Style 68 Saline Filled Breast Implant
Received Jul 27, 2026 · Event occurred Jun 30, 2026
Report 9617229-2026-14109 · MDR key 50027950
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68-330
Lot number
562949
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Healthcare professional reported "deflation". Healthcare professional later reported "Hole in valve". This record is for the right side. The device was explanted.
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 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.