Silicone gel or saline?

Allan J. Parungao, MD FACS
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If you are considering breast augmentation, the FDA's Nov. 17, 2006 approval of silicone gel implants gives you more options than ever before. This is certainly good news—but it makes it even more important to make an informed decision.

Silicone gel implant FAQ

Q.	Who can get the new silicone gel implants?
A.	The FDA has approved silicone gel breast implants for cosmetic surgery in women age 22 and older, and for reconstructive surgery in women of all ages. “The age restriction for cosmetic surgery is so teenage girls will not get the implants until their bodies have fully developed,” said Dr. Daniel Schultz, director of the FDA Center for Device and Radiological Health.
Q.	How do silicone gel implants compare with saline implants?
A.	Silicone gel implants are widely regarded as looking and feeling more natural than saline implants. In Europe, where silicone gel implants have been widely available, they quickly replaced the saline-filled alternatives.
Q.	How are today's silicone gel implants different from those banned in 1992?
A.	The filling of the new silicone gel implants is thicker than that of the implants made in 1992 and before. Today's implants are filled with what is called cohesive gel, a substance with the consistency of a jellybean's filling. Even if the implant ruptures, the gel holds together, as shown in the photo to the right. And the shell of the new implants is also thicker to help prevent ruptures. Silicone gel implants were taken off the market in 1992 by then-FDA Commissioner Dr. David Kessler due to safety concerns, such as how often the implants ruptured in a woman's body and whether leaking silicone could lead to diseases as some women claimed.
Q.	What does the FDA say about the safety of cohesive silicone gel implants?
A.	After rigorous review, the FDA can offer a “reasonable assurance” that today's silicone implants are “safe and effective,” said Donna-Bea Tillman, director of the FDA Office of Device Evaluation. Studies have found no association between silicone implants and cancer or other life-threatening diseases, although the FDA is continuing to monitor for these risks. The FDA is also requiring each of the two manufacturers of silicone gel implants, Inamed Aesthetics and Mentor Corp., to study 40,000 women for 10 years to assess potential health problems. These studies will help answer questions on the implants' long-term safety.
Q.	What happens when an implant ruptures?
A.	One of the biggest differences between silicone gel and saline implants is what happens when they rupture. If a saline implant ruptures, the implant deflates almost immediately and the saline, or saltwater, is absorbed into the body. The rupture is immediately apparent from the loss of breast volume. A cohesive silicone gel implant may develop a “silent” rupture—one that is not noticeable and perhaps cannot even be felt. A woman may have a ruptured implant and never know it until she has a screening mammogram or MRI. A ruptured silicone implant should be removed as soon as possible.
Q.	What follow-up care does the FDA recommend for women with silicone implants?
A.	To help detect silent ruptures, the FDA recommends that women with silicone implants get an MRI screening three years after breast augmentation surgery, and every two years thereafter. Because these MRIs are not typically covered by health insurance, it is important to factor in the cost of the MRIs when considering silicone gel implants.

Patient: Debbie, age 40
Cup size before: AA
Cup size after: C

“I'm very thin—only 100 pounds—and after nursing three children, I was lacking in breast tissue. I got saline implants three years ago, but they didn't look natural—and then I developed rippling.

“I decided to get silicone gel breast implants, and they're fabulous! The new implants have made my breasts look much more natural. I'm a workout fanatic, and my silicone gel implants move with me—they bounce like natural breasts. And there's not that ridge that I had with the saline implants.”

Compare silicone and saline implants

Even when cut in half, the filling of a cohesive gel implant will not run. Today's silicone gel implants are designed to reduce the risk of silicone leaking into the body.

Photo courtesy of Mentor Corp.

There are now three grades of cohesive silicone gel breast implants.

The FDA's Nov. 17, 2006 decision approved level 1 implants.
The level 2 version, containing a thicker silicone filling, is expected to receive FDA approval soon.
The level 3 cohesive implants—popularly known as “gummi bear” implants—have the greatest density. It is not known when they will receive the nod from the FDA.

Patient: Heather, age 37
Cup size before implants: B-
Cup size after implants: C+

“My saline implants look very natural. I still see the same slope and curvature of my breasts now as before—only now they're bigger. And my clothes fit me so much better.”