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Types of Breast Implants
A breast implant for plastic surgeryis a silicone elastomer (rubber) shell filled with a salt-water solution known as saline.
In 1992, the Food & Drug Administration (FDA) decided that more safety and effectiveness information was needed on the type of breast implant filled with silicone gel, and greatly restricted the use of these implants in the United States. Saline-filled implants continue to be available to breast augmentation patients on an unrestricted basis.
Saline-Filled Breast Implants
The three types of saline-filled breast implants are as follows:
Type I
One type is a single lumen implant that is filled during the operation with a fixed volume of saline through a valve. There are no adjustments of the saline volume after the operation.
Type II
A second type is a single lumen implant that is filled during the operation with saline through a valve. This type of implant allows for adjustments of the saline volume after the operation.
Type III
A third type is a single lumen implant that is prefilled by the manufacturer with a fixed volume of saline. There are no valves for filling during the operation or for adjustments of the saline volume after the operation.
The silicone rubber shell for a saline-filled breast implant has the following general composition:
cured polymeric (large) silicones
approximately 20% of finely powdered silica that is tightly bound to the silicone polymers
small amounts of smaller silicones
minute amounts (parts per million) of metals, including a metal catalyst (usually tin, zinc, or platinum) (A catalyst is something that causes a change in material.)
traces of readily evaporating materials (volatiles), such as xylene and other organic compounds.
The filler is sterile saline that should conform to United States Pharmacopeia (USP) standards for Normal Physiological Saline (injection grade). 2
Silicone Gel-Filled Breast Implants
The three types of silicone gel-filled breast implants are as follows:
- One type is a single lumen implant that is prefilled by the manufacturer with a fixed volume of silicone gel.
- A second type is a double lumen implant with (1) an inner lumen prefilled by the manufacturer with a fixed volume of silicone gel and (2) an outer lumen that is filled during the operation with a fixed volume of saline through a valve.
- A third type is a double lumen implant with (1) an outer lumen prefilled by the manufacturer with a fixed volume of silicone gel and (2) an inner lumen that is filled during the operation with saline through a valve. This type of implant allows for adjustments of the saline volume after the operation.
A silicone gel-filled breast implant has a silicone rubber shell with the same general composition as shown in the Saline-Filled Breast Implants section above.
The filler is silicone gel that has the general composition of:
silicone oil
cured polymeric (large) silicones
small amounts of uncured large and smaller silicones
minute amounts (parts per million) of metals, including a metal catalyst (usually platinum). (A catalyst is something that causes a change in material.)
Alternative Breast Implants
An alternative breast implant plastic surgery typically has a silicone rubber shell with a filler other than saline or silicone gel. The filler material may or may not be a gel. An alternative breast implant may also have an alternative shell other than one made from silicone rubber.
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