No safety data on breast implants

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Breast Implants

Silicone Breast Implants: No Safety Data Mean No Real Choices

Written by Judy Norsigian and Zuckerman November 2003

A split decision by an advisory panel to the Food and Drug

Administration (FDA) recently recommended that restrictions be lifted

and silicone gel breast implants be approved for the first time. The

9-6 closer-than-usual vote was orchestrated by the four plastic

surgeons and two breast surgeons on the panel, who voted in lock-step

for a product that would bring these doctors and their colleagues

billions of dollars in future patient fees. Most of the scientists and other doctors on the panel voted

against approval. The toxicologist, epidemiologist, radiologist,

statistician, dermatologist, and cancer surgeon bemoaned the lack of

safety research for a product that has been sold for 40 years. They asked why the company seeking approval for silicone gel

implants studied them for only 3 years, after selling the same implant

since at least 1990. They pointed out that the main concern about

breast implants is how to predict when an implant will leak, how to

remove it safely before that happens, and what the health risks of that

leakage are. They reminded us that these questions have never been

answered. Both of us have been in touch with hundreds of women with

breast implants over the last dozen years. Together, we and our

organizations have read every epidemiological study ever published on

the topic, from start to finish. We've read the Institute of Medicine

report on implants -- an often-quoted but rarely read tome that has

been widely misquoted and misunderstood, so that thousands of teenagers

and women are now sorely misinformed.Marcia Angell and others have

said that there is no conclusive proof that implants cause disease.

That is true. So what is the problem? There are at least 4: #1: Silicone gel implants break and can leak to breasts, lungs, and lymph nodes We have spoken to dozens of women who describe the pain and

deformity of having leaked silicone scraped from their own breast

tissue or their chest wall. Others have told us of coughing up silicone

from their lungs, or having nodules containing silicone on their faces,

arms, breasts, and backs. Nipples dripping with silicone have been

described by numerous clinicians as well as patients. According to research conducted by FDA scientists, all

silicone gel implants will eventually break, most within 10 years, many

without any obvious symptoms. When silicone leaks out of a broken

implant, it can migrate to healthy breast tissue, the lungs, lymph

nodes, and elsewhere where it is often impossible to remove. These

leaks and the subsequent need for surgery are considered "local

complications" rather than "diseases" but they show implants are not

"safe" in the usual sense of the term, whether or not they cause

disease.

# 2: Long-term Safety Studies are Needed Research shows extremely high complication rates in the first three

years. For example, 46% of breast cancer patients will have problems

requiring additional surgery within three years. Long-term research is

needed to study the health risks over 5 and 10 and 15 years, especially

from leaking silicone. The FDA panel chair was "flabbergasted" that the

company studied women who had implants for only two or three years,

since FDA research shows that most silicone implants break after 10

years. Some argue that a 4-year-old Institute of Medicine report

proves that implants are safe. Not true. The IOM report expressed

strong safety concerns about "local complications" such as leaking

implants. Although they were less concerned about implants causing

diseases, their analysis was based on studies of women with implants

for as briefly as a few months. Most diseases develop several years

after an exposure, so longer studies are needed. After all, even chain

smokers usually don't develop lung cancer within 5 or 10 years.

#3: Government Scientists have found links between implants and disease After the IOM report, the National Cancer Institute and the FDA

completed studies on women who had implants for at least seven years.

Among their disturbing findings: women with breast implants are more

likely to die from brain cancer, lung cancer, or suicide compared to

other plastic surgery patients, and women with leaking implants were

more likely to have fibromyalgia and several other painful autoimmune

diseases than women with intact implants. Also, government-funded

pathologists have found silicone from leaked implants in lymph nodes,

lungs, and other organs.

#4 Research is Needed on Implant Safety for Women of Color The safety of silicone breast implants is not the major health

concern of women of color, but those who are breast cancer patients

frequently consider reconstruction with implants. Research shows that

African Americans are more likely to get autoimmune diseases -- the

major health concern for breast implants. And yet only six African

American breast cancer patients were in the "core study" submitted by

Inamed to prove implant safety to the FDA. Research also shows that

African Americans and Asian Americans are more likely to have excessive

scarring, which is an important concern for cosmetic surgery, and could

cause pain or deformity and interfere with mammograms for women with

breast implants.

We reluctantly conclude that silicone gel implants cause pain and

suffering for many women, while the long-term risks remain unstudied.

The lack of research and difficulty with diagnosis has been used to

unfairly discredit these women as well as the physicians trying to help

them. Unfortunately, recent, better-designed studies give new reasons

for concern.

The "choice" to get breast implants is not a real choice, until we

collect the much- needed data on long-term risks. These risks are not

remote "hypothetical" problems – as thousands of women have already

made clear – and the FDA should require this long-overdue proof of

safety before approving any silicone gel implants.