MAUDE Adverse Event Report: MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS

Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Headache (1880); Memory Loss/Impairment (1958); Miscarriage (1962); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Palpitations (2467)
Date of Event	07/01/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Approx.5 years after receiving mentor saline siltex textured implants in (b)(6) of 1999, i started to display many symptoms of autoimmune disorders among other strange symptoms.Ultimately, i have been diagnosed with celiac disease, vitiligo, rheumatoid arthritis, hashimoto's, lyme disease and a liver disorder, among many other accompanying side effects (anxiety, depression, fasciculations, ringing in ears, heart palpitations, memory loss, migraines, hormone deficiency and many others).I have also experienced several miscarriages and became pregnant with one child with a severe birth defect.I ultimately explanted in (b)(6) of 2016.

• Brand Name: MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6890804
• Report Number: MW5072411
• Device Sequence Number: 12161966
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 04/20/2017

1 Device was Involved in the Event

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Disability
• Patient Age: 51.000 YR