Fw: Breast Implant Research and Information Act ...continued

[Guest guest]

FYI

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

----- Original Message ----- From: S3733@...

keeling.m@...

Sent: Friday, May 25, 2001 11:58 PM

Subject: Re: Breast Implant Research and Information Act ...continued

In a message dated 5/25/2001 11:47:23 PM Central Daylight Time, keeling.m@... writes:

( Purpose - It is the purpose of this Act to promote research to identify and evaluate the health effects of breast implants, to ensure that women receive accurate information about such implants and to encourage the Food and Drug Administration to conclude its criminal investigation based on the allegations of wrong-doing by one of the implant manufacturers which ultimately may affect their products and the health of American women. (3) Rule of Construction - Nothing in this Act shall be construed to affect any rule or regulation promulgated under the authority of the Federal Food, Drug and Cosmetic Act (21 U.S. 301 et seq.) that is in effect on the date of enactment of this Act relating to the availability of silicone breast implant for reconstruction after mastectomy, correction of congenital deformities, or replacement for ruptured silicone implants for augmentation. SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE BREAST IMPLANTS AT THE NATIONAL INSTITUTES OF HEALTH. (a) Status of Existing Research. - The Director of the National Institutes of Health shall report to all appropriate committees of Congress on the status of the existing breast implant research funded by such Institutes within 90 days after the date of the enactment of this Act. ( Amendment to Public Health Service Act. - Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seg.) is amended by adding at the end of the following: "SEC.489c. BREAST IMPLANT RESEARCH. "(a) INSTITUTE-WIDE COORDINATOR. - The Director of NIH shall appoint an appropriate official of the Department of Health and Human Services to serve as the National Institutes of Health coordinator regarding breast implant research. Such coordinator shall encourage and coordinate the participation of all appropriate Institutes research including - "(1) The Office of Research on Women's Health; "(2) the National Institute of Allergy and Infectious Diseases: "(3) the National Institute of Arthritis and Musculoskeletal and Skin diseases; "(4) the National Institute of Child Health and Human Development; "(5) the National Institute of Environmental Health Sciences; "(6) the National Institute of Neurological Disorders and Stroke; and "(7) the National Cancer Institute "( Study Sections. - The Director of NIH shall establish a study section or special emphasis panel if determined to be appropriate, for the National Institutes of Health to review extramural research grant applications regarding breast implants to ensure the appropriate design and high quality of such research and shall take appropriate action to ensure the quality of intramural research activities. "© Clinical Study. - (1) In General. - The Director of NIH shall conduct or support research to expand the understanding of the health implications of both saline and silicone breast implants. Such research should, if determined to be scientifically appropriate, include multidisciplinary, clinical, case-controlled study of women with breast implants for at least eight years whether it be one prosthesis or multiple, and differentiate between women receiving implants for mastectomy, reconstructive or cosmetic purposes and include subsets of women with saline implants and silicone implants. Such a study should focus on the rate of local complications which includes capsular contracture, leakage, loss of nipple sensation, deflation and rupture as well the presentation of atypical symptoms, silicone migration, neurological dysfunction, and immune system irregularities, and evaluate to what extent if any, their health differs from that of suitable controls. "(2) Annual Report. - The Director of NIH shall annually prepare and submit to the appropriate Committees of Congress a report concerning the results of the study conducted under paragraph (2)." SEC. 4. INTENSIFICATION OR ACTIVITIES REGARDING POSTMARKET RESEARCH OF SALINE BREAST IMPLANTS AT THE FOOD AND DRUG ADMINISTRATION. To ensure that the Food and Drug Administration conducts postmarket evaluations of saline implant manufacturers' data based on the postmarket recommendations made by the Food and Drug Administration's General and Plastic Surgery Devices Panel, the Commissioner of Food and Drugs shall report to Congress on the implementation status of the postmarket recommendations at 6, 12, and 18 month intervals after the date of enactment of this Act and annually thereafter. SEC. 5. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE BREAST IMPLANTS AT THE FOOD AND DRUG ADMINISTRATION. To assist women in receiving accurate and complete information about the risks of silicone breast implants, the Commissioner of Food and Drugs shall - (1) expedite the conclusion of the agency's criminal investigation into allegations of wrong-doing by one of the implant manufacturers; brief appropriate Committees of Congress on the findings and take appropriate action within 90 days after the date of the enactment of this Act; (2) ensure that the toll-free consumer information line and materials concerning breast implants provided by the Food and Drug Administration are available, up to date, and responsive to reports of problems with breast implants, and that timely aggregate data concerning such reports shall be made available to the public upon request and consistent with existing confidentiality standards; (3) require that manufactures of silicone breast implants update implant package inserts and informed consent documents regularly to reflect accurate information about such implants, particularly the rate of local complications and ruptures of such implants; (4) require that any manufactures of such implants that are conducting clinical studies on silicone breast implants - (A) require its clinical investigators to provide prospective patients with the Food and Drug Administration's breast implant booklet; ( amend such study protocol and informed consent document to reflect that patients must be provided with a copy of informed consent documents at the initial, or earliest possible, consultation regarding breast prosthesis; © amend the informed consent protocol to inform women about how to obtain a Medwatch form and encourage any woman who withdraws from the study, or who would like to report such problem or concerns with the study and reason for withdrawing; and (D) amend the informed consent document to provide potential participants with the inclusion criteria for the clinical trial and the toll-free Consumer Information number; and (5) appoint a special ad hoc patient information panel that - (A) convenes annually for the sole purpose of reviewing breast implant information and advertisements provided by the manufacturers and the Food and Drug Administration to ensure consumer information is thorough and accurate; and ( includes in its membership (but is not limited to) saline and silicone breast implant recipients, bioethicists, rheumatologists, and oncologists with experience in both clinical care and research regarding breast implants.

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Friday, May 25, 2001 10:10 PM

Subject: Breast Implant Research and Information Act ...continued

> (posted on alt.support.breast-implant & talk.politics.medicine)

>

> many thanx to Keeling

> keeling.m@...

>

> ( Purpose - It is the purpose of this Act to promote research to

identify

> and evaluate the health effects of breast implants, to ensure that women

> receive accurate information about such implants and to encourage the Food

> and Drug Administration to conclude its criminal investigation based on

the

> allegations of wrong-doing by one of the implant manufacturers which

> ultimately may affect their products and the health of American women.

>

> (3) Rule of Construction - Nothing in this Act shall be construed to

affect

> any rule or regulation promulgated under the authority of the Federal

Food,

> Drug and Cosmetic Act (21 U.S. 301 et seq.) that is in effect on the date

of

> enactment of this Act relating to the availability of silicone breast

> implant for reconstruction after mastectomy, correction of congenital

> deformities, or replacement for ruptured silicone implants for

augmentation.

>

> SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE

> BREAST IMPLANTS AT THE NATIONAL INSTITUTES OF HEALTH.

> (a) Status of Existing Research. - The Director of the National Institutes

> of Health shall report to all appropriate committees of Congress on the

> status of the existing breast implant research funded by such Institutes

> within 90 days after the date of the enactment of this Act.

> ( Amendment to Public Health Service Act. - Part H of title IV of the

> Public Health Service Act (42 U.S.C. 289 et seg.) is amended by adding at

> the end of the following:

> " SEC.489c. BREAST IMPLANT RESEARCH.

> " (a) INSTITUTE-WIDE COORDINATOR. - The Director of NIH shall appoint an

> appropriate official of the Department of Health and Human Services to

serve

> as the National Institutes of Health coordinator regarding breast implant

> research. Such coordinator shall encourage and coordinate the

participation

> of all appropriate Institutes research including -

> " (1) The Office of Research on Women's Health;

> " (2) the National Institute of Allergy and Infectious Diseases:

> " (3) the National Institute of Arthritis and Musculoskeletal and Skin

> diseases;

> " (4) the National Institute of Child Health and Human Development;

> " (5) the National Institute of Environmental Health Sciences;

> " (6) the National Institute of Neurological Disorders and Stroke; and

> " (7) the National Cancer Institute

>

> " ( Study Sections. - The Director of NIH shall establish a study section

> or special emphasis panel if determined to be appropriate, for the

National

> Institutes of Health to review extramural research grant applications

> regarding breast implants to ensure the appropriate design and high

quality

> of such research and shall take appropriate action to ensure the quality

of

> intramural research activities.

>

> " © Clinical Study. - (1) In General. - The Director of NIH shall conduct

> or support research to expand the understanding of the health implications

> of both saline and silicone breast implants. Such research should, if

> determined to be scientifically appropriate, include multidisciplinary,

> clinical, case-controlled study of women with breast implants for at least

> eight years whether it be one prosthesis or multiple, and differentiate

> between women receiving implants for mastectomy, reconstructive or

cosmetic

> purposes and include subsets of women with saline implants and silicone

> implants. Such a study should focus on the rate of local complications

> which includes capsular contracture, leakage, loss of nipple sensation,

> deflation and rupture as well the presentation of atypical symptoms,

> silicone migration, neurological dysfunction, and immune system

> irregularities, and evaluate to what extent if any, their health differs

> from that of suitable controls.

>

> " (2) Annual Report. - The Director of NIH shall annually prepare and

submit

> to the appropriate Committees of Congress a report concerning the results

of

> the study conducted under paragraph (2). "

>

> SEC. 4. INTENSIFICATION OR ACTIVITIES REGARDING POSTMARKET RESEARCH OF

> SALINE BREAST IMPLANTS AT THE FOOD AND DRUG ADMINISTRATION. To ensure

that

> the Food and Drug Administration conducts postmarket evaluations of saline

> implant manufacturers' data based on the postmarket recommendations made

by

> the Food and Drug Administration's General and Plastic Surgery Devices

> Panel, the Commissioner of Food and Drugs shall report to Congress on the

> implementation status of the postmarket recommendations at 6, 12, and 18

> month intervals after the date of enactment of this Act and annually

> thereafter.

>

> SEC. 5. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE

> BREAST IMPLANTS AT THE FOOD AND DRUG ADMINISTRATION. To assist women in

> receiving accurate and complete information about the risks of silicone

> breast implants, the Commissioner of Food and Drugs shall -

> (1) expedite the conclusion of the agency's criminal investigation into

> allegations of wrong-doing by one of the implant manufacturers; brief

> appropriate Committees of Congress on the findings and take appropriate

> action within 90 days after the date of the enactment of this Act;

> (2) ensure that the toll-free consumer information line and materials

> concerning breast implants provided by the Food and Drug Administration

are

> available, up to date, and responsive to reports of problems with breast

> implants, and that timely aggregate data concerning such reports shall be

> made available to the public upon request and consistent with existing

> confidentiality standards;

> (3) require that manufactures of silicone breast implants update implant

> package inserts and informed consent documents regularly to reflect

accurate

> information about such implants, particularly the rate of local

> complications and ruptures of such implants;

> (4) require that any manufactures of such implants that are conducting

> clinical studies on silicone breast implants -

>

> (A) require its clinical investigators to provide prospective patients

> with the Food and Drug Administration's breast implant booklet;

> ( amend such study protocol and informed consent document to reflect

> that patients must be provided with a copy of informed consent documents

at

> the initial, or earliest possible, consultation regarding breast

prosthesis;

> © amend the informed consent protocol to inform women about how to

> obtain a Medwatch form and encourage any woman who withdraws from the

study,

> or who would like to report such problem or concerns with the study and

> reason for withdrawing; and

> (D) amend the informed consent document to provide potential

participants

> with the inclusion criteria for the clinical trial and the toll-free

> Consumer Information number; and

>

> (5) appoint a special ad hoc patient information panel that -

> (A) convenes annually for the sole purpose of reviewing breast implant

> information and advertisements provided by the manufacturers and the Food

> and Drug Administration to ensure consumer information is thorough and

> accurate; and

> ( includes in its membership (but is not limited to) saline and

silicone

> breast implant recipients, bioethicists, rheumatologists, and oncologists

> with experience in both clinical care and research regarding breast

> implants.

>

>