MAUDE Adverse Event Report: MENTOR/JOHNSON & JOHNSON MENTOR BREAST IMPLANTS; PROSTHESIS, BREAST

Device Problem Degraded (1153)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Anxiety (2328); Fungal Infection (2419)

Event Date 11/09/2018

Event Type  Injury  

Event Description

Beginning as early as 2016, i have noticed a steep decline in my health due to my breast implants.I have suffered multiple recurring staph infections, yeast infections, chronic fatigue, and anxiety.I know it is due to my implants, because up until this point of implant degradation i have been in good health.

• Brand Name: MENTOR BREAST IMPLANTS
• Type of Device: PROSTHESIS, BREAST
• Manufacturer (Section D): MENTOR/JOHNSON & JOHNSON
• MDR Report Key: 8301475
• MDR Text Key: 135686035
• Report Number: MW5083669
• 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: Patient
• Type of Report: Initial
• Report Date: 01/31/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 52