Reporting breast implant complications.
The Food and Drug Administration (FDA) defines a complaint (or complication) as "any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution." The FDA, the medical device manufacturers, and the health care providers using these devices share the responsibility for complaint reporting, investigation and follow-up. Each has unique yet interrelated roles and responsibilities in this process.
Breast Implants↗