Silicone Breast Implants Now Legal For
On July twenty-eight 2005, the FDA ended a 13
year ban on
silicone-gel breast implants and issued a letter of approval to
Mentor Corp allowing the reintroduction of these controversial
implants into the medical marketplace. This move came about as
Mentor Corp. persuaded the FDA that its newer silicone implants
are less dangerous and even more durable than older versions.
The company will employ these implants only under the following
strict safety conditions approved per FDA guidlines:
- Prospective patients must sign a consent form acknowledging
that they realise the risks of a silicone breast implant
including the fact that they may break and require replacement
or even removal.
- Mentor is only allowed to sell silicone breast implants to
board-certified plastic surgeons who complete a successful
practical training program to learn how to insert these
implants in a way that minimizes the odds of tears and
- Mentor must make and maintain a registry to track the implant
patients long term results.
- Patients must be educated about the fact that if an implant
breaks, the effect of the breakage occasionally does not cause
immediate symptoms. Further, patients are advised to have an
MRI after five years and two years thereafter to check for
- Mentor must conduct a 10 year study to determine the
percentage of breast implants that will break in that time.
- The implant study must be audited by an independent
- The FDA will review the results of the Mentor breast implant
program in five years to verify that the implants are
performing as expected.
Based on data from the American Society for Aesthetic Plastic
Surgery, 334,052 breast augmentations were performed in the
United States in 2004, mostly using salt water filled implants
being sold without restriction. Consumer studies predict that
if the silicone breast implants return to the market, 200,000
women will visit plastic surgeons to get them in the first
year. Health concerns aside, silicone implants have a more
"natural" appearance and consistency than the saline version,
and are therefore preferred by consumers.
Silicone-gel breast implants were first introduced in 1962 andwere banned in 1992 amid health fears. Research since then has
shown no statistical correlation between silicone breast
implants and cancer or even rare auto-immune diseases such as
lupus. A select few women will swear that their health
deteriorated from the moment they received their implants,
however this is anecdotal evidence. When researchers do studies
comparing a large group of women with implants to an equal-sized
group without them, no difference between the 2 groups is
observed in the number of women with tumors or autoimmune
The most commom problem reported is formation of excess scar
tissue around the breast implant due to a foreign-body
reaction. If it's localized, it can cause traction and rippling
effects in the appearance of the implant. If the scar tissue
entirely encircles the implant the condition is called capsular
contraction. These scars can mold the implant into an unnatural
rounded shape, so that the implant patient appears to have a
baseball stuck under the skin on her chest. This condition
develops more frequently with smooth-walled silicone implants,
though it occurs to a lesser extent with saline implants as
well. Implants set behind the chest muscle have a much lower
incidence of this problem. As the scar tissue tends to re-form,
surgeons can every now and again break the scar tissue manually.
However this is proscribed by the manufacturer, as it can break
the implant and void the manufacturer's warranty. Typically,
patients with breast implant contractures require follow-up
Surprisingly , the asthma drug Accolate has proven useful in
preventing and even reversing capsular contraction, though
months of drug treatment may be necessary.
Other possible complications include seroma (a collection of
serous fluid), hematoma (blood), synmastia (breasts that pop up
to be fused in the center), bottoming out (implant slides too
far down the chest), double-fold ( the implant's outline
doesn't corresspond to the natural crease of the breast),
deflation (the implant breaks), tissue necrosis (localized
demise of tissue) and infection.
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