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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

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MENTOR SALINE BREAST IMPLANT Back to Search Results
Event Date 05/01/2015
Event Type  Injury  
Event Description

A few years ago i was having hormone inbalance issues. After seeking medical attention for this, i learned through labwork. I had very high levels of several heavy metals in my blood. I underwent treatment for this. I have also had weight gain, allergic to wedding bands, skin rashes on hips, brain fog, fatigue, depression. I was informed that many women are having similar issues that have breast implants. The correlation makes sense to me. I am very healthy, eat healthy, exercise, and live an overall healthy lifestyle. I should not be sick like i am. Labs show inflammation in my body, which is likely due to the implants. I am having the implants removed on (b)(6). Please look at breast implant illness and healing by (b)(6). There is a group of 30,000 women. Many of having symptoms even much worse then i. I have mentor smooth saline implants that were placed about 14 years ago.

 
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Brand NameSALINE BREAST IMPLANT
Type of DeviceSALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key7179039
Report NumberMW5074505
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 01/06/2018
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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: 01/09/2018 Patient Sequence Number: 1
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