ilena

http://www.sagamore.iupui.edu/33_11/viewPoints/eitCol_siliconeChoice.html

Bravo!

Silicone not a choice women need


Eleven years after prohibiting most silicone breast implants the Food
and Drug Administration lifted the ban this month.

In an emotional debate before the FDA Inamed Corp., a maker of breast
implants, doctors who oppose the widespread use of silicone and women
with implants argued their cases.

In 1992 the FDA limited silicone implants to breast cancer patients
who were monitored in studies after women showed serious health
problems such as fibromyalgia – a disease that causes muscle pain in
much of the body.

Inamed wants to broaden its market and the FDA in a 9-6 vote decided
they should be able to do so with a few restrictions.

One Inamed spokeswoman said women should have the choice whether they
want to put potentially hazardous materials into their bodies.

Women who received silicone implants testified before the panel that
prolonged leaking contributed to painful health problems. One study
warns that up to 46 percent of silicone implant patients needed
additional surgeries because of painful complications.

Inamed says there is no evidence that the silicone implants are more
likely to leak than the saline-filled implants that are commonly used
today.

After two days of deliberation, the FDA panel decided the evidence
does not conclusively show that silicone is more dangerous than the
saltwater alternative.

The new guidelines for silicone breast implants require that women be
monitored and have regular mammograms.

But there is no way to ensure that women get the follow-up care they
need to make sure breaking and leaking have not occurred.

It is almost impossible to tell when silicone implants begin to leak,
allowing the toxic substance to spread throughout the breast
unnoticed.

With the saline alternative, the leak is apparent instantaneously
because the breast deflates.
Plastic surgeons who make a lucrative living from the procedure
contend that women can make the decision for themselves after reading
about the known problems.

When silicone implants were all but taken off the market 11 years ago
the FDA and manufacturers had a perfect opportunity to increase
research on a safer product that does not jeopardize the health of
breast-cancer survivors and women who choose the cosmetic surgery.
This opportunity was squandered and there are no conclusive reports.

The FDA made a hasty decision that places big business before
legitimate health concerns.
We know that saline-filled implants, if they leak, lead to no serious
health risks. We know that a slow leaking of silicone into the body
creates painful conditions.

Why do women still want the choice to put a potentially hazardous
object in their body when there is a safer alternative on the market?

Shape, firmness and beauty, as one woman said in testimony before the
FDA. She is dissatisfied with her "saggy" saline implants and wants
the silicone option.

A story last week on CNN.com reported that in countries where both
implants are available, 90 percent of women chose the silicone-gel
implant.

But beauty is not a valid argument. And neither is money.

Corporations have never cared about the health or well being of
customers and they have an especially sketchy history with women.
Inamed wants to increase profits. What's new?

The FDA failed us. Patients under the care of board certified
physicians have a reasonable expectation of safety when they elect for
an FDA approved medical device.

Once again corporate greed trumps health.


By Ginny LaRoe
Viewpoints Editor

ilena

http://www.sagamore.iupui.edu/33_11/viewPoints/eitCol_siliconeChoice.html

Bravo!

Silicone not a choice women need


Eleven years after prohibiting most silicone breast implants the Food
and Drug Administration lifted the ban this month.

In an emotional debate before the FDA Inamed Corp., a maker of breast
implants, doctors who oppose the widespread use of silicone and women
with implants argued their cases.

In 1992 the FDA limited silicone implants to breast cancer patients
who were monitored in studies after women showed serious health
problems such as fibromyalgia – a disease that causes muscle pain in
much of the body.

Inamed wants to broaden its market and the FDA in a 9-6 vote decided
they should be able to do so with a few restrictions.

One Inamed spokeswoman said women should have the choice whether they
want to put potentially hazardous materials into their bodies.

Women who received silicone implants testified before the panel that
prolonged leaking contributed to painful health problems. One study
warns that up to 46 percent of silicone implant patients needed
additional surgeries because of painful complications.

Inamed says there is no evidence that the silicone implants are more
likely to leak than the saline-filled implants that are commonly used
today.

After two days of deliberation, the FDA panel decided the evidence
does not conclusively show that silicone is more dangerous than the
saltwater alternative.

The new guidelines for silicone breast implants require that women be
monitored and have regular mammograms.

But there is no way to ensure that women get the follow-up care they
need to make sure breaking and leaking have not occurred.

It is almost impossible to tell when silicone implants begin to leak,
allowing the toxic substance to spread throughout the breast
unnoticed.

With the saline alternative, the leak is apparent instantaneously
because the breast deflates.
Plastic surgeons who make a lucrative living from the procedure
contend that women can make the decision for themselves after reading
about the known problems.

When silicone implants were all but taken off the market 11 years ago
the FDA and manufacturers had a perfect opportunity to increase
research on a safer product that does not jeopardize the health of
breast-cancer survivors and women who choose the cosmetic surgery.
This opportunity was squandered and there are no conclusive reports.

The FDA made a hasty decision that places big business before
legitimate health concerns.
We know that saline-filled implants, if they leak, lead to no serious
health risks. We know that a slow leaking of silicone into the body
creates painful conditions.

Why do women still want the choice to put a potentially hazardous
object in their body when there is a safer alternative on the market?

Shape, firmness and beauty, as one woman said in testimony before the
FDA. She is dissatisfied with her "saggy" saline implants and wants
the silicone option.

A story last week on CNN.com reported that in countries where both
implants are available, 90 percent of women chose the silicone-gel
implant.

But beauty is not a valid argument. And neither is money.

Corporations have never cared about the health or well being of
customers and they have an especially sketchy history with women.
Inamed wants to increase profits. What's new?

The FDA failed us. Patients under the care of board certified
physicians have a reasonable expectation of safety when they elect for
an FDA approved medical device.

Once again corporate greed trumps health.


By Ginny LaRoe
Viewpoints Editor