FDA Adverse Event Injury Summary report: N

BREAST IMPLANT

MDR report key: 5994929 · Received October 3, 2016

Report

Report Number
1645337-2016-00132
Event Type
Injury
Date Received
October 3, 2016
Date of Event
January 1, 2012
Report Date
September 29, 2016
Manufacturer
MENTOR WW LLC
Product Code
FTR
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT A (B)(6) YEAR-OLD WOMAN WITH MASTECTOMY AND AXILLARY DISSECTION (2004) FOR LYMPH NODE-FREE LOBULAR CARCINOMA OF HER RIGHT BREAST WAS IN COMPLETE REMISSION FOR 11 YEARS. SHE UNDERWENT RECONSTRUCTIVE SURGERY WITH BILATERAL ALLERGAN IMPLANTS IN 2005, REPLACED BY MENTOR IMPLANTS IN 2008. A MODERATELY-LARGE LEFT PERI-PROSTHETIC EFFUSION SEEN BY MRI IN 2012 CONTAINED NON-ATYPICAL LYMPHOCYTES AND MACROPHAGES IN A PROTEINACEOUS BACKGROUND, AND WAS CYTOLOGICALLY INTERPRETED AS A SEROMA. SHE HAD TWO OTHER SEROMAS OF HER RIGHT BREAST (2013) THAT SPONTANEOUSLY REGRESSED WITHOUT EVACUATION. ON (B)(6) 2015, SHE COMPLAINED OF PAIN AND SWELLING OF HER RIGHT BREAST. A LARGE PERI-IMPLANT EFFUSION SUSPICIOUS OF AN INFLAMMATORY PROCESS BY ULTRASOUND WAS COMPLETELY DRAINED BY FNA, RECOVERING 85 CC OF CLOUDY YELLOW FLUID. BILATERAL IMPLANTS WERE REMOVED. SHE IS CURRENTLY UNDERGOING A WAIT-AND-SEE STRATEGY AND IS ALIVE WITHOUT DISEASE 8 MONTHS AFTER HER LYMPHOMA DIAGNOSIS. TITLE: "THE CASE AGAINST BIOFILM AS THE PRIMARY INITIATOR OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA." THE PURPOSE OF THIS STUDY WAS TO PRESENT THE FIRST PUBLISHED REPORT OF A BILATERAL ALK-NEGATIVE ANAPLASTIC LARGE CELL LYMPHOMA DIAGNOSED BY CYTOLOGY. SUSPECT DEVICE IS MENTOR IMPLANT, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN." CONTACT: (B)(6), AGE (STUDY AVERAGE) (B)(6), DOS UNK, SURGEON UNK, DEVICE INFO UNK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
644478 BREAST IMPLANT FTR MENTOR WW LLC UNK

Patients

Seq Age Sex Outcome Treatment
1 Other