MAUDE Adverse Event Report: MENTOR MENTOR SALINE SMOOTH; BREAST IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Gastritis (1874); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Thyroid Problems (2102); Vertigo (2134); Loss of Vision (2139); Complaint, Ill-Defined (2331); Breast Mass (2439); No Code Available (3191)
Date of Event	02/20/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2004 i had mentor saline implants put in by dr.(b)(6) in (b)(6).I was (b)(6) at the time.Exactly 3 months later i began having pain and swelling in my neck.I was diagnosed with acute thyroiditis.During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism.I was diagnosed with graves disease and then eventually hashimoto's disease.I have been sick with countless sinus infections, gerd, leaky gut syndrome, loss of vision, headaches, vertigo, decreased libido, hormonal imbalance, food allergies, hair loss and breast masses at the last three mammograms.I was never explained of the possible health risks to my immune system and quality of life.I have lost the last 13 years to being sick and have an appointment tomorrow to have another mammogram and ultrasounds to begin testing for bia-alcl.Breast implant illness is a real condition and needs to be explored further and of public health concern.Not only do implants cause immune system cancer as recently released by your administration, but it begins with a snowfall effect of damage to the immune system.

• Brand Name: MENTOR SALINE SMOOTH
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6431321
• Report Number: MW5068630
• Device Sequence Number: 505388
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 03/22/2017
• 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: 03/22/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTC MEDS: NA; RX MEDS: LEVOTHYROXINE
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 38 YR
• Patient Weight: 57