Article: "[Medical] device makers and sellers are the only entities required to report adverse events to the FDA ... 'When a physician does report, what they’ll generally do is tell the device rep ... After that you’re just trusting that device rep'"
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medscape.com
FDA Recall Problems Raise Questions About Safety, Liability
Recalls of implanted medical devices rely on a confusing, ineffective system that can endanger patients’ lives and expose clinicians to legal liability, medical device safety advocates say.