| Catalog Number |
ERSD-300Q |
| Medical Device Problem Code |
Break (1069)
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| Health Effect - Clinical Codes |
Unspecified Infection (1930); Insufficient Information (4580)
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| Date of Event |
11/25/2025
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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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¿.Infection: "signs of acute infection reported in association with breast implants include edema, erythema, tenderness, pain, and fever.As with other invasive surgeries, toxic shock syndrome (tss), a life-threatening condition, has been reported in rare instances following breast implant surgery.Symptoms of tss occur suddenly and can include high fever (102°f (38.8°c) or higher), vomiting, diarrhea, sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should immediately contact their physician for diagnosis and treatment if any of these symptoms occur." the human breast is not a sterile anatomic structure; it contains endogenous flora, derived from the nipple ducts, that is essentially similar to that found in normal skin.Multiple breast ducts provide a passage from the skin surface to deep within the breast tissue (pittet et al, 2005).Symptoms of infection usually manifest during the first 2 postoperative weeks, but delayed infections may occur months or even years after the operation (skandalakis, 2009).Establishment labs requests 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.).The explant from this case is available for analysis.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.Establishment labs will continue to monitor for similar complaints/trends.As part of the post market surveillance process, monitoring of the primary endpoints reported is performed to determine unfavorable trends.Per our current complaint data report, no unfavorable trends were detected on this product.No further actions are required.
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Event or Problem Description
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Australia.Allegedly, a patient who underwent a breast augmentation in (b)(6) 2025 was diagnosed with a device rupture in the right breast after experiencing redness and pain.An ultrasound confirmed the rupture, and a pathology study revealed an infection.A revision surgery was performed.No patient demographics, such as weight, or ethnicity, were provided by the reporter.Efforts to gather additional information are ongoing, and the investigation remains in progress.
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Additional Manufacturer Narrative
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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¿.Establishment labs requests 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.).The explant from this case is available for analysis.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.
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Event or Problem Description
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Australia.Allegedly, a patient who underwent a breast augmentation in (b)(6) 2025 has a ruptured implant.Side and serial number involved are not yet specified.No patient demographics, such as weight, or ethnicity, were provided by the reporter.Efforts to gather additional information are ongoing, and the investigation remains in progress.
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Additional Manufacturer Narrative
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General conclusion
device involvement: a causal relationship between the reported event and the device has not been established.Event characterization: the event was classified as rupture.Laboratory testing
laboratory evaluation was conducted in accordance with wi-001048 "pms laboratory testing units." key findings include:
visual inspection: macroscopic examination of the returned device revealed clear evidence of shell rupture.Microscopic analysis: under magnification, the shell exhibited trace marks indicative of interaction with a sharp instrument.The morphology of these marks closely matched those reproduced under controlled laboratory conditions simulating instrument-related damage.These findings differ significantly from patterns associated with spontaneous rupture (e.G.,
fatigue or shell degradation).Shell compliance testing: mechanical and material integrity testing confirmed that the implant shell met all applicable international specification standards.Root cause analysis
based on the testing results, the most probable root cause of the iatrogenic rupture is a damage from a sharp surgical instrument.Such damage may have compromised the shell¿s integrity, predisposing it to failure during clinical procedure.Clinical confirmation
upon thorough evaluation of the submitted clinical documentation and supporting evidence, infection was not confirmed by clinical affairs.Root cause analysis
this event is a well-documented complication inherent to breast implant surgery.Based on the analysis of the available data, including clinical findings and product traceability records, there is no evidence indicating a causal link between this specific case and any product-related factors, including raw materials or manufacturing processes.The etiology of the alleged event is recognized as multifactorial, given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to the manufacturing process and/or the product itself.Dfu and labeling evaluation
the event is a known, well-documented complication associated with silicone breast implants.It is clearly addressed in the product¿s directions for use (dfu), which states:
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 mimplants 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.Infection ¿ infection can occur with any surgery or implant.Most infections resulting from surgery appear within a few days to weeks after the operation.7 however, infection is possible at any time after surgery.In addition, breast and nipple piercing procedures may increase the possibility of infection.Infections in tissue with an implant present are more challenging to treat than infections in tissue without an implant present.If an infection does not respond to antibiotics, the implant may have to be removed, with replacement occurring only after the infection is resolved.The dfu also emphasizes the responsibility of the surgeon to fully inform the patient of potential risks and complications during the pre-operative consultation.Patients are provided with the document ¿motiva implants®: information for the patient,¿ accessible at ifu.Motiva.Health.Literature reference:
handel, n., garcía, m.E., & wixtrom, r.(2013).Breast implant rupture: causes, incidence, clinical impact, and management.Plast.Reconstr.Surg.132(5), 1128."a number of risk factors for rupture have been identified; the most common cause is surgical instrument damage."
infection:
infection following breast augmentation is reported in 1¿4% of cases in different studies.Many risk factors have been correlated with breast infection.General conditions such as obesity, diabetes, immunodeficiency, and cigarette smoking are associated with an increased risk of infection.Symptoms of infection usually manifest during the first 2 postoperative weeks, but delayed infections may occur months or even years after the operation.(john e.Skandalakis, 2009)
the origin of infection in women with implants remains difficult to determine, but potential sources include a contaminated implant, the surgery itself or the surgical environment, the patient's skin or mammary ducts, or, as suggested by many reports, seeding of the implant from remote infection sites.(pittet et al, 2005)
¿systemic antibiotic prophylaxis at the time of surgery is associated with a significant reduction of the infection rate (0·42% vs 0·87%) in a large study of 39 455 patients undergoing breast augmentation.¿ (pittet et al, 2005)
several authors suggest that contamination of the prosthesis at the time of insertion may cause a subclinical infection, and thus stimulate a chronic inflammatory response leading to the development of clinically significant capsules (snell & brown, 2009; steiert, boyce & sorg, 2013; wong, 2006).Results demonstrate that there is a significant association between capsular contracture and the presence of bacteria on the implant (snell & brown, 2009), which calls for an improved surgical care and the development of implant surfaces that do not promote bacteria settlement on the implant (bronz & elberg, 2009; hvilsom et al., 2010).Device history record (dhr) review
a comprehensive review of the device history record (dhr) for the affected lot was completed.No deviations, non-conformances, or anomalies were identified during manufacturing.All raw materials and process parameters conformed to specified quality requirements.Trend and signal monitoring
the event has been evaluated as part of ongoing trend analysis activities within the pms program.Per the current complaint data report:
no adverse or unexpected trends related to device rupture have been identified.No further corrective or preventive actions are required at this time.Establishment labs will continue to monitor for similar events as part of routine pms surveillance.
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