Breast implants are pads of silicone or saline encased in a rubber-like shell. They look like nipple-less falsies and are surgically implanted generally under the pectoralis muscle (located under the breast).
Silicone Gel-filled Implants
In 1992, the Food and Drug Administration (FDA) called an immediate halt to silicone breast enlargement. The moratorium did not apply to breast implants that are filled with salt water (saline). This halt resulted from evidence that the devices had been known to leak or rupture, bleeding silicone into the body. The makers had not been able to determine how often it happened or with what consequences. Nor could the manufacturers say how long silicone implants normally last, or how often migrating silicone prompts the immune system to attack health tissues.
An advisory panel recommended leaving the devices on the market pending safety studies. The FDA, however, after canvassing rheumatologists about implant-related immune problems and reviewing confidential industry documents, called for a halt until further study. After a careful evaluation of the risks and the alternatives to silicone gel-filled breast implants, the FDA decided the implants should continue to be available. In 2001, more study data suggested a possible association between silicone gel (that had leaked outside the scar capsule that forms around the implant) and fibromyalgia. In other words, women should know there is a potential risk of developing fibromyalgia if their breast implants rupture and silicone gel escapes the fibrous scar capsule (see Possible Risks section).
In May 2000, the FDA granted approval of Mentor and McGhan Saline-filled Implants. All other manufacturer’s saline-filled implants are considered investigational and you must enroll in a study to receive them.
Alternative Breast Implants
In 1997, there was one approved Investigational Device Exemption study of an implant called Trilucent (a silicone shell filled with soybean oil), which resulted in the FDA advising women with Trilucent breast implants to have them removed (see http://www.trilucentinfo.com).