UNK Mammary Implant
Received Jul 27, 2026
Report 9617229-2026-14079 · MDR key 50022095
Device
Generic name
Prosthesis, Breast, Inflatable, Internal, Saline
Manufacturer
Allergan (costa Rica)Catalog number
UNK Mammary Implant
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Seroma
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)
Narrative
Description of Event or Problem
Healthcare professional reported "Biocell implants with large >100cc seromas that have been aspirated but keep recurring", "No formal diagnosis of ALCL has been made yet but it is quite suspicious", "metastatic lung cancer that is stable" and "textured to smooth implant exchange". The event of metastatic lung cancer is not related to the device. Histopathological markers CD30+ and ALK- have not been received. This record is for the left side. The device remains implanted.
Additional Manufacturer Narrative
This report was impacted by eMDR scheduled maintenance occurring July 22-27, 2026.¿The events of Seroma and Lymphoma ALCL suspected are physiological complications and analysis of the device generally does not assist Allergan in determining a probable cause for these events.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: "Biocell implants with large >100cc seromas that have been aspirated but keep recurring", "No formal diagnosis of ALCL has been made yet but it is quite suspicious", "metastatic lung cancer that is stable" and "textured to smooth implant exchange".