Washington Times, Sunday, Oct 26, 2003, p B5
A Split Decision on Breast Implants
By Diana Zuckerman
Breast implants are back in the headlines, with two equally passionate
sides to the story. Both claim the science is on their side. Who is
right?
In a split decision on October 15, advisers to the Food and Drug
Administration voted to recommend that silicone gel breast implants
are safe enough to have the FDA ‘seal of approval.'
The 9-6 vote for approval was orchestrated by the six plastic surgeons
and breast surgeons on the panel who voted in lock-step. In contrast,
most of the other doctors and scientists voted against approving the
implants, citing the lack of safety information. To add to the drama,
a panel member who seemed ready to vote against approval mysteriously
disappeared before the vote. And the panel chairman, who only votes
when there is a tie, said he would have voted against and was
flabbergasted by the lack of safety information.
The spin machines are already working overtime. Plastic surgeons and
implant manufacturers (and the lobbying and PR firms they generously
support) remind us that women like silicone gel breast implants. They
tell us that there is "no scientific evidence" that breast implants
cause disease and that it is time to make them widely available again.
They often back up this statement with a 4-year old Institute of
Medicine report, which they claim proves that implants are safe.
On the other side, patients testified about the pain and deformity of
having leaked silicone scraped from their chest wall-- a problem that
is considered a "local complication" rather than a "health risk."
Their testimony is the heartbreaking illustration of the Institute of
Medicine report's concerns that breast implants can break, leaking
silicone inside the body. Although the Institute concluded that
research did not prove implants cause disease, their report was only a
review of the research available four years ago, most of it of women
with implants for just a few months or years.
Most diseases -- lung cancer for example -- take more than a few years
to develop. Implants tend to break after eight years or more, and the
health risks of leaking silicone implants aren't known. When
scientists from the National Cancer Institute and the FDA recently
conducted several studies on women who had implants for at least seven
years, their results were frightening: Women with breast implants were
twice as likely to die from brain cancer, 3 times as likely to die
from lung diseases, and 4 times as likely to commit suicide, compared
to other plastic surgery patients. Women with leaking implants were
more likely to have fibromyalgia and several other autoimmune
diseases.
The FDA advisors who voted against approval included a toxicologist,
epidemiologist, radiologist, statistician, dermatologist, and cancer
surgeon. They understood diseases take time to develop, especially
since breast implants tend to break after 10 years, not two years.
Their vote against approval was based on their concerns about
long-term safety, and their criticisms that the company didn't bother
to study women who had implants for more than three years.
There's even a divided opinion among our government health officials
about the safety of breast implants. At the very moment when the FDA
is considering lifting restrictions on silicone gel implants, the
Medicare program has successfully sued implant manufacturers for tens
of millions of dollars. Why? Because the government claims that women
who became sick from their silicone implants have cost Medicare a lot
of money in medical care.
You might wonder why the FDA would consider making a product more
available when scientists question their safety and when government
experts believe that it has cost our already-strapped healthcare
system millions of dollars. This is a health question where it doesn't
help to ask your doctor --but you might try the lobbyists on
Washington's K Street. The companies that were successfully sued for
billions of dollars by breast implant patients -- such as Dow Corning,
3M, and Bristol Myers Squibb -- are among the most powerful companies
in the country. Perhaps their lobbyists are more effective than the
women with implants who are coping with leaking silicone in their
bodies.
The FDA's mission is to safeguard all of us when we eat, use medical
products, or are vaccinated. The division of opinion among FDA
advisers reflects a frequent split -- between those who are selling a
product or procedure and think it is safe based on personal clinical
experience, and those who believe research is necessary to prove such
safety
There is passion (often called hysteria when it's the "other side"😉
and science on both sides of this issue. The short-term research shows
most women with breast implants don't get diseases in the first few
years. But there is little long-term research, and those studies
raises serious questions about leaking silicone, illness, and death
related to implants. In the meantime, research also shows extremely
high complication rates -- including the need for repeated surgeries.
The bottom line is: Will the FDA demand a company prove its product is
safe before "approving" it, or decide a company can experiment on
millions of women while we wait for research to be completed?
We'll find out soon.
Diana Zuckerman, Ph.D. is president of the National Center for Policy
Research (CPR) for Women & Families.
~~~~~~~~~~~~~~~
Dr. Zuckerman's website is:
www.BreastImplantInfo.org
For more information on the breast implant debacle, you are welcome to
visit:
www.BreastImplantAwareness.org