MAUDE Adverse Event Report: Establishment Labs S.A. MOTIVA IMPLANTS; SilkSurface Plus with Qid

Catalog Number	RSF-335+Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Brazil.Allegedly, a patient who underwent a breast augmentation surgery, had an ultrasound that reveals signs of extrcapsular rupture on her left implan and a small amount of silicone present in the breast tissue and in the axilary lymph nodes.There is no information on wheter th patient underwent an explantation surgery.The investigation is ongoing.
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¿.Lymphadenopathy: "silicone-induced lymphadenopathy is a well-known rare complication of implant insertion.It is a disease of the lymph nodes (small, round structures that operate as part of the body¿s immune system).They become abnormal in size or consistency (most commonly producing swollen or enlarged lymph nodes).After implant insertion, axillary lymphadenopathy causes are multifactorial, with possible factors including granulomatous reaction, inflammation, and/or malignancy.Literature reports associate lymphadenopathy with intact and ruptured silicone breast implants since microscopic silicone droplets can migrate to body tissues even when the implant surface remains intact.Breast implant rupture and/ or leakage through an intact surface can cause fibrosis and granulomatous reactions, which in turn can result in a contracture or regional lymphadenopathy that sometimes mimics malignancy.Various patterns of lymphadenopathy and even extranodal pathology may be observed.Tissue examination is essential to identify the cause of lymphadenopathy.When in doubt, spectrometry analysis can confirm a diagnosis of silicone-induced lymphadenopathy".Establishment labs requested the units 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, no information regarding device return has been received.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: SilkSurface Plus with Qid
• 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 ; +1(800)355-4164
• MDR Report Key: 50055809
• Report Number: 3012883202-2026-02684
• Device Sequence Number: 10539622
• Product Code: FTR
• UDI-Device Identifier: 07445161002891
• UDI-Public: (01)07445161002891(11)211102(17)261102
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 07/28/2026

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 Expiration Date: 02/11/2026
• Device Catalogue Number: RSF-335+Q
• Device Lot Number: 21102119
• 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: 07/07/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2021
• 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: Other
• Patient Sex: Unknown