ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
|
Back to Search Results |
|
Catalog Number 115-378 |
Device Problems
Device Appears to Trigger Rejection (1524); Insufficient Information (3190)
|
Patient Problems
Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/27/2022 |
Event Type
Injury
|
Event Description
|
Patient reported right side "feels harder like there is a ball in there", and exchange "due to patient's concern with product." healthcare professional later reported "capsular contracture baker grade unknown" and "exchange of textured device due to product concern".Device remains implanted.
|
|
Manufacturer Narrative
|
A review of the device history record has been completed.No deviations or non-conformances noted.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.
|
|
Event Description
|
Healthcare professional later reported baker grade "i or ii".Events reported are non serious.
|
|
Search Alerts/Recalls
|
|
|