Style 68 Saline Filled Breast Implant
Received Jul 31, 2026
Report 9617229-2026-14513 · MDR key 50107859
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68-420
Lot number
1197823
Product problems
- Device Appears to Trigger Rejection
Patient
Female
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "Capsular contracture" Baker Grade unknown and "rippling ". This record is for the left side. Device remains implanted.
Additional 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.