MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

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

Patient Problems Autoimmune Disorder (1732); Thyroid Problems (2102); Complaint, Ill-Defined (2331)

Event Date 06/24/2014

Event Type  Injury  

Event Description

I had silicone gel breast implants placed under the muscle.Since that date my health has steadily declined with a fast decline noted after 2.5 post implants.I have multiple autoimmune issues ,thyroid issues and pain all of which only became present after silicone breast implants.I have been to several drs and surgeons who thankfully acknowledge implant illness and i am on my way to having implants removed next month.

• Brand Name: SILICONE BREAST IMPLANTS
• Type of Device: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6352624
• MDR Text Key: 68245562
• Report Number: MW5068040
• 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: 02/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: CURRENTLY TAKE AN ARRANGE OF NATURAL ; SUPPLEMENTS TO HELP WITH MY SYMPTOMS.
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 79