InjuryFWM

UNK Mammary Implant

Received Jul 30, 2026

Report 9617229-2026-14391 · MDR key 50088136

Device

Generic name

Prosthesis, Breast, Inflatable, Internal, Saline

Manufacturer

Allergan (costa Rica)

Catalog number

UNK Mammary Implant

Product problems

Material Rupture

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Healthcare professional reported "rupture". This record is for an unknown side. Device has been explanted.

Additional Manufacturer Narrative

Additional Report Source email E1: (b)(6).Continued E1 Phone Number: (b)(6). Further information from the reporter regarding event, product, or patient details has been/will be requested. No additional information is available at this time. The Reason(s) for reoperation is/are: rupture.