Style 68 Saline Filled Breast Implant
Received Jul 27, 2026
Report 9617229-2026-14113 · MDR key 50028116
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68HP-465
Lot number
3191806
Product problems
- Device Appears to Trigger Rejection
Patient
Not reported
- Capsular Contracture
Narrative
Description of Event or Problem
Patient reported "breast pain and Capsular Contracture Baker grade Unknown". This record is for the left side. Device remains implanted.
Additional Manufacturer Narrative
This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026. 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.