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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems 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)

Event Date 02/20/2005

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6431321
• MDR Text Key: 70907894
• Report Number: MW5068630
• Device Sequence Number: 1
• Product Code: FWM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NA; RX MEDS: LEVOTHYROXINE
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 57