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

Catalog Number	3542251
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Reason for device explant and/or reoperation: right rupture d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(6).
Event or Problem Description
It was reported that a female patient underwent primary breast augmentation with 225cc mentor memorygel breast implant on both sides and experienced bilateral breast implant ruptures.The patient underwent bilateral replacement surgery with catalog number smhb375; serial number(b)(6) on the left side, and with catalog number smhb375; serial number (b)(6) on the right side on (b)(6), 2024.This medwatch report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On april 2, 2025, the mentor failure analysis lab received the device for evaluation.Per paperwork received with the device, patient's initials under field a1 has been updated to "t.W.F.L." on this form.On april 21, 2025, device evaluation was completed as follows: mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned device revealed that the sx mpp gel 225cc breast implant was found to have a tear between the shell and the patch on the posterior view.In addition, the patch was received completely separated.A microscopic examination was performed, and the cause of the rupture could not be identified.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.Although no conclusion could be reached on the cause of the rupture found, the instructions for use contain the following caution: rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause the implant to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.This supplemental medwatch report is for the patient¿s right-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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 21298760
• Report Number: 1645337-2025-01025
• Device Sequence Number: 9327862
• Product Code: FTR
• UDI-Device Identifier: 00081317000839
• UDI-Public: 00081317000839
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 08/31/2017
• Device Catalogue Number: 3542251
• Device Lot Number: 6617548
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2012
• 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