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

Model Number STYLE: 2600 SILEX-R AND L

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.

• Brand Name: SILICONE SALINE FILLED MAMMARY PROSTHESIS
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE
• Manufacturer (Section D): MENTOR TEXAS LP
• MDR Report Key: 8009284
• MDR Text Key: 125433970
• Report Number: MW5080856
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STYLE: 2600 SILEX-R AND L
• Device Catalogue Number: 354-2645
• Device Lot Number: 137052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 54