MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

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

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Neck Pain (2433); Sleep Dysfunction (2517)

Event Date 10/01/2007

Event Type  Injury  

Event Description

I have been ill since having silicone implants - fibromyalgia, sleep disorder, pain in neck, shoulders, hips, legs, feet, and back.I have had 5 surgeries for shoulders and 2 on my hands.After having the breast implants removed on (b)(6) all the pain and disorders are gone.

• Brand Name: SILICONE BREAST IMPLANTS
• Type of Device: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6996121
• MDR Text Key: 90969147
• Report Number: MW5073098
• 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: 10/31/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 73