MAUDE Adverse Event Report: MENTOR BREAST IMPLANT SILICONE

Catalog Number 350-5501BC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fatigue (1849); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Tingling (2171); Anxiety (2328); Depression (2361); Numbness (2415); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 07/29/2013

Event Type  Injury  

Event Description

Received mentor silicone breast implants on (b)(6) 2013. Have had several health issues since. Extreme fatigue, migraines, digestive issues, worsening depression/anxiety, brain fog, memory issues, hair loss, numbness and tingling in left arm and leg, breast pain, chest pain. Explanting asap.

• Brand Name: BREAST IMPLANT SILICONE
• Type of Device: BREAST IMPLANT SILICONE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6857663
• Report Number: MW5072103
• 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: 09/09/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 350-5501BC
• Device Lot Number: 6514842
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 39 YR
• Patient Weight: 63
• Patient Outcome(s): Disability