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.
Wyatt
Jeanne Prin
JP
D018427:Breast Implants / Q000009:adverse effects*; D004282:Documentation / Q000592:standards; D020408:Health Insurance Portability and Accountability Act / Q000331:legislation & jurisprudence; D006801:Humans; D024802:Nurse's Role; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011475:Prosthesis Failure; D013518:Surgery, Plastic / Q000451:nursing; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration