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

Model Number	3545507
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069); Deformity/ Disfigurement (2360)
Date of Event	01/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: n/a.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 60-year-old caucasian female who underwent breast augmentation revision with a 550cc mentor memorygel breast implant experienced left sided rupture post procedure.The rupture was diagnosed through mammogram, ultrasound, and computed tomography.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This patient was part of a post approval study.
Additional Manufacturer Narrative
Additional information was received on april 26, 2023.The implant date was clarified to be (b)(6) 2001.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on august 3, 2023.The device was explanted on (b)(6) 2023.In addition to the rupture reported initially the patient also experienced baker grade iii capsular contracture and late onset seroma.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.Reason for device explant and/or reoperation: capsular contracture/rupture/seroma.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on september 4, 2023.The investigation of the returned device was completed by the failure analysis lab on september 18, 2023.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the breast implant had an area of siltex cracking on the posterior view.In addition, a tear was noted within the siltex cracking measuring approximately 1.1 cm.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 16498736
• Report Number: 1645337-2023-02569
• Device Sequence Number: 6366906
• Product Code: FTR
• UDI-Device Identifier: 00081317000747
• UDI-Public: 00081317000747
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: Health Professional
• Device Expiration Date: 08/01/2006
• Device Model Number: 3545507
• Device Catalogue Number: 3545507
• Device Lot Number: 231624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/26/2023; 08/03/2023; 09/04/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/16/2023; 08/23/2023; 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2001
• 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; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White