MAUDE Adverse Event Report: MENTOR TEXAS SILTEX HPG, 800CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3544800
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On april 8, 2025, the mentor failure analysis lab received two devices for evaluation.On (b)(6) 2025 , device evaluation was completed as follows: mentor conducted a visual inspection.Visual analysis of the returned device revealed that the siltex hpg, 800cc breast implant was found to be ruptured.As the authorization form for examination was not received, the product evaluation lab could not reach a conclusion regarding the specific nature of the ruptures.The evaluation was limited to non-destructive testing.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.No corrective and preventive action (capa) is required now.Since no lot number was provided, no manufacturing record evaluation review could be performed.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available reason for device explant and/or reoperation: na additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number (b)(4).
Event or Problem Description
It was reported that a 72-year-old caucasian female patient underwent primary breast augmentation with 800cc mentor memorygel breast implant on both sides and experienced breast implant rupture on her left side postoperatively.As a result, the patient underwent replacement surgery on (b)(6) 2025.No product quality issues were reported for the right-side device.On (b)(6) 2025 , the mentor failure analysis lab received two devices for evaluation, it cannot be determined which device is the suspect medical device for the reported rupture, since the two received products have the same volume engraved, both devices were found damaged per analysis findings.Hence, both device result are being submitted.Hence, this report is for the right side.

• Brand Name: SILTEX HPG, 800CC
• 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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 21875770
• Report Number: 1645337-2025-04154
• Device Sequence Number: 7899751
• Product Code: FTR
• UDI-Device Identifier: 00081317001164
• UDI-Public: 00081317001164
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3544800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White