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A Primer on Breast Implants
According to the American Society of Plastic
Surgeons (ASPS),
there were nearly 255,000 breast enhancement implant surgeries in
2003, nearly twice the number done in 1998. Another 68,000 women
received breast implants for reconstruction following mastectomy due
to cancer or other disease.
But also in 2003, 45,000 augmentation patients and 17,000
reconstruction patients had their breast implants removed. The
medical community and others, including the Food and Drug
Administration, would like to better understand why.
Breast implants are designed for augmentation, a cosmetic procedure;
reconstruction; and replacement of existing implants, called revision.
There are two primary types: saline-filled and silicone gel-filled.
Depending on the type of implant, the shell is either pre-filled with a
fixed volume of solution or filled through a valve during the surgery to
the desired size. Some allow for adjustments of the filler volume after
surgery. Breast implants vary in shape, size, and shell texture.
At this time, there are two manufacturers with approved saline-filled
breast implants. No manufacturer has yet received FDA approval to
market a silicone gel-filled breast implant.
The Silicone Controversy
Breast implants were first marketed in the early 1960s, before the
1976 Medical Device Amendments to the Federal Food, Drug, and
Cosmetic Act required a reasonable assurance of safety and
effectiveness to be shown for certain medical devices.
The 1976 law gave the FDA authority over such devices, but breast implants
were
"grandfathered" into the regulatory scheme, meaning that
manufacturers were not required to provide the agency with scientific
evidence of product safety unless questions arose about the safety
and effectiveness of these already-marketed devices. Silicone was
initially assumed by manufacturers to be biologically inactive and,
therefore, to have no harmful effects. |
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