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By admin, June 18, 2009 3:13 pm

The so-called “gummy bear” implants are more cohesive silicone gel-filled breast implants made of a firmer silicone gel filler to help maintain the shape of the implant. At this time, these breast implants are available only through clinical studies being conducted by Mentor and Allergan (formerly Inamed).

Source: http://www.fda.gov/

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By admin,

Platinum is a metal used in the manufacture of the shell and gel components of silicone breast implants. FDA fully evaluated the scientific literature on platinum. Based on the existing literature, FDA believes that the platinum contained in the implant shell and gel is in the zero oxidation state, which poses the lowest health risk. This is further supported by the available biocompatibility testing, gel bleed testing, and clinical data on these implants.

Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063719.htm#1

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By megdilts, June 3, 2009 4:49 pm

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 Implant.

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 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.

Source: FDA

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By admin, May 15, 2009 12:11 pm

There are several ongoing clinical studies (i.e., investigational device exemption (IDE) applications) of saline and silicone gel-filled breast implants. These studies include those for the more cohesive silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed), as well as studies conducted by other manufacturers. These devices are still in research and have not been approved for marketing.

In addition, Mentor and Allergan will are conduct studies on patients who get silicone gel-filled breast implants after they are approved.

Source: U.S. Department of Health and Human Services