and Governmental officials.

(Header removed but were addressed to the following)

The Honorable Bob Graham

The Honorable Connie Mack

Congressman Cliff Stearns

US Senators for Florida

and Rep. for my area

Dear Sir:

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. No breast implants have ever been approved as safe or effective by the FDA. During the meeting, panel member 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.

I belong to a very large support group of women who have or have had both silicone and saline implants. I for one am a survivor of silicone breast implants. In 1974/75, I had breast augmentation surgery out of the desire to become more normal looking due to a birth defect of non-development. At that time silicone-gel implants were used. However, I began to suffer severe breast pain due to capsular constriction, which required me to have a second surgery eight-month later. This surgery found that one of the implants had ruptured. Unbeknown to me at that time I was not aware that the FDA had never approved these implants and I was informed they were completely safe and would last a lifetime. Unfortunately, this is not the truth. I have suffered many years with many health problems since then. I have seen many doctors that have looked away with my complaints of pains and hardening of both my breasts. It took me six years to finally convince a doctor that the pain I was in was real and killing me. I was sent to a Plastic Surgeon who took only 5 minutes to exam me to say these implants must be removed "now". The surgery I was told originally would be a simple one and only take an hour and a half. However, as the surgery began this surgeon was faced with a mass of silicone gel from two ruptured implants. The scar tissue capsule that had formed around the implant as well as the silicone gel had embedded into my chest muscles making it impossible for the surgeon to remove it in a normal manor with surgical scissors. He was finally successful removing all of this, but not without removing what little good breast tissue there was, but some muscle as well. The total time in surgery was around three and half-hours. Due to the extent of rupture and the surgical procedure I had to be rushed to the hospital next door to be administered morphine and put on a morphine drip. My surgery one could say reflected a double mastectomy and my physical outcome is proof of that.

Besides the pain I have described above my health has suffered and continues to suffer. The medical problems I have and now suffer with are to numerous to list. I am one of the fortunate ones who are still able to continue working although with great difficulty. I am also fortunate to have health insurance through the company I work with. However, this is not the case with many women who are now being turned down by health insurance companies due to having or have had any type of breast implants.

I know women who unlike me did not have the silicone-gel implants, but the saline implants. The reports I am getting are they too are facing and having the same difficulties as the silicone-gel implants. The implants are leaking and rupturing. The one thing that the public does not understand is these saline implant shells are made out of silicone just like the silicone-gel filled implants. They too do not last a lifetime and the saline within these shells does not have an undetermined shelf life. In fact, many of these women I have talked to have found that the saline within these shells can and are forming bacteria and fungus. Should these saline implants leak or rupture (which they "will) these women are exposed to sever infections and death. This is also true to this danger to the children of those women who have or will breast feed.

There were many women with their stories of horror at this FDA meeting. 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 these women have nor as I have - especially not from products, which our government has allowed on the market.

Since the FDA did not listen to these women, I hope they will listen to you. I am writing to ask you to write to the FDA Commissioner, Jane Henney, MD, 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 these women and me will not happen to others. For example, they should not even consider saline breast implants until they analyze all the thousands of adverse reactions that have been reported through the Medical Device Reports (MDRs). The safety of any product or devise needs years of study and personal reports of all problems. I am only one of many of thousand of women who have or are experience major problems regarding both silicone-gel and saline filled breast implants.

I am hoping with your help that the FDA will do these studies first before any approval of these implants is give. Please help us make sure that women and young girls are not put in danger or their health in danger because of these devices.

Sincerely,

Sharyn L. Noakes

Keystone Heights, Fl 32656