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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Inflammation (1932); Rash (2033); Depression (2361); Confusion/ Disorientation (2553); Weight Changes (2607)
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 Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
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
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 Age36 YR
Patient Weight61
Patient Outcome(s) Required Intervention; Disability;
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