MAUDE Adverse Event Report: MENTOR TEXTURED SALINE IMPLANT

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fatigue (1849); Hair Loss (1877); Pain (1994); Burning Sensation (2146); Anxiety (2328); Palpitations (2467)
Date of Event	09/10/1994
Type of Reportable Event	Serious Injury
Event or Problem Description
I got textured saline implants over muscle.I was told that these were lifetime devices.These implants unknowingly caused me severe neurological problems, extreme unnatural fatigue, hair loss, developed lipomas, heart palpitations, experience severe burn like pain in arms, neck, under armpit, early menopause, anxiety, loss of dreams and more.I believe the body's eventual reaction to the implants aged me prematurely.

• Brand Name: TEXTURED SALINE IMPLANT
• Common Device Name: TEXTURED SALINE IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6972010
• Report Number: MW5072914
• Device Sequence Number: 626817
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/22/2017
• 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?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Weight: 77