MAUDE Adverse Event Report: MENTOR SILICONE COHESIVE GEL IMPLANTS

Lot Number (R) 5635876

Device Problem Fluid/Blood Leak (1250)

Patient Problems Arrhythmia (1721); Complaint, Ill-Defined (2331); Joint Disorder (2373); Reaction (2414)

Event Date 05/01/2007

Event Type  Injury  

Event Description

I had mentor cohesive gel implants placed.The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement.Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds.Also.I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements.I also developed severe reactions to some foods.

• Brand Name: SILICONE COHESIVE GEL IMPLANTS
• Type of Device: SILICONE COHESIVE GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6773145
• MDR Text Key: 82151967
• Report Number: MW5071414
• Device Sequence Number: 2
• 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: Patient
• Type of Report: Initial
• Report Date: 08/05/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: (R) 5635876
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 56 YR
• Patient Weight: 64