Style 68 Saline Filled Breast Implant
Received Jul 30, 2026 · Event occurred May 24, 2026
Report 9617229-2026-14356 · MDR key 50084675
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
68HP-465
Lot number
2925542
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Patient reported of the right side device: "deflation". Later, healthcare professional reported "deflation". Later healthcare professional reported "breast ptosis" not device related. The device was 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.