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U.S. Department of Health and Human Services


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MENTOR BREAST IMPLANT Back to Search Results
Model Number 350-2375
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Tinnitus (2103); Anxiety (2328); Arthralgia (2355); Depression (2361); Respiratory Tract Infection (2420); Palpitations (2467)
Event Type  Injury  
Event Description
I have mentor breast implants that were placed in (b)(6)2007.I have had numerous health issues over the years since the implants but this winter, things got worse.Ongoing unexplained upper respiratory infections (went to sinus specialist and despite numerous tests she could not find cause), body rash, large itchy painful welts on my breasts, heart palpitations, anxiety and depression, joint pain, ringing in my ears, etc.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key6662959
MDR Text Key78356831
Report NumberMW5070578
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/21/2017
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
Device Model Number350-2375
Device Lot Number5688105
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/21/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight61