A study of 1,680 women who had saline breast implants (supposedly the 'safe type') revealed that up to 27 percent of the implants were removed within three years of implantation, most because patients suffered painful scar tissue, an infection, or the implant broke and leaked, FDA officials said. The study was conducted by one of the implant manufacturers, Mentor.
An FDA panel has been investigating the saline implants to see if they are safe enough to be approved.
Saline implants have been sold as the breast augmentation of choice due to the bad rap silicon implants received a couple of years ago. Silicon implants are still available but only for surgeries for breast cancer survivers.
About a dozen saline breast implant recipients, some tearful, told the panel Wednesday that saline implants are defective and dangerous and should be banned. Some held up implants removed from their bodies that were blackened with fungus, and blamed them for causing infections, excruciating breast pain or repeated surgeries.
"Only fools will call these risks acceptable," said Patricia Faussett of Henderson, Nev., who said her illnesses disappeared once her implants were removed.
Saline implants are highly prone to deflating as the salt water leaks into patients' bodies, FDA said. Up to 9 percent deflated within three years.
Despite the dangers of saline implants, the advisory panel recommended that the FDA allow them to remain on the market if women who were to receive them would be properly warned about the risks. This decision came, following a tense 13 hours of testimony and debate.
Calling the implants' failure rates "alarmingly high," Dr. Stephen Li of New York's Hospital for Special Surgery added: "It's amazing to me it seems to be tolerated as just something you have to live with in these implants."
The FDA noted that the longer all women have implants, the more likely
they are to suffer a side effect.
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