Style 68 Saline Filled Breast Implant
Received Jul 31, 2026 · Event occurred Jul 8, 2026
Report 9617229-2026-14441 · MDR key 50096464
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68-480
Lot number
1368537
Product problems
- Break
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Healthcare professional reported "Deflation". Later healthcare professional reported "Hole in valve, hole non specific, leaking valve". This record is for the right side. Device has been explanted.
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 and Valve leak and/or Damage.