Fw: Breast Implant Research and Information Act

[Guest guest]

Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

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

keeling.m@...

Sent: Friday, May 25, 2001 10:54 PM

Subject: Re: Breast Implant Research and Information Act

In a message dated 5/25/2001 10:46:12 PM Central Daylight Time, keeling.m@... writes:

Please send the following to your e-mail lists: On May 24th the following bill was introduced into the House of Representatives by Representative Roy Blunt (R-MO) and Representative Gene Green (D-TX) A BILL 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 thoroughly review the implant manufacturers' standing with the agency. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled. SECTION 1. SHORT TITLE - This Act may be cited as the "Breast Implant Research and Information Act". SECTION 2. FINDINGS AND PURPOSE - (a) Findings. Congress makes the following findings: (1) According to the Institute of Medicine, it is estimated that 1,000,000 to 2,000,000 American women have received breast implants over the last 35 years. Because there has never been a patient registry for breast implant recipients it is impossible to more accurately determine the number of women who have received breast implants. Yet, the American Society of Plastic Surgeons estimates that in 1999 alone 82,975 women had breast reconstruction following mastectomies and another 167,318 American women received breast implants for cosmetic purposes. (2) From 1985 until January 2000, FDA received 127,770 adverse reaction reports for silicone gel-filled breast implants and 65,720 adverse reaction reports for saline-filled implants. (3) Women need complete and accurate information about the potential health risks and advantages of breast implants so that women can make informed decisions. (4) Silicone breast implants have never been approved by the Food and Drug Administration; saline breast implants, which consist of a saline solution injected into a silicone envelope, were approved by the agency in 2000 despite alarmingly high complication and reoperation rates. After three years, 43 percent of the augmentation patients experienced local complications and 40 percent of the reconstruction patients were forced to undergo additional surgery for local complications and device failure. (5) In 1998, the Food and Drug Administration opened a criminal investigation following allegations that one of the breast implant manufacturers was manipulating research data in breast implant studies. When the Food and Drug Administration's General and Plastic Surgery Devices Panel convened in March 2000 to consider market approval for saline implants, it was not informed of the investigation. Although the manufacturer's saline breast implant was approved by the Food and Drug Administration in May 2000, the investigation remains open. (6) According to a 1997 Mayo Clinic study, within 5 years of receiving such implants, 1 in 4 women required additional surgery. (7) In 2000, research sponsored by the Food and Drug Administration found that even among women who had not sought medical treatment for implant problems, almost 70 percent had at least one ruptured implant after 10 to 15 years. Silicone was found to be migrating away from the implants in 21 percent of those women. The FDA researchers concluded that "the relationship of free silicone to development or progression of disease is unknown". (8) A 1993 study by Dr. Suzanne S. Teuber et al., University of California, published in The Journal of Autoimmunity, investigated the influence of silicone breast implants on the expression of anticollagen antibodies and found a statistically significant incidence of anticollagen antibodies in women with implants. The researchers concluded that silicone breast implants should not be considered a benign or immunoligically inert material; serious implications may result from their use. (9) The Institute of Medicine's 1999 study of silicone breast implant safety found that local complications with silicone breast implants were the primary safety issue, that they have not been well studied, and that information on these complications is crucial for women deciding whether or not they want breast implant surgery. Concern remains that exposure to silicone breast implants may result in currently undefined connective tissue or autoimmune diseases. (10) A 2001 National Cancer Institute study found breast implant recipients suffer from higher rates of lung and brain cancer than other plastic surgery patients. (11) A 1999 case report by Dr. Suzanne S. Teuber et al., University of California, published in The Journal of Rheumatology, found evidence of silicone migration in women with ruptured or leaking silicone breast implants. These patients experienced severe local inflammation and complications resulting from silicone migration to the axilla, arm or abdominal wall. Researchers concluded that once silicone gel leaves the implant, it is not biologically inert and in some persons can elicit profound pathologic responses. (12) According to many reports, including a study published in the Journal of the National Cancer Institute, the presence of a silicone breast implant may create difficulties in obtaining accurate and thorough mammograms because as much as 40 percent of the breast tissue can be masked by the implant. This delays the early detection breast cancer in women, (13) According to a 2000 Food and Drug Administration publication, women of childbearing age who want to breast feed should be aware of the negative impact of breast implants on breast feeding. It is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. to be continued...

[Guest guest]

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

Sent: Friday, May 25, 2001 9:24 PM

Subject: Breast Implant Research and Information Act

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

>

> many thanx to Keeling

> keeling.m@...

>

> ~~~~~~~~~~

>

> On May 24th the following bill was introduced into the House of

> Representatives by Representative Roy Blunt (R-MO) and Representative Gene

> Green (D-TX)

> A BILL

>

> 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 thoroughly

> review the implant manufacturers' standing with the agency.

>

> Be it enacted by the Senate and House of Representatives of the United

> States of America in Congress assembled.

>

> SECTION 1. SHORT TITLE - This Act may be cited as the " Breast Implant

> Research and Information Act " .

>

> SECTION 2. FINDINGS AND PURPOSE - (a) Findings. Congress makes the

> following findings:

>

> (1) According to the Institute of Medicine, it is estimated that 1,000,000

> to 2,000,000 American women have received breast implants over the last 35

> years. Because there has never been a patient registry for breast implant

> recipients it is impossible to more accurately determine the number of

women

> who have received breast implants. Yet, the American Society of Plastic

> Surgeons estimates that in 1999 alone 82,975 women had breast

reconstruction

> following mastectomies and another 167,318 American women received breast

> implants for cosmetic purposes.

>

> (2) From 1985 until January 2000, FDA received 127,770 adverse reaction

> reports for silicone gel-filled breast implants and 65,720 adverse

reaction

> reports for saline-filled implants.

>

> (3) Women need complete and accurate information about the potential

health

> risks and advantages of breast implants so that women can make informed

> decisions.

>

> (4) Silicone breast implants have never been approved by the Food and Drug

> Administration; saline breast implants, which consist of a saline solution

> injected into a silicone envelope, were approved by the agency in 2000

> despite alarmingly high complication and reoperation rates. After three

> years, 43 percent of the augmentation patients experienced local

> complications and 40 percent of the reconstruction patients were forced to

> undergo additional surgery for local complications and device failure.

>

> (5) In 1998, the Food and Drug Administration opened a criminal

> investigation following allegations that one of the breast implant

> manufacturers was manipulating research data in breast implant studies.

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

Devices

> Panel convened in March 2000 to consider market approval for saline

> implants, it was not informed of the investigation. Although the

> manufacturer's saline breast implant was approved by the Food and Drug

> Administration in May 2000, the investigation remains open.

>

> (6) According to a 1997 Mayo Clinic study, within 5 years of receiving

such

> implants, 1 in 4 women required additional surgery.

>

> (7) In 2000, research sponsored by the Food and Drug Administration found

> that even among women who had not sought medical treatment for implant

> problems, almost 70 percent had at least one ruptured implant after 10 to

15

> years. Silicone was found to be migrating away from the implants in 21

> percent of those women. The FDA researchers concluded that " the

> relationship of free silicone to development or progression of disease is

> unknown " .

>

> (8) A 1993 study by Dr. Suzanne S. Teuber et al., University of

California,

> published in The Journal of Autoimmunity, investigated the influence of

> silicone breast implants on the expression of anticollagen antibodies and

> found a statistically significant incidence of anticollagen antibodies in

> women with implants. The researchers concluded that silicone breast

> implants should not be considered a benign or immunoligically inert

> material; serious implications may result from their use.

>

> (9) The Institute of Medicine's 1999 study of silicone breast implant

safety

> found that local complications with silicone breast implants were the

> primary safety issue, that they have not been well studied, and that

> information on these complications is crucial for women deciding whether

or

> not they want breast implant surgery. Concern remains that exposure to

> silicone breast implants may result in currently undefined connective

tissue

> or autoimmune diseases.

>

> (10) A 2001 National Cancer Institute study found breast implant

recipients

> suffer from higher rates of lung and brain cancer than other plastic

surgery

> patients.

>

> (11) A 1999 case report by Dr. Suzanne S. Teuber et al., University of

> California, published in The Journal of Rheumatology, found evidence of

> silicone migration in women with ruptured or leaking silicone breast

> implants. These patients experienced severe local inflammation and

> complications resulting from silicone migration to the axilla, arm or

> abdominal wall. Researchers concluded that once silicone gel leaves the

> implant, it is not biologically inert and in some persons can elicit

> profound pathologic responses.

>

> (12) According to many reports, including a study published in the Journal

> of the National Cancer Institute, the presence of a silicone breast

implant

> may create difficulties in obtaining accurate and thorough mammograms

> because as much as 40 percent of the breast tissue can be masked by the

> implant. This delays the early detection breast cancer in women,

>

> (13) According to a 2000 Food and Drug Administration publication, women

of

> childbearing age who want to breast feed should be aware of the negative

> impact of breast implants on breast feeding. It is not known if a small

> amount of silicone may pass from the silicone shell of an implant into

> breast milk. If this occurs, it is not known what effect it may have on

the

> nursing infant.

>

> to be continued...

>

>