Dear Flat as a board,

Saline implants are made up of silicone packets filled with salt water. They were already in use in 1976, when the Food and Drug administration began regulating medical devices. Under a "grandfathering" clause, they were allowed to stay on the market without regulation, although there was a provision that at some point in the future, manufacturers of the implants would have to prove their safety and effectiveness. As of April, 1995, the FDA has not yet demanded any research to be submitted, making the safety and efficacy of the implants unknown at this point. This may be why you had trouble finding any information.

The Department of Health and Human Services does however, provide information for women considering saline-filled breast implants. For each woman, whether her goal is augmentation or reconstruction, the benefits and risks may be different. It's important that you make an informed decision together with your doctor to decide whether or not you want to accept the possible risks in order to achieve the expected results.

Known risks of saline breast implants are as follows:

• The same general risks as any other surgery, including anesthesia.
• Implant deflation. Breast implants can deflate or rupture at any time due to an injury to the breast or through normal wear over time. The deflation usually happens quickly, and because salt water is a natural part of the body, it is absorbed by the body. Surgery is necessary to remove, and perhaps replace, the silicone envelope.
• Breast cancer detection. During a mammography, it may be more difficult to detect breast cancer because the implant can cover up areas that might otherwise give reason to take precautions. The mammography technician must be made aware of your breast implant before taking x-rays, because there are special techniques that can be employed to get the best possible views of the breast tissue with the implant in place.
• Capsular Contracture. The scar tissue or capsule that normally forms around the implant might tighten and squeeze the implant (called capsular contracture). Over months to years, some women have changes in breast shape, hardness or pain as a result of this contraction.
• Calcium deposits in the tissue around the implant.
• Additional surgeries.
• Infection.
• Hematoma.
• Delayed wound healing.
• Changes in feeling in the nipple and breast.
• Shifting of the implant.

The FDA espouses that saline implants have a lower risk of causing physical problems than silicone implants. However, there are still many unanswered questions due to the lack of adequate research. The FDA has a 60 page information package available about breast implants. To request the packet, write: Breast Implant Information, Office of Consumer Affairs, 5600 Fishers Lane, Room 1685, Rockville, MD 20857 or call (301)443-3170. Good luck with your decision and remember: although breasts have come to mean a variety of things in our society, if you FEEL beautiful, you ARE beautiful, no matter what size breasts you have!

Alice