Date: Wed, 19 Apr 2000 01:04:15 -0700

To: Recipient List Suppressed:;

The Honorable Tom Bliley

U.S. House of Representatives

Washington, DC

I am writing to you as Chairman of the Commerce Committee, about the saline breast implant PMA's currently before the FDA for approval by May 10, 2000. I also want to applaud you for your prompt response to the Mentor issues. The attached letter to Senator Barbara Boxer clearly explains my interest on this subject.

Since a great majority (over 80%) of breast implants today are used for cosmetic augmentation purposes, rather than reconstruction following a mastectomy, I feel it is critical that appropriate measures and safeguards are used to protect the safety of the young women who are undergoing these procedures in increasing number.

Unfortunately, because of all the legal and media pressure attached to the Dow litigation, almost no testing has been performed regarding breast feeding with implants. When one simply realizes that this is the only purposeful body function for the female breast, its remarkable that so little testing and studies have been required. As a result there is a growing number of children, born with a variety of highly unusual illnesses, that are falling through the cracks. This has to stop!

As you know FDA is severely limited in their ability to perform post market surveillance, just look at the Rezulin and gene therapy issues for example. As a result the FDA has nearly 200,000 outstanding WedWatch complaints which have not received followup. I understand several thousand of these regard 2nd. generation complaints, those of implantee's children. All of the families I know with these problems have never heard from FDA regarding their MedWatch applications.

Congressman Bliley, for the FDA to continue to allow implants for breast augmentation without addressing this issue is absolutely criminal and inhumane! We cannot allow these devices to be declared 'conditionally' safe, while knowing full well that we have no resources to perform the necessary follow up and testing that is expected by the Medical Devices Advisory Committee. One has only to read the voting instructions and the panel's voting discussions to realize the meaninglessness of these PMA hearings.

Congressman Bliley, I urge you to take control of this situation, and do the right thing to protect the thousands of unborn children who will be affected by this decision. Yes, more research is absolutely necessary. So lets start that research with the thousands who are currently suffering the most!

Sincerely,

Dan A. Buck

430 N. Broadway

Redondo Beach, CA 90277

CC: Senators Boxer and Feinstein

Congressman Kuykendall

Media

Full-name: UBCDan

Date: Tue, 18 Apr 2000 03:53:33 EDT

Subject: Breast Implant Hearings

MIME-Version: 1.0

Content-Type: text/plain

X-Mailer: AOL 4.0 for Windows 95 sub 100

April 17, 2000

U.S. Senate

112 Hart Building

Washington, DC 20510

Dear Senator Boxer,

I just became aware of a letter you and Senator Lincoln sent to Dr. Jane Henney at the FDA regarding their pending approval of Saline Breast Implants. I had recently written you on this topic as one of your constituents, and the husband of a deceased silicone victim. In my wife’s final year I became very active with several implant support groups and did a remarkable amount of research on this subject. While I had planned to do more research from the March hearings before writing you again, I feel it is urgent that you also ask Dr. Henney to focus special attention on the safety of breast feeding with implants.

Historically there have been thousands of studies performed about breast implants with every one of them concluding that more long term study was required. The latest studies from the Institute of Medicine and Judge Pointer’s National Science Panel were not new studies at all, but rather studies of previous studies (Harvard, Mayo, etc) that were concluded in the mid-90’s. Their purpose was not to determine the safety of implants, or the effects of breast feeding with implants, but rather to determine their association to known connective tissue diseases. These too concluded that more long term study was needed!

In his presentation to the Medical Devices Advisory Committee, Dr. David Sarwer spoke on behalf of the American Society for Aesthetic Plastic Surgery regarding the psychological benefits of implants to establish their efficacy. He too, concluded his presentation by saying , "Given that the benefits of breast augmentation surgery are more in the psychological than physical realm, more research demonstrating the psychological benefits of the procedure is clearly warranted". At the end of the hearings the Committee voted (under duress) to issue conditional approval, with one of the conditions being more studies!

Senator Boxer, to date it is estimated that nearly 2,000,000 American women have received breast implants. Yet very little study has been performed about their effects on breast feeding, the primary biological function of the female breast. During this time the FDA has received nearly 200,000 (10%) adverse reaction reports, over 60,000 of these regard saline implants. If everyone agrees that more long term study is warranted, why then should we continue to surgically insert more implants into new patients, when we already have hundreds of thousands of candidates from which to continue to conduct these studies?

On March 1, a Canadian scientist and one of the worlds most renowned experts on breast implants, Dr. Pierre Blais, gave his testimony to the committee. He states, " In the light of any reasonable person who is briefed about breast physiology and in the light of the laboratory findings that we are getting from saline implant, there is no basis in any science, any technology, not even in psychology, that would justify breast feeding…" (His testimony begins on page 248 of day one). Yet the literature that the implant manufacturers currently provide prospective patients casually states that "only very limited research has been conducted in this area...it is unknown if the children of women with breast implants are more likely to have health problems…".

Senator Boxer, of all the families I know whose children are suffering the 2nd. generation effects of breast implants, not one of them has been contacted by the FDA for follow-up on their Med Watch reports. Please tell me how the FDA can find these devices even conditionally safe, when they haven’t the slightest idea of their long term effects on the biological function of the human breast?

Sincerely,

Dan A. Buck

430 N. Broadway

Redondo Beach, CA 90277

(310) 798-1963

CC: Senators Feinstein, Lincoln,

Congressman Bliley