InjuryFWM
Style 68 Saline Filled Breast Implant
Received Jul 30, 2026 · Event occurred May 1, 2026
Report 9617229-2026-14435 · MDR key 50093842
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68-390
Lot number
3375430
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Patient reported "leaking" with "emotional distress and physical distress". This record is for the left side. The device remains implanted.
Additional Manufacturer Narrative
A review of the Device History Record has been completed. No deviations or non-conformances noted.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: Deflation.