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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR CORP. MENTOR SMOOTH ROUND HIGH PROFILE GEL, 450CC SILICONE GEL BREAST IMPLANT

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MENTOR CORP. MENTOR SMOOTH ROUND HIGH PROFILE GEL, 450CC SILICONE GEL BREAST IMPLANT Back to Search Results
Model Number 350-4505BC
Event Date 06/28/2012
Event Type  Injury  
Event Description

Pt is a (b)(6) female who underwent left mastectomy in 1996, for ductal carcinoma in situ, with tissue expander and saline implant reconstruction. She presented in (b)(6) 2010, with a peri-implant hematoma, thought possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in (b)(6) 2012, with a spontaneous hematoma, and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl.

 
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Brand NameMENTOR SMOOTH ROUND HIGH PROFILE GEL, 450CC
Type of DeviceSILICONE GEL BREAST IMPLANT
Manufacturer (Section D)
MENTOR CORP.
santa barbara CA
MDR Report Key2718829
Report NumberMW5026653
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/23/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number350-4505BC
Device Catalogue Number350-4505BC
Device LOT Number6004844
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/23/2012 Patient Sequence Number: 1
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