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 Code	Capsular Contracture (1761)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation revision procedure with a mentor memorygel breast implant 550cc gel breast prosthesis that ruptured post implantation.Rupture of the patient¿s right breast prosthesis was diagnosed via a mammogram and a physical.Additionally, baker grade iii capsular contracture in the right breast was diagnosed.As a result, the patient underwent bilateral explantation and replacement with unspecified mentor gel breast prostheses on (b)(6) 2021.
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: breast prosthesis rupture, capsular contracture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 03-dec-2021, 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.On 08-dec-2021, mentor received additional information about the event.The patient¿s removed breast prostheses were replaced with mentor memorygel breast implant 600cc gel breast prostheses.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor completed the investigation on the suspect medical device.Two devices were received at the mentor failure analysis lab.Since the devices were indistinguishable, both were analyzed.Device evaluation summary: according to the information received, the patient experienced a rupture in the breast implant and developed capsular contracture.Two indistinguishable devices were returned to mentor for evaluation.Mentor conducted a visual inspection of the returned devices.For device # 1, 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 6.6 cm.For device #2, 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 on the posterior view extending to the anterior view measuring approximately 5.9 cm.The evaluation determined that the 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.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.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsules, and effusion to pathology for examination.It should be noted that 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).
Additional Manufacturer Narrative
It was previously reported that two devices were received by the mentor failure analysis lab.Both were analyzed and tears were found on both implants.On (b)(6) 2022, mentor received additional information stating that rupture of the left breast prosthesis was discovered during explant surgery.A separate medwatch report will be submitted for the patient¿s left breast prosthesis.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: 12866231
• Report Number: 1645337-2021-13060
• Device Sequence Number: 14937994
• Product Code: FTR
• UDI-Device Identifier: 00081317000747
• UDI-Public: 00081317000747
• 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: 1998
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2003
• Device Model Number: 3545507
• Device Catalogue Number: 3545507
• Device Lot Number: 170782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/03/2021; 12/22/2021; 01/13/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/16/2021; 12/23/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/1998
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White