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

• 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: 08/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Weight: 56