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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Headache (1880); Memory Loss/Impairment (1958); Miscarriage (1962); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Palpitations (2467)

Event Date 07/01/2007

Event Type  Injury  

Event 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
• MDR Text Key: 87230992
• Report Number: MW5072411
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 51.000 YR