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
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE
• Manufacturer (Section D): MENTOR TEXAS LP
• MDR Report Key: 8009284
• Report Number: MW5080856
• Device Sequence Number: 1632641
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 54