MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Inflammation (1932); Rash (2033); Sweating (2444); Sleep Dysfunction (2517); No Code Available (3191)

Event Type  Injury  

Event Description

I have breast implants and they are causing chronic inflammation in my body leading to various health conditions even to hospitalization.I have chronic candida overgrowth hormone fluctuations, chronic fatigue, various gut issues, digestion problems.I have hot and cold sensitivities.I have night sweats, i get insomnia, i have a couple different autoimmune diseases that have come about.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7037436
• MDR Text Key: 92471587
• Report Number: MW5073341
• 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: 11/14/2017
• 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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 46 YR
• Patient Weight: 59