Allergan did not submit this mdr within 30 days of becoming aware. Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume. Allergan is implementing a plan to address the increased volumes. ? A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Reason for reoperation: capsular contracture, baker grade unknown and gel bleed.
Patient Sequence No: 1, Text Type: N, H10
A patient reported they experienced the events of? Recurrent capsular formation with painful symptoms? ,? General malaise? ,? Joint pains? ,? Increase in known allergies? ,? Asia (autoimmune syndrome induced by adjuvants) syndrome? , and? Release of silicone particles? With a style 410 cohesive silicone gel filled breast implant on the left side. Device has been explanted.
Patient Sequence No: 1, Text Type: D, B5