MAUDE Adverse Event Report: MENTOR MENTOR MEMORY SHAPE BREAST IMPLANT; SILICONE GEL IMPLANTS

Model Number REF 354-1708

Device Problem Insufficient Information (3190)

Patient Problem Anaplastic Large Cell Lymphoma (3264)

Event Date 06/06/2017

Event Type  Injury  

Event Description

Pt with breast implants s/p reconstruction for cancer.Pt was three years out from exchange of implants.Pt developed fluid around right breast implant.Fluid eval done, pt found to have breast implant associated anaplastic large cell lymphoma.(bia-alcl).Implant and capsule removed.Pt found to have smooth gel implants- mentor memory shape breast implant.

• Brand Name: MENTOR MEMORY SHAPE BREAST IMPLANT
• Type of Device: SILICONE GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6849535
• MDR Text Key: 85165963
• Report Number: MW5072020
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REF 354-1708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR