FDA Looks At Rupture Rates 

In Silicone Implants

8/03 UPDATE: FDA will begin to review data on silicone implants. See below for the letter Ann Fonfa wrote about this and for their response.

Scientists at the Food and Drug Administration looked at rupture rates among women who received implants as part of a National Cancer Institute study. All of the women had their first implants before 1988.

Using magnetic resonance imaging (MRI) scans of 344 women, they found that 69 percent had at least one ruptured implant. And 21 percent of the women had silicone gel that had leaked outside one or both breasts, the study said.

“In the past, breast implant rupture was thought to be rare, but the FDA study indicates that rupture of silicone gel implants is much more common than previously thought,” the agency said in a statement.

Also, a look at 907 women in the FDA study found that one-third had at least one surgery to have an implant removed or replaced.

Millions of women have silicone implants. Some alleged that silicone leaking from implants caused a range of serious illnesses including chronic autoimmune diseases. Last year, a study by the Institute of Medicine concluded the implants did not cause chronic disorders but did rupture or present other problems.

FDA approves saline breast implants

The FDA findings came amid renewed questions about breast implants. Just last week, the FDA said implants filled with saline, or salt water, were safe enough to stay on the market despite high rates of complications, including ruptures. Consumer groups and lawmakers have criticized the decision.

With silicone-gel implants, only women participating in studies can receive them. The FDA restricted their use in 1992 in response to the safety questions.

Consumer groups said the new findings should lead the FDA to ban all use of silicone-gel implants until it can make sure women are aware of how frequently complications may occur.

“We want to give breast cancer patients as many options as possible, but we think it’s absolutely essential they get better information than they’ve been getting,” said Diana Zuckerman, executive director of the National Center for Policy Research for Women and Families.

Thanks to Reuters Health


(Significant)Variability &Properties:Silicone Implants

Plastic & Reconstructive Surgery, 8/01

Prevalence of Silicone Breast Implant Rupture

Plastic & Reconstructive Surgery 9/01

In Vivo Aging Characteristics

Plastic & Reconstructive Surgery, 5/02

Silicone-related Symptoms One Year Later

Study from the Netherlands, 7/02

Ann Fonfa's Letter to FDA re Silicone Implants

August 1, 2003 to FDA

FDA Review of Premarket Approval:Silicon Gel Implants
Groups Oppose Breast implant Approval
Unsafe at Any Size
FDA Response to 2004 Ltr from Ann Fonfa
Implant Forum

LINK to site w/research, opinions and more

15% + of Silicone Implants Rupture w/in 3- 10 Years

Archives of Surgery, 7/03

Pathology of Lymph Nodes w/Breast Implants
Plastikos

LINK to Dr. Susan E. Kolb, MD Certified by Am Bd of Holisitic Med FAQs on Silicone

High Platinum Concentrations in Women w/Silicon Implants

American Chemical Society, 8/04

Letter re Silicone Implants to Washington Post
Toxic Discovery -Silicone Implants

LINK to Org run by former cancer nurse w/implants Established in 1994, extensive library, much more

Letter to Dr. Lester Crawford, FDA Acting Commissioner

March 10, 2005 We are signees

Excerpt on April, 2005 decision to approve Mentor implants
Alliance for Justice on Silicone Implants

LINK to PDF report, 2006


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