MAUDE Adverse Event Report: MENTOR SMOOTH SILICONE GEL BREAST IMPLANT

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

Patient Problems Fever (1858); Hair Loss (1877); Unspecified Infection (1930); Pain (1994); Tachycardia (2095); Chills (2191)

Event Date 11/22/2011

Event Type  Injury  

Event Description

I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. I've been sick ever since. No doctor can help me and i fully believe it's the breast implants making me ill. I have constant infections. Shooting and sharp pain in the breasts. I have arthritis and thyroid issues. It's never been ending and i can't get medical assistance to have them removed.

• Brand Name: SMOOTH SILICONE GEL BREAST IMPLANT
• Type of Device: SMOOTH SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6581397
• MDR Text Key: 75761144
• Report Number: MW5069907
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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 Treatment Data

Date Received: 05/18/2017 Patient Sequence Number: 1