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

Model Number	3547001
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Local Reaction (2035); Post Operative Wound Infection (2446)
Date of Event	01/01/2018
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.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: right wound infection, and skin reaction, rupture, and bubbles.Date of explant: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent revision breast augmentation with a 700cc mentor memorygel breast implant on both sides and experienced bilateral wound infection, bilateral skin reaction, and right side bubbles and breast implant rupture.Cat scan on (b)(6) 2018 captured the rupture of the right breast.As a result, the devices will be explanted on (b)(6) 2021.This medwatch report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On april 21, 2021, mentor became aware that patient also experienced bilateral capsular contracture; baker grade iii.Clinical code capsular contracture has been added to field h6 on this form.Reason for device explant and/or reoperation: right wound infection, skin reaction, rupture, bubbles, and capsular contracture; baker grade iii this supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 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.This supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 27, 2021, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the sx mpp gel 700cc breast implant had parallel lines of shell wear on the anterior aspect.No bubbles were noted in the implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture status identified by mri evaluation includes both suspected ruptures, which are those ruptures identified by mri but not confirmed by explantation and examination of the device, and confirmed ruptures, which are those ruptures that are confirmed by evaluation of the explanted devices.The event described could not be confirmed as the breast implant was returned without detectable leakage.Although no rupture was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If infection does not subside promptly with the appropriate treatment, removal of the implant is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.A skin reaction is a noticeable change in the texture and/ or color of the skin.This can include bumps, scales, pustules, or redness that can be inflamed, irritated, painful, or itchy.This can be due to a variety of factors such as infections, heat, allergens, or immune system disorders.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.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.This supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that the replacement devices used on (b)(6) 2021 were catalog number smpx605; serial number (b)(6), on the left side and catlaog number smpx605; serial number (b)(6) on the right side.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
• MDR Report Key: 11693037
• Report Number: 1645337-2021-04214
• Device Sequence Number: 19607150
• Product Code: FTR
• UDI-Device Identifier: 00081317000952
• UDI-Public: 00081317000952
• 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: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/31/2021

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: 01/19/2020
• Device Model Number: 3547001
• Device Catalogue Number: 3547001
• Device Lot Number: 6896026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 05/17/2021; 05/27/2021; 06/09/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/07/2021; 05/20/2021; 05/27/2021; 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68