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

Model Number	3544057MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Seroma (2069); No Code Available (3191)
Date of Event	03/01/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: seroma, soft-tissue necrosis.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast reconstruction with mentor memorygel breast implant 405cc and experienced a painful rupture on the left side post-operatively.It was also reported that the patient has experienced bilateral late onset seroma and lymphadenopathy on the left side.Biopsy for evaluation of fluid around the breast implants and enlarged nodes was performed on (b)(6) 2020.No pathology result have been provided.It was also reported that some fat necrosis was noted around breast implant on the right side.The tissue was sent to pathology, but no pathology results have been provided.As a result, the patient underwent explantation on (b)(6) 2020.This report is for the right side device.
Additional Manufacturer Narrative
On september 23, 2020, mentor completed evaluation of a returned photo of the device.Device evaluation summary: during the visual evaluation of the picture, no apparent damage or visual anomalies were observed in the product.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.You should consider the possibility of bia-alcl when a patient presents with late onset, persistent peri-implant seroma.In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.When testing for bia-alcl, collect fresh seroma fluid and representative portions of the capsule, and sent to a laboratory with appropriate expertise for pathology test to rule out alcl, including immunohistochemistry testing for cd30 and alk (anaplastic lymphoma kinase).If your patient is diagnosed with peri-implant bia-alcl, develop an individualized treatment plan in coordination with a multidisciplinary care team.The national comprehensive cancer network (nccn) recommends surgical treatment that includes implant removal and complete capsulectomy ipsilaterally as well as contralaterally, where applicable.Report all confirmed cases of bia-alcl to the fda (https://www.Fda.Gov/safety/medwatch).Fda also recommends reporting cases of bia-alcl to the profile registry (https://www.Thepsf.Org/research/clinical-impact/profile.Htm) where you can submit more comprehensive data.Lastly, please notify mentor, because as the device manufacturer, we are collecting data on these cases as well.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.Necrosis may prevent or delay wound healing and require surgical correction, which may result in additional scarring and/or loss of tissue.Implant removal may also be necessary.Necrosis is a known complication associated with these devices and is referenced in our current product insert data sheet.Although the product was not received, the manufacturing records of the lot-serial number provided were identified.The manufacturing records 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.Complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.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: 10461475
• Report Number: 1645337-2020-10663
• Device Sequence Number: 2391444
• Product Code: FTR
• UDI-Device Identifier: 00081317004448
• UDI-Public: 00081317004448
• 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: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 3544057MC
• Device Catalogue Number: 3544057MC
• Device Lot Number: 6780426
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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: 31 YR