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For Immediate Release
October 16, 2003
F.D.A. Panel Backs Silicone Breast
Implants
Gaithersburg, MD. After eleven years
off the market, an advisory panel to the Food and Drug
Administration has voted to recommend that silicone breast
implants be allowed to be used in breast surgery.
The FDA typically follows the recommendations
of the advisory panel and expects to make a ruling on
this decision within weeks, although no specific time
frame has been given.
Inamed Corporation, maker of silicone gel implants, has
agreed to certain conditions, such as increased education
for physicians and patients who use the implants and continued
monitoring of women who get implants.
Breast augmentation and reconstruction
surgery has been performed primarily with saline-filled
implants over the last decade, due to health concerns
with silicone gel implants. The studies haven't concluded
these health risks to be attributable to the silicone
implants, which many women believe feel softer and more
natural. Inamed testified that their device has been improved
over the last decade with a thicker shell and filling
it with a more cohesive gel, to reduce risk of rupture.
Should you be interested in finding out
more about silicone gel breast implants, please contact
our office at (425) 827-7878, or Make
an Appointment here.
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