MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Thyroid Problems (2102); Complaint, Ill-Defined (2331)
Date of Event	06/24/2014
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6352624
• Report Number: MW5068040
• Device Sequence Number: 1194303
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 02/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RX MEDS: CURRENTLY TAKE AN ARRANGE OF NATURAL ; SUPPLEMENTS TO HELP WITH MY SYMPTOMS.
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 79