MAUDE Adverse Event Report: MOTIVA USA LLC MOTIVA IMPLANTS; ERGONOMIX ROUND SILKSURFACE

Catalog Number	ERSF-550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2024
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, garcía and winxtrom, 2013.Breast implant rupture: causes, incidence, clinical impact, and management.Plast.Reconstr.Surg.132: 1128.) adittionally, 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 needs to conduct the necessary tests, which include, but are not limited to, a microscopic examination and characterization of the rupture section, along with mechanical testing in compliance with approved standards.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 contibuted to this incident.When the investigation process is completed, the applicable findings will be included in a supplemental medwatch.
Event or Problem Description
It was reported that an ultrasound examination of the patient's right breast implant revealed an intracapsular rupture, primarily located in the central lower portion of the implant.There was no evidence of axillary silicone lymphadenopathy.The implant filler remained within normal range and was not thickened.
Additional Manufacturer Narrative
The reported device was returned for evaluation.There was a relationship between the reported event and the device.The initial visual inspection found a device rupture.Microscope inspection showed trace marks in the shell consistent with those of a sharp instrument reproduced in our laboratory, this is distinct from the pattern resulting from a spontaneous tear in the shell of the implant.Elongation tests confirmed the shell complied with the international specification standards.A complete review of the dhr for lot 22030984 was carried out, no deviation was found in the manufacturing process.Review of complaint history for the reported lot number and sterilization run found no other similar complaints reported in the past.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 rupture when the shell develops a tear or hole.Rupture can occur at any time after implantation but is more 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, implant age and design, submuscular rather than subglandular 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.Silicone gel-filled implant ruptures are most often silent; this means that most of the time, neither the doctor nor the patient can determine with the physical examination if the implant has a tear or hole in the shell.The integrity of breast implants (and detection of gel fractures and/or silent ruptures) can be evaluated through several techniques.High-resolution ultrasound (hrus) is widely accepted by healthcare providers and patients for rupture diagnosis.Additionally, the usfda recommends magnetic resonance imaging (mri) surveillance with the first mri performed three years postoperatively and subsequent mris performed every two years after that.These recommendations may vary from country to country, so please provide the patient with additional guidance based on your country's current care standards.Establishment labs does not recommend closed capsulotomy for treating capsular contracture because it can cause implant rupture.Some symptoms may appear, such as lumps surrounding the implant or in the axilla, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.These symptoms are not specific to rupture and may also be experienced by patients who have capsular contracture.Some cases have been reported suggesting that silicone-implant leakage should be considered in the differential diagnosis of eosinophilia.In conclusion, it was determined that a probable cause for the event reported was a cut resulting from a sharp instrument used which could have weakened the shell.Establishment labs will continue to monitor for similar complaints/trends.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: ERGONOMIX ROUND SILKSURFACE
• Manufacturer (Section D): MOTIVA USA LLC; 125 east de la guerra street; santa barbara 93101
• Manufacturer (Section G): ESTABLISHMENT LABS S.A; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer Contact: susana hidalgo ; 125 east de la guerra street; santa barbara 93101 ; 8003554164
• MDR Report Key: 20684675
• Report Number: 3012883202-2024-00117
• Device Sequence Number: 15585614
• Product Code: FTR
• UDI-Device Identifier: 07445161010827
• UDI-Public: (01)07445161010827(11)220316(17)270316
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: ERSF-550
• Device Lot Number: 22030984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 02/12/2025
• Date Device Manufactured: 03/16/2022
• 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: 43 YR
• Patient Sex: Female