Breast Implants Talk » silicone gel-filled breast implants

Safety Information of Silicone Gel-Filled Breast Implants

admin — Tue, 11 Oct 2011 20:53:55 +0000

Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.

Breast implants are not lifetime devices. The longer you have implants, the more likely it is that you will need to have surgery to remove them.

The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).

MRI continues to be the most effective method of detecting silent rupture of silicone gel-filled breast implants. If you have silicone gel-filled breast implants, the FDA recommends that you receive MRI screening for silent rupture 3 years after receiving your implant and every 2 years after that.

Source: The FDA

You need to be 22 in order to have silicone gel-filled breast implants

admin — Wed, 11 Aug 2010 20:02:53 +0000

As younger and younger women are considering breast implants. We get many questions such as the age limit. The FDA has the following age limits:

You need to be 22 in order to have silicone gel-filled breast implants
You need to be 18 to get saline-filled breast implants for augmentation

However, these are required by the FDA, it doesn’t mean that you should consider them at such young age. There are, many risks associated with breast implants. You could experience breast pain, changes in nipples, and even rupture with deflation for saline-filled implants.

Source: FDA

Will the platinum in silicone breast implants harm me?

admin — Thu, 18 Jun 2009 19:04:47 +0000

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: FDA

Several ongoing clinical studies of saline and silicone gel-filled breast implants

admin — Fri, 15 May 2009 16:11:19 +0000

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