MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	ERSD-425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/21/2025
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: ¿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.).For this specific case, the device was already returned and the laboratory testing is pending.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
Korea.It was reported that a patient who underwent augmentation surgery with implants on (b)(6) 2022 required a revision surgery due to a rupture in the left breast.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
A causal relationship between the reported event and the device has been established.Laboratory evaluation was conducted in accordance with internal procedures.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.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.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 alleged 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.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 22956874
• Report Number: 3012883202-2025-01102
• Device Sequence Number: 8453307
• Product Code: FTR
• UDI-Device Identifier: 07445161010612
• UDI-Public: (01)07445161010612(11)220701(17)270701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/09/2025

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 Catalogue Number: ERSD-425
• Device Lot Number: 22062239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female