There's still a risk



Orlando Sentinel: "FDA APPROVED" undoubtedly will accompany promotions trumpeting the reintroduction of silicone implants to the cosmetic breast-enhancement market.
But so should this: "BUYER BEWARE."
The devices' return next month comes after a government imposed, 14-year ban that caused 300,000 women annually to select the less comfortable, less natural-looking saline implants.
But the Federal Drug Administration's finding that the new silicone implants carry a "reasonable assurance" for safety and effectiveness falls short of saying they're risk-free. They're not, though they're improved over earlier models that frequently ruptured. Still, anyone who gets them will need regular MRI exams and at least one additional surgery to replace the devices as they wear out.
Ten-year audited studies
Moreover, though the FDA insists large, credible studies failed to find a definitive connection between the silicone implants and cancer or connective-tissue disease, smaller, less reliable studies by other groups suggest linkages to serious illnesses. Because of that, the FDA will require the implants' manufacturers to conduct 10-year, audited studies of thousands of women receiving the new implants.
The agency says nothing it approves carries definitive proof that it's absolutely safe for all people. And the silicone implants will carry warnings about possible problems.