InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 31, 2026 · Event occurred Apr 15, 2026

Report 9617229-2026-14489 · MDR key 50103088

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68HP-700

Lot number

3594162

Product problems

Fluid/Blood Leak

Patient

54 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Patient reported "rupture" for a saline device. This record is for the right 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.