Proud Supporter of
|
|
| ISSUE |
 Safety
of US Breast Implants Back in Spotlight
By Lisa Richwine Facts about Breast Augmentation
USafety of US Breast Implants Back in Spotlight
By Lisa Richwine
WASHINGTON, Mar 01 (Reuters) -- With more women than ever seeking
bigger, shapelier, surgically enhanced breast in the United
States, the spotlight returns this week to the possible safety
risks patients face when they decide to get implants.
A much-publicized controversy over silicone-gel implants in the
early 1990s has made them unavailable for most women. But critics
say most are unaware that the alternative --saline-filled implants
-- has never been formally approved by the government.
"Most people have assumed saline must be safer than silicone gel,"
said Diana Zuckerman, head of the National Center for Policy
Research for Women and Families, which has criticized the US Food
and Drug Administration (FDA) for allowing the implants to stay on
the market without proof of safety.
"People should be making informed decisions based on objective
research information," she told Reuters. The first public scrutiny
of saline implants will come this week, when a panel of federal
advisers reviews the data at a three-day meeting starting on
Wednesday. The panel is expected to vote on whether implants made
by three firms meet safety and effectiveness standards and should
win formal FDA approval. The FDA has the final say but usually
follows its panels' advice.
The agency has permitted the sale of saline implants without
official approval because they were on the market before the
agency had authority over medical devices. The agency assumed they
were safe unless proven otherwise.
Three saline implants makers, Mentor Corp., Poly Implant
Prostheses and Inamed Corp.'s McGhan Medical unit, will present
data to the panel this week. If any product is deemed unsafe, the
FDA could take it off the market.
But most experts do not expect that to happen. They predict the
implants will win formal approval and spur even more interest in
breast augmentation. "Should they get the actual endorsement, it
should be extremely positive for the industry," said Preferred
Capital Markets analyst Kate Sharadin.
Silicone implants are currently available only for women with
breast cancer who want reconstructive surgery, about 5 percent of
all implant patients.
Implant makers and plastic surgeons acknowledge the potential for
some complications, including rupturing and infections, with
either implant type.
They note, however, that reports have cleared silicone implants of
any role in serious, chronic diseases such as cancer or lupus.
Dr. Lin Puckett, head of the American Society of Plastic Surgeons,
said physicians try to present a balanced view when they discuss
breast augmentation with women. "We're obliged to tell them to
deal with all of the alleged complications as well as the known
and real complications," Puckett said. Health groups, meanwhile,
say dozens of women with saline implants have reported breast
pain, implants that turn as hard as rocks and potentially serious
bacterial infections. Implants can also require replacement,
exposing women to the risks of repeated surgery and loss of their
own breast tissue.
Other women, some of whom will testify before the FDA panel, say
their saline implants caused autoimmune diseases that destroyed
their health. "Everything that has been reported with silicone gel
implants has been reported with saline implants," Zuckerman said.
"What's not clear is how often that happens."
The new attention comes when the breast implant business is
booming. About 150,000 women received implants last year, an
increase from the 125,000 annually before safety questions arose,
Puckett said, adding that about 95 percent of women were happy
with their implants.
To win new customers, manufacturers advertise in women's magazines
and offer financing plans, and surgeons' Web sites give women the
chance to send in photos and view themselves online with different
breast sizes. |
|
ARE SALINE
IMPLANTS SAFE? |
|
We recommend the use of surgery only as a last
resort, because of the possible hazards involved with such procedures.
We recommend first trying
Breast Enlargement Pills
|
|
If you have a testimonial you would like to share with us
Contact Us
|
Click
Here to BOOKMARK This Site
Click Here to make Breast Enlargement Magazine your Homepage
We would love to have your feedback about
our site!
If there's anything you think
should be added, omitted, or changed please Contact Us
and let us know.
We place a lot of stock in what our
readers have to say so please
let us know your
opinions!
| |
Home Page
