MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/01/2017

Event Type  Injury  

Event Description

Mentor silicone implants caused a slew of health issues.I just explained and am getting my health back.Lived with 20+ symptoms for over 5 years.I immediately felt relief in my joints and muscles as soon as they were removed.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6367701
• MDR Text Key: 68842312
• Report Number: MW5068195
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B COMPLEX; LYRICA; MAGNESIUM; OTC MEDS: OMEGA 3; RX MEDS: CYMBALTA; VITAMIN D
• Patient Outcome(s): Disability
• Patient Age: 39 YR
• Patient Weight: 75