MAUDE Adverse Event Report: MENTOR SILICONE COHESIVE GEL BREAST IMPLANTS

Model Number 350-5504BC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abrasion (1689); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Menstrual Irregularities (1959); Rash (2033); Skin Irritation (2076); Swelling (2091); Swollen Lymph Nodes (2093); Thyroid Problems (2102); Tinnitus (2103); Visual Impairment (2138); Weakness (2145); Cramp(s) (2193); Anxiety (2328); Depression (2361); Sweating (2444); Palpitations (2467); Cognitive Changes (2551); Weight Changes (2607)

Event Date 05/01/2015

Event Type  Injury  

Event Description

Hair loss and dryness, skin dryness and itchiness, dry, brittle flaky nails, extreme sensitivity to cold, night sweat, depression (feeling like the world would be better without me in it), and anxiety.Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog.Ringing in ears, metalic taste in mouth, skin rashes - bug bites, scratches and other wounds take forever to heal.Weight gain, heavy and abnormal menstrual cycles, heart palpitations, chronic diarrhea, muscle cramping/frequent charlie horses, frequent swollen and sore lymph nodes - usually under arms sometimes neck, sensitive eyes, enlarged thyroid, allergies for the first time in my life, pain where the ribs meet the sternum.

• Brand Name: SILICONE COHESIVE GEL BREAST IMPLANTS
• Type of Device: SILICONE COHESIVE GEL BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6776816
• MDR Text Key: 82397144
• Report Number: MW5071454
• 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: 08/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 350-5504BC
• Device Lot Number: 6832795
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 82