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

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 07/14/2017 Patient Sequence Number: 1