In my Walnut Creek Plastic Surgery practice I use both silicone gel implants and saline implants. The ratio of Silicone to Saline Implants is about 50:50. For my San Francisco Bay Area Breast Augmentation patients I make the decision of which to use based on patient preference and the relative advantages and disadvantages of the two implants. Below I have tried to summarize where we stand with Silicone Gel Implants as of the Summer of 2009, including the fourth generation Gummy Bear implants.
The FDA Approved silicone gel implants as safe and effective two and one-half years ago. While they were available long before this, this was before the FDA had its current approval process. The number of breast augmentations increases yearly, and since FDA approval the use of silicone gel implants has continued to increase.
Currently in the United States there are two fillers available for breast implants. Both have been used for decades. The Saline filled breast implants received FDA approval in 2000, and Silicone Gel filled breast implants received approval in 2006.
A newer Silicone Gel Filled Breast Implant is still awaiting FDA approval. (Edit: they have been approved since the time this article was published.) Sometimes referred to as Gummy Bear (or Gummi-Bear) implants because of the nature of the filling, these implants are a polymerized silicone gel that retains its shape similar to the candy treat. While soft and deformable, these implants have a memory, and like a stress ball, return to their original dimensions. The biggest advantage of these implants is that they cannot leak.
While the implants are very similar, and in some ways superior to the currently available breast implants, the FDA has yet approve them for unrestricted use. The same implants have been approved in Canada for two years and in Europe for a decade with good results.
Three companies manufacture these “4th generation’ breast implants. Allergan Aesthetic’s brand name Natrelle “gummi-bear” implants are called 410’s from their catalogue number. Mentor calls theirs the Contour Profile Gel (CPG) implants. Silimed, also makes these types of implants; however, Silimed implants are not currently available in the US.
The shell covering all these implants is silicone. It is well tolerated in the body. Silicone is used to make many devices that are implanted in the body – from breast implants to catheters to artificial joints.
The main advantage to silicone filled breast implants is the way they feel. The implant is soft and more difficult to feel inside the breast. Saline implants ripple (wrinkle) more frequently and this can be felt (and sometimes seen) through thin skin. Gel implants are less likely to have palpable rippling.
The disadvantage is that it is more difficult to tell if a silicone gel implant has a leak. If the gel is contained inside the normal pocket of scar around the implant, everything may look and feel completely normal. Silicone gel implants are also more likely to get capsular contracture (tightening of the scar around the implant) especially if placed in front of the pectoralis muscle.
As an investigator for both US implant manufacturers I can say that the choice of which to use depends on many variables. It is important to discuss with your Board Certified Plastic Surgeon the goals for your breast augmentation. The relative risks and benefits can be evaluated, and the best implant for you can then be determined.