MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC SMOOTH ROUND MEMORY GEL IMPLANTS; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number 350-3501BC

Device Problem Degraded (1153)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Failure of Implant (1924); Arthralgia (2355); Depression (2361); Sweating (2444); Cognitive Changes (2551); Test Result (2695)

Event Date 09/01/2015

Event Type  Injury  

Event Description

Summer 2015 had mentor silicone breast implants in.At this time i was very healthy and active.Almost immediately but within 3 months i experienced hormonal problems (extreme fatigue, hair loss, night sweats, depression, brain fog, acne, joint pains, etc).After a year and half of dr visits and bedridden days (i felt like i was dying and was suicidal).Was told i had hashimotos thyroid.I stumbled upon and started to research breast implant illness.My best friend was experiencing same issues (same type implants) as well and i didn't think it was coincidence.I had my implants removed summer 2017 to discover the left implant was severely deteriorated.Now 3 years post explant and a year of aggressive detox i am finally starting to gain some health back.My girlfriend is still dealing with health issues.I have all dr labs results.Too many to list here.Fda safety report id# (b)(4).

• Brand Name: SMOOTH ROUND MEMORY GEL IMPLANTS
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR WORLDWIDE LLC
• MDR Report Key: 9770461
• MDR Text Key: 181408795
• Report Number: MW5093386
• Device Sequence Number: 2
• 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: 02/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 350-3501BC
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADRENAL ; CALCIUM ; CELLULAR DETOX SUPPLEMENTS ; FEMICRINE; NEUROSYN ; PUREFORM OMEGA ; TUDCA ; VIT C
• Patient Outcome(s): Disability
• Patient Age: 46 YR
• Patient Weight: 54