UNK Saline Implant
Received Jul 31, 2026
Report 9617229-2026-14492 · MDR key 50104249
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
Female
- Capsular Contracture
- Breast Mass
Narrative
Description of Event or Problem
Healthcare professional reported "Capsular Contracture Baker Grade III", "Device Migration/Implant Malposition", "Correction of Asymmetry", "Change shape/size/style", "Ptosis" which is not device related and "Need for Biopsy/Tumor" via National Breast Implant Registry. Capsulectomy/Capsulotomy was performed. This record is for the left side. The device has been explanted.
Additional Manufacturer Narrative
The reported events are physiological complication and analysis of the device generally does not assist Allergan in determining a probable cause for these events.No contact information was provided for the initial reporter, therefore additional event, product, and/or patient details are not attainable.Reason for reoperation: Lump/Nodule and Capsular contracture, Baker grade III.