| Catalog Number |
RSD-205+ |
| Medical Device Problem Code |
Break (1069)
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| Health Effect - Clinical Code |
Insufficient Information (4580)
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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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The alleged event is a risk associated with breast surgery and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of occurrence.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.).Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.A complete review of the dhr for lot involved was carried out, no deviation was found in the manufacturing process.Additionally, there were no indications of abnormalities in raw materials or manufacturing processes which may have affected this particular batch.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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Germany.Allegedly, a patient had one of her implants ruptured.Revision surgery was required.At this point, the side affected is unknown.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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1.Overview:
the quality department (pms) received a complaint involving a motiva® device.Further details are provided in the cq ¿details¿ section.2.General conclusion:
¿ device involvement: a causal relationship between the reported event and the device has been established only a device rupture.¿ event characterization: the event was classified as a capsular contracture, hematoma, ptosis and device rupture.3.Clinical confirmation:
upon thorough evaluation of the submitted clinical documentation and supporting evidence, the reported case was not confirmed meeting the requirements for a capsular contracture, classified as baker grade iii/iv.This classification indicates moderate to severe contracture, characterized by firmness, distortion, and potential patient discomfort or pain.Intracapsular rupture of the left device can be confirmed based on the attached mri report.However, due to the lack of supporting clinical evidence ptosis, and hematoma cannot be confirmed.Root cause analysis:
capsular contracture 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 capsular contracture is recognized as multifactorial, with potential contributing elements including postoperative patient-specific biological responses, and surgical technique.Given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to a defect in the device or its production.4.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:
capsular contracture:
"a capsular contracture pertains to hypertrophic scar tissue investing in a foreign body or surgically implanted device, compromising the aesthetic outcome, resulting in pain, breast deformity, and often necessitating further operations.Detection of breast cancer by mammography may also be challenging.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 the most common complication following implant- based breast surgery and is one of the most common reasons for reoperation" 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 fi rm 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.Device rupture:
¿breast implants can rupture when the shell develops a tear or hole.Rupture can occur at any time after implantation, but it is more likely to occur over time.Silent rupture is common and often asymptomatic; therefore, patients should undergo regular mri screenings starting at 3 years post-op, then every 2 years.¿
hematoma:
a hematoma is a collection of blood within the breast tissue.Hematomas are one of the several complications that may follow a breast augmentation procedure.Symptoms of hematomas generally include swelling, bruising and pain around the incision area10.While most hematomas are small and will completely drain on their own and the blood re-absorbs into the body, those patients that are experiencing moderate to severe pain should undergo a follow-up visit.Most hematomas will either resolve on their own or will only require draining.Drains are small surgical tubes that lead out of the breast with a small bulb attached to collect blood and other fluids.Ptosis:
the ¿waterfall effect¿ is a descriptive term to indicate sliding ptosis of parenchymal breast tissue over a fixed or encapsulated implant.It occurs more frequently than surgeons anticipate and especially over the long term after augmentation.Certain breast implants are more prone to contribute to this problem as are implants placed in submuscular pockets that ride high, especially in women with anatomical musculoskeletal variance or asymmetry.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.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.Literature reference:
the aetiology of capsular contracture is multifactorial and consisting of patient, type of surgery, prosthetic material used, the implant pocket placement, the incision type and the duration of follow-ups (liu et al., 2015) (headon, kasem & mokbel, 2015).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."
hematoma is a complication often associated with surgery and has been reported following breast implantation.Franck duteille, *michel rouif, sophie laurent, and máirín cannon, 2014.Five-year safety data for eurosilicone¿s round and anatomical silicone gel breast implants.Plast reconstr surg glob open.2014 apr; 2(4): e138.Doi: 10.1097/gox.0000000000000082).5.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 the reported event 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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