MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Complaint, Ill-Defined (2331); Neck Pain (2433)

Event Date 03/17/2004

Event Type  Injury  

Event Description

I have been feeling terrible for at least the last ten years or more.I've seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing.I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc.Among many symptoms that make me feel like i'm dying a slow death.I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed.Functioning in life is difficult and painful.My quality of life is very poor.

• Brand Name: MENTOR SALINE BREAST IMPLANTS
• Type of Device: MENTOR SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7209059
• MDR Text Key: 97959673
• Report Number: MW5074696
• Device Sequence Number: 2
• Product Code: FWM
• 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: 01/17/2018
• 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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 59