Amendments to the Medical Device User Fee Bill

[Guest guest]

FYI! And thanks to all who wrote to our representatives re this Bill!

Through the bi-partisan leadership efforts of Congressman Roy Blunt (R-MO),

his legislative aide Annissa Mc, the women of Missouri led by Kim

Hoffman, Congressman Gene Green (D-TX), his legislative aide Sharon

Scribner, the women of Texas led by Keeling, Zuckerman, Ph.D.,

with the National Center for Policy Research for Women and Families,

Beth Buchholz with The Sheridan Group - the House of Representatives

included in the amendments to the Medical Device User Fee Bill provisions

for an NIH study on breast implants and a GAO (General Accounting Office)

study on informed consent issues. In a paper issued by the Commerce

Committee, the NIH is directed to focus on the long-term health of breast

cancer survivors including neurological and/or auto-immune irregularities

that show possible links to silicone migration. The NIH is also directed to

focus on young women who may have local complications including problems in

breast-feeding with saline or silicone gel-filled implants. Many thanks to

the many women who wrote letters and contacted their Congressional offices

regarding this important women's health issue. If you would like to write a

think-you letter, it may be sent to:

Representative Roy Blunt

217 Cannon House Office Building

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

blunt@...

Representative Gene Green

2335 Rayburn House Office Building

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

www.house.gov/green

Device makers are hoping the Senate will act on the legislation before

Congress adjourns this year.

The text of the Commerce Committee paper reads as follows:

FDA Report Language

The Committee believes that it is vital that women considering an implant

procedure be provided objective, understandable information about the risks

and benefits of implant surgery. Therefore, the Committee strongly

encourages the Food and Drug Administration ensure that women receive such

information in a timely fashion, particularly if the procedure is elective.

In particular, the agency should consider working with an advisory panel,

patients, consumer groups, implant manufacturers, plastic surgeons, and

other interested parties to ensure such information is updated correctly,

and as soon as possible when new information about adverse events becomes

available. The agency should consider writing product guides if it believes

it could help communicate fair and balanced information, and to ensure that

such guides are appropriately updated.

The agency should also work with patients, consumer groups, manufacturers,

plastic surgeons, and other interested parties to ensure that women

enrolling in clinical trails for silicone breast implants are provided with

up-to-date, easy to understand informed consent documents, early in the

clinical trial enrollment process. The agency should also take appropriate

steps to ensure that clinical trail participants receive information on how

to report problems about their participation or continued enrollment in a

study or a particular clinical trial.

NIH Report Language

The Committee is aware of conflicting research as to the long-term health

implications of breast implants. Therefore, the Committee has asked the NIH

to report on all of its research in this area. Furthermore, we urge the NIH

to continue and expand research programs that examine the long-term health

implications of breast implants. If scientifically appropriate, such a

study should allow for comparisons of women receiving implants for

reconstruction after mastectomy to breast cancer patients who have not had

reconstruction. The committee believes that it is important for these

studies to include women who have had implants for at least eight years,

separately analyzing women with saline implants and those with silicone gel

implants. Such a study should include the rate of local complications,

which may include capsular contracture, leakage, loss of nipple sensation,

problems in breast feeding, deflation and rupture as well as systemic health

problems which may include neurological and/or auto-immune irregularities

that show possible links to silicone migration, or other leakage or breakage

related issues.

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537