MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANT

Model Number 350-1640

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Swelling (2091); Weakness (2145); Tingling (2171); Arthralgia (2355)

Event Type  Injury  

Event Description

Silicone implants causing symptoms such as weakness, as if something is sucking the life out of me, low thyroid, low wbc count, intense joint and muscle pain.I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness.Swollen hands, tingling in the hands and arms when i bend my joints.Had frozen shoulder.I feel weak more as time goes by.I have had the implants since 1998, had them removed and put new ones in from mentor back in 2004, before the fda lifted the ban on implants.Apparently mentor did not get the message about a ban on implants.Now all i want is my life back.To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish.

• Brand Name: SILICONE BREAST IMPLANT
• Type of Device: SILICONE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6568640
• MDR Text Key: 75368922
• Report Number: MW5069787
• Device Sequence Number: 1
• 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: 05/14/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-1640
• Device Lot Number: 5542113
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INSULIN; INSULIN PUMP; IODINE SUPPLEMENT; MINERALS; MULTIVITAMIN
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 70