MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS (SALINE)

Device Problem Insufficient Information (3190)

Patient Problem Autoimmune Disorder (1732)

Event Date 05/15/2013

Event Type  Injury  

Event Description

Mentor saline breast implants that i got in 2003.I have several autoimmune diseases and symptoms related to the implants.I believe i have bii (breast implant illness).

• Brand Name: BREAST IMPLANTS (SALINE)
• Type of Device: BREAST IMPLANTS (SALINE)
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6656713
• MDR Text Key: 78174549
• Report Number: MW5070530
• Device Sequence Number: 2
• Product Code: FWM
• 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: 06/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 43 YR
• Patient Weight: 63