MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; ERGONOMIX ROUND SILKSURFACE WITH QID

Catalog Number	ERSD-285Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Breast Discomfort/Pain (4504)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: information for the patient¿ during her surgical consultation, it is the surgeons´ responsibility to ensure that the patient completely understands the information regarding the risks, benefits, and recommendations associated with silicone gel-filled breast implant surgery, as well as the complications typical of any type of surgery.This document is available in motiva® website: ifu.Motiva.Health the instructions for use in the directions for use were reviewed to determine if there are indications that ensure the prevention and good handling of the product.For this event, it is considered that the information is suitable for the section of surgical precautions as follows: seroma: "seroma is an accumulation of fluid that results from tissue inflammation.The etiology of seroma is known in breast surgery and is connected to a hypovascular milieu or trauma following the surgery.Often, seromas are reabsorbed by the body over several weeks, but needle drainage is sometimes needed to remove the fluid.While seromas do not increase breast cancer risk, they sometimes heal with scar tissue or calcifications that can raise a concern about mammograms in the future.Seroma symptoms most often appear a week to 10 days after surgery; the area may feel tender and swollen, with a discrete lump and redness arising within a day or two.Early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time.In addition to causing pain, a seroma increases the risk of developing an infection in the breast.Depending on the location, it may also increase pressure over the surgical site and sometimes cause wound dehiscence".Early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time (sforza, et al.2017).Establishment labs will continue to monitor for similar complaints/trends.As part of the post market surveillance process, monitoring of the primary endpoints reported is performed to determine unfavorable trends.Per our current complaint data report, no unfavorable trends were detected on this product.No further actions are required.
Event or Problem Description
Mexico.Allegedly, a patient who underwent a breast augmentation surgery in (b)(6) 2025, referred pain and physical changes in skin texture in (b)(6) 2025.A breast ultrasound was requested, and revealed a seroma on both breasts, predominating on the right.Analgesic and antibiotic treatment was prescribed, and 14 days later, a new ultrasound showed no changes.The patient reported pain upon movement and anatomical changes.An exploratory surgery was performed, and a rupture was found in her right breast (sns: (b)(6)).No patient demographics, such as weight, or ethnicity, were provided by the reporter.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
General conclusion: device involvement: a causal relationship between the reported events and the device have been established.Event characterization: the event was classified as early seroma.Clinical confirmation: upon thorough evaluation of the submitted clinical documentation and supporting evidence, the reported case was confirmed by clinical affairs.Root cause analysis: this event is a well-documented complication inherent to breast implant surgery.Based on the analysis of the available data, including clinical findings and product traceability records, there is no evidence indicating a causal link between this specific case and any product-related factors, including raw materials or manufacturing processes.The etiology of the alleged event is recognized as multifactorial, given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to the manufacturing process and/or the product itself.Dfu and labeling evaluation: the event is a known, well-documented complication associated with silicone breast implants.It is clearly addressed in the product¿s directions for use (dfu), which states: seroma ¿ seroma is an accumulation of fluid that results from tissue inflammation7.The etiology of seroma is known in breast surgery and is connected to a hypovascular milieu or trauma following the surgery.Often, seromas are reabsorbed by the body over several weeks, but needle drainage is sometimes needed to remove the fluid8.While seromas do not increase breast cancer risk, they sometimes heal with scar tissue or calcifications that can raise a concern about mammograms in the future.Seroma symptoms most often appear a week to 10 days after surgery; the area may feel tender and swollen, with a discrete lump and redness arising within a day or two.Early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time9.In addition to causing pain, a seroma increases the risk of developing an infection in the breast.Depending on the location, it may also increase pressure over the surgical site and sometimes cause wound dehiscence.The dfu also emphasizes the responsibility of the surgeon to fully inform the patient of potential risks and complications during the pre-operative consultation.Patients are provided with the document ¿motiva implants®: information for the patient,¿ accessible at ifu.Motiva.Health.Literature reference: ¿early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time.¿ (sforza, et al.2017) ¿seroma can present both early and late, with the latter being recently linked with malignant growths and prolonged onset.¿ (sforza, et al.2017).Some analysis have revealed that the pocket plays a significant role in developing seroma, patients with submammary pocket developed seroma in higher rates when compared with patients with submuscular pocket.Submammary pocket increases the odds of developing seroma by 7.5 times.(sforza, et al.2017) device history record (dhr) review: a comprehensive review of the device history record (dhr) for the affected lot was completed.No deviations, non-conformances, or anomalies were identified during manufacturing.All raw materials and process parameters conformed to specified quality requirements.Trend and signal monitoring: the event has been evaluated as part of ongoing trend analysis activities within the pms program.Per the current complaint data report: no adverse or unexpected trends related to device rupture have been identified.No further corrective or preventive actions are required at this time.Establishment labs will continue to monitor for similar events as part of routine pms surveillance.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: ERGONOMIX ROUND SILKSURFACE WITH QID
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela ; 8003554164
• MDR Report Key: 23426825
• Report Number: 3012883202-2025-01391
• Device Sequence Number: 13225268
• Product Code: FTR
• UDI-Device Identifier: 07445161012159
• UDI-Public: (01)07445161012159(11)240817(17)290817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Catalogue Number: ERSD-285Q
• Device Lot Number: 24080599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2024
• 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: 46 YR
• Patient Sex: Female