UNK Saline Implant
Received Jul 28, 2026
Report 9617229-2026-14235 · MDR key 50054452
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
UNK Saline Implant
Product problems
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Healthcare professional reported "capsular contracture, Baker grade IV". This record is for the right side. Device remains implanted.
Additional Manufacturer Narrative
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 IV.sThis report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.