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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT

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MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT Back to Search Results
Catalog Number UNKNOWN_MENTOR
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2016
Event Type  Injury  
Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. Device history record (dhr) review cannot be conducted because no lot number was provided by the customer. Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported by a physician that a (b)(6) caucasian female patient who underwent multiple breast augmentation procedures was diagnosed with bilateral stage ie alcl on (b)(6) 2016. The patient has no known medical comorbidities and no history of breast cancer. The mentor spectrum saline implants were the devices implanted at the time of diagnosis. The patient's known implant history is the following: the patient had bilateral augmentation in 1992 with unknown implant brand, texture, and fill. The patient then had a revision augmentation in 2002 with textured saline implants (brand unknown). In 2008, the patient has a bilateral revision augmentation due to capsular contracture with unknown implant brand, texture, and fill. The patient then began having problems in left breast (capsular contracture) and underwent revision procedure with unknown implant brand, texture, and fill. The patient then had an infection and underwent explantation without replacement. Four months later, the patient underwent additional revision augmentation with unknown implant brand, texture, and fill. In (b)(6) 2015, the patient began developing capsular contracture in the left breast and in (b)(6) 2015, began developing capsular contracture in the right breast. The patient also experienced seroma. The patient didn't experience systemic symptoms such as fever, night sweat, or weight loss. On (b)(6) 2016, the patient was diagnosed with bilateral stage ie alcl (cd30 positive, alk negative) via aspiration cytology. The lymphoma cells were found in the effusion fluid surrounding the implant and in the fibrous capsule. There is no invasion beyond the fibrous capsule into breast parenchyma. The patient underwent bilateral explantation with total capsulectomies and no replacement implants in (b)(6) 2016. The patient did not receive chemotherapy or radiation therapy. As of (b)(6) 2016, the patient is alive and has no evidence of alcl.

 
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Brand NameMENTOR MEMORYSHAPE BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
949789-383
MDR Report Key6890749
Report Number1645337-2017-00106
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN_MENTOR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/25/2017 Patient Sequence Number: 1
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