MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; ERGONOMIX ROUND SMOOTHSILK

Catalog Number	ERSD-425
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A causal relationship between the reported event and the device has not been established.Upon thorough evaluation of the submitted clinical documentation and supporting evidence, the reported case was not confirmed meeting the requirements for a capsular contracture, classified as baker grade iii/iv.This classification indicates moderate to severe contracture, characterized by firmness, distortion, and potential patient discomfort or pain.Capsular contracture 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 capsular contracture is recognized as multifactorial, with potential contributing elements including postoperative patient-specific biological responses, and surgical technique.Given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to a defect in the device or its production.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: "a capsular contracture pertains to hypertrophic scar tissue investing in a foreign body or surgically implanted device, compromising the aesthetic outcome, resulting in pain, breast deformity, and often necessitating further operations.Detection of breast cancer by mammography may also be challenging.Capsular contracture may be more common following infection, hematoma and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in patients undergoing revision surgery than in patients undergoing primary implantation surgery.Capsular contracture is the most common complication following implant- based breast surgery and is one of the most common reasons for reoperation" capsular contracture is graded into 4 levels depending on its severity.Baker grade i: the breast is normally soft and looks natural; baker grade ii: the breast is a little fi rm but looks normal; baker grade iii: the breast is firm and looks abnormal; baker grade iv: the breast is hard, painful, and looks abnormal.Patients should also be advised that additional surgery might be needed in cases where pain and/or firmness are severe (baker grades iii or iv) and that capsular contracture may happen again after additional surgeries.Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself.Capsular contracture: normally, capsules of collagen fibers form as an immune response around a foreign body, such as a breast implant, tending to isolate it.Capsular contracture occurs when the capsule tightens and squeezes the implant.This can cause the implant to turn rigid (from slightly firm to quite hard) and the firmest ones can cause varying degrees of discomfort, pain and palpability.In addition to the firmness, capsular contracture can result in a deformed breast, visible surface wrinkling and/or displacement of the implant.Detection of breast cancer by mammography may also be more difficult.Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in patients undergoing revision surgery than in patients undergoing primary implantation surgery.Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.¿ 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.The aetiology of capsular contracture is multifactorial and consisting of patient, type of surgery, prosthetic material used, the implant pocket placement, the incision type and the duration of follow-ups (liu et al., 2015) (headon, kasem & mokbel, 2015).Capsular contracture is a risk associated with breast surgery (handel, 2006) and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of capsular contracture occurrence.The cause of capsular contracture is multifactorial (calobrace, 2018), and we cannot conclude that the reported event was caused by the manufacturing process and/or the product itself.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.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 the reported event 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.
Event or Problem Description
Usa.Allegedly, the patient presents with bilateral capsular contracture, baker grade iv, associated with implant lateralization.Implant replacement surgery is scheduled for (b)(6) 2026.The investigation is complete.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: ERGONOMIX ROUND SMOOTHSILK
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113 ; 8003554164
• MDR Report Key: 24262135
• Report Number: 3012883202-2026-01860
• Device Sequence Number: 8010244
• Product Code: FTR
• UDI-Device Identifier: 07445161010612
• UDI-Public: (01)07445161010612(11)241122(17)291122
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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-425
• Device Lot Number: 24111694
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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 Sex: Unknown