Fw: CORRECTION: Silicone implants still restricted

[Guest guest]

FOR IMMEDIATE RELEASE BY CPR for Women & Families

September 18, 2002

SILICONE IMPLANTS DO NOT HAVE FDA APPROVAL, CONTRARY TO RECENT REPORTS!

Inaccurate news stories have confused physicians and patients across the country. In fact, the U.S. Food and Drug Administration (FDA) has never approved silicone gel breast implants except for research purposes.

Silimed, a company that has no FDA-approved breast implants on the market in the United States, sent out a press release saying, "Silicone Implants are Back with FDA Approval!" The results of the company's promotional efforts have been inaccurate and confusing stories on TV and other media across the country.

The FDA has restricted the availability of silicone gel breast implants and required studies since 1992, because of unanswered questions about how long implants lasted, what happened to women with leaking silicone implants, the rate of local complications, and the possible link to systemic disease.

Silimed recently received FDA approval to conduct a study of women who will receive silicone gel breast implants in clinical trials. This is not news, since similar studies conducted by other implant companies have been in place for several years.

"It is very important that women, and their doctors, are aware of the investigational status of implants so that they can make informed decisions" explains Dr. Zuckerman, president of the National Center for Policy Research (CPR) for Women & Families. "Calling implants ‘FDA approved’ when they are only permitted for research but not general sale, is inaccurate and may violate the Food, Drug and Cosmetic Act." CPR for Women & Families is a research-based nonprofit center that provides information on health and regulatory issues affecting women, children, and families.

The press release issued by Silimed has been sent to FDA consumer protection officials by several consumers and consumer groups.

In the past two years, scientists at the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and several medical schools have conducted federally-funded research indicating the following risks of silicone breast implants.

Women with breast implants were twice as likely to die from brain cancer, three times as likely to die from lung cancer or other respiratory diseases, and four times as likely to commit suicide, compared to other plastic surgery patients. This NCI study of women who had implants for more than 7 years raised questions about long-term safety.

Women with breast implants had a 21% higher overall risk of cancer, compared to other women of the same age. This NCI study also only included women who have implants for more than 7 years.

Most women who have silicone gel implants for 11 years or longer have at least one broken breast implant, even if they have no symptoms. This study was conducted by the FDA, using Magnetic Resonance Imaging (MRI).

For every five women with broken silicone implants, MRIs indicated that at least one has silicone that has escaped from the breast implant area to other parts of the body. These women are more likely to have fibromyalgia or other painful and potentially fatal autoimmune diseases, according to FDA scientists.

The FDA describes their study of ruptured implants at http://www.fda.gov/fdac/departs/2001/601_upd.html. A summary of the FDA cancer studies is at: http://www.center4policy.org/implantgovstdy.html.

###

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWSuite 901Washington, DC 20006202 223-4000www.center4policy.org

Remember CPR when you give to United Way or CFC, by designating #9884!

[Guest guest]

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

Eileen M. Swanson ; toxicdiscovery@... ; ruby rahn ; Martha Murdock

Cc: Hudak

Sent: Thursday, September 19, 2002 8:00 AM

Subject: CORRECTION: Silicone implants still restricted

FOR IMMEDIATE RELEASE BY CPR for Women & Families

September 18, 2002

SILICONE IMPLANTS DO NOT HAVE FDA APPROVAL, CONTRARY TO RECENT REPORTS!

Inaccurate news stories have confused physicians and patients across the country. In fact, the U.S. Food and Drug Administration (FDA) has never approved silicone gel breast implants except for research purposes.

Silimed, a company that has no FDA-approved breast implants on the market in the United States, sent out a press release saying, "Silicone Implants are Back with FDA Approval!" The results of the company's promotional efforts have been inaccurate and confusing stories on TV and other media across the country.

The FDA has restricted the availability of silicone gel breast implants and required studies since 1992, because of unanswered questions about how long implants lasted, what happened to women with leaking silicone implants, the rate of local complications, and the possible link to systemic disease.

Silimed recently received FDA approval to conduct a study of women who will receive silicone gel breast implants in clinical trials. This is not news, since similar studies conducted by other implant companies have been in place for several years.

"It is very important that women, and their doctors, are aware of the investigational status of implants so that they can make informed decisions" explains Dr. Zuckerman, president of the National Center for Policy Research (CPR) for Women & Families. "Calling implants ‘FDA approved’ when they are only permitted for research but not general sale, is inaccurate and may violate the Food, Drug and Cosmetic Act." CPR for Women & Families is a research-based nonprofit center that provides information on health and regulatory issues affecting women, children, and families.

The press release issued by Silimed has been sent to FDA consumer protection officials by several consumers and consumer groups.

In the past two years, scientists at the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and several medical schools have conducted federally-funded research indicating the following risks of silicone breast implants.

Women with breast implants were twice as likely to die from brain cancer, three times as likely to die from lung cancer or other respiratory diseases, and four times as likely to commit suicide, compared to other plastic surgery patients. This NCI study of women who had implants for more than 7 years raised questions about long-term safety.

Women with breast implants had a 21% higher overall risk of cancer, compared to other women of the same age. This NCI study also only included women who have implants for more than 7 years.

Most women who have silicone gel implants for 11 years or longer have at least one broken breast implant, even if they have no symptoms. This study was conducted by the FDA, using Magnetic Resonance Imaging (MRI).

For every five women with broken silicone implants, MRIs indicated that at least one has silicone that has escaped from the breast implant area to other parts of the body. These women are more likely to have fibromyalgia or other painful and potentially fatal autoimmune diseases, according to FDA scientists.

The FDA describes their study of ruptured implants at http://www.fda.gov/fdac/departs/2001/601_upd.html. A summary of the FDA cancer studies is at: http://www.center4policy.org/implantgovstdy.html.

###

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWSuite 901Washington, DC 20006202 223-4000www.center4policy.org

Remember CPR when you give to United Way or CFC, by designating #9884!