| Model Number |
BREAST IMPLANT ROUND DEMI 425 S |
| Medical Device Problem Codes |
Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
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| Health Effect - Clinical Codes |
Capsular Contracture (1761); Seroma (2069)
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| Date of Event |
09/24/2024
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Type of Reportable Event
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Serious Injury
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Event or Problem Description
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It was reported that the patient experienced a sudden and significant increase in the size of the right breast and imaging studies, revealed bilateral periprosthetic fluid, predominantly in the upper inner quadrant of the right breast.Clinical examination noted enlargement and firmness of the right breast.By (b)(6) 2024, the patient underwent an explantation procedure that included analysis of the periprosthetic fluid and tumor-like lesion, a total capsulectomy, and replacement of the implants with motiva ergonomix.
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Additional Manufacturer Narrative
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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).It has been identified several significant risk factors for capsular contracture, including device features (surface, size), surgical factors (periareolar incision, subglandular placement, antibiotic irrigation), the development of hematoma/seroma, and the use of a surgical bra.(calobrace, 2018).Periprosthetic capsules become pathologically active and undergo a ¿constrictive fibrosis¿ due to retraction of the fibrous tissue, which deforms their contents and impairs the aesthetic outcome, manifested by hardening of variable degree and, in advanced cases, by deformity of the breast.(baker et al., 1990).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: ¿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¿."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".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.At establishment labs, we are committed to patient safety and continually evaluate the performance of our devices through post-market surveillance of reported complaints & adverse events.
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Additional Manufacturer Narrative
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Quality department received a complaint from a customer, notifying ¿unilateral right side capsular contracture baker grade iii/iv and seroma¿.The device involved corresponds to a motiva implant, details referenced on ¿d¿ section.Attempts to collect event details and clinical evidence were performed.Dfu: the instructions for use in the directions for use were reviewed, to determine 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: "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.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.¿ ¿hematoma/seroma is a collection of blood within the space around the implant, and a seroma is a build-up of fluid around the implant.Having a hematoma and/or seroma following surgery may result in infection and/or capsular contracture later.Symptoms from a hematoma or seroma may include swelling, pain, and bruising.If a hematoma or seroma occurs, it will usually be soon after surgery.However, they can also occur at any time after injury to the breast.While the body absorbs small hematomas and seromas, some will require surgery, typically involving draining, and potentially placing a surgical drain in the wound temporarily for proper healing.A small scar can result from surgical draining.Implant rupture also can occur from surgical draining if there is damage to the implant during the procedure¿.As stated in the literature: potential factors unrelated to the design or 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.¿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.).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).¿capsular contracture is a risk associated with breast surgery (handel, 2006) and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of capsular contracture occurrence.The cause of capsular contracture is multifactorial (calobrace, 2018), and we cannot conclude that the reported event was caused by the manufacturing process and/or the product itself.Seroma is recognized as an early complication of breast implant surgery and its incidence is reported together with hematomas in 6.6% for primary surgery.For other authors the incidence of early-stage seroma is 0.1%.Mcardle b, layt c.A case of late unilateral hematoma and subsequent late seroma of breast after bilateral breast augmentation.Aesth plast surg 2009; 33: 669-670.Scott l.Breast augmentation.Clin plast surg 2009; 36(1): 105-115.Oliveira vm, roveda d jr, lucas fb et al.Late seroma after breast augmentation with silicone prostheses: a case report.Breast j 2007; 13(4): 421-423.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, m., husein, r., atkinson, c., & zaccheddu, r.(2017).Unraveling factors influencing early seroma formation in breast augmentation surgery.Aesthetic surgery journal, 37(3), 301¿307.Https://doi.Org/10.1093/asj/sjw196.General conclusion: final investigation was generated, and it was not possible to confirm the alleged events due to insufficient clinical evidence provided.Capsular contracture and seroma are considered a potential risks of the surgery as indicated in the product directions for use.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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