Are
silicone breast implants safe? Thirteen years after most use of
silicone-gel breast implants was banned due to safety concerns,
the Food and Drug Administration (FDA) seems to have changed its
tune.
In a three-day hearing, two silicone implant manufacturers -- Inamed
and Mentor corporations -- were given the opportunity to prove their
implants were safe and durable enough to re-enter the U.S. market.
And, in addition to the manufacturers' "sales pitches,"
more than 160 witnesses presented their pleas on both sides of the
issue -- some of which shared horrific testimonies of ruptured silicone
implants squeezing out of their eyes and ears.
FDA's Verdict
Despite arguments about serious health
problems caused by silicon implants, the FDA panel unexpectedly
approved Mentor's application in a 7-2 vote. The decision
surprised many experts for two compelling reasons:
-
Not only had the panel voted to reject a similar application
from Inamed, Mentor's top competitor, one
day prior, but
-
Mentor was largely considered the weaker of the two applications,
as it followed patients in its principal breast-implant study
a year less than Inamed.
Trouble-a-Brewin'
Silicone implants have only been available since 1992 to women
participating in controlled research studies; however, due to the
FDA's approval of Mentor's application, more women have become eligible.
What does this mean? Considering more than 260,000 breast augmentation
procedures and more than 62,000 breast reconstruction procedures
were performed in the United States last year alone, the number
of women vulnerable to the adverse side effects of silicone implants
is poised to rise.
USA
Today
April 11, 2005
New
York Times April 14, 2005
Houston
Chronicle April 14, 2005