They say that besides ruptures, implants can lead to sometimes painful scar tissue, and occasional infections in a small number of women. Dr. Norman Anderson, associate professor of medicine at Johns Hopkins School of Medicine and a vocal critic of implants, says he's seen many women who have had trouble with their saline implants. Other difficulties include trouble with the valve through which the saline solution is pumped into the implant, and irritation to the surrounding breast tissue. There is not the scientific data to approve the implants. But Petrow, the Westchester County plastic surgeon, reports only two implant ruptures out of about 200 surgeries she's performed since 1978.
Any foreign body carries a risk of infection.
But with breast implants, it is less than 1 percent. Mentor Corp. The ruling mandates that women be apprised of the devices' risks before surgery. Those risks include the potential for rupture, requiring replacement of the implant, as well as the build up of some scar tissue and potential pain. With the data that has been presented, women and their physicians will be able to make informed decisions about whether the benefits are worth the risks. Breast implants were first marketed in the 1960s without FDA approval because the agency wasn't required to sign off on medical devices like implants until 1976.