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WASHINGTON (AP) - One in five adults has a little hole in the heart. Most will never know it. But the defect may play a role in certain strokes and severe migraines, leading thousands to get devices implanted to seal it shut.
The problem: Doctors haven't yet proved when the hole is harmful, and whether fixing the heart in turn helps the head.
It's a controversy dividing cardiologists, even as use of the umbrella-shaped implants steadily rises. Now the Food and Drug Administration has taken an unusual step to push manufacturers to settle the issue, stopping promotion of the expensive implants.
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