MAUDE Adverse Event Report: MENTOR LUMERA BREAST IMPLANTS

Model Number 675CC LUMER HIGH PROFILE IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Muscle Weakness (1967); Nausea (1970); Pain (1994)

Event Date 12/10/2008

Event Type  Injury  

Event Description

After having bilateral mastectomies for dcis (b)(6) 2005, i had immediate reconstruction with tissue expanders and "lumera" breast implants.After having the implants for about three years i developed problems with my gut (diarrhea and nausea) as well as muscle weakness and constant pain.In the ensuing years, i have now developed bilateral shoulder and sternal pain as well as a decrease in stamina for performing my normal activities of daily living.I can no longer cut the grass, it is hard for me to open my dryer with my right hand (i am right-handed) and i have developed an "essential" head tremor requiring me to take primidone four times a day.

• Brand Name: LUMERA BREAST IMPLANTS
• Type of Device: LUMERA BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 8155398
• MDR Text Key: 130384551
• Report Number: MW5082063
• Device Sequence Number: 4
• 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: 12/10/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 675CC LUMER HIGH PROFILE IMPLANT
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 59