Inside Implants

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In 1992 the FDA placed a moratorium on silicone gel implants. From that time until 2006, saline breast implants were the standard implant, until the approval granted in 2006 for silicone gel implants which are the round gel-filled breast implants now widely available and which most people are familiar with. Anatomic shaped silicone gel implants (aka gummy bear implants, cohesive, form stable) have only been approved in the USA since April 2013. There seems to be a lot of confusion as a result of the different marketing tactics used by the manufacturers.

Why did the FDA finally approve the gel implants again?
In 2006 the FDA released silicone breast implants back on the market after studies were unable to clearly link the silicone gel implants to any specific illness, including autoimmune diseases or cancer. The implants which were released were considered to be the fourth generation of implants, with increased thickness of the implant shell, and increased cohesiveness of the silicone gel inside.

Why do some people prefer saline versus gel, or vice versa?
People often consider the saline implants to be “safer”, due to fewer worries about leakage of the saline, as the body will absorb the saline and the implant will deflate. The downside is that the patient may wake up one morning having lost all volume on one side and remain asymmetric until it can be replaced. Since this is not considered a medical emergency, this could take a few weeks to schedule the necessary surgery.

People who prefer gel implants like them because they are softer to the touch and feel more natural than the saline implants. They can also look more natural as well. They have less of a tendency for rippling at the top of the breast, which is an unwanted side effect of many large implants which stretch and thinthe overlying tissue, and is usually worse with saline implants than silicone.

What does cohesive gel mean?

Cohesivity means how “sticky” is the gel versus how “runny” it is. This is varied based on the crosslinking between the molecules. In the past, the silicone gel was more “runny”, almost like the toy “Slime” of many years ago. Most round implants now have gel which has more the consistency of jelly or slightly stiffer. The form stable anatomic gel implants have gel which maintains its shape even better, often being described like a gummy bear consistency. This allows the form stable implant maintain its shape better in different positions and helps influence the shape of the overlying breast more than its less cohesive counterparts.

What are the benefits of the anatomic form stable implants?

They can provide a more natural looking breast form, with the portion of the breast above the nipple not having a noticeable a “shelf” appearance which can often occur with round high profile or large implants. They can also help shape a breast which needs more fullness, especially in the lower portion of the breast. This often occurs with women who have tight or constricted breast deformities. They can help alleviate rippling which may occur with women who have previously been augmented or who have thin overlying tissue. Their early statistics regarding capsular contracture and leakage are significantly less than their other counterparts.

What are the concerns with these implants?

They can rotate in the pocket, causing an unusual shape. They are slightly firmer than the other gel implants. They tend to cost more, and require more expertise in placing them. They differ in their measurements, and require more thought and precise dissection by the surgeon. Additional training is of great benefit to the surgeon as these implants are not quite the same as other implants.

Breast augmentation is still one of the most popular procedures in the USA; in fact there has been a 210% increase from 1997 to 2013. The options available to improve breast shape and volume continue to increase our ability to give better results, tailored to what the individual is seeking.

Article by
Orlando Plastic Surgeon