Fw: Letter to NIH asking for research on implants

[Guest guest]

----- Original Message ----- From: Zuckerman

Undisclosed-Recipient:;@...

Sent: Wednesday, March 12, 2003 7:16 PM

Subject: Letter to NIH asking for research on implants

Dear Friends,

After many months of work, I am very pleased to tell you that two members of Congress have written to the director of NIH to ask NIH to conduct research on the long-term safety of breast implants. This is to follow-up on legislation that included an NIH study (also championed by these 2 Congressmen).

You may want to consider sending thank you letters to these Representatives , one Democrat and one Republican, who worked hard to get legislation passed last year and continue to work to make sure that objective research is conducted on the long-term safety of breast implants.

This letter also indirectly sends a message to the FDA that Congress is concerned about the safety of implants.

It is an important step forward, and in addition to thanking the Congressmen, I want to thank my staff and the key advocates who helped to make this happen.

Best wishes,

Zuckerman

Representative Gene Green

2335 Rayburn House Office Building

Washington, D. C. 20515 FAX: 202/225-9903

Representative Roy D. Blunt

217 Cannon House Office Building

Washington, D. C. 20515 FAX: 202/225-5604 blunt@...

Elias Zerhouni, M.D.

Director

National Institutes of Health

1 Center Drive

Bethesda, MD 20892-0148

Dear Dr. Zerhouni:

As you know, breast implants have been sold in the United States for almost four decades. Although a number of studies have not found a link between breast implants and systemic disease, other articles have raised questions about their long-term safety. Dut to these concerns, Congress included provisions in the Medical Device Act of 2002, which directs the National Institutes of Health to conduct research to evaluate the safety of breast implants.

Language included in the legislation specifically directs the National Institutes of Health to develop techniques to measure concentrations of silicone in body fluids and tissues, and conduct prospective and retrospective research to examine the long-term implications of both saline and silicone breast implants.

While breast implants for the purposes of augmentation or reconstruction have been broadly available through FDA-approved clinical trials of silicone gel implants and currently approved saline-filled devices, questions have been raised as to their safety beyond two to five years after implantation. To the extent feasible and applicable, and statistically controlling for major changes in breast implants since the 1970's, we ask that the National Institutes of Health conduct a more long-term comparison of the health status (morbidity and mortality) and quality of life outcomes of the following:

(1) breast cancer patients who had reconstruction with silicone gel breast implants, compared to those who had reconstruction with saline breast implants, compared to breast cancer patients who had mastectomies but did not have reconstruction;

(2) augmentation patients with silicone gel breast implants, compared to augmentation patients with saline breast implants, compared to other plastic surgery patients.

For the purpose of this study, we ask that the evaluation of heath status include a wide range of conditions, symptoms, diseases, and deaths from all causes. Further, we ask that, if possible, quality of life aspects, such as overall mental health, self-esteem and self-image be considered as part of your study. Whenever possible, the study should evaluate participants in this study with a medical exam, not by self-report or medical records.

It is our understanding that Dr. Louise Brinton at the National Cancer Institute has been conducting research on breast implants for some time. We would appreciated an update on the progress and findings of Dr. Brinton's research.

Sincerely,

Gene Green Roy Blunt

Member of Congress Member of Congress