MAUDE Adverse Event Report: MENTOR MEMORY GEL BREAST IMPLANT

Model Number 350-4001BC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Dyspnea (1816); Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Liver Damage/Dysfunction (1954); Cramp(s) (2193); Dizziness (2194); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Date 07/01/2015

Event Type  Injury  

Event Description

I had a breast augmentation on (b)(6) 2015.Since that day i've suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance.Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping.As time continues to pass, more symptoms seem to be showing up.

• Brand Name: MEMORY GEL BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6533466
• MDR Text Key: 74176675
• Report Number: MW5069445
• Device Sequence Number: 2
• Product Code: FTR
• 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: 04/27/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-4001BC
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADRENAL SUPPORT; FISH OIL; MACA ROOT; MULTI-VITAMIN; PROBIOTIC
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 75