MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Muscle Weakness (1967); Rash (2033); Sweating (2444); Confusion/ Disorientation (2553)

Event Date 05/05/2001

Event Type  Injury  

Event Description

I got mentor implants. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. Have had so many tests/labs and everything from chronic fatigue, fibromyalgia, sjogrens, non-specific autoimmune, rashes, brain fog, body aches, night sweats, headaches, muscle weakness, always cold. Can't handle the sun anymore, can no longer jog/run. Some days can't get out of bed.

• Brand Name: BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6773548
• MDR Text Key: 82171974
• Report Number: MW5071436
• 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: 08/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 08/06/2017 Patient Sequence Number: 1