MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH SALINE BREAST IMPLANTS

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

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Arthralgia (2355); Confusion/ Disorientation (2553)

Event Date 01/01/2013

Event Type  Injury  

Event Description

What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants.I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain.As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition.Testing was done immediately as well as steroid treatment and then other immune modulating drugs.I became very sensitive to many foods, smells, lights, sounds even.I've suffered with pain and feeling like i'm honestly not sure that i can get through most days due to fatigue.I continue to work, but have such horrible brain fog that it worries me.I am going to schedule an explant and go through detox in hopes to feel better.I wish these side effects and possibility for this happening would have been explained to me.Not just that, but i hope women can know how severe it can be and how often it is occurring.Rx meds: none, still have implants as date hasn't been scheduled quite yet for explant.

• Brand Name: MENTOR SMOOTH SALINE BREAST IMPLANTS
• Type of Device: MENTOR SMOOTH SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6721468
• MDR Text Key: 80440985
• Report Number: MW5071057
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• 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: 07/14/2017
• 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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Weight: 64