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

Model Number	3544751
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	08/31/2020
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: rupture and capsular contracture.(b)(4) manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female underwent breast augmentation revision with 475cc mentor memorygel breast implants and experienced rupture on the left, baker grade iii capsular contracture on the left side and baker grade ii capsular contracture on the right side postoperatively.The rupture and capsular contractures were confirmed with an mri.As a result, the patient underwent bilateral device removal and replacement with mentor memorygel breast implants, serial numbers (b)(4) on the left side and (b)(4) on the right side on (b)(6) 2020.This report is for the patient's left-sided device.
Additional Manufacturer Narrative
Additional information: on (b)(6) 2020, 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.Manufacturing reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed.Device investigation summary: during a visual evaluation of the product, parallel lines of shell wear were observed on the anterior aspect.Additionally, within the wear a tear was observed measuring approximately 10.5 cm.The evaluation determined that the loss of shell integrity is consistent with a rupture caused by wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.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, capsule, and effusion to pathology for examination.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 10708834
• Report Number: 1645337-2020-13349
• Device Sequence Number: 3630353
• Product Code: FTR
• UDI-Device Identifier: 00081317003892
• UDI-Public: 00081317003892
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2020

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: 04/05/2014
• Device Model Number: 3544751
• Device Catalogue Number: 3544751
• Device Lot Number: 5900244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/28/2020; 11/18/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/09/2020; 11/20/2020
• 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: 57 YR