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

Catalog Number	ERSF-295Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As stated in the literature, ¿a number of risk factors for rupture have been identified; the most common cause is surgical instrument damage.¿ (handel, garcía and winxtrom, 2013.Breast implant rupture: causes, incidence, clinical impact, and management.Plast.Reconstr.Surg.132: 1128).Additionally, rupture is a common and known reason for complaints, and it is clearly characterized in the product dfu included with the implant, as stated above.Additionally, no cases of rupture because of product failure have been reported to establishment labs ever.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 determinate 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: rupture: ¿breast implants can potentially remain intact for decades in the body, but all such devices will fail at some point.Breast implants rupture when the shell develops a tear or hole.Rupture can occur at any time after implantation, but it is most likely to occur; the longer the implant is in place.The following may cause implants to rupture: damage by surgical instruments, implant stress, and weakening during implantation, age and design of the implant, submuscular rather than sub-glandular location, the occurrence of post-operatory hematomas or seromas, folding or wrinkling of the implant shell, excessive force to the chest, trauma, compression during mammographic imaging, and severe capsular contracture¿.Rotation ¿ anterior/posterior rotation, also called flipping, has been observed more frequently with cohesive gel implants.The flat base of the implant is positioned anteriorly, deforming the breast of the patient.Proper placement and pocket dissection reduce the risk of occurrence.Flipping can be treated with bimanual manipulation in the office and can be done repeatedly in recurrent cases.However, in some cases, revision surgery may be necessary to reduce pocket dimensions.Literature has reported that the interaction between breast envelopes, the implant's physical characteristics, and pocket dissection could cause malposition.Other theories include the involution of breast tissue.Regarding implant characteristics, flipping has been associated with the presence or absence of texturing implant shape/profile, and the gel-filling ratio (i.E., to what degree the implant has been filled).Other factors such as infection, hematoma/seroma, capsular contracture, dissection, surgeon¿s experience, physical activity, and external manipulation of the implant could potentially contribute to the development of this complication.Establishment labs must conduct the necessary testing, including but not limited to microscopic examination and characterization of the rupture site, as well as mechanical testing in accordance with approved standards.Breast implants are not lifetime devices, and rupture is an inherent risk of breast surgery that may occur at any time.In addition, a review of the device history record was conducted, and it was concluded that there were no deviations in the manufacturing process of this device that would have caused or contributed to this incident.When the investigation process is completed, the applicable findings will be included in a supplemental medwatch.At establishment labs, we are committed to patient safety and continually evaluate the performance of our devices through post market surveillance of reported complaints & adverse events.
Event or Problem Description
Taiwan.It was reported a patient operated in (b)(6) 2020; in (b)(6) 2021 she presented with discomfort and increased tenderness in the left breast, and an mri revealed that the implant was rotated and deformed.In (b)(6) 2025 the discomfort increased, and an ultrasound confirmed rupture of the left implant (sn: (b)(6)).Revision surgery was necessary.
Additional Manufacturer Narrative
1.Overview the quality department (pms) received a complaint involving a motiva® device.Further details are provided in the cq ¿details¿ section.2.General conclusion device involvement: a causal relationship between the reported event and the device has been established.Event characterization: the events was classified as a rupture and a rotation.3.Laboratory testing laboratory evaluation was conducted in accordance with wi-001048 "pms laboratory testing units." key findings include: visual inspection: macroscopic examination of the returned device revealed clear evidence of shell rupture.Microscopic analysis: under magnification, the shell exhibited trace marks indicative of interaction with a sharp instrument.The morphology of these marks closely matched those reproduced under controlled laboratory conditions simulating instrument-related damage.These findings differ significantly from patterns associated with spontaneous rupture (e.G., fatigue or shell degradation).Shell compliance testing: mechanical and material integrity testing confirmed that the implant shell met all applicable international specification standards.Root cause analysis based on the testing results, the most probable root cause of the iatrogenic rupture is a damage from a sharp surgical instrument.Such damage may have compromised the shell¿s integrity, predisposing it to failure during clinical procedure.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.4.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: rupture breast implants can rupture when the shell develops a tear or hole.Rupture can occur at any time after implantation, but it is more likely to happen when the implant has been in place for a long time.Rupture of a silicone gel-filled breast implant is most often silent (the patient does not experience any symptoms and there are no physical signs of changes with the implant) rather than symptomatic.Therefore, patients should be advised to have regular mris over their lifetime to screen for silent rupture even if they are not having any apparent problems.The first mri should be performed at 3 years postoperatively, then regularly at 2-year intervals, and the images submitted to the treating surgeon.Patients should be provided with a list of radiology centers with experience with breast implant mri films to scan for signs of rupture.The importance of these mri evaluations should be emphasized.If rupture is noted on an mri, the patient should be strongly encouraged to have her implant removed¿ rotation anterior/posterior rotation, also called flipping, has been observed more frequently with cohesive gel implants.The flat base of the implant is positioned anteriorly, deforming the breast of the patient.Proper placement and pocket dissection reduce the risk of occurrence15.Flipping can be treated with bimanual manipulation in the office and can be done repeatedly in recurrent cases.However, in some cases, revision surgery may be necessary to reduce pocket dimensions.Literature has reported that the interaction between breast envelopes, the implant's physical characteristics, and pocket dissection could cause malposition.Other theories include the involution of breast tissue.Regarding implant characteristics, flipping has been associated with the presence or absence of texturing, implant shape/profile, and the gel-filling ratio (i.E., to what degree the implant has been filled).Other factors such as infection, hematoma/seroma, capsular contracture, dissection, surgeon¿s experience, physical activity, and external manipulation of the implant could potentially contribute to the development of this complication.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: handel, n., garcía, m.E., & wixtrom, r.(2013).Breast implant rupture: causes, incidence, clinical impact, and management.Plast.Reconstr.Surg.132(5), 1128."a number of risk factors for rupture have been identified; the most common cause is surgical instrument damage." 5.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.6.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: 22021082
• Report Number: 3012883202-2025-00678
• Device Sequence Number: 9484002
• Product Code: FTR
• UDI-Device Identifier: 07445161012333
• UDI-Public: (01)07445161012333(11)190809(17)240809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/14/2025

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: 08/09/2024
• Device Catalogue Number: ERSF-295Q
• Device Lot Number: 19085009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• 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: 41 YR
• Patient Sex: Female