MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS; SMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS

Model Number REF 350-3501BC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rheumatoid Arthritis (1724); Autoimmune Reaction (1733); Fatigue (1849); Inflammation (1932); Pain (1994); Skin Irritation (2076); Discomfort (2330); Arthralgia (2355); Cognitive Changes (2551)

Event Date 07/21/2009

Event Type  Injury  

Event Description

On (b)(6) 2009 is the date i had surgery to have implants.Within 6 months of that time frame, i started to have medical concerns, which were unusual for me.Previous to implants i was on medication for thyroid issues, but nothing else and was in very good health.Over time, the number of health concerns increased or became increasingly worse.Over the past 3-4 years, the intensity of issues has become severe.Yet, when i seek the care of specialists, few are able to set a solid diagnosis and i also received clashing diagnosis when seeking second opinions.What they are clear about is that i have autoimmune/inflammatory issues in addition to memory issues/brain fog.These issues impact daily.I had mris to check for issues with neck- diagnosed at first as herniated discs but then as arthritis.Due to memory issues and based on disclosure of history only, one doctor diagnosed dementia.Another said i was "an interesting case" as tests for memory mostly showed fairly bad short term memory.Mris of brain to check for memory related causes were inconclusive.Additional xrays and a great deal of blood work to determine arthritis issues which seem to be taking over my body (was diagnosed as rheumatoid arthritis, but medications have not helped reduce the issues it causes.Pain is intense, particularly in the mornings or after sitting for a while.Fatigue was addressed with a suggestion to get more sleep.Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort).Hugs hurt.Skin issues were addressed with various creams/meds, none which resulted in improvement.

• Brand Name: SMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS
• Type of Device: SMOOTH ROUND MODERATE PLUS PROFILE GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6584693
• MDR Text Key: 75855801
• Report Number: MW5069928
• 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: 05/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: REF 350-3501BC
• Device Lot Number: 5905331
• 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 Age: 47 YR
• Patient Weight: 68