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

Catalog Number	ERSF-295Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Ptosis (2620); Insufficient Information (4580)
Date of Event	04/01/2025
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 et al., 2013).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¿.Establishment labs requests the unit to confirm the event and to perform the corresponding testing (including but not limited to: revision and characterization under the microscope of the rupture section, mechanical testing according to approved standards, etc.).The explant from this case is available for analysis.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.
Event or Problem Description
Germany.It was reported that a patient had motiva implants in (b)(6) 2020.A tear in the right implant was detected during a routine checkup.Revision surgery was performed in (b)(6) 2025.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.
Event or Problem Description
Germany.It was reported that a patient presented for consultation in (b)(6) 2025, requesting an implant replacement.In 2020, she underwent aesthetic breast augmentation with motiva implants.Subsequently, she experienced bilateral bottoming out, requiring reoperation without implant replacement.During a routine checkup, a rupture of the right implant was discovered (sn (b)(6)).
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 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: bottoming out: this refers to the inferior displacement of a breast implant that increases the distance between the nipple-areolar complex and the inframammary fold (imf) after breast implant surgery.Risk factors reported in the literature are, but not limited to, the lack of quality of pre-existing breast tissue (i.E., thin subcutaneous tissue, defective dermal elements and breast tuberosity), characteristics of the selected breast implant (such as being overly large), imf dissection, and the type of implant placement during surgery (i.E., submuscular and subglandular planes).The clinical symptoms resulting from a bottomed-out implant include asymmetry, upward-pointing nipples, sagging, palpability, etc.Appropriate surgical planning can mitigate the possible causes of bottoming out.Recommendations include a careful and individual assessment of mammary tissues, careful implant selection, application of risk-minimizing surgical techniques, and adequate breast support after surgery.Treatments may vary depending on the severity of the complication and range from a simple sub-mammary fixation to the use of additional supporting materials.
Additional Manufacturer Narrative
General conclusion - device involvement: a causal relationship between the reported event and the device has been established.Event characterization: the event was classified as rupture.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.Reference: (b)(4) ¿ complaint investigation unit testing results.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, bottoming out was not 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: 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 occur over time.Silent rupture is common and often asymptomatic; therefore, patients should undergo regular mri screenings starting at 3 years post-op, then every 2 years.¿ bottoming out: this refers to the inferior displacement of a breast implant that increases the distance between the nipple-areolar complex and the inframammary fold (imf) after breast-implant surgery.Risk factors reported in the literature are, but not limited to, the lack of quality of pre-existing breast tissue (i.E., thin subcutaneous tissue, defective dermal elements and breast tuberosity), characteristics of the selected breast implant (such as being overly large), imf dissection, and the type of implant placement during surgery (i.E., submuscular and subglandular planes).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." bottoming out: mañero, ivan m.D.; montull, patricia m.D.; guisantes, eva m.D.Bottoming out: a simple technique for correcting breast implant displacement.Plastic and reconstructive surgery: december 2009 - volume 124 - issue 6 - p 452e-453e 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: MOTIVA 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: 22845821
• Report Number: 3012883202-2025-01042
• Device Sequence Number: 9305961
• Product Code: FTR
• UDI-Device Identifier: 07445161012333
• UDI-Public: (01)07445161012333(11)190801(17)240801
• 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,Followup
• Report Date (Section B): 09/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Catalogue Number: ERSF-295Q
• Device Lot Number: 19075997
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 08/25/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2019
• 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: 40 YR
• Patient Sex: Female