MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: generalized illness.Health effect - clinical code e2402: generalized illness.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported (via fda mw5097425) that a female patient, who's undergone breast prosthesis implantation surgery post preventative double mastectomy with two 555cc mentor memoryshape breast implants, suffered several unexplained systemic symptoms, including increased fatigue, muscle soreness, joint issues, chronic infections, mono, severe anemia, contracted the flu, body pain in muscles and joints, poor recovery from any activity, chronic fatigue, nerve issues, aphasia, chronic headaches, increased/severe anxiety, finger and ankle swelling, little to no libido, poor sleeping patterns, chronic facial rash with swelling, dry hair, dry skin, dry mouth, and dry eyes.No device issue such as rupture was reported.The root cause of the patient¿s symptoms is unclear.As a result, the patient underwent bilateral implant explantation on (b)(6) 2020.Symptoms were reportedly began to reside almost immediately after the implants removal.Patient is 75% healed and their thyroid has shown improvement for the first time since diagnosis in 2011.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On may 3, 2021, mentor received additional information indicating that the patient's age at the time of event was 32, the patient's ethnicity was not hispanic/latino, patient's race is white, and that they also experienced severe dry skin, rashes, body swelling, and night sweats.In addition, the suspect medical devices information are the following: (left) lot: 6871741 sn: (b)(6) and (right) lot: 6871741 sn: (b)(6).A manufacturing record evaluation (mre) was performed for the complaint device.As a result, the manufacturing date and expiration date fields have been updated.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On september 28, 2022, mentor received additional information indicating that the patient also suffered the following: patient's implants were adhered to chest wall and had to be scraped off, brittle nails and dental health problems.The patient's date of birth was also provided and has been populated.

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11128018
• Report Number: 1645337-2021-00160
• Device Sequence Number: 837255
• Product Code: FTR
• UDI-Device Identifier: 00081317005117
• UDI-Public: 00081317005117
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2019
• Device Model Number: 3341409
• Device Catalogue Number: 3341409
• Device Lot Number: 6871741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 05/03/2021; 09/28/2022
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 05/27/2021; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White