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Catalog Number 3341352G
Device Problem Material Rupture (1546)
Patient Problems Capsular Contracture (1761); Swollen Lymph Nodes (2093); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative
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.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) review is in progress.Once completed, the information will be submitted in a supplemental.Manufacturer's ref.No: (b)(4).
Event Description
It was reported that a female patient of unknown age who underwent breast prothesis implantation with mentor siltex memoryshape medium height, high projection gel implants on (b)(6) 2011 (catalog #3341352g, serial #(b)(4) ) has been diagnosed with bia-alcl in (b)(6) 2017.The patient also reported left breast implant rupture, free silicone in her chest area and enlarged lymphnodes.The patient is still implanted but planned course of treatment is explantation with mentor replacement.She is unsure what other treatments, such as chemotherapy or radiation, would be required.Multiple attempts have been made to obtain more information regarding this complaint, however, no further information has been made available.
Manufacturer Narrative
The device history record (dhr) of lot number 6008186 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Manufacturer Narrative
On (b)(6) 2015, the patient reported she has a left implant rupture that was diagnosed in (b)(6) 2017 and that she has not yet undergone explantation because she would like to be tested for bia-alcl due to the fluid in her left implant that was noted on us.The patient reported that she is scheduling on consultation at md anderson cancer center with dr.(b)(6) to get tested for bia-alcl in the near future, however, no date has been scheduled thus far.The patient did not have a bia-alcl diagnosis in the past and does not currently have a diagnosis of bia-alcl now.The patient also reported bilateral baker grade iv capsular contracture, left implant device migration outside of the pocket and shape distortion and hard/swollen left side lymph nodes.The patient also reported headaches, kidney problems, elevated labs (platelets, wbcs, mcv, mpv), and other issues.Patient will schedule explantation and treatment based on results of testing she will complete with md anderson.This report is for the patient¿s left-sided device.Right side is being reported in a separate report.Manufacturer's ref no: (b)(4).
Manufacturer Narrative
On 10/21/2019, mentor became aware that date of explantation was (b)(6) 2019.Hence, following has been updated (b)(4).This supplemental report is for the patient¿s left-sided device.Manufacturer's ref no: (b)(4).
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Brand Name
Type of Device
Manufacturer (Section D)
3041 skyway circle north
irving TX 75038
Manufacturer Contact
gabriel alfageme
3041 skyway circle north
irving, TX 75038
MDR Report Key6863086
MDR Text Key86068829
Report Number1645337-2017-00104
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3341352G
Device Lot Number6008186
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/21/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age54 YR