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

Catalog Number	RSF-275+Q
Medical Device Problem Codes	Break (1069); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most common overall indication for reoperation is capsular contracture.(handel, 2006).Breast prostheses are no different from any foreign material implanted into the human body in the sense of triggering a protective immune reaction from the host.This ¿foreign body response¿ (fbr) is universal and ideally removes or otherwise surrounds the ¿irritant material¿ with fibrous tissue to prevent unwanted immune sequelae.A capsule around a breast implant is, therefore, a necessary mechanism of body defense, but if excessive it can lead to pain and deformity of the breast (steiert, et al., 2013).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).¿it is imperative that careful planning and exacting surgical technique are used to reduce iatrogenic damage of implants during primary placement and subsequent reoperations.¿ (handel, garcía and winxtrom, 2013).¿early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time.¿ (sforza, et al.2017).¿seroma can present both early and late, with the latter being recently linked with malignant growths and prolonged onset.¿ (sforza, et al.2017).Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: seroma: "seroma is an accumulation of fluid that results from tissue inflammation7.The etiology of seroma is known in breast surgery and is connected to a hypovascular milieu or trauma following the surgery.Often, seromas are reabsorbed by the body over several weeks, but needle drainage is sometimes needed to remove the fluid.While seromas do not increase breast cancer risk, they sometimes heal with scar tissue or calcifications that can raise a concern about mammograms in the future.Seroma symptoms most often appear a week to 10 days after surgery; the area may feel tender and swollen, with a discrete lump and redness arising within a day or two.Early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time9.In addition to causing pain, a seroma increases the risk of developing an infection in the breast.Depending on the location, it may also increase pressure over the surgical site and sometimes cause wound dehiscence".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¿.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.¿ 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.
Event or Problem Description
Patient implanted with motiva implants presented late seroma, evolved capsular contracture and rupture signs on right breast according to rmn.Is it unknown if the patient has been explanted.No patient demographics, such as age, 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.
Event or Problem Description
Brazil.Patient implanted with motiva implants presented late seroma, evolved capsular contracture and rupture signs on right breast according to rmn.Is it unknown if the patient has been explanted.No patient demographics, such as age, weight, or ethnicity, were provided by the reporter, and no adverse outcomes for the patient have been noted.Efforts to gather additional information were made, and the investigation was completed.
Additional Manufacturer Narrative
¿ a relationship between the reported rupture and the device could not be established as the product was not returned for evaluation.Additionally, neither the contracture nor the seroma could be confirmed due to insufficient clinical evidence.A complete review of the dhr for lot 23021953 was carried out, no deviation was found in the manufacturing process.Review of complaint history for the reported lot numbers and sterilization run found no other similar complaints reported in the past.¿ a definitive root cause could not be determined.Potential factors nonrelated to the manufacture of the device that may lead to the events reported include but are not limited to: (1) damage by surgical instruments.(2) implant stress and weakening during implantation.(3) patient undergoing revision surgery.(4) subclinical infection or allergic phenomena.¿ 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.

• 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 20113 ; CS 20113
• Manufacturer (Section G): ESTABLISHMENT LABS; 125 east de la guerra street; alajuela
• Manufacturer Contact: susana hidalgo ; coyol free zone, building b25; alajuela 20113 ; CS 20113 ; 8003554164
• MDR Report Key: 21149635
• Report Number: 3012883202-2025-00299
• Device Sequence Number: 9134549
• Product Code: FTR
• UDI-Device Identifier: 07445161002860
• UDI-Public: (01)07445161002860(11)230222(17)280222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: RSF-275+Q
• Device Lot Number: 23021953
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2023
• 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