MAUDE Adverse Event Report: MENTOR MENTOR BREAST IMPLANT

Model Number 350-2325

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

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Thyroid Problems (2102); Cognitive Changes (2551); Weight Changes (2607)

Event Date 01/04/2008

Event Type  Injury  

Event Description

Mentor saline breast implants caused hashimotos and sjogrens auto immune.Hair loss, fatigue, brain fog, weight gain.

• Brand Name: MENTOR BREAST IMPLANT
• Type of Device: MENTOR BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6224791
• MDR Text Key: 64029925
• Report Number: MW5067035
• 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: 01/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-2325
• Device Lot Number: 5689013
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MILK THISTLE; MULTI VITAMIN; VITAMIN D; VITAMIN K2
• Patient Outcome(s): Disability
• Patient Age: 36 YR
• Patient Weight: 82