"We want to have graphical representations of what the poor cosmetic outcomes are, because that's the major problem with the products," says Feigal.
Plastic surgeons are understandably unhappy with that idea. "Unfortunately, there's a great deal of possibility of misinformation being given by such a tack, and we have not actively encouraged the FDA to proceed in that way," says Daniel Morrello, MD, president of the American Society for Aesthetic Plastic Surgery.
Activists want patients to get explicit information. "So we're going to try to do as much as we can on a grassroots level to let women know: if you're talking to a doctor about implants, and you're not getting handed the FDA brochure, you're not getting good quality care. Don't go any further," says Pearson. Another question is whether doctors will follow the three-to-seven day waiting period suggested by the FDA before doing the operation. Individual states, not the FDA, must enforce that requirement.
The FDA specifically approved the implants for women at least 18 years old, but some doctors at their discretion will probably put the devices in younger patients. "That [limitation] short changes many younger women who've got congenital birth defects who could really have their adolescence and their life significantly improved," says Cunningham.
But is that a decision some patients will come to regret? "No breast is worth your life. These are cosmetic devices, whether you receive them for augmentation or reconstruction," says Swanson.