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

Catalog Number	RSF-335+Q
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Impaired Healing (2378); Insufficient Information (4580)
Date of Event	10/16/2024
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 requested 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.).However, we did not receive information on whether the device is available.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
A patient reported experiencing a rupture in her right breast implant.The patient was advised to undergo breast implant removal surgery.No patient demographics, such as weight or ethnicity were provided by the reporter, and no adverse outcomes for the patient have been noted.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
"extrusion represents potential complications associated with the use of breast implants, it involves the implant coming through the skin, normally through the incision where it¿s been placed.Extrusion can happen for several reasons, such as the skin over the implant thinned too much leaving too little coverage for the implant, the implant used is too large, the incision did not heal well and broke open.Implant exposure due to poor tissue coverage frequently obligates the surgeon to remove the breast implant and begin anew" (gargano, ciminello & de santis, 2009).The most common overall indication for reoperation is capsular contracture (handel, 2006).Extrusion: "breast implant extrusion, or breast implant exposure, occurs when the breast skin and tissues that are holding the implant fail, causing the implant to protrude through the skin and become exposed.It happens in less than 2% of patients; it is shortly after breast augmentation or down the road.Breast-implant extrusion can occur for various reasons, such as improper wound healing due to an infection, trauma, too little soft-tissue coverage, oversized implant coupled with too little tissue coverage, or lack of blood supply.Breast-implant extrusion calls for surgery and removal of the implant".Capsular contracture: "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 a 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 is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.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¿.
Event or Problem Description
New information was received for this case.Patient manifested inflammation, pain, capsular contracture baker grade iii and exposure of the implant that required re-admission to surgery for explantation.
Additional Manufacturer Narrative
A clinical evaluation of the report was performed and from the evidence provided, extrusion on the right side was confirmed.However, implant rupture and grade iii capsular contracture were not confirmed due to insufficient clinical evidence.A complete review of the dhr for lots 22040426/ 22021518 was carried out, no deviation was found in the manufacturing processes.Review of complaint history for the reported lot number and sterilization run found no other similar complaints reported in the past.A definitive root cause could not be determined.Potential factors related to the manufacture of the device that may lead to capsular contracture, extrusion and rupture include, but are not limited to: capsular contracture: 1.Patient undergoing revision surgery.2.Previous infection, hematoma and/or seroma.3.Patient has previous history of capsular contracture.4.Surgical factors.Rupture: 1.Improper technique.2.Damaged shell.3.Trauma.Extrusion: 1.Lack of adequate tissue coverage.2.Previous trauma or infection.As no manufacturing, material or design issues were identified, no further investigation or additional actions are required at this time.Establishment labs will continue to monitor for similar complaints/trends.
Event or Problem Description
Mexico.Patient manifested rupture, inflammation, pain, capsular contracture baker grade iii and exposure of the implant that required re-admission to surgery for explantation.

• Brand Name: MOTIVA SILKSURFACE PLUS WITH QID
• Common Device Name: MOTIVA IMPLANTS
• Manufacturer (Section D): ESTABLISHMENT LABS S.A; coyol free zone, building b25; alajuela CA ; CS
• Manufacturer (Section G): ESTABLISHMENT LABS; coyol free zone, building b25; alajuela
• Manufacturer Contact: susana hidalgo ; coyol free zone, building b25; alajuela, CA ; CS ; 8003554164
• MDR Report Key: 20845084
• Report Number: 3012883202-2024-00181
• Device Sequence Number: 17086474
• Product Code: FTR
• UDI-Device Identifier: 07445161002891
• UDI-Public: (01)07445161002891(11)220409(17)270409
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/03/2025

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: Lay User/Patient
• Device Catalogue Number: RSF-335+Q
• Device Lot Number: 22040426
• 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: 11/09/2024
• Supplement Date Received by Manufacturer: 12/09/2024; Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/03/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2022
• 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: 24 YR
• Patient Sex: Female