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

Catalog Number	RSF-295+Q
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A clinical evaluation of the report and evidence provided was executed and a unilateral capsular contracture baker grade iv was confirmed.There was a relationship between the reported event and the device.A complete review of the dhr for lot 23061396 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 include, but are not limited to: 1.Patient undergoing revision surgery.2.Previous infection, hematoma and/or seroma.3.Patient has previous history of capsular contracture.4.Surgical factors.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: capsular contracture - normally, capsules of collagen fibers form as an immune response around a foreign body, such as a breast implant, tending to isolate it.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 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 occurs more commonly in patients undergoing revision surgery than in patients undergoing primary implantation surgery.Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.Capsular contracture is graded into 4 levels depending on its severity.Baker grade i: the breast is normally soft and looks natural; baker grade ii: the breast is a little firm but looks normal; baker grade iii: the breast is firm and looks abnormal; baker grade iv: the breast is hard, painful, and looks abnormal.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.Closed capsulotomy (external manipulation of the capsule in order to ¿pop¿ the tissue capsule and open it up) used to be a common procedure for treating capsular contracture, but most manufacturers, including establishment labs, contraindicate it because it can cause implant rupture.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.It was reported that, a patient that was implanted in (b)(6) 2024, started to have symptoms of capsular contracture in her right breast a month after the surgery.45 days after surgery, patient had pain, induration, and evident signs of capsular contracture; at this point, the symptoms were present in the left breast as well.An mri, ultrasound and ct confirmed the diagnosis.The patient had revision surgery only for the right-side breast as the pain in the left breast ceased.

• 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 ; 8003554164
• MDR Report Key: 21552793
• Report Number: 3012883202-2025-00448
• Device Sequence Number: 4474871
• Product Code: FTR
• UDI-Device Identifier: 07445161002877
• UDI-Public: (01)07445161002877(11)230619(17)280619
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 03/07/2025

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-295+Q
• Device Lot Number: 23061396
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2023
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female