Safety Issues Related to Saline and Silicone Implants

The Food and Drug Administration (FDA) has approved both saline and silicone implants as safe and effective alternatives for women who wish to undergo breast augmentation or reconstruction surgery. This was not always the case for silicone implants, however. The FDA actually banned the use of silicone implants for 14 years, from 1992 to 2006 due to claims that the silicone was responsible for causing harm to patients, including disease and cancer. (Some mastectomy patients during the ban as well as clinical trial patients were still able to get silicone implants.) Extensive FDA studies during this timeframe concluded that the claims were not substantiated and silicone implants were back on the market.

Today, the FDA approves:

• Saline implants for women age 18 and older
• Silicone implants for women age 22 and older

At the onset, both saline and silicone implants start out the same way: with a silicone shell. It is what the shells are filled with that makes the two distinct.

• Saline implants are inserted into the chest cavity empty and then filled with a sterile saline solution until the desired size is achieved. The solution is not compressible and can result in more firm breasts if not given special consideration by Dr. Joseph.
• Silicone implants are pre-filled with a sticky consistency that is similar to human fat. As a result, some women feel that this type of implant produces a more natural appearance.

Potential Risks

Any type of breast implant carries potential risks and complications. Women who have implants should be keenly aware of any odd sensations or appearances with their breasts to keep themselves as safe and healthy as possible. Risks can include:

• Rupture/leaks and breast deflation
• Infection
• Capsular contracture (tightening of the scar tissue around the implant)
• Pain in one or both breasts
• Sensation changes in the breasts

Considerations

It can be more difficult to have accurate mammograms with breast implants. It is important for women with implants to inform mammography technicians about the implants prior to the screening.

The FDA continues to closely monitor patients who have received both silicone and saline implants to ensure that these products are truly safe.

Dr. Brian Joseph, Orlando cosmetic surgeon, is committed to giving patients all of the information necessary to make an informed decision about breast augmentation surgery. Please contact our office today for a free breast implant information consultation.

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