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In 1992, at the height of the panic over
the safety of silicone breast implants, some women were so alarmed that they
tried to remove their own implants with razor blades. That year, the Food and
Drug Administration blocked general use of the silicone implants, citing lack
of conclusive evidence about their safety and effectiveness.
A decade later, a key advisory committee to the Food and Drug Administration
recommended that silicone breast implants be allowed back on the market. The
FDA should listen to its advisory board's informed conclusion and permit silicone
implants to be used again.
The use of silicone implants, either to enlarge breast size or reconstruct a
breast damaged by cancer, dates back to 1963. Since then, more than one million
American women have received them.
The possibility that silicone implants could cause disease was recognized as
early as 1978, though the issue gained notoriety when CBS aired an implant feature
on "Face to Face with Connie Chung" in 1990. During the show, Chung called silicone
gel "an ooze of slimy gelatin that could be poisoning" women. The comment caused
one stampede of women rushing to have their implants removed and another to
file lawsuits against implant makers.
Largely swayed by public opinion, the FDA restricted the use of silicone implants
to clinical studies and breast reconstruction in cancer patients. Meanwhile,
the barrage of lawsuits drove the main implant manufacturer, Dow Corning, to
bankruptcy and led to settlements worth billions of dollars for the 'victims.'
Saline implants, though considered to be second-rate in look and feel, took
over the market.
Those who scorn cosmetic surgery may see no good reason to give the implants
another chance, but a lot of women want them. In 2001, American women spent
$668.9 million on breast augmentation, according to the American Society of
Plastic Surgeons. Women between the ages of 19 and 34 accounted for 56 percent
of the spending.
Plus, silicone implants are generally preferred to saline ones because they
give the breast a more natural feel and look. Katina Hudson, a Pompano Beach,
Fla., resident who prefers silicone, received saline implants five years ago
and soon grew unhappy with them. "You were able to see the saline bag," Hudson
said. "My husband wasn't happy at all. He could feel the sack."
Though silicone implants provide a better cosmetic effect, some say they are
dangerous since the implants may rupture, releasing silicone into the body.
Implants do break: Data from FDA studies indicates that on average, a quarter
of implants rupture within 12 years and 55 percent break within 16 years. In
the first few years though, the rupture rate is about 1.2 percent. Opponents
claim that the silicone released from the broken implants triggers an immune
system response that causes a wide variety of diseases, from cancer to rheumatoid
arthritis. However, there is little to no scientific evidence to support this
assertion.
The Institute of Medicine released a 500-page document in 2000 in which they
evaluated research done on silicone implants. After assessing a wide range of
scientific studies performed, the Institute concluded that silicone from the
breast implants did not result in a nasty immune response, or that the implants
were linked to any disease.
Comparatively, the saline implants currently used break as well. Researchers
at the Washington University School of Medicine have shown that bacteria and
fungi can grow in the saline implant, and there is concern that these may be
released into the body if the implant breaks. If saline implants can be approved
by the FDA, then silicone ones should be as well.
Also, some 1.5 million patients receive silicone eye lenses and another 670,000
get artificial silicone joints each year. These medical devices have not produced
the side effects attributed to silicone implants, though they contain the same
chemical. Since both the lenses and the joints are approved by the FDA, silicone
implants should be no different.
Even so, a surprisingly high proportion of silicone implant patients - from
21 percent to 46 percent depending on the type of patient - require further
surgery within two years due to complications from the implants or to achieve
a better cosmetic result.
But, silicone implants should not be banned because of this. Rather, women who
wish to use them should know that a large number of patients tend to need follow-up
surgery. It makes sense for the FDA to give women the choice of which implant
to get as long as the patients are warned of the safety risks.