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

Model Number	3544057MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Pain (1994); Seroma (2069); Swollen Lymph Nodes (2093); 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 (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, breast pain, seroma, lymphadenopathy.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast reconstruction with mentor memorygel breast implant 405 cc 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 left side device.
Additional Manufacturer Narrative
On (b)(6) 2020, mentor completed evaluation of a returned photo of the device.Device evaluation summary: upon the visual evaluation of the image provided in the complaint, the implant was observed ruptured.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some pain postoperatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Chronic pain can be associated with a variety of factors.Surgeons should instruct their patients to inform them if there is significant pain or if pain persists.Pain is a known complication associated with these devices and is referenced in our current product insert data sheet.Lymphadenopathy or palpable lymph nodes may be the result of bacterial or viral infection, neoplasm (primary or metastatic), or as the result of an idiopathic inflammatory process or foreign body reaction.There have been reports regarding movements of silicone gel material to lymph nodes even with or without evident of rupture leading to lymphadenopathy.A number of epidemiology studies have evaluated large populations of women with breast implants from a variety of manufacturers and implant models.The studies do not, taken together, support an association of breast implants and a diagnosed rheumatic disease.Other than one study, these studies do not distinguish whether the women had ruptured or intact implants.Because there were no supporting pathology reports or physician consultation summaries forwarded to product evaluation, we are unable to confirm the presence of or the possible etiology of the reported lymphadenopathy.Lymphadenopathy is a known complication associated with this surgery and is referenced in our current product insert data sheet.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.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: 10461472
• Report Number: 1645337-2020-10664
• Device Sequence Number: 2391443
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 3544057MC
• Device Catalogue Number: 3544057MC
• Device Lot Number: 6830533
• 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