Why do companies file summary reports of adverse events, instead of individual MDR reports for breast implants?
Summary reporting is an alternative way of reporting to FDA for well known and well documented adverse events. It has been in effect for silicone gel-filled and saline-filled breast implants for many years. Summary reporting for these types of events promotes more efficient processing and analytic review for FDA and the companies. On the other hand, companies are required to file individual MDR reports for any unexpected or unusual adverse events that may be related to breast implants. Deaths must always be reported individually.
