InjuryFWM

Style 68 Saline Filled Breast Implant

Received Jul 31, 2026 · Event occurred May 13, 2026

Report 9617229-2026-14448 · MDR key 50098232

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

68-240

Lot number

1674355

Product problems

Fluid/Blood Leak

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "deflated". This record is for the right side. 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. The reason for reoperation: Deflation.