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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MEMORY SHAPE GEL TEXTURED BREAST IMPLANTS

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MENTOR MEMORY SHAPE GEL TEXTURED BREAST IMPLANTS Back to Search Results
Model Number 334-1305
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Capsular Contracture (1761)
Event Date 10/14/2015
Event Type  Injury  
Event Description
Started having a capsule around this date. I still have the textured implant in my body. I fit several symptoms of the rare cancer symptoms. I have contacted mentor and they have informed me a few cases doesn't make them have to stand behind removing them although i am one clearly having many symptoms. They said fda had done no recalls there for it was my problem and i could take out a loan and pay to have them removed if i was that concerned or worried. They also decided assisting with any cost to my ps office as well. Have been on a medication to help the capsule or blood vessels and it no longer works. My left breast is distorted and double the size of right one from capsule and hardened tissues. I also have pictures of all this.
 
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Brand NameMEMORY SHAPE GEL TEXTURED
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6584865
MDR Text Key75857910
Report NumberMW5069938
Device Sequence Number2
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 05/19/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number334-1305
Was Device Available for Evaluation? No Answer Provided
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: 05/19/2017 Patient Sequence Number: 1
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