MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH MPP BREAST IMPLANTS

Model Number 350-350 1BC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Malaise (2359)

Event Date 12/31/2009

Event Type  Injury  

Event Description

I had to have a double mastectomy in 2009 with immediate breast implants.I have been extremely sick about 1 year after surgery.I am getting sicker and sicker.I have called the surgeon that performed the surgery to get in for check up.I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance.I have not been followed up with after my last post-up appointment in 2010.I have 3 children and i'm extremely scared that i'm going to die from this illness.Please help me before i lose my life.

• Brand Name: MENTOR SMOOTH MPP BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6990022
• MDR Text Key: 90762313
• Report Number: MW5073053
• 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: 10/27/2017
• 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
• Device Model Number: 350-350 1BC
• Device Lot Number: 5791187
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 46 YR
• Patient Weight: 45