Silicone vs. Saline Implants

Millions of women have silicone and saline breast implants. Saline implants, like silicone gel implants, do not last a lifetime and are not free of risk. Both kinds of implants are associated with risk and complications listed in the FDA Consumer Handbook. Even though saline and silicone implants are FDA approved, there are doctors and scientists who question both silicone and saline implant safety and effectiveness.

Breast implants have been on the market for over forty years. Silicone gel-filled breast implants have been used by women since the early 1960s, but were not FDA approved until 2006. Saline implants were approved by the Food and Drug Administration (FDA) in 2000, and marketed as an alternative to silicone gel implants which had been embroiled in safety controversy.

Saline implants are not “silicone free”

A saline implant is comprised of a shell or “sac” that is filled with sterile saline solution. Many women do not know that that the shell of saline breast implants is made with silicone components. Since saline implants have been marketed as an alternative to the more controversial silicone gel implant, many women assume that saline implants are silicone free and therefore safer.

The FDA handbook states that platinum is used in the manufacturing of the shell of saline and silicone implants. Some researchers believe that platinum is linked to illness in some breast implant users. The FDA has reviewed studies on platinum and stated that there was no evidence that platinum or other changed forms of platinum cause illness in women.

Both Saline and Silicone Implants have risks

Rupture and Deflation are risks associated with both saline and silicone implants. Studies presented to the FDA in 2000 showed saline implant rupture and deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients. These same studies showed rupture and deflation rates of 6-9% at three years and 8-18% at 5 years for reconstruction patients.

Rupture rates for silicone implants are sharply debated. Some experts argue that the rupture rate for silicone implants reaches 50% more after 10-12 years and as high as 90% after 15-20 years. Manufacturers presented short-term safety data to the FDA, only following women for four years, showing much lower rupture rates.

If a saline breast implant ruptures, the sac deflates and the saline solution is usually absorbed into the body’s natural fluids. Most women will know that their saline implant has ruptured because the breast will feel or look different.

Unlike in saline implants, a rupture in a silicone implant often goes undetected because the breast may not change in shape or appearance. This is often referred to as a “silent rupture.” The FDA recommends regular MRIs to detect ruptures.

Wendi, one of the main characters in ABSOLUTELY SAFE experienced a silent rupture. Her silicone implants were severely ruptured, but outwardly her breasts did not appear changed. In fact, numerous doctors told Wendi that her breasts looked healthy and her implants were intact. During Wendi’s ex-plant operation, Dr. Melmed discovered two severely ruptured silicone breast implants. Dr. Melmed believes Wendi’s ruptured silicone implants were connected with her many illnesses.

Loss of nipple and breast sensation is another risk associated with saline and silicone implants. Deneé, one of the characters in ABSOLUTELY SAFE, temporarily lost breast sensation after her implant surgery.

For a thorough list of risks and complications associated with saline and silicone breast implants, please visit the FDA website and read the Consumer Handbook chapter on breast implant complications.

• Return to the Absolutely Safe film info page.