MAUDE Adverse Event Report: MENTOR BREAST IMPLANT; PROSTHESIS, BREAST, NON INFLATABLE SILICONE GEL

Model Number 350-6004BC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arthritis (1723); High Blood Pressure/ Hypertension (1908); Lupus (1956); Pain (1994); Sjogren's Syndrome (2073); Discomfort (2330); Reaction (2414)

Event Date 06/19/2017

Event Type  malfunction  

Event Description

I will be having my silicone implants removed.After several years of pain and discomfort and being diagnosed with sjogren's syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants.This is so my body can have an opportunity to try and heal and settle down from all of the reactions my body is experiencing.The implants are scheduled to be removed on (b)(6).Other diagnosis are for fibromyalgia due to the chronic pain i suffer.

• Brand Name: BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NON INFLATABLE SILICONE GEL
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6659907
• MDR Text Key: 78257028
• Report Number: MW5070556
• 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: 06/20/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 350-6004BC
• Device Lot Number: 6564715
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 100