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

Catalog Number	3507250BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Deformity/ Disfigurement (2360)
Date of Event	01/20/2025
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 valid lot number was provided, no manufacturing record evaluation could be performed.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.D4: udi: as the lot/serial number was not provided, the (01) gtin is not available.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation primary with mentor memorygel breast implants 250cc and experienced bilateral rupture post-operatively, which was confirmed via mammogram.As a result, the patient underwent removal on (b)(6) 2025.This report is for the second of two devices.The reported lot number does not correspond to any current mentor devices.Multiple attempts were made to get clarification about the lot number; however, no further information is available.If additional information is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
On apr 1, 2025, additional information was received indicating the patient also experienced bilateral implant site calcification, discovered via mri.On apr 9, 2025, additional information was received indicating the replacement devices were mentor gel breast implants (serial numbers (b)(6)).On apr 22, 2025, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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 device revealed that the gel mod-rnd 250cc breast implant was found to be ruptured.Because of the now settled u.S.Class action that applied, in part, to implants manufactured in texas, usa that were implanted on or before may 31, 1993, to avoid any potential allegation of spoliation of evidence, mentor is prohibited from conducting a further physical evaluation of this covered device.Mentor performs 100% inspection of all devices prior to release, product evaluation concluded that the tear occurred sometime subsequent to the removal of the device from its protective packaging.Although no conclusion could be reached on the cause of the reported event, 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.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: 21698343
• Report Number: 1645337-2025-03202
• Device Sequence Number: 9059024
• Product Code: FTR
• UDI-Device Identifier: 00081317000075
• UDI-Public: 00081317000075
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1985
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Catalogue Number: 3507250BC
• Device Lot Number: 6914
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 04/29/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 76 YR
• Patient Sex: Female
• Patient Race: White