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

Model Number	3544250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent breast augmentation with a 250cc mentor memorygel breast implant on both sides and experienced bilateral capsular contracture; (b)(6).As a result, the devices were explanted on an unknown date.This medwatch report is for the patient¿s left-sided device.
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.A manufacturing record evaluation (mre) was performed, 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.Reason for device explant and/or reoperation: left capsular contracture; (b)(6).Manufacturer¿s reference number: (b)(4).
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.A manufacturing record evaluation (mre) was performed, 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.Reason for device explant and/or reoperation: left capsular contracture; baker grade iii.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent breast augmentation with a 250cc mentor memorygel breast implant on both sides and experienced bilateral capsular contracture; baker grade iii.As a result, the devices were explanted on an unknown date.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
On december 7, 2021, photo evaluation was completed.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the siltex hpg, 250cc breast implant was observed with no apparent damage or visual anomalies.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware of the following: 1.The date of implant was (b)(6) 2019; field d6a has been updated on this form 2.The date of explant was (b)(6) 2021; field d6b has been updated on this form this supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022, the mentor failure analysis lab received the device for evaluation.Paperwork received indicated patient's initials.Field a1 has been correctly updated on this form.On (b)(6) 2022, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the siltex hpg, 250cc returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL 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: 12955980
• Report Number: 1645337-2021-13575
• Device Sequence Number: 4647458
• Product Code: FTR
• UDI-Device Identifier: 00081317001027
• UDI-Public: 00081317001027
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/28/2021

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: 11/04/2023
• Device Model Number: 3544250
• Device Catalogue Number: 3544250
• Device Lot Number: 7650294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 12/07/2021; 01/05/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/07/2021; 12/09/2021; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2018
• 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 Sex: Female