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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS LP SILICONE SALINE FILLED MAMMARY PROSTHESIS PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE

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MENTOR TEXAS LP SILICONE SALINE FILLED MAMMARY PROSTHESIS PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE Back to Search Results
Model Number STYLE: 2600 SILEX-R AND L
Event Date 03/07/2018
Event Type  Injury  
Event Description

Implanted with mentor textured implants in 1996. In (b)(6) 2018 - routine annual mammo showed the left breast was folding over. This was an anatomical change in contrast to the 2017 study. Therefore, explanted in (b)(6) 2018. Left implant had evidence of blackish fluid within the implant. Lymphoma was ruled out fortunately, ps discussed recent findings of this type of implant and stated that he did not use them. Note: another surgeon in 1996 performed the implantation. On my own i called mentor, ((b)(6) 2018) inquired about the texturized implant findings. I wanted to know how many women had been diagnosed with lymphoma. The research person on the phone was very dismissive and said that such records were not kept. As a pt and an rn, i felt that was not given accountability by mentor due to the findings that came out after my initial implantation. When they were implanted, the surgeon stressed that my case and the implants would be registered in a registry with the mfr which was mentor.

 
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Brand NameSILICONE SALINE FILLED MAMMARY PROSTHESIS
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE
Manufacturer (Section D)
MENTOR TEXAS LP
MDR Report Key8009284
Report NumberMW5080856
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 10/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberSTYLE: 2600 SILEX-R AND L
Device Catalogue Number354-2645
Device LOT Number137052
Was Device Available For Evaluation? No
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: 10/25/2018 Patient Sequence Number: 1
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