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Journal articles on the topic 'Breast implants'
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Lotter, Luisa, Isabel Zucal, Vanessa Brébant, Norbert Heine, Robin Hartmann, Karolina Mueller, Lukas Prantl, and Daniel Schiltz. "Intraoperative 3D Comparison of Round and Anatomical Breast Implants: Dispelling a Myth." Journal of Clinical Medicine 11, no. 1 (December 28, 2021): 149. http://dx.doi.org/10.3390/jcm11010149.
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Background: Thanks to 3D imaging, it is possible to measure the influence of different parameters on breast augmentation. In this study, we compare the effect of different shapes and sizes of breast implants on the topography of the resulting breast. Furthermore, the impact of different breast implants on inter-landmark distances and on changes of the nipple position was assessed. Methods: This interventional prospective study was carried out on 10 female patients after collecting informed consent. 3D scans of the native and augmented breasts were performed intraoperatively with small, medium, and large sizes of both anatomical and round implants, resulting in a total of n = 130 single breast scans. These scans were analyzed for topographic shift quantification, nipple migration, and inter-landmark distances of the breast. Results: Implant size, but not implant shape leads to significant topographic shifts of the breast (p < 0.001 and p = 0.900, respectively). Both round and anatomical implants lead to a significantly higher volumetric increase in the upper quadrants compared to the lower quadrants (p < 0.001). Nipple migration into the superomedial quadrant was seen in about 90% of augmentations. No evident differences in inter-landmark distances were observed when round and anatomical implants of different sizes were compared. Conclusions: Implant size rather than shape influences the postoperative aesthetic results. No significant difference in topographic shift was found comparing round and anatomical implants, suggesting that both implant shapes result in comparable aesthetic outcomes.
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Magno-Padron, David A., Jessica Luo, Terry C. Jessop, Jared W. Garlick, Joanna S. Manum, Gentry C. Carter, Jayant P. Agarwal, and Alvin C. Kwok. "A population-based study of breast implant illness." Archives of Plastic Surgery 48, no. 4 (July 15, 2021): 353–60. http://dx.doi.org/10.5999/aps.2020.02117.
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Background Despite evidence supporting the safety of breast implants, some women associate their implants with adverse health effects and have called this syndrome “breast implant illness.” We sought to characterize breast implant illness symptoms and to report how implant removal affects their symptoms.Methods An anonymous 20 question survey was administered to the Facebook group: “UTAH Breast Implant Illness” to characterize the symptoms these women attributed to their breast implants. Several questions allowed us to evaluate how implant removal affected women’s symptoms.Results Of the 182 respondents, 97% report that implants negatively affect their health and 95% identify these symptoms with breast implant illness. Ninety-six percent of respondents had implants placed for cosmetic reasons and 51% had silicone implants. The most common symptoms associated with breast implant illness are brain fog (95%), fatigue (92%), joint pain (80%), and hair loss (74%). Sixty percent of respondents learned about breast implant illness from family/friends and/or social media platforms (56%), 40% of respondents had their implants removed, and 97% report relief of their symptoms post-removal (23% complete, 74% partial). Following explantation, there was a significant improvement in all but one reported symptom. An association was found between the number of symptoms reported prior to explantation and the number of symptoms resolving following explantation.Conclusions Breast implant illness is a syndrome characterized by fatigue, decreased focus, hair loss, and joint pain after the placement of breast implants. Nearly all patients report improvement of symptoms after implant removal. Significant efforts should be made to better understand breast implant illness and its etiology.
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Lee, Joo Hyuck, Jae Hyuk Jang, and Kyung Hee Min. "A Comparison of Smooth and Microtextured Breast Implants in Breast Augmentation: A Retrospective Study." Archives of Plastic Surgery 50, no. 02 (March 2023): 160–65. http://dx.doi.org/10.1055/s-0042-1760405.
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Abstract Background The number of cosmetic and reconstructive surgeries that use breast implants is increasing in Korea. Recently, it has been reported that breast implant-associated anaplastic large-cell lymphoma is related to textured breast implants, and interest in classification according to the texture of breast implants is increasing. However, there is currently no clear and unified classification. In particular, the definition of “microtextured” is highly varied. In this study, we retrospectively investigated and analyzed the clinical outcomes of smooth and microtextured breast implants. Methods A retrospective chart review of all patients who underwent breast augmentation surgery with smooth and microtextured silicone gel implants between January 2016 and July 2020 was performed. We retrospectively analyzed implant manufacturer, age, body mass index (BMI), smoking status, incision location, implant size, follow-up period, complications, and reoperation rate. Results A total of 266 patients underwent breast augmentation surgery, of which 181 used smooth silicone gel implants and 85 used microtextured silicone gel implants. Age, BMI, smoking status, implant size, and follow-up period were not significantly different between the two groups. Similarly, complications and reoperation rates were not significantly different between the two groups. Conclusion It is important to provide information regarding the clinical risks and benefits of breast implants to surgeons and patients through a clear and unified classification according to the texture of the breast implant.
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Varela-Chinchilla, Carlos Daniel, Gabriel Salinas-McQuary, Nancy de los Ángeles Segura-Azuara, and Plinio A. Trinidad-Calderón. "Breast Implant Illness: Surgical, Autoimmune, and Breast Reconstruction Associations." Surgeries 3, no. 2 (May 13, 2022): 111–25. http://dx.doi.org/10.3390/surgeries3020013.
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Breast implant illness refers to a combination of different symptoms related to breast implant surgery, including fatigue, brain fog, and arthralgias. This malaise occurs after cosmetic and reconstructive breast surgeries, although it has not been proven to be a disease. Even recent studies have reported concluding statements of the etiology, diagnosis, and treatment as unclear and widely unknown. Therefore, this review aimed to determine the associations between the manifestations of breast implant illness in surgery and breast reconstruction, as well as the autoimmune responses involved. Complications associated with breast implants include breast pain, capsular contracture, infections, as well as other manifestations specific to breast reconstruction. Moreover, patients with implants may present with new-onset systemic sclerosis, Sjögren’s syndrome, and connective tissue diseases. However, the incidence of capsular contracture has steadily decreased with each generation of implants, particularly since the development of textured implants, as well as with the use of antibiotics and antiseptic pocket irrigation. However, the incidence of anaplastic large cell lymphoma has increased with the use of textured implants. Remarkably, the autoimmune response to these implants remains unclear. Therefore, close follow-up, careful observation of any symptom presentation, and evidence-based treatment decisions are necessary for patients with breast implants.
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Lieffering, Annemiek S., Juliëtte E. Hommes, Lotte Ramerman, Hinne A. Rakhorst, Marc A. M. Mureau, Robert A. Verheij, and René R. W. J. van der Hulst. "Prevalence of Local Postoperative Complications and Breast Implant Illness in Women With Breast Implants." JAMA Network Open 5, no. 10 (October 7, 2022): e2236519. http://dx.doi.org/10.1001/jamanetworkopen.2022.36519.
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ImportanceIt is unknown how often breast implant illness (BII) is the indication for revision in women with silicone breast implants.ObjectiveTo examine how often women with silicone breast implants have their implants explanted or replaced because of BII compared with local postoperative complications.Design, Setting, and ParticipantsA legacy cohort study on breast implant revision surgery was conducted between April 1, 2015, and December 31, 2020, and a prospective cohort study on breast implantation and revision surgery was conducted between April 1, 2015, and December 31, 2019 (with follow-up until December 31, 2020). Data were obtained from the Dutch Breast Implant Registry. Data analysis was performed from September 2021 to August 2022.ExposuresSilicone breast implant.Main Outcomes and MeasuresBreast implant revision with the indication BII or local postoperative complications.ResultsAll 12 882 cosmetic breast implants (6667 women; mean [SD] age, 50.6 [12.7] years) and 2945 reconstructive breast implants (2139 women, mean [SD] age, 57.9 [11.3] years) in the legacy cohort and all 47 564 cosmetic breast implants (24 120 women, mean [SD] age, 32.3 [9.7] years) and 5928 reconstructive breast implants (4688 women, mean [SD] age, 50.9 [11.5] years) in the prospective cohort were included for analysis. In the prospective cohort, 739 cosmetic breast implants (1.6%) were revised after a median (IQR) time to reoperation of 1.8 (0.9-3.1) years, and 697 reconstructive breast implants (11.8%) were revised after a median (IQR) time to reoperation of 1.1 (0.5-1.9) years. BII was registered as the reason for revision in 35 cosmetic revisions (4.7%) and 5 reconstructive revisions (0.7%) in the prospective cohort, corresponding to 0.1% of the inserted implants. In the legacy cohort, 536 cosmetic revisions (4.2%) and 80 reconstructive breast implant revisions (2.7%) were performed because of BII.Conclusions and RelevanceIn this cohort study of women with silicone breast implants, BII was an uncommon indication for revision compared with local complications, both in the short and long term. In contrast to the increasing public interest in BII, these results showed that local complications are a far more common reason for breast implant revision.
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Brandon, Harold J., Larry S. Nichter, and Dwight D. Back. "New Evaluation Procedure for Multi-Dimensional Mechanical Strains and Tangent Moduli of Breast Implants: IDEAL IMPLANT® Structured Breast Implant Compared to Silicone Gel Implants." Bioengineering 6, no. 2 (May 12, 2019): 43. http://dx.doi.org/10.3390/bioengineering6020043.
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The IDEAL IMPLANT® Structured Breast Implant is a dual lumen saline-filled implant with capsular contracture and deflation/rupture rates much lower than single-lumen silicone gel-filled implants. To better understand the implant’s mechanical properties and to provide a potential explanation for these eight-year clinical results, a novel approach to compressive load testing was employed. Multi-dimensional strains and tangent moduli, metrics describing the shape stability of the total implant, were derived from the experimental load and platen spacing data. The IDEAL IMPLANT was found to have projection, diametric, and areal strains that were generally less than silicone gel implants, and tangent moduli that were generally greater than silicone gel implants. Despite having a relatively inviscid saline fill, the IDEAL IMPLANT was found to be more shape stable compared to gel implants, which implies potentially less interaction with the capsule wall when the implant is subjected to compressive loads. Under compressive loads, the shape stability of a higher cross-link density, cohesive gel implant was unexpectedly found to be similar to or the same as a gel implant. In localized diametric compression testing, the IDEAL IMPLANT was found to have a palpability similar to a gel implant, but softer than a cohesive gel implant.
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Jovic, Marko, Ivan Radosavljevic, Jovan Mihaljevic, Jelena Jeremic, and Milan Jovanovic. "Breast implant rupture 37 years after breast augmentation." Srpski arhiv za celokupno lekarstvo, no. 00 (2021): 69. http://dx.doi.org/10.2298/sarh210401069j.
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Introduction Silicone implants have been used ever since the second half of the 20th century. Over that period several generations of implants have been developed that differed in thickness of the shell and viscosity of the silicone gel. Development of these generations of implants was accompanied with different complication rates. The first-generation implants had the lowest tendency to rupture, but were more prone to capsular contracture and calcification formation. Case outline An 81-year-old female patient had her silicone implants placed in 1983. After a chest injury in 2015. on the lateral aspect of the left breast a tumefaction becomes palpable and she complains of pain. She denies any subjective problems before the injury. After pertinent diagnostic procedures and clinical examination, silicone implant rupture was suspected. Surgical findings confirmed ruptures of both implants so that they were extracted, capsulectomy was performed and the surrounding tissue imbibed with silicone removed. Samples were sent for histopathological examination. Conclusion Implant rupture is one of late complications of breast augmentation. The incidence of ruptures has changed with development of newer generations of silicone implants. We believe that our patient had the first-generation silicone implants, knowing the time from their placement to the occurrence of symptoms and macroscopic appearance of the shell after extraction. The fact is that these implants have proved to be very durable, but regardless of the lack of symptoms, current guidelines recommend regular screening for rupture, while possible preventive extraction, particularly in case of so old implants should be considered.
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Peters, Walter. "The Evolution of Breast Implants." Canadian Journal of Plastic Surgery 10, no. 5 (December 2002): 223–36. http://dx.doi.org/10.1177/229255030201000508.
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The present review traces the evolution of breast implants over the past 50 years. During the early years (from 1951 to 1962), a number of different sponges were used for breast augmentation. The first of these was Ivalon, a polyvinyl alcohol sponge. Other sponges were introduced subsequently, including Etheron (a poly-ether sponge popularized by Dr Paule Regnault in Montreal) and Polystan (fabric tapes that were wound into a ball). Subsequently, polyethylene strips enclosed in a fabric or polyethylene casing were also used for breast augmentation. All of these materials had similar outcomes. Although the initial results were encouraging, within one year of augmentation, breasts became very firm and lost over 25% of their volume. This was due to capsular contracture, a process that would lead to the collapse of the sponge and would continue to plague plastic surgeons and their patients for the next 50 years. In 1963, Cronin and Gerow introduced the silicone gel ‘natural feel’ implant, which revolutionized breast augmentation surgery. Approximately 10 companies have manufactured many types of silicone gel breast implants over the years. They obtained their raw materials for gels and shells from a similar number of other companies that entered and left the market at intervals. Many of the suppliers and manufactures changed their names and ownership over the years, and most of the companies no longer exist. No formal process of United States Food and Drug Administration premarket testing was in effect until 1988. There have been three generations of gel implants and a number of other lesser variations. First-generation implants (1963 to 1972) had a thick gel and a thick wall. They have generally remained intact over the years. Second-generation implants (1973 to the mid-1980s) had a thin gel and a thin wall. They have tended to disrupt over time. Third-generation implants (mid-1980s to 1992) had a thick wall and a thick gel. Except for those made by Surgitek, these implants remain intact. The breast implant business was competitive and companies introduced changes such as softer gels; barrier low-bleed shells; greater or lesser shell thickness; surface texturing; different sizes, contours and shapes; and multiple lumens in search of better aesthetics. Ultimately, more than 240 styles and 8300 models of silicone gel breast implants were manufactured in the United States alone. Inflatable breast implants were introduced in Toulons, France in 1965 (the Simaplast implant). There have been three main eras of inflatable implants: seamed, high-temperature vulcanized and room temperature vulcanized implants. In 1973, spontaneous deflation rates of 76% to 88% over three years were reported for many types of inflatable implants. Because of this, most plastic surgeons abandoned their use. From 1963 until the moratorium on gel implants (January 6, 1992), about 95% of all breast implants inserted were silicone gel filled. Only 5% were saline filled. Since the moratorium, this ratio has been reversed and 95% of all implants have been saline-filled, with only 5% being gel filled. Polyurethane-coated (PU) silicone gel implants were introduced in 1968. Over the next 20 years, they were shown to reduce the prevalence of capsular contracture to 2% to 3%. Other forms of surface texturing (Biocell, Siltex, multistructured implant) also appear to reduce capsular contracture with gel implants, but the reduction has been much less dramatic than that seen with PU implants. Contoured (anatomical) shaping appears to have advantages in some patients with gel implants. No such advantage has been seen for texturing or shaping with saline-filled implants. The story of gel implants has culminated in the largest class action lawsuit in medical history, with US$4.2 billion being awarded to women with silicone gel implants. During the past decade, there has been a tremendous amount of research on the reaction of a woman's body to gel implants. A plethora of studies have demonstrated that silicone gel implants are not associated with the development of any medical diseases. Silicone gel-filled implants have therefore been approved for use under Health Canada's Special Access Program. Silicone gel-filled implants may now be used in certain patients in whom they would provide advantages over saline implants. Silicone gel implants have not been approved for unrestricted general use. The evolution of breast implants occupies the past half century. It has been a stormy course, with many exciting advances and many bitter disappointments. The universe of breast implants is large and the variation among the implants is substantial. The purpose of the present review is to trace the evolution of breast implants over the past 50 years.
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Kim, Yang-Hee, Dong-Wook Park, Keun-Yeong Song, Hyung-Guhn Lim, Jeong-Pil Jeong, and Jae-Hong Kim. "Use of High-Resolution Ultrasound in Characterizing the Surface Topography of a Breast Implant." Medicina 59, no. 6 (June 5, 2023): 1092. http://dx.doi.org/10.3390/medicina59061092.
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Background and Objectives: With the emergence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), it has become necessary to identify the implant shell type patients have received. Therefore, an immediate, reliable method for identifying a breast implant shell type is essential. Evidence-based research and applying a real-world technique that identifies the surface topographic information of the inserted breast implants, without surgery, has become of paramount importance for breast implant physicians. Methods and Materials: A review of the medical records of 1901 patients who received 3802 breast implants and subsequently received an ultrasound-assisted examination was performed. All patients received not only a breast cancer examination but also a high-resolution ultrasonography (HRUS) assisted examination of the device at a single center between 31 August 2017 and 31 December 2022. Results: Most patients had breast implants within 10 years (77.7%) of the examination. Of the 3802 implants screened, 2034 (53.5%) were identified with macro-textured shell topography in ultrasonography. A macrotextured shell type implant was used in 53.5% of cases and a smooth type in 42.7% of cases. Seventy-three (1.9%) breast implant shell types could not be identified due to ruptures. However, 250 breast implant shell types could be identified despite rupture cases (6.5%). Conclusions: HRUS was found to be a useful and reliable image modality for identifying various surface shell types of breast implants. The shell type information would be helpful to patients who lack information about their breast implants and are concerned about BIA-ALCL.
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Cala Uribe, Laura C., Mauricio Perez Pachon, Andres Villate Hernandez, and Andreina Zannin Ferrero. "Kite Mastopexy: Small Scar and Tissue-conserving Technique." Plastic and Reconstructive Surgery - Global Open 11, no. 9 (September 2023): e5265. http://dx.doi.org/10.1097/gox.0000000000005265.
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Background: Breasts are considered one of the most physically and sexually appealing features of the female body. Reduction/augmentation techniques have greatly evolved in the last decades. We are reporting our experience with an innovative technique for mastopexy that recovers the aesthetics of the breast and avoids over-resection of its lower pole. Methods: Inclusion criteria were women who underwent kite mastopexy with or without implants between January 2018 and May 2022 in a single center (Bogota, Colombia). Exclusion criteria were patients with American Society of Anesthesiology score more than II, with any uncontrolled chronic illness and/or medical history of diabetic mellitus, metabolic syndrome, body mass index more than 32 kg per m2, and active smokers. Results: We found 133 consecutive female patients. Age range was 18 and 67 years (median 39). Breast implants were used for the purpose of kite mastopexy in 52% cases. Patients were divided into two groups: implants (group 1) versus no implants (group 2). Procedure 1 involved mastopexy without implants; procedure 2 included current implant users who underwent either implant removal or in whom implants were not used for the sake of mastopexy. Procedures 3 and 4 included patients who underwent either new implant placement or implant exchange, respectively. Average time of surgery was 1.5 hours. Minor complications were mostly related to wound dehiscence. No major complications were reported. Conclusions: Kite mastopexy restores the breast aesthetics by following specific markings, a new plication of breast pillars, and a reduced scar. Our technique demonstrates a very low rate of complications while entailing natural and appealing results.
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Nichter, Larry S., Robert A. Hardesty, and Gregg M. Anigian. "IDEAL IMPLANT Structured Breast Implants." Plastic and Reconstructive Surgery 142, no. 1 (July 2018): 66–75. http://dx.doi.org/10.1097/prs.0000000000004460.
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Eisenberg, Ted. "One-Stage Correction of Tuberous Breast Deformity Using Saline Implants: Without the Need for Radial Scoring or Lowering the Inframammary Fold." American Journal of Cosmetic Surgery 36, no. 4 (April 13, 2019): 191–96. http://dx.doi.org/10.1177/0748806819841466.
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Tuberous breasts are a congenital anomaly in which the breasts fail to develop normally. This abnormality may include hypoplasia, a tubular appearance, a higher inframammary fold (IMF), and sometimes a herniated nipple-areolar complex. Correction of tuberous breast deformity (TBD) is traditionally done with a 1-stage breast augmentation with radial scoring of the constricted breast tissue and/or the lowering of the IMF. An alternative 2-stage approach first uses a tissue expander to correct the deformity; the expander is later replaced with a permanent breast implant. Sixteen patients are presented in which a 1-stage correction of TBD was successfully accomplished with saline implants acting as tissue expanders. In all cases, the expansion remedied the deformity without the need for radial scoring of the breast tissue or lowering of the IMF. This approach has not been reported in the literature. Sixteen women (32 breasts) were treated, with TBD ranging from mild to severe. All patients had a breast augmentation with round, smooth saline implants placed through an IMF incision in the dual plane (partially subpectoral and partially submammary). Implants ranged in size from 225 cc to 675 cc. The IMF was never lowered and the breast parenchyma was never radially scored. Three patients had asymmetry requiring breast implants of different sizes, and one had a circumareolar mastopexy to repair a herniated areolar complex. Representative case examples are provided. The average follow-up time was 9 months. All deformities were corrected, and the patients expressed satisfaction with their results. There were no occurrences of hematoma, infection, capsular contracture, or malposition. This review has shown that saline breast implants alone, with their inherent expansion capability, can correct TBD without the increased morbidity associated with radial scoring and lowering the IMF. For patients who choose saline implants, this single-stage, less invasive surgical approach can provide a good aesthetic result.
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Leduey, Alexandre, Chafika Mazouni, Nicolas Leymarie, Heba Alkhashnam, Benjamin Sarfati, Jean-Rémi Garbay, Amélie Gaudin, Frédéric Kolb, and Françoise Rimareix. "Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority." International Journal of Breast Cancer 2015 (2015): 1–5. http://dx.doi.org/10.1155/2015/519497.
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Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert.Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared.Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were stillin situ. There was no difference in removal rate among implant brands.Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.
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Jaeger, Marie, Charles Randquist, and Jessica Gahm. "Anatomical Breast Implant Assessment Using Ultrasound: A Case Series from the International Breast Implant Check Clinic." Plastic and Reconstructive Surgery - Global Open 11, no. 12 (December 2023): e5469. http://dx.doi.org/10.1097/gox.0000000000005469.
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Background: Breast augmentation with anatomic implants can achieve a natural look, but over time, implant-related complications can occur. This includes a risk of potential rotation, which can cause a change in breast shape. Reported rates of rotation vary widely (0%–42%). Implant rotation is often detected by physical examination only or as a perioperative finding. Change in breast shape after augmentation requires clinical evaluation. In-office ultrasound allows for detailed assessment of implants for rotation and other complications. Methods: Women with anatomical breast implants seeking follow-up at the International Breast Implant Check Clinic in Stockholm, Sweden, from April 2020 to July 2022 were included in the study. Using a standardized protocol, subjective symptoms were recorded, and a physical examination followed by an ultrasound assessment was performed by a single board-certified plastic surgeon (M.J.) trained in implant assessment via ultrasound. Rotation was defined as an implant rotated past 30 degrees off the breast midline at 6 o’clock. Results: The study included 308 women (mean age 40.1, range 20-78) with bilateral anatomical implants. Overall, 40 women (13.0%) reported a change in breast shape; 35 had one or more implant-related complications, including five with rotation on ultrasound. Of the 308 women, 11 (3.6%) had rotations upon physical examination, and an additional 10 cases were identified using ultrasound. Conclusions: Rotation is a potential complication of anatomical breast implants. However, in this study, change in breast shape was more commonly caused by other implant-related complications. Ultrasound is a valuable tool in evaluating causes of change in breast shape.
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Azahaf, Siham, Karlinde A. Spit, Christel J. M. de Blok, Peter Bult, and Prabath W. B. Nanayakkara. "Silicone Migration from Intact Saline Breast Implants." Plastic and Reconstructive Surgery - Global Open 12, no. 2 (February 2024): e5608. http://dx.doi.org/10.1097/gox.0000000000005608.
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Summary: Breast augmentation is a widely performed surgical procedure worldwide, predominantly using silicone gel-filled implants. Concerns have primarily revolved around ruptures and the potential health risks associated with leaked silicone from silicone gel-filled implants. Cases of silicone migration from the shell of saline breast implants remain scarce. This case report introduces a unique case of a 66-year-old patient with silicone migration from intact saline breast implants. The patient presented with a range of symptoms consistent with breast implant illness. Radiological findings suggested the presence of silicone in the axillary lymph nodes, despite the integrity of the implants, thereby confirming silicone migration. Histopathological evaluation revealed a foreign body reaction and the presence of silicone in the axillary lymph nodes. Given the saline filling, the source is likely the polydimethylsiloxane shell. The rarity of documented silicone migration from intact saline breast implants, especially in patients with breast implant illness, underscores the need for more research into the health implications of leaked silicone particles from breast implants.
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Peters, Walter. "Current Status of Breast Implant Survival Properties and the Management of the Woman with Silicone Gel Breast Implants." Canadian Journal of Plastic Surgery 8, no. 2 (April 2000): 54–67. http://dx.doi.org/10.1177/229255030000800201.
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The survival properties of silicone gel breast implants are dependent on their vintage (year of manufacture), duration in situ and manufacturer. A total of 527 gel implants have been explanted and analyzed in the author's laboratories. Of the 28 first-generation implants (1963 to 1972), 27 (96.4%) remained intact after 14 to 28 years in situ (mean 20.8 years). Of the 216 second-generation implants (1973 to mid-1980s) that were explanted from 1992 to 1998, 158 (73%) had disrupted. Kaplan-Meier survival curves demonstrated significantly different survival properties among second-generation manufacturers. Surgitek implants were by far the least durable. After 14 years, all second-generation Surgitek implants had disrupted. By contrast, after 20 years, about half of the Dow Corning and Heyer-Schulte implants remained intact. Among third-generation implants (mid-1980s to 1992), 43 of 46 (93.4%) remained intact after a mean of 6.3 years (range three to 12 years). The three disruptions were Surgitek implants. Implants from other manufacturers remained intact. However, the disruption frequencies of third-generation implants have yet to be measured over the relevant periods of time. Survival patterns appeared to be related to the thickness of the elastomeric shell of the three generations of implants. Mechanical strength analyses of the elastomeric shells of explants have exhibited little or no large scale material degradation, even after as long as 28 years in situ. The mechanism of implant disruption likely involves the ‘fold flaw’ theory, whereby an internal abrasion can develop over time at the site of a fold in the implant wall. Diagnosis of disruption is difficult. Mammography is helpful only if there has been extravasation of silicone gel into breast tissue. Extravasation was observed in only 4.2% of second-generation implants removed from 1992 to 1998. It was not seen with first- or third-generation implants. Ultrasound analyses are not generally helpful to predict disruption because they are very operator dependent and because capsular contracture causes folds in the implant wall, which result in false positives. Magnetic resonance imaging is the most accurate imaging modality to detect implant disruption. However, this technology is not indicated for monitoring implant status because it is too costly and time consuming, and because it has significant limitations, particularly with first-generation and textured implants. Careful explantation and direct visual examination are the standards for diagnosing gel implant disruption. Many implant disruptions are likely ‘silent’, with no specific symptoms or clinical findings. After disruption, none of the following are elevated above the levels seen in control women without implant exposure: serum autoantibodies, blood and serum silicon, and the incidence of breast cancer, autoimmune disease or any other medical disease. There is no evidence to support the existence of any ‘novel’ or ‘atypical’ syndrome associated with gel implants. Women over 30 years of age with breast implants require regular monitoring for breast cancer detection. This should include monthly breast self examination and annual clinical breast examination. In addition, women over 50 years old require annual eight-view mammographic assessment using the implant displacement technique. Even then, breast implants have been shown to interfere with complete imaging, particularly if the implants are subglandular, large or associated with significant capsular contracture. A logical approach to explantation should involve consideration of a patient's personal concerns and anxiety, her implant vintage, the plane of insertion of her implants, her current clinical status and whether she chooses to replace her gel implants. Women requesting explantation require extensive information before deciding on surgery. At explantation, capsulectomy seems to be indicated if there is capsular calcification or major capsular thickening. (Pour le résumé, voir page suivante)
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Rukanskienė, Dalia, Greta Bytautaitė, Agnė Česnauskaitė, Loreta Pilipaitytė, Tautrimas Aštrauskas, and Eglė Jonaitienė. "The Value of Ultrasound in the Evaluation of the Integrity of Silicone Breast Implants." Medicina 57, no. 5 (May 3, 2021): 440. http://dx.doi.org/10.3390/medicina57050440.
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Background and Objective: Breast implant surgery for cosmetic purposes is the most popular plastic surgery and it has been performed for over 100 years. Rupture of silicone gel-filled breast implants usually is asymptomatic and is one of the more dangerous complications due to free silicone migration. The aim of our study was to evaluate the diagnostic value of ultrasound (US) in the evaluation of the integrity of silicone breast implants and identify the main sign of intact and ruptured breast implants. Patients and Methods: In this retrospective study, the medical documentation of women who underwent breast implant surgery and US checkups at Tautrimas Aštrauskas Clinic in Kaunas, Lithuania, during 2015–2020 was analyzed. The patients were divided into two groups: patients with intact and ruptured breast implants. The accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) as well as the signs of implant integrity of US examination were evaluated. Results: In this study, 76 women with bilateral breast implants (n = 152) were reviewed. On a US examination, ruptured implants were found in 41.1% (n = 61) of the cases; of them, 78.7% (n = 48) of the cases had ≥2 US signs of a ruptured implant, and in all these cases, implant rupture was confirmed at surgery. Overall, one US sign of a ruptured implant was found in 21.3% (n = 13) of the cases. Of them, inhomogeneous content in all cases (n = 3) was found in the intact implant group, and an abnormal implant shell was documented more often in the ruptured implant group, not intact one (n = 9, 90% vs. n = 1, 10%). US had a diagnostic accuracy of 94.7%, sensitivity of 98.3%, specificity of 89.2%, PPV of 93.4%, and NPV of 97.1% in the evaluation of implant integrity. Conclusions: Our results show that US is a very reliable alternative in evaluating breast implant integrity and could be the investigation of choice for implant rupture, while MRI could be advocated only in inconclusive cases. Uneven implant shell was found to be the most important US sign of breast implant rupture. Based on the findings, we recommend performing US examination after breast augmentation surgery with silicone gel-filled implants annually.
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Nam, Sun-Young, Han Bi Ji, Byung Ho Shin, Pham Ngoc Chien, Nilsu Donmez, Xin Rui Zhang, Beom Kang Huh, Min Ji Kim, Young Bin Choy, and Chan Yeong Heo. "Silicone Breast Implant Coated with Triamcinolone Inhibited Breast-Implant-Induced Fibrosis in a Porcine Model." Materials 14, no. 14 (July 14, 2021): 3917. http://dx.doi.org/10.3390/ma14143917.
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Cosmetic silicone implants for breast reconstruction often lead to medical complications, such as abnormally excessive fibrosis driven by foreign body granulomatous inflammation. The purpose of this study was to develop a silicone breast implant capable of local and controlled release of a glucocorticoid drug triamcinolone acetonide (TA) for the prevention of silicone-breast-implant-induced fibrosis in a Yorkshire pig model (in vivo). Implants were dip-coated in a TA solution to load 1.85 μg/cm2 of TA in the implant shell, which could release the drug in a sustained manner for over 50 days. Immunohistochemical analysis for 12 weeks showed a decline in tumor necrosis factor-α expression, capsule thickness, and collagen density by 82.2%, 55.2%, and 32.3%, respectively. Furthermore, the counts of fibroblasts, macrophages, and myofibroblasts in the TA-coated implants were drastically reduced by 57.78%, 48.8%, and 64.02%, respectively. The TA-coated implants also lowered the expression of vimentin and α-smooth muscle actin proteins, the major profibrotic fibroblast and myofibroblast markers, respectively. Our findings suggest that TA-coated silicone breast implants can be a promising strategy for safely preventing fibrosis around the implants.
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Mishalov, V. G., О. І. Zakhartseva, V. V. Khrapach, and L. Yu Markulan. "SURGICAL TREATMENT OF BREAST IMPLANTS ROTATION." Medical Science of Ukraine (MSU) 13, no. 3-4 (June 21, 2018): 10–14. http://dx.doi.org/10.32345/2664-4738.3-4.2017.02.
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Relevance. Using anatomical breast implants with high and ultrahigh profile in augmentation mammoplasty provides nearly natural shape of breasts. Using the drop-like shape implants instead of round ones can cause complication called breast implant rotation (BIR), that have negative influence on patients life quality. There is not enough data about the effective methods of surgical treatment of clinically significant rotation.
Objective of our study was to determine the effectiveness of «neo pocket» upper pole inhancement with mesh for the treatment of BIR after primary submuscular breast augmentation in a postoperative period.
Materials and methods. The study included 42 women with an average age of 29.4 ± 0.7 years (20 to 39 years) who underwent surgery for a clinically significant (more than 90o) BIR that occurred after the classical primary breast augmentation. Treatment of BIR was performed by enhancement of upper pole of neo-pocket redublication of implant capsule with prolene mesh between the capsule layers and fixation to ribs periosteum and pectoral muscules. The endpoint of the study was the frequency and degree of the prosthesis rotation one year after BIR treatment. Data analysis was performed using the IBM SPSS Statistics 22.
Results. 13 (31,0%) of patients admitted to hospital for prothesis enlargment and BIR – 29 (69,0%). From 84 number of implants 66 (78,6%) were rotated. Two women (4,7%) had same degree of implants rotation. In all other cases BIR had different angle. Clinically significant rotation of implants was diagnosed in 4 patient: 90 ° / 90 ° two patients; 90° / 150° – one patient ; 90° / 180° – one patient. 38 (90,5%) patients had clinically significant implants rotation. In one year after primary surgery significant BIR (90%) was diagnosed in one patient, who didn’t need breast augmentation, she also had a small rotation of breast on 60о before surgery. From number of breasts, when developed procedure was performed (56), in one case significant BIR was diagnosed, in a patient with preoperative BIR 1800. Significant BIR was diagnosed in 6 (11,5 %) patients, and one patient BIR 60о (1,8 %) and five 300 (8,9%).
Conclusion: The developed method of «neo pocket» upper pole enhancement by redublication of prothesis capsule with prolene mesh between the capsule layers and fixation to ribs periosteum and pectoral muscules helps to avoid BIR in 98,2% in one year follow up period.
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Peters, Walter. "Current status of silicone gel breast implants." Canadian Journal of Plastic Surgery 2, no. 1 (March 1994): 18–23. http://dx.doi.org/10.1177/229255039400200103.
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There are currently three main areas of concern regarding the safety of silicone gel implants: implant failure; a potential link to autoimmune connective tissue disease; and a possible link to breast cancer. All silicone gel implants ‘bleed’ small levels of silicone. In addition, silicone gel implants appear to fail (leak or rupture) with time. Most implants in place for less than seven years appear to be intact. It appears that many silicone gel implants implanted for over seven years are probably ruptured or leaking. Implant failure may occur simply from deterioration. Implants can also rupture following closed capsulotomy. Mammography and ultrasound studies are generally not helpful in predicting implant failure. Magnetic resonance imaging (MRI) studies appear to be useful, but the ‘breast coil’ necessary to perform these studies is not currently available in most MRI units in Canada. The significance of implant failure is not known. There is a growing (but unproven) concern that immunological sensitization to silicone could develop in women with silicone gel implants. An extensive review of all clinical and immunological studies in the current literature has failed to demonstrate any conclusive link between silicone gel implants (whether intact or nonintact) and the development of autoimmune connective tissue disease or other disease process. However, large scale epidemiological studies remain to be done. Several large studies have proven that there is no relationship between silicone gel implants and the development of breast cancer.
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Carmona-Torre, Francisco, Leire Fernández-Ciriza, Carlos Berniz, Cristina Gomez-Martinez de Lecea, Ana Ramos, Bernardo Hontanilla, and Jose L. del Pozo. "An Experimental Murine Model to Assess Biofilm Persistence on Commercial Breast Implant Surfaces." Microorganisms 10, no. 10 (October 11, 2022): 2004. http://dx.doi.org/10.3390/microorganisms10102004.
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Capsular contracture is the most frequently associated complication following breast implant placement. Biofilm formation on the surface of such implants could significantly influence the pathogenesis of this complication. The objective of this study was to design an experimental model of breast implant infection that allowed us to compare the in vivo S. epidermidis ability to form and perpetuate biofilms on commonly used types of breast implants (i.e., macrotexturized, microtexturized, and smooth). A biofilm forming S. epidermidis strain (ATCC 35984) was used for all experiments. Three different implant surface types were tested: McGhan BIOCELL® (i.e., macrotexturized); Mentor Siltex® (i.e., microtexturized); and Allergan Natrelle Smooth® (i.e., smooth). Two different infection scenarios were simulated. The ability to form biofilm on capsules and implants over time was evaluated by quantitative post-sonication culture of implants and capsules biopsies. This experimental model allows the generation of a subclinical staphylococcal infection associated with a breast implant placed in the subcutaneous tissue of Wistar rats. The probability of generating an infection was different according to the type of implant studied and to the time from implantation to implant removal. Infection was achieved in 88.9% of macrotextured implants (i.e., McGhan), 37.0% of microtexturized implants (i.e., Mentor), and 18.5% of smooth implants (i.e., Allergan Smooth) in the short-term (p < 0.001). Infection was achieved in 47.2% of macrotextured implants, 2.8% of microtexturized implants, and 2.8% of smooth implants (i.e., Allergan Smooth) in the long-term (p < 0.001). There was a clear positive correlation between biofilm formation on any type of implant and capsule colonization/infection. Uniformly, the capsules formed around the macro- or microtexturized implants were consistently macroscopically thicker than those formed around the smooth implants regardless of the time at which they were removed (i.e., 1–2 weeks or 3–5 weeks). We have shown that there is a difference in the ability of S epidermidis to develop in vivo biofilms on macrotextured, microtextured, and smooth implants. Smooth implants clearly thwart bacterial adherence and, consequently, biofilm formation and persistence are hindered.
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Shiffman, Melvin A. "Manufacture of Silicone Implants." American Journal of Cosmetic Surgery 13, no. 3 (September 1996): 191–97. http://dx.doi.org/10.1177/074880689601300302.
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Research and development of breast implant manufacturing technology continues with the dual objectives of finding better processes for manufacturing implant shells and finding better filler solutions or gels. The Mentor HIS manufacturing process exemplifies improved techniques of implant shell production and quality control. The process is described in detail, and the Mentor HIS and McGhan processes of manufacturing breast implants are compared. Recognized shell weaknesses include thin spots, valve malfunction, rupture because of overfilling, and folding and leakage because of underfilling. All implants are inspected. Smooth implants are inspected 22 times while textured implants are inspected 23 times.
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Jari, Irina, Alexandru G. Naum, Liliana Gheorghe, Dragos Negru, Paloma Horjinec, Bogdan M. Ciuntu, Daniel Timofte, and Manuela Ursaru. "Granuloma of Silicone Breast Implants A case report and literature review." Revista de Chimie 70, no. 3 (April 15, 2019): 940–42. http://dx.doi.org/10.37358/rc.19.3.7035.
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Silicone, a synthetic polymer containing the element silicon, has been used for breast implants. Complications resulting from the placement of silicone breast implants are becoming more frequent in clinical practice. Breast implant rupture is common and poses challenges for radiologists and physicians. Radiologists must be familiar with the normal and abnormal findings of common implants. Clinically apparent silicone granulomas are a relatively rare complication of breast implant placement and surgical resection is indicated when they are symptomatic or of diagnostic concern. The objective of this study is to examine the latest generations of silicone breast implants and the clinical literature related to silicone granulomas together with a case of silicon granuloma diagnosed in our service. The findings are based on diagnostic breast Ultrasound and MRI scans performed at our service.
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Eveline, Kezia, Beta Subakti Nata'admadja, Rizqi Shabrina Lestari, and Lavonia Berlina Adzalika. "SYSTEMATIC REVIEW: ANAPLASTIC LARGE CELL LYMPHOMA FOLLOWING BREAST IMPLANT SURGERY." Jurnal Rekonstruksi dan Estetik 8, no. 1 (June 1, 2023): 47–58. http://dx.doi.org/10.20473/jre.v8i1.31215.
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Highlights: BIA-ALCL, a T-cell lymphoma associated with breast implants, is posing a growing medical challenge due to the increasing use of implants for cosmetic and reconstructive purposes The majority of BIA-ALCL cases were associated with cosmetic reasons for breast implants, and textured implants were predominantly implicated. Abstract: Introduction: BIA-ALCL, a T-cell lymphoma associated with breast implants, poses a growing medical challenge despite its relatively low occurrence, due to the increasing use of implants for cosmetic and reconstructive purposes. Our objective is to review the incidence, characteristics of patients, implant types, management, and outcome of BIA-ALCL. Methods: Pubmed and Science Direct databases were searched to identify case series and observational research. A systematic review was conducted by looking up the keywords “breast implant” and “anaplastic large cell lymphoma”. Result: 11 relevant articles were assessed. A total of 353 BIA-ALCL cases have been reported. The mean age at diagnosis was 59.6 years. More than half (53.26%) of the reasons for the breast implants in BIA-ALCL patients were cosmetic. The mean time from breast implant placement to diagnosis was 9.99 years. The majority (71.39%) of documented BIA-ALCL cases have been associated with textured devices. BIA-ALCL patients mainly presented with seroma (54.67%). Outcomes included remission (71%), death because of the disease (4.25%), and recurrence (3.96%) with a mean time of duration of follow-up was 2.53 years. Conclusion: BIA-ALCL is rare cancer in some patients with breast implants but is increasing in incidence largely due to consistent and long-term follow-up. It is important for physicians involved in the care of patients with breast implants to be aware of BIA-ALCL and do routine breast exams.
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Norris, Michelle, Melissa Jones, Chris Mills, Tim Blackmore, Chris Inglefield, and Joanna Wakefield-Scurr. "The Kinematics of Breasts Implanted With a Reduced Mass Implant: A Pilot Study." Aesthetic Surgery Journal 40, no. 5 (October 24, 2019): NP253—NP262. http://dx.doi.org/10.1093/asj/sjz239.
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Abstract Background Breast implants may increase breast skin tension and interact with surrounding tissues to alter breast position and motion during dynamic activity. Reducing implant mass and changing implant location (submuscular/subglandular) may also affect breast kinematics and the subsequent loads on breast structures. Objectives The aim of this pilot study was to describe the kinematics of breasts augmented with reduced-mass implants during standing, walking, and running, compared with natural breasts, and to provide insight into how implant location (submuscular/subglandular) alters breast kinematics. Methods Two breast augmentation participants (12–15 months postsurgery: 32AA presurgery, anatomical submuscular 255 cc B-Lite reduced-mass implant; 32A presurgery, anatomical subglandular 285 cc B-Lite reduced-mass implant) and 2 natural-breasted participants of similar breast size and anthropometrics were recruited. Nipple and torso positional data were recorded with electromagnetic sensors during standing, walking, and running. Nipple kinematics relative to the torso were calculated. Results The B-Lite participants both displayed greater nipple projection and elevation during standing and a 50% reduction in nipple acceleration during walking, when compared with their natural counterparts. During running, the B-Lite subglandular participant displayed decreased nipple kinematics compared with her natural counterpart and lower nipple kinematics compared with the B-Lite submuscular participant during walking and running. Conclusions A combination of implant location (subglandular) and reduced mass minimized nipple kinematics during running. Reducing nipple kinematics during dynamic activity may decrease the loading on breast structures, helping to decrease ptosis and increase the longevity of procedure outcomes. Level of Evidence: 4
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Spit, K. A., S. Azahaf, C. J. M. de Blok, and P. W. B. Nanayakkara. "Measuring Platinum Levels in Hair in Women with Silicone Breast Implants and Systemic Symptoms." Plastic and Reconstructive Surgery - Global Open 10, no. 6 (June 2022): e4373. http://dx.doi.org/10.1097/gox.0000000000004373.
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Background: It has been suggested that compounds present in silicone breast implants (eg, silicone particles or heavy metals such as platinum) migrate into the body and can cause systemic symptoms in susceptible women, causing what is known as breast implant illness. This pilot study investigates possible associations between hair platinum levels in patients with breast implants and breast implant illness, and evaluates its possible use for diagnostic purposes. Methods: Patients were included from the silicone outpatient clinic at Amsterdam University Medical Centre. Platinum concentration in hair samples of 10 women with breast implants and systemic symptoms (group A) was compared with that in 10 women with breast implants but no symptoms (group B), and a control group of 10 women without implants or symptoms (group C), using laser ablation inductively coupled plasma mass spectrometry. Radiological imaging was used to assess implant ruptures or silicone leakage. Results: A median platinum concentration of 0.09 μg per kg [IQR 0.04–0.15] was found in group A, 0.08 μg per kg [IQR 0.04–0.12] in group B, and 0.04 μg per kg [IQR 0.02–0.13] in group C, with no statistical significant difference between the groups (Kruskal-Wallis test, P = 0.43). No correlation between radiologically proven implant leakage and platinum level was found. Conclusions: There was no statistically significant difference in hair platinum levels in women with or without silicone breast implants or breast implant illness. Therefore, based on this pilot study, we do not recommend this test for clinical use. Given the small sample size, more research is required to fully assess its possible use for diagnostic purposes.
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Lista, Frank, Ryan E. Austin, Maryam Saheb-Al-Zamani, and Jamil Ahmad. "Does Implant Surface Texture Affect the Risk of Capsular Contracture in Subglandular Breast Augmentation and Breast Augmentation-Mastopexy?" Aesthetic Surgery Journal 40, no. 5 (September 16, 2019): 499–512. http://dx.doi.org/10.1093/asj/sjz241.
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Abstract Background Previous studies have reported decreased rates of capsular contracture associated with the use of textured surface breast implants placed in the subglandular plane during breast augmentation. However, since the publication of these studies, our understanding of the pathophysiology of capsular contracture, as well as the surgical techniques utilized to minimize bacterial contamination of the implant, have advanced considerably. Objectives The purpose of this study was to re-evaluate the relation between implant surface texturization and capsular contracture rates for breast implants placed in the subglandular plane during primary breast augmentation. Methods Retrospective chart review was performed of all primary subglandular breast augmentation procedures involving the use of either smooth or textured round silicone gel implants, with or without simultaneous mastopexy. The primary outcome measures included clinically significant capsular contracture (Baker grade III/IV) and revision surgery for capsular contracture. Results Between 2010 and 2017, 526 patients underwent primary subglandular breast augmentation with either smooth (n = 212) or textured (n = 314) round silicone gel implants; 248 patients underwent breast augmentation, whereas 278 underwent breast augmentation-mastopexy. Average follow-up was 756 days in the textured group and 461 days in the smooth group. Five cases of capsular contracture were observed in the textured group, and 7 cases of capsular contracture were observed in the smooth group (P = 0.20). Conclusions Smooth surface implants placed in the subglandular plane were not at a significantly increased risk of capsular contracture compared with textured surface implants. We suggest that adherence to a surgical technique focused on minimizing bacterial contamination of the implant is of greater clinical significance than implant surface characteristics when discussing capsular contracture. Level of Evidence: 4
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Pannucci, Christopher J., Chad K. Wheeler, Krista M. Cyr, and Adam J. Cyr. "Breast Implants Decrease Chest Wall Trauma in Low-speed, Unrestrained Motor Vehicle Crash: An Experimental Model." Plastic and Reconstructive Surgery - Global Open 11, no. 7 (July 2023): e5161. http://dx.doi.org/10.1097/gox.0000000000005161.
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Introduction: Breast implants improve quality of life in patients seeking improved breast aesthetics, and are known to minimize human injury in the less common scenario of penetrating trauma. People commonly sustain rib and sternum fractures and thoracic injury in motor vehicle crashes (MVC), a form of blunt traumatic injury. Whether breast implants minimize injury during MVC is unknown. This study examines the potential protective effect of breast implants in low speed, unrestrained MVC. Methods: Control (medical gel) and implant (medical gel with embedded breast implant) blocks were subjected to load approximating a low speed, 10mph MVC (n=12 blocks per group). Colormetric pressure film measured pressure at the neo-chest wall position in response to load, across the gel block base. Maximum pressure and average pressure across the gel block base were compared, by group. Results: Presence of an implant significantly decreased, by 22.8%, maximum pressure experienced by the neo-chest wall (333.0 ± 58.7 psi vs 431.6 ± 37.3 psi, p=0.0006). Average pressure experienced by the neo-chest wall across the gel block base was also significantly decreased, by 28.1%, in the implant group (53.4 ± 5.6 psi vs 74.3 ± 15.7 psi, p=0.0017). Subjective analysis of all implant and control blocks supported an overall reduction in pressure for the implant group. Conclusions: Presence of a breast implant decreased maximum pressure at the chest wall by 23%, and average pressure by 28%. Patients with breast implants involved in low speed, unrestrained MVC may be less likely to sustain rib and sternum fractures and thoracic injury, when compared to patients without implants.
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Lee, Won-Seob, Tae-Gon Kim, Jun-Ho Lee, and Il-Kug Kim. "Breast Reconstruction after Breast Implant-Associated Anaplastic Large Cell Lymphoma Treatment: A Case Report and Literature Review." Journal of Clinical Medicine 12, no. 5 (February 27, 2023): 1885. http://dx.doi.org/10.3390/jcm12051885.
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Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a T-cell non-Hodgkin’s lymphoma that occurs in patients with at least one prior textured breast implant. BIA-ALCL has a relatively good prognosis when treated promptly. However, data on the methods and timing of the reconstruction process are lacking. Herein, we report the first case of BIA-ALCL in Republic of Korea in a patient who underwent breast reconstruction using implants and an acellular dermal matrix (ADM). A 47-year-old female patient was diagnosed with BIA-ALCL stage IIA (T4N0M0) and underwent bilateral breast augmentation using textured breast implants. She then underwent removal of both breast implants, total bilateral capsulectomy, adjuvant chemotherapy, and radiotherapy. There was no evidence of recurrence at 28 months postoperatively; therefore, the patient wished to undergo breast reconstruction surgery. A smooth surface implant was used to consider the patient’s desired breast volume and body mass index. The right breast was reconstructed with a smooth surface implant and an ADM in the prepectoral plane. Breast augmentation was performed on the left breast using a smooth surface implant. The patient was satisfied with the results and recovered fully with no complications.
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Pirjavec Mahić, Aleksandra, Damir Grebić, Paola Čargonja, and Domagoj Kustić. "Silicone Gel Breast Implants." Acta medico-historica Adriatica 18, no. 1 (2020): 165–76. http://dx.doi.org/10.31952/amha.18.1.10.
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The authors have provided an in-depth review of the history of saline and silicone gel–filled breast implants. In the history of medicine, no devices have been more scrutinized and thoroughly studied than breast implants. Although we as plastic surgeons recognize and appreciate the benefits that our patients derive from these devices, society as a whole continues to remain skeptical. The reasons for this are complex and multifactorial but appear to be fueled by the media, oppositional organizations, and several trial lawyers. Prior to 1990, when the silicone gel implant controversy began, there were only eight indexed publications that dealt with the issue of silicone gel breast implants. Since 1990, there have been more than 500 indexed publications dealing with silicone gel implants. At the time of the moratorium in 1992, we as plastic surgeons did not have a leg to stand on because there was a paucity of scientific evidence to support our observations that silicone breast implants were safe and effective devices.
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Suh, Lily J., Imran Khan, Christine Kelley-Patteson, Ganesh Mohan, Aladdin H. Hassanein, and Mithun Sinha. "Breast Implant-Associated Immunological Disorders." Journal of Immunology Research 2022 (May 4, 2022): 1–13. http://dx.doi.org/10.1155/2022/8536149.
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Background. Breast implants are commonly placed postbreast cancer reconstruction, cosmetic augmentation, and gender-affirming surgery. Breast implant illness (BII) is a systemic complication associated with breast implants. Patients with BII may experience autoimmune symptoms including fatigue, difficulty concentrating, hair loss, weight change, and depression. BII is poorly understood, and the etiology is unknown. The purpose of this literature review is to characterize BII autoimmune disorders and determine possible causes for its etiology. Methods. The PubMed, Google Scholar, Embase, Web of Science, and OVID databases were interrogated from 2010 to 2020 using a query strategy including search term combinations of “implants,” “breast implant illness,” “autoimmune,” and “systemic illness.” Results. BII includes a spectrum of autoimmune symptoms such as fatigue, myalgias/arthralgias, dry eyes/mouth, and rash. A review of epidemiological studies in the past ten years exhibited evidence affirming an association between breast implants and autoimmune diseases. The most commonly recognized were Sjogren’s syndrome, rheumatoid arthritis, systemic sclerosis, chronic fatigue syndrome, and Raynaud’s syndrome. Explantation resulted in alleviation of symptoms in over 50% of patients, strengthening the hypothesis linking breast implants to BII. Studies have shown that silicone is a biologically inert material and unlikely to be the cause of these symptoms. This is supported by the fact that increased risk of autoimmune disease was also reported in patients with other implantable biomaterials such as orthopedic implants. Recent studies shed light on a possible role of bacterial biofilm and subsequent host-pathogen interactions as a confounding factor to this problem. Conclusion. BII could be dependent on biofilm infection and the microenvironment around the implants. The true pathophysiology behind these complaints must be further investigated so that alternative treatment regimens other than explantation can be developed. Translational significance of these studies is not limited to breast implants but extends to other implants as well.
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Aladari, Nadia, Madalina M. Palaghia, Ana-Maria Trofin, Elena Cojocaru, Carmen Ungureanu, Victor Ianole, Eugenia Morosan, et al. "Reducing Capsular Contracture Formation in Breast Augmentation with Silicone Implants: Experimental Study on Rats." Applied Sciences 12, no. 8 (April 17, 2022): 4056. http://dx.doi.org/10.3390/app12084056.
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Silicone implants are frequently used for breast augmentation and reconstruction. However, late complication, such as capsular contracture, remain the most important side effect. In this study we compare different methods for reducing the inflammatory reaction around the silicone implant by introducing one microtextured breast implant in wistar rats. The rats were dividing in 4 groups: the first one was the control group that received untreated implant; in the second we used silicone implants impregnated with rifampin solution, the third one had implant combined with intramuscular dexamethasone injection and the last one had silicone implant associated with autologous centrifuged fat introduced in the implant pocket. The implants and the capsular tissue surrounding were removed after eight weeks. Capsule samples were submitted to histological evaluations. The present study demonstrated that fat grafting may have a role in reducing and preventing capsular contractures after breast augmentation with silicone implants by decreasing the inflammatory process.
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Agochukwu-Nwubah, Nneamaka, Ashley Boustany, Margaret Wetzel, Jacob Maus, and Brian Rinker. "Anatomic Implants in Breast Reconstruction: A Comparison of Outcomes and Aesthetic Results Compared to Smooth Round Silicone Implants." Aesthetic Surgery Journal 39, no. 8 (March 15, 2019): NP322—NP330. http://dx.doi.org/10.1093/asj/sjz074.
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Abstract Background Direct comparison studies of outcomes and aesthetic satisfaction of anatomic implants compared to other implants are scarce in the literature. Objectives The objective of this study was to compare outcomes and aesthetic satisfaction of patients who underwent breast reconstruction with anatomic implants vs other implants (smooth round silicone). Methods A retrospective chart review was performed of patients who underwent implant-based breast reconstruction over 3 years. Outcomes including complications, number of surgeries, need for revisions, and aesthetic satisfaction of patients were tracked and compared. Results A total of 156 patients met inclusion criteria for this study. A total of 123 underwent reconstruction with a round implant, and 33 underwent reconstruction with an anatomic implant. Of the 156 patients, 38 underwent a 1-stage direct-to-implant reconstruction and the remainder underwent a 2-stage implant reconstruction. The round and anatomic implant groups did not differ with regards to number of surgeries, revisions, utilization of contralateral symmetry procedures, implant-related reoperations, complications, implant loss, infection, capsular contracture, and seroma. The Breast Q survey had a response rate of 27%. On all parameters, the round and anatomic implant groups did not significantly differ. Conclusions There were no significant differences among round and shaped implants in regards to complications, revision surgeries, and overall outcomes. Furthermore, patients showed no differences regarding satisfaction and well-being when surveyed on the Breast Q survey. The decision of implant choice in breast reconstruction should be based on surgeon comfort and the patient’s needs/body type. Level of Evidence: 4
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Hecker, Andrzej, Barbara Giese, Anna-Lisa Pignet, Marlies Schellnegger, Lars-Peter Kamolz, and David Benjamin Lumenta. "Textured vs. Smooth Breast Implants Using the Jones Criteria—What Is the Currently Available Evidence for BIA-ALCL?: A Systematic Review." Journal of Personalized Medicine 13, no. 5 (May 11, 2023): 816. http://dx.doi.org/10.3390/jpm13050816.
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Breast-Implant-Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL) is a rare low-incidence type of T-cell non-Hodgkin lymphoma, arising in the capsule around breast implants, and predominantly associated with the use of macro-textured breast implants. The purpose of this study was to use an evidence-based approach to systematically identify clinical studies comparing smooth and textured breast implants in women with regard to the risk of developing BIA-ALCL. Methods: A literature search in PubMed in April 2023 and the article reference list of the French National Agency of Medicine and Health Products decision from 2019 were screened for applicable studies. Only clinical studies where the Jones surface classification could be applied (required information: breast implant manufacturer) for comparison of smooth and textured breast implants were considered. Results: From a total of 224 studies, no articles were included due to the lack of fit to the strict inclusion criteria. Conclusions: Based on the scanned and included literature, implant surface types in relation to the incidence of BIA-ALCL were not evaluated in clinical studies and data from evidence-based clinical sources plays a minor to no role in this context. An international database that combines breast implant-related data from (national, opt-out) medical device registries is, therefore, the best available option to obtain relevant long-term breast implant surveillance data on BIA-ALCL.
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Robinson, Kristin A., Richard J. Gray, Aneri Tanna, Heidi E. Kosiorek, Richard J. Butterfield, Jennifer M. Palmieri, Mary Ann T. McDonough, Alanna M. Rebecca, and Bhavika K. Patel. "Patient-Awareness Survey: Do Breast Implants Affect the Acquisition and Accuracy of Screening Mammography?" Journal of Breast Imaging 1, no. 4 (October 18, 2019): 297–302. http://dx.doi.org/10.1093/jbi/wbz062.
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Abstract Objective Breast implant augmentation is the most common cosmetic surgical procedure performed in the United States. The purpose of this study was to determine if patients with breast augmentation surgery are aware of the effect of breast implants on the mammographic detection of cancer. Methods An institutional review board exempt patient awareness survey was distributed at a single breast imaging facility to women undergoing screening mammography. Comparative statistical analyses were performed between patients with and without breast implants. Results The respondents were divided into three groups: no prior breast surgery (74%; 524/711), breast surgery with implants (21%; 152/711), and breast surgery without implants (5%; 35/711). Patients with breast implants were more aware that implants decrease the amount of breast tissue seen on a mammogram (75%; 105/141) and that implants result in the need for more mammogram views (70%; 103/147), as compared with patients with no surgery (46%; 221/484 and 31%; 147/478, respectively) (P < 0.001). More women with breast implants reported learning from breast imaging staff rather than from their surgeon that implants decrease the amount of breast tissue seen on a mammogram (46%; 49/106 vs. 38%; 40/106). Of 137 respondents, 35% (n = 48) reported that the effect of implants on their mammogram was discussed preoperatively. Of those who did not recall a preoperative discussion, 42% (16/38) indicated this knowledge would have factored into their decision to get breast implants. Conclusion This study highlights an opportunity for providers to engage in more education and shared decision-making with patients considering breast augmentation surgery to ensure preoperative counseling includes discussion of the effect of implants on mammography.
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Myckatyn, Terence M., Jesus M. Duran Ramirez, Jennifer N. Walker, and Blake M. Hanson. "Management of Biofilm with Breast Implant Surgery." Plastic & Reconstructive Surgery 152, no. 5 (October 23, 2023): 919e—942e. http://dx.doi.org/10.1097/prs.0000000000010791.
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Learning Objectives: After studying this article, the participant should be able to: 1. Understand how bacteria negatively impact aesthetic and reconstructive breast implants. 2. Understand how bacteria infect breast implants. 3. Understand the evidence associated with common implant infection-prevention strategies, and their limitations. 4. Understand why implementation of bacteria-mitigation strategies such as antibiotic administration or “no-touch” techniques may not indefinitely prevent breast implant infection. Summary: Bacterial infection of aesthetic and reconstructive breast implants is a common and expensive problem. Subacute infections or chronic capsular contractures leading to device explantation are the most commonly documented sequelae. Although bench and translational research underscores the complexities of implant-associated infection, high-quality studies with adequate power, control groups, and duration of follow-up are lacking. Common strategies to minimize infections use antibiotics—administered systemically, in the breast implant pocket, or by directly bathing the implant before insertion—to limit bacterial contamination. Limiting contact between the implant and skin or breast parenchyma represents an additional common strategy. The clinical prevention of breast implant infection is challenged by the clean-contaminated nature of breast parenchyma, and the variable behavior of not only specific bacterial species but also their strains. These factors impact bacterial virulence and antibiotic resistance.
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Mesa, Felipe, Sebastian Cataño, and Oscar Tuberquia. "Study of Infections in Breast Augmentation Surgery with Implants in 9,691 Patients over 5 Years." Plastic and Reconstructive Surgery - Global Open 9, no. 8 (August 2021): e3752. http://dx.doi.org/10.1097/gox.0000000000003752.
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Background: This study presents a review of a single retrospective cohort of patients who underwent surgery for breast augmentation with implants, during a period of 5 years, aged 17–60 years (mean 32 years), in a single institution, IQ Interquirofanos, a private clinic in the city of Medellín, Colombia. Method: A single retrospective cohort study was carried out, in which the database of patients who underwent breast augmentation with implants during 5 years was analyzed. Results: In this period of time, 9,691 female patients and a total of 19,382 breast implants implanted by 66 plastic surgeons underwent breast augmentation surgery. All the breast prostheses used were round, made of silicone gel in all cases and textured in most of them. 37 patients presented infection at the surgical site, 33 were unilateral and four bilateral, with an incidence of 0.38% per patient. The form of presentation was cellulitis in 46% of the cases, followed by seroma and hematoma in 25%. It was found that there is no difference in the incidence of infection between patients with breast augmentation for the first time and implant replacement due to different causes (OR 1.25, 95% CI 0.66–2.3, P = 0.49). One of the surgeons was associated with 37.8% of the infections and was found to be an asymptomatic carrier of Staphylococcus aureus, requiring medical treatment. The relationship of the infection with the treating surgeons was also analyzed and it was found that there is an association between these two variables. The infection appeared in the first 2 weeks after surgery in 92.7% of the cases. The main isolated germ was Staphylococcus aureus, followed by Pseudomona aeruginosa, Staphylococcus epidermidis, Serratia marcescens, Candida parapsilosis, Enterobacter cloacae, and a patient with Mycobacterium fortuitum in both breasts. Of the 37 patients with infection, six breast implants were required to be explanted in five patients, who were repositioned 3–6 months later without complications. Conclusions: Incidence of infection in augmentation mammoplasty with implants was 0.38% in patients infected in one or both breasts, during 5 years. There is a relationship between the presence of breast infection and the surgeon who performed the intervention. The most frequent germs found in breast implant infections continue to be Staphylococcus aureus followed by Pseudomonas aeruginosa.
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Webb, Leland H., Victoria L. Aime, Annie Do, Kenneth Mossman, and Raman C. Mahabir. "Textured Breast Implants: A Closer Look at the Surface Debris Under the Microscope." Plastic Surgery 25, no. 3 (June 28, 2017): 179–83. http://dx.doi.org/10.1177/2292550317716127.
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Background: Texturing of breast implants is done to decrease the risk of associated complications. Each manufacturer utilizes unique and at times proprietary techniques to texture the surface of their implants. Little is known about the integrity of this surface structure texturing or the propensity for the surfaces to shed particulate matter. This study aimed to determine the extent of surface particulate shedding from 3 textured implants approved by the US Food and Drug Administration (FDA), which are manufactured by Allergan, Mentor, and Sientra. Methods: Control images of each of the 3 textured breast implants were obtained with scanning electron microscopy (SEM). A liquid adhesive, ethylene vinyl acetate (EVA) copolymer was then applied to the external shell of the implants, allowed to cool, and peeled from the surface. Images of the EVA copolymer were taken with SEM to qualitatively analyze displacement of surface particulate debris. Scanning electron microscopy imaging of the implants was repeated for qualitative comparisons with the control images. Results: The peeled copolymer of the 3 implants exhibited surface shedding. Comparison of the 3 breast implants showed the shedding to be greatest for the Allergan implant. Conclusions: This study highlights the dynamic surface material properties of the 3 FDA-approved breast implants. Shedding of particulate matter from the implant surfaces can be precipitated by moderate adhesion. Our qualitative examination of SEM findings showed more debris shed from the Allergan breast implants than from the Mentor or Sientra implants.
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Bertozzi, Nicolò, Marianna Pesce, Pierluigi Santi, and Edoardo Raposio. "One-Stage Immediate Breast Reconstruction: A Concise Review." BioMed Research International 2017 (2017): 1–12. http://dx.doi.org/10.1155/2017/6486859.
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Background. One-stage direct-to-implant immediate breast reconstruction (IBR) is performed simultaneously with breast cancer resection. We explored indications, techniques, and outcomes of IBR to determine its feasibility, safety, and effectiveness.Material and Methods. We reviewed the available literature on one-stage direct-to-implant IBR, with or without acellular dermal matrix (ADM), synthetic mesh, or autologous fat grafting. We analyzed the indications, preoperative work-up, surgical technique, postoperative care, outcomes, and complications.Results. IBR is indicated for small-to-medium nonptotic breasts and contraindicated in patients who require or have undergone radiotherapy, due to unacceptably high complications rates. Only patients with thick, well-vascularized mastectomy flaps are IBR candidates. Expandable implants should be used for ptotic breasts, while anatomical shaped implants should be used to reconstruct small-to-medium nonptotic breasts. ADMs can be used to cover the implant during IBR and avoid muscle elevation, thereby minimizing postoperative pain. Flap necrosis, reoperation, and implant loss are more common with IBR than conventional two-staged reconstruction, but IBR has advantages such as lack of secondary surgery, faster recovery, and better quality of life.Conclusions. IBR has good outcomes and patient-satisfaction rates. With ADM use, a shift from conventional reconstruction to IBR has occurred. Drawbacks of IBR can be overcome by careful patient selection.
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Mericli, Alexander F., and Safa E. Sharabi. "Breast Implants and Radiation." Seminars in Plastic Surgery 33, no. 04 (October 17, 2019): 240–46. http://dx.doi.org/10.1055/s-0039-1696963.
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AbstractOne of the most influential factors in the success of breast reconstruction is whether or not radiation therapy has or will be performed. While traditional teaching is that all breasts treated with radiation therapy must be reconstructed with an autologous component, many reconstructive surgeons perform implant-based breast reconstruction without an autologous component and have success doing so. The purpose of this article is to explore the risks, benefits, and nuances of performing implant-based breast reconstruction in the setting of radiation therapy. The authors performed a review of the literature of all topics relevant to performing implant-based reconstruction with radiation therapy.
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Peters, Walter, and Victor Fornasier. "Missed Breast Cancer in Two Patients with Prepectoral Silicone Gel Breast Implants following Implant Displacement Mammography." Canadian Journal of Plastic Surgery 5, no. 2 (May 1997): 127–29. http://dx.doi.org/10.1177/229255039700500202.
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Two patients with prepectoral silicone gel breast implants and class IV capsular contractures presented at explantation with incidental breast carcinomas, which had been missed following implant displacement mammography. In both patients, the radiologists had commented that imaging was difficult because of the presence of the implants and their associated capsular contractures. Both patients had metastases – one had involvement of multiple axillary lymph nodes and the other had widespread metastases to the liver and to multiple skeletal sites. The cases reinforce the findings that breast implants can mask the early detection of breast carcinoma.
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Oh, Joon Seok, Jae Hoon Jeong, Yujin Myung, Jeongseok Oh, Shin Hyeok Kang, Eonju Park, Ara Kim, Sa Ik Bang, and Chan Yeong Heo. "BellaGel breast implant: 6-Year results of a prospective cohort study." Archives of Plastic Surgery 47, no. 3 (May 15, 2020): 235–41. http://dx.doi.org/10.5999/aps.2019.01858.
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Background This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of BellaGel breast implants have already been published, and we now report 6-year data.Methods This study was designed to take place over 10 years. It included 103 patients who underwent breast reconstruction or augmentation using BellaGel breast implants. The rates of implant rupture and capsular contracture were measured and analyzed to evaluate the effectiveness of the breast implant.Results At patients’ 6-year postoperative visits, the implant rupture and capsular contracture rates were 1.15% and 2.30%, respectively. The implant rupture rate was 3.77% among reconstruction cases and 0% among augmentation cases. The capsular contracture rate was 5.66% among reconstruction cases and 0.83% among augmentation cases.Conclusions The 6-year data from this planned 10-year study suggest that the BellaGel cohesive silicone gel-filled breast implant is an effective and safe medical device that can be used in breast reconstruction and augmentation.
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Shiffman, Melvin A. "Advances in Breast Implant Fillers." American Journal of Cosmetic Surgery 15, no. 3 (September 1998): 291–94. http://dx.doi.org/10.1177/074880689801500310.
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Introduction: The moratorium on the use of silicone-gel-filled breast implants in the U.S., Canada, and France has resulted in a flurry of research to find a mammary implant that will replace or surpass the performance of the silicone-gel breast implant and the saline breast implant. The purpose of this review is to briefly present the latest information from the literature on potential breast implant fillers currently under evaluation. Materials and Methods: The latest scientific findings on mammary augmentation implants and fillers were reviewed. Conclusions: There is still a long way to go before a satisfactory implant filler is found and is approved by the FDA. It is essential that all proposed fillers be researched carefully so that harmful effects are discovered before patients are exposed.
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Han, So-Eun, Kyeong-Tae Lee, and Saik Bang. "Comprehensive Comparison Between Shaped Versus Round Implants for Breast Reconstruction: A Systematic Review and Meta-Analysis." Aesthetic Surgery Journal 41, no. 1 (May 25, 2020): 34–44. http://dx.doi.org/10.1093/asj/sjaa128.
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Abstract Background Prosthetic breast reconstruction has been gaining popularity and a variety of implant options are currently available. Therefore, it is important to evaluate the safety and efficacy of newly developed shaped implants compared with those of conventional round implants. To date, few studies have investigated the outcomes of breast reconstruction with shaped versus round implants. Objectives The present study aimed to comprehensively compare, via meta-analytic methodology, shaped and round breast implant reconstruction in terms of complication profiles and aesthetic satisfaction. Methods PubMed/MEDLINE, Ovid, and Cochrane databases were searched to identify relevant studies presenting the complication rates for shaped and round implant groups. The relative risks of the following complications between the groups were calculated: infection, seroma, capsular contracture, rupture, rippling, reconstruction failure, and implant exchange or removal. Outcomes of aesthetic satisfaction included aesthetic results and patient-reported outcomes. Results Meta-analysis of 8 retrospective cohort studies, representing 2490 cases of implant-based breast reconstruction, was performed. There were no significant differences in the risks of infection, seroma, capsular contracture, and reconstruction failure between the 2 groups. The risks of implant rupture and rippling were significantly reduced with shaped implants. In a subgroup analysis of shaped/textured and round/smooth implants, the risk of infection was significantly enhanced in the former, whereas incidences of other complications, including capsular contracture and reconstruction failure, were similar. Aesthetic satisfaction analysis of the 2 groups demonstrated similar outcome scores with favorable overall results. Conclusions Our results suggest that both shaped and round implants might provide favorable breast reconstruction outcomes with similarly low complication rates and aesthetic results. Level of Evidence: 4
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Ramião, N. G., P. S. Martins, M. L. Barroso, D. C. Santos, and A. A. Fernandes. "Biomechanical analysis of intact versus ruptured Poly Implant Prothèse breast implants." Interface Focus 9, no. 4 (June 14, 2019): 20180086. http://dx.doi.org/10.1098/rsfs.2018.0086.
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Despite there being many studies that have evaluated breast implant rupture, there is no consensus about causes and incidence. Most studies lack a multifactorial analysis of what causes breast implants to rupture. To fill this gap, an experimental protocol was developed to compare ruptured and intact Poly Implant Prothèse (PIP) breast implants from the same woman. These conditions guarantee that the physical/biological variables are the same for each pair of ruptured and intact implants. A total of 1008 samples from 22 PIP explants (11 intact and 11 ruptured) and three control PIP implants were analysed. The mechanical properties (tensile strength) of the ruptured and intact implants were compared according to brand, lot, implantation time and demographic conditions. In general, statistically significant differences were found between the intact and ruptured PIP implants. Ruptured implants were thinner (0.73 ± 0.10 mm versus 0.91 ± 0.11 mm) and weaker (7.42 ± 2.65 MPa versus 9.59 ± 2.37 MPa) than intact implants. Intact and ruptured implants have shown distinct mechanical behaviours and variations in thickness. Our understanding is that these differences may be associated with the typical manufacturing process of breast implant shells. These results stress the importance of thorough control of the shell thickness. Given its relevance, shell thickness should be used as a quality control measure for homologation purposes. Thus, the homogeneity of the shell should be considered as a relevant parameter during the manufacturing process. This will translate into an improved quality of life for patients and will potentiate safer and longer lasting products.
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Muller, Guy-Henri. "Hydrogel-Filled Mammary Prosthesis." American Journal of Cosmetic Surgery 15, no. 3 (September 1998): 259–62. http://dx.doi.org/10.1177/074880689801500306.
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Introduction: The silicone breast implant controversy and the moratorium on the use of silicone-gel-filled breast implants in the U.S., Canada, and France has led to a search for substitutes for silicone-gel implants that are safe, pliable, and still firm enough to hold its shape. Hydrogel is being evaluated as an alternative to silicone gel for filling breast implants. Materials and Methods: Eighteen hundred ninety hydrogel-filled breast implants were inserted into patients in France and Italy between 1992 and 1993. The postoperative results of these procedures were reviewed. Results: Twelve implant ruptures occurred at the time of insertion secondary to too small an incision and lack of prewarming of the implant. Two ruptures went unnoticed and were satisfactorily resolved with a revision of the first procedure. One capsule contracture occurred within one year. Visual results according to patients and surgeons were satisfactory. The palpable results are less favorable than silicone-gel implants, but better than saline-filled implants. Discussion: Hydrogel is biocompatible. The breakdown products of the implant filler, if they migrate outside the shell, should not be toxic. Because hydrogel is a biomaterial filler to which water is added to reach an equilibrium point, it mimics the consistency of living tissue. Conclusions: Hydrogel appears to be a favorable substitute for silicone gel.
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Choi, Jangyoun, Young Bin Yang, and Deuk Young Oh. "Unilateral autoinflation of a saline-filled breast implant initially diagnosed as capsular contracture: a case report and review of the literature." Archives of Aesthetic Plastic Surgery 28, no. 3 (July 30, 2022): 90–93. http://dx.doi.org/10.14730/aaps.2022.00437.
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Spontaneous inflation of saline breast implants is a rare phenomenon. In this case report, we share our experience treating a patient who complained of asymmetric breasts from what appeared to be a straightforward case of capsular contracture. Spontaneous autoinflation of the right breast implant was subsequently found to be the cause of breast asymmetry and hardness. The presentation, diagnostic challenge, management, and mechanism of this rare phenomenon are presented here.
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Busse, Brittany, Hakan Orbay, and David E. Sahar. "Sterile Acellular Dermal Collagen as a Treatment for Rippling Deformity of Breast." Case Reports in Surgery 2014 (2014): 1–5. http://dx.doi.org/10.1155/2014/876254.
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Prosthetic implants are frequently used for breast augmentation and breast reconstruction following mastectomy. Unfortunately, long-term aesthetic results of prosthetic breast restoration may be hindered by complications such as rippling, capsular contracture, and implant malposition. The advent of use of acellular dermal matrices has greatly improved the outcomes of prosthetic breast reconstruction. We describe a case of rippling deformity of breast that was treated using an acellular dermal matrix product, AlloMax. The patient presented with visible rippling of bilateral prosthetic breast implants as well as significant asymmetry of the breasts after multiple excisional biopsies for right breast ductal carcinoma in situ. A6×10 cm piece of AlloMax was placed on the medial aspect of each breast between the implant and the skin flap. Follow-up was performed at 1 week, 3 months, and 1 year following the procedure. The patient recovered well from the surgery and there were no complications. At her first postoperative follow-up the patient was extremely satisfied with the result. At her 3-month and 1-year follow-up she had no recurrence of her previous deformity and no new deformity.
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Fritsch, Hanna, Melisa Celik, Matthias Warm, Fabinshy Thangarajah, Anett Pisek, and Christian Eichler. "Abstract PO1-07-06: Sonographic assessment of breast implants using strain elastography and shear wave elastography in an animal model." Cancer Research 84, no. 9_Supplement (May 2, 2024): PO1–07–06—PO1–07–06. http://dx.doi.org/10.1158/1538-7445.sabcs23-po1-07-06.
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Abstract Purpose: To date, MRI remains the gold standard for the diagnosis of breast implant rupture. As MRI is an expensive procedure with limited availability, improvement in sonographic assessment is desirable. A potentially useful tool in this regard is the assessment of tissue stiffness using ultrasound elastography. Strain elastography provides a qualitative analysis by producing a coloured map in the B-mode image comparing the stiffness of adjacent tissues in the region of interest, whereas shear wave elastography provides a quantitative analysis. To evaluate the diagnostic utility of both methods under standardised conditions, we developed an animal model. Under natural conditions, the physiology of the patient (e.g. the amount and stiffness of the breast tissue covering the implant in question) can influence the measurements and alter the data. Therefore, the animal model provides an excellent opportunity to compare ruptured and intact implants of different types and sizes under exactly the same conditions, neglecting individual characteristics of real patients. Methods: An animal model was created by preparing an implant site in a chicken breast, mimicking the layers of tissue typically covering a breast implant after mastectomy (skin, fat, muscle). Different fractured and intact implants were inserted. Measurements were made using strain elastography and shear wave elastography by an investigator with no further experience of breast ultrasound. Implants were scanned in five pre-defined planes in both intact and ruptured conditions. For strain elastography, the resulting images were examined for repetitive patterns. Shear wave elastography data were analysed for significant differences between ruptured and intact implants. Results: The chicken breast animal model produced realistic images and measurements comparable to those of a human breast. Therefore, ruptured and intact implants could be compared under standardised conditions. Statistical analysis showed no significant difference between intact and ruptured implants in shear wave elastography data. However, qualitative analysis using strain wave elastography showed different patterns when comparing intact and ruptured implants in the animal model. Intact implants showed a characteristic three-layer sonographic image at certain levels. Conclusion: Shear wave elastography does not appear to provide reliable data for the evaluation of breast implants, whereas qualitative analysis using strain wave elastography may be a useful tool to improve diagnostic accuracy. Citation Format: Hanna Fritsch, Melisa Celik, Matthias Warm, Fabinshy Thangarajah, Anett Pisek, Christian Eichler. Sonographic assessment of breast implants using strain elastography and shear wave elastography in an animal model [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-07-06.
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Zaussinger, Maximilian, Dominik Duscher, and Georg M. Huemer. "Nagor Impleo Round Silicone Gel Breast Implants: Early Outcome Analysis after 340 Primary Breast Augmentations." Journal of Clinical Medicine 12, no. 11 (May 27, 2023): 3708. http://dx.doi.org/10.3390/jcm12113708.
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For decades, implant-based breast augmentation has been one of the most performed surgical procedures for cosmetic purposes around the world. Hence, novel manufactured implants should be critically investigated to prove them safe and effective. Here, the authors describe the first independently conducted clinical study on Nagor Impleo textured round breast implants. For this retrospective study, outcomes of 340 consecutive female patients undergoing primary cosmetic breast augmentation were analyzed. Demographic and surgical data as well as outcomes and complications were evaluated. Furthermore, a survey concerning effectiveness and aesthetic satisfaction after breast augmentation was examined. All 680 implants were placed in a submuscular plane with incisions at the inframammary fold. The main indications for surgery were hypoplasia and hypoplasia with asymmetry. The mean implant volume was 390 cc and the main type of projection was high profile. The most common complications were hematoma and capsular contracture (0.9 percent, respectively). The overall revision rate for complications was 2.4%. Additionally, almost all patients showed increased quality of life and aesthetic satisfaction after a breast augmentation. Hence, all patients would undergo breast augmentation again with these newly launched devices. Nagor Impleo implants demonstrate a low complication rate and high safety profile. Although high aesthetic satisfaction and quality of life results were achieved, analysis of an even larger series over a longer period of time would be beneficial to evaluate the reliability of this implant.