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

Health Effect - Clinical Codes	Chest Pain (1776); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Vertigo (2134); Dizziness (2194); Anxiety (2328); Depression (2361); Numbness (2415); Sleep Dysfunction (2517)
Date of Event	11/01/1999
Type of Reportable Event	Serious Injury
Event or Problem Description
In october, 1999, i had my plastic surgeon put in mentor saline implants, smooth over the muscle.I had several contractors of the capsule.In about 2003 or thereabouts, i went on disability with an array of problems.Initially, ra, depression, fm ,and was put on drugs that made me worse and i had 3 heat strokes.My health never got better, but i continued with other issues.Changes in thyroid, polyarthritis, rls, rashes, pain and numbness in left arm and right hand, vertigo, loss of balance, dizziness, cognitive dysfunction, fatigue, memory loss, hair loss, deep chest wall pain, nodules in lungs, sleep apnea, adrenal, severe insomnia, anxiety attacks, slow to heal, headaches, back problems, neck pain, joint issues, and more.It was not until i did some research in (b)(6) 2015 that i realized it may be leaking implants.I had surgery with dr.(b)(6), in (b)(6).On (b)(6) 2016.She found mold in my left implant, yeast and bacteria, and my implants were leaking, the valves were defective.I am going on (b)(6) and still disabled.I am getting a little better but i want some compensation for all the missed years of life due to faulty implants.I was not told of all the complications one could have with implants.I was aware of infection and surgical disruption but not that they would leak and cause harm.When i contacted the plastic surgeon, he said they did not have to be removed ever."don't fix what ain't broke" and an "elephant could sit on you and they will not leak or burst".

• Brand Name: BREAST IMPLANT SALINE
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 5633649
• Report Number: MW5062082
• Device Sequence Number: 80014
• Product Code: MRD
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/02/2016
• 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: 05/02/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 66