Saline-filled Breast Implants Research Articles

Does Overfilling Smooth Inflatable Saline-Filled Breast Implants Decrease the Deflation Rate? Experience with 4761 Augmentation Mammaplasty Patients

Does Overfilling Smooth Inflatable Saline-Filled Breast Implants Decrease the Deflation Rate? Experience with 4761 Augmentation Mammaplasty Patients

Developing a Specific MRI Technology to Identify Complications Caused by Breast Implants

With advancements in aesthetic medicine, breast augmentation has become a popular plastic surgery worldwide, typically performed using either fine-needle injection or silicone implants. Both carry complication risks from rupture over time. In this study, we aimed to reduce misjudgments and increase diagnostic value by developing an MRI technique that can produce water- and silicone-specific images from MRI scans of phantoms (Natrelle® saline-filled breast implants) and human bodies. Pig oil, soybean oil, and normal saline were used to simulate human breast tissue, and two common types of breast implants, saline bags, and silicone bags, were selected as well, resulting in five materials scanned. Six pulse sequences were applied: T1W fast spin echo (FSE), T1W SPGR/60, T2W, T2W fat-saturation, STIR, and STIR water-saturation. Human body scans were additionally investigated using 3D SPGR fat-saturation dynamic contrast enhancement. Results show that the best way to enhance tissue contrast in images of silicone implants is to apply STIR combined with water suppression, and the best way to enhance saline bag implants is to apply T2W fat-saturation combined with fat suppression. Both offered very high sensitivity and specificity, rendering this method especially useful for distinguishing normal mammary glands from siliconoma.

Does Overfilling Smooth Inflatable Saline-Filled Breast Implants Decrease the Deflation Rate? Experience with 4761 Augmentation Mammaplasty Patients

BackgroundResearch suggests that overfilling saline inflatable breast implants may decrease their deflation rates. To date, there has been no large-scale study comparing breast implants filled within vs. beyond the manufacturer’s recommended fill volumes.MethodsA retrospective comparative study was conducted for 4761 women who underwent aesthetic augmentation mammaplasty by the author. Patients were divided into two groups: Group 1 includes 2960 patients who had breast augmentation between 2002 and 2009 with implants filled within the manufacturer’s recommended fill volumes. Group 2 includes 1801 patients who had breast augmentation between 2011 and 2018. Their implants were overfilled with an average volume between 42 and 50 cc, or 10–13%, respectively.All surgeries were performed with Mentor Style 1600 saline breast implants (smooth, round moderate profile) through an inframammary incision; implants were placed in the subpectoral (dual) plane. Also evaluated was the yearly increase in deflation rates.ResultsGroup I had 119 deflations, representing a deflation rate of 4.02%. Group 2 had 33 deflations, providing a deflation rate of 1.83%. The author found a protective effect in overfilling the device (p < 0.00001 and Z-score of 4.17). Fold failure was the major reason for deflation in both groups.The implants filled within the manufacturer’s recommended volume had a yearly increase in deflation rate of 0.41%, not 1% as is commonly reported. The overfilled implants did not have a yearly increase in deflation rate.ConclusionOverfilling Mentor Style 1600 saline breast implants (smooth, round moderate profile) 10–13% significantly reduced the deflation rate.Level of Evidence IIIThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Was ist neu bei der Diagnostik und Therapie des Mammakarzinoms? – Aktuelle Standards in der Behandlung von Brustkrebs

Breast cancer is the most frequently diagnosed type of cancer in women and there are continuously new findings in research for further treatment approaches. Mammography is already a well-established prevention method in Germany for women aged 50-69, reducing mortality rates significantly. The benefit of extending the screening period including women older than 70 years has been proven recently. Intensive research in hereditary breast cancer makes it possible to identify high risk patients and include them to a more frequent screening program with additional MRI. In early as well as in advanced stages of breast cancer the treatment should be as targeted and as noninvasive as possible. After neoadjuvant therapy a mastectomy is needed less frequently and axillary lymph node dissection can be limited to rare cases. Molecular subtyping allows more individualized treatment in curative and palliative intention. BIA-ALCL is an uncommon and highly treatable T-cell lymphoma associated with textured silicone or saline filled breast implants. Despite increasing incidence the usage of those implants is possible - but only after adequate information. Due to new insights into the biology of breast cancer the period of follow-up care has been expanded to ten years. The detection of an ESR1 mutation could possibly be used as a predictive marker regarding endocrine therapy in the future. Furthermore, there are promising results for blocking the PD-1 axis in primary systemic chemotherapy for triple-negative breast cancer.

Breast Implants: Protocol for Retrieval and Analysis.

The Center for Implant Retrieval and Analysis has been established at Washington University's Division of Plastic and Reconstructive Surgery for the purpose of studying implantable devices retrieved after surgery or autopsy and assessing their condition after implantation. Since the early 1990s, significant experience has been gained in testing and analyzing silicone gel breast implants and, to a lesser extent, saline-filled devices. However, there has been no systematic method reported for collecting and evaluating these implants in a way that would permit di. erent laboratories to compare their data. This article offers the plastic and reconstructive surgery community a standardized protocol for analyzing explanted silicone gel and saline-filled breast implants. The protocol gives surgeons a clearly defined approach for removing, handling, documenting, and shipping explanted breast implants. At the same time, biomaterials researchers can use the protocol to acquire implant data with reliable and reproducible methods. Because the study of saline implants has lagged behind the study of silicone gel implants, the article concludes with a demonstration of how this protocol can be applied to obtain mechanical properties data and use scanning electron microscopy to illuminate failure mechanisms of saline devices, including three explants removed after 20+ years in vivo.

Longitudinal Ultrasound Study of Breast Implant Rupture Over a Six-Year Interval.

Silicone gel-filled implants as opposed to saline-filled breast implants are the most commonly used breast implants in Europe, and this has recently also become the case in the United States. Modern implants have a multiple layer silicone shell and high to very high levels of cohesive silicone gel inside. Although breast magnetic resonance imaging is at present considered the gold standard imaging method for breast implant rupture detection, breast ultrasound (US) imaging is still the first-step investigation in Europe. The aim of this study was to verify whether or not the stepladder sign at US is still associated to intracapsular rupture among the last generation silicone breast implant. In this study, 156 patients presenting for breast augmentation, mastopexy with implants and breast reconstruction for a total number of 303 breast implants inserted were enrolled. A preoperative breast ultrasonography was performed, and patients underwent a routine US scan every 6 months for 24 months to evaluate the implant status. A final US evaluation 6 years after implantation was also performed. Stepladder signs were seen at 6 years in 170 implants (56%) of the examined implants at US scan, and only 2 implants showed signs of possible rupture because of severe distortion of the implant profile with or without external silicone collection. A third ruptured implant was detected at magnetic resonance imaging by the presence of breach of the shell at the posterior surface of the implant with small external silicon collection and was eventually confirmed at surgery. Therefore, the overall rupture rate found at the United States at 6 years was about 1% (3 of 303 implants). According to our findings, the stepladder sign at the United States is no longer associated to intracapsular rupture. Plastic surgeons, patients, and financial departments of hospitals would also be delighted to know that surgeons should not take patients back to theater for implant explantation when aging signs are not associated with a visible breach of the implant shell or external silicone collections.

Natrelle Saline-Filled Breast Implants: A Prospective 10-Year Study

Natrelle saline-filled breast implants (Allergan, Santa Barbara, CA) are in widespread use in the United States for both breast augmentation and reconstruction. The primary safety concerns are local complications and secondary surgeries. This study provides long-term data on complications and effectiveness. The study began as a prospective, multicenter study of 901 augmentation subjects and 237 reconstruction subjects implanted with Natrelle saline breast implants. After completing 5 years of annual visits with physician examinations, subjects were asked to enroll in a survey-based study for follow-up through 10 years. Survey questions encompassed the major safety outcomes of implant deflation, capsular contracture, breast pain, reoperation, and implant removal/replacement as well as subject satisfaction. Safety results were analyzed with Kaplan-Meier cumulative risk rates, and subject satisfaction was measured on a 6-point scale from definitely satisfied to definitely dissatisfied. Of the 876 augmentation subjects and 194 reconstruction subjects who completed the 5-year study, 781 augmentation subjects (89.2%) and 170 reconstruction subjects (87.6%) consented to participate in the survey study. The survey response rate at 10 years was 91.4% for augmentation subjects and 85.9% for reconstruction subjects. Reoperation was the most frequent safety issue for both subject groups, and 90% of the implants remained intact at 10 years. Subject satisfaction was 87.5% for augmentation subjects and 86.3% for reconstruction subjects at 10 years. This study demonstrates the long-term safety and effectiveness of Natrelle saline breast implants. The 10 years of data amassed in the clinical study provide a solid foundation to facilitate the informed decision process.

Transumbilical breast augmentation with insertion of saline-filled breast implants

Objective To evaluate the surgical technique and procedures of transumbilical breast augmentation with an inverse U-shape incision and insertion of saline-filled breast implants. Methods With specialized instruments, the subcutaneous tunnel was undermined to the inframammary crease after inverse U incision made along the umbilical border. The subpectoral space was dissected with a dissector after the advancement of obturator across the inframammary crease. The expander was inserted into the subpectoral pocket to be filled to obtain the high degree of symmetry of the breasts. Finally, the previously prepared implants were inserted after the expander deflated and removed. Results All patients gained satisfactory results with no complications, such as hematoma, infection, implant deflation and Baker III or IV capsular contracture. Conclusions Breast augmentation could be performed through umbilical incision with the usage of saline-filled breast implant. This is an alternative of incisions in breast augmentation. Key words: Umbilicus; Augmentation mammoplasty; Breast implants; Endoscope

One-Stage Immediate Breast Reconstruction With Implant Following Skin-Sparing Mastectomy in Asian Patients

The Asian breast reconstruction patient is usually of lower mean age, lower body mass index (BMI), and has relatively small breasts. This study aimed to investigate the outcome of 1-stage immediate breast reconstruction using saline-filled implants in the Asian patients.Between April 2002 and July 2005, 30 patients underwent skin-sparing mastectomy and 1-stage immediate breast reconstruction with a saline-filled implant. Mean age was 42.9 years, with a mean BMI of 21.9 and a mean implant volume of 283 mL. The overall success rate was 96.6%, with 1 case of implant exposure secondary to chest skin necrosis. At mean follow-up of 21.5 months (range 6 to 40 months), 1 patient developed local recurrence (3.33%). Perfusion of the chest skin flap is reliable enough to allow 1-stage breast reconstruction with small saline-filled breast implants. We present this as an additional option for immediate breast reconstruction in thin women with small breasts.

Implications of Transaxillary Breast Augmentation: Lifetime Probability of Breast Cancer Development and Sentinel Node Mapping Interference

After the "fifth-generation" breast implants with ultracohesive silicone gel technology are introduced, the Food and Drug Administration (FDA) will sooner or later retire the ban on the use of these devices in the United States. When this happens, the plastic surgery community must be prepared to face a massive demand for reoperations to change saline-filled breast implants because cohesive gel devices have the potential to provide a more natural breast shape, to minimize the risk of postoperative rippling, and to provide a greater degree of safety if the implant loses its integrity. Despite these advantages and extensive use throughout the rest of the world during the ban in the United States, silicone implants also have disadvantages. One drawback is that transaxillary breast augmentation with more "rigid" gel-filled implants may produce trauma to the armpit, may interfere with sentinel node mapping for breast cancer treatment, and may have future medicolegal implications.

Autoinflation of Saline-Filled Inflatable Breast Implants

Spontaneous autoinflation of saline-filled breast implants is a rare phenomenon; only 20 cases have been reported in the world literature. Over the past seven years, three patients have presented with significant unilateral autoinflation of their smooth, single-lumen, round, saline-filled implants. This developed at various times: progressively over 23 years with a Simaplast implant; between the ninth and 10th year after augmentation with a leaflet valve implant; and slowly over the first four years with a leaflet valve implant. The etiology of the autoinflation was shown to be different for the two types of implants. The Simaplast implant had likely been injected with a hypertonic filling solution - one that was twice as concentrated as 'normal saline'. This would have created an osmotic gradient, which would have facilitated autoexpansion by diffusion. The implant solution remained clear and transparent. In addition, there were no detectable levels of glucose, uric acid or albumin in the fluid. By contrast, auto-inflation of the leaflet valve implants likely resulted from mechanical alterations of the valve mechanism. This type of implant is known to have a high deflation rate, with frequent partial deflations. It is interesting that one of the patients with the leaflet valve implants presented with an autoexpansion on one side and a partial deflation on the other side. Both implants were from the same lot number. The same mechanism that caused partial deflations may have also allowed fluid from the implant pocket to pass through the valve into the lumen of these implants. This could allow glucose, protein and cellular elements to enter into the lumen (these would not pass through an intact elastomeric shell) which would create an osmotic gradient, allowing water to enter the elastomeric shell by diffusion. The fluid in these leaflet valve implants was brownish yellow, very viscous and turbid. It contained elevated levels of glucose and uric acid which would not have passed through the elastomeric shell. Over the past 10 years, four different theories have been proposed in an attempt to explain the etiology of autoinflation. However, the findings of the present study indicate that there are only two mechanisms - a hypertonic filling solution and alterations of the valve mechanism.

Textured Saline-Filled Breast Implants for Augmentation Mammaplasty: Does Overfilling Prevent Deflation? A Long-Term Follow-Up

Augmentation mammaplasty is the second most commonly performed aesthetic operation. Since the moratorium on gel-filled devices in 1992, saline-filled devices have become the prosthesis of choice in the United States. Although inflatable breast implants have been available since 1965, high rates of complete implant deflation have been reported. In this retrospective study, the authors highlight the effect of filling volume on the incidence of implant deflation, other implant-related trade-offs, and implant survival. Forty-nine women who had undergone aesthetic augmentation mammaplasty were followed up for up to 139 months. Twelve implants were underfilled (group 1), 47 devices were filled within the recommended volume (group 2), and 37 implants were overfilled beyond the manufacturer's maximum recommended volume (group 3). All the implants used were of the same type and from the same manufacturer (Siltex by Mentor, 2600). Through an inframammary approach, subpectoral placement of the device was used exclusively. Nineteen women experienced complete deflation of their implants, with an overall implant complete deflation rate of 19.79 percent. This complication occurred in 16.6 percent of group 1 patients, 21.2 percent of group 2, and 18.9 percent of group 3. Skin wrinkling and rippling were encountered in 50 percent of group 1, 29.78 percent of group 2, and 43.2 percent of group 3, with an overall incidence of 37.5 percent. In this series, the authors could not find a protective effect of overfilling on complete deflation (p = 0.925) nor on the avoidance of rippling and wrinkling (p = 0.285). Moreover, overfilling by more than 25 ml beyond the maximum recommended dose showed no statistical significance for the frequency of complete deflation (p = 0.982) or for the incidence of wrinkling and rippling (p = 0.828). However, Kaplan-Meier survival analysis revealed that overfilling the implants prolonged their longevity and had a statistically significant effect on the implants' 10-year survival rate. Of the 49 women, 34 (69.3 percent) needed a secondary surgical procedure, mainly for complete deflation (38.7 percent) and skin wrinkling/rippling (20.4 percent). At the end of the current study, eight of 49 women, representing 15 implants, retained their original implants for more than 120 months. Use of Mentor 2600 prostheses for aesthetic breast augmentation led to a very high incidence of complete deflation and skin wrinkling and a high reoperation rate. Filling the implants within the recommended range or overfilling them increased device longevity and had a statistically significant effect on the implants' 10-year survival rate.

The semi-permeability of silicone: a saline-filled breast implant with intraluminal and pericapsular Aspergillus flavus

Fungal infection of breast implants is a rare complication. Growth of fungi within the lumen of saline-filled implants has previously been demonstrated in laboratory studies, however, clinical infections are rare. We report a case of Aspergillus flavus growth within and around a saline-filled breast implant that was inserted 18 months previously. This was successfully treated with implant removal and wound irrigation. Possible routes of microbial contamination as well as survival mechanisms of organisms within saline-filled implants are discussed. This case re-iterates that the silicone envelope of a saline-filled implant is selectively permeable and we believe this is instrumental in facilitating intraluminal microbial growth. This also emphasises the importance of stringent asepsis when dealing with saline-filled breast implants including avoiding contamination of the saline filling fluid.

Mechanical and sensory testing of overfilled breast implants

To obtain an ideal outcome in breast augmentation procedures, breast implants may be overfilled to reduce wrinkles and improve longevity. Determination of the optimal volume for saline-filled breast implants remains problematic for plastic surgeons. We sought to evaluate the effect of overfilling or underfilling implants on sensory response and on implant shell mechanical properties. Fifty-three Mentor Style 1600 smooth saline-filled mammary implants (275-cc base volume) were examined. Saline fill volumes ranged from 230 cc to 1650 cc. Implants were incubated at 37 degrees C and 100% humidity for 6 weeks. Before destructive testing to determine strength, elasticity, and toughness, 22 women ranging in age from 18 to 55 years graded the implants for firmness to palpation. Objective indices of firmness were measured by durometer. Implants filled 50% above manufacturer's recommended volume were considered firm, whereas implants 50% below manufacturer's recommended volume were considered natural or soft. A linear relationship was observed between sensory response and durometer hardness data. Fill volume did not affect shell mechanical properties: shell strength, toughness, and elasticity remained unchanged (P > .05). Saline-filled breast implants can be safely filled far beyond manufacturer's recommendations with regard to the mechanical properties of the Silastic polymer implant shell. Clinical judgment is required to avoid hardness due to overfill. Repeating this study using an in vivo incubation method is required to determine how overfill will affect implant shells over time in the harsh milieu of a biologic environment.

Spontaneous autoinflation of saline mammary implants: Further studies

Previous studies have reported a hyperinflation of saline-filled breast implants. On removal, the implant fluid had changed from clear saline to a yellowish-brown color, with a viscous consistency similar to serum. Our objective was to identify further the components of saline from implants that had undergone spontaneous autoinflation. Our hypothesis was that if serum albumin is present in the fluid, then other proteins would likely be found. To screen and identify proteins in implant fluid, we used a proteomics-based approach that included 1- and 2-dimensional gel electrophoresis and mass spectrometry of protein samples. Four known proteins and 1 unknown protein product were identified. Based on 2-dimensional gel electrophoresis and mass spectrometry, 2 general observations can be made about the saline from the autoinflated implants: serum albumin was the most prevalent protein, and there are a large number of proteins that remain to be identified. There are multiple macromolecules that cross into the lumen of the prosthesis. We believe spontaneous autoinflation is occurring more often than is believed or reported.

Protocol for retrieval and analysis of breast implants.

The Center for Implant Retrieval and Analysis has been established at Washington University's Division of Plastic and Reconstructive Surgery for the purpose of studying implantable devices retrieved after surgery or autopsy and assessing their condition after implantation. Since the early 1990s, significant experience has been gained in testing and analyzing silicone gel breast implants and, to a lesser extent, saline-filled devices. However, there has been no systematic method reported for collecting and evaluating these implants in a way that would permit different laboratories to compare their data. This article offers the plastic and reconstructive surgery community a standardized protocol for analyzing explanted silicone gel and saline-filled breast implants. The protocol gives surgeons a clearly defined approach for removing, handling, documenting, and shipping explanted breast implants. At the same time, biomaterials researchers can use the protocol to acquire implant data with reliable and reproducible methods. Because the study of saline implants has lagged behind the study of silicone gel implants, the article concludes with a demonstration of how this protocol can be applied to obtain mechanical properties data and use scanning electron microscopy to illuminate failure mechanisms of saline devices, including three explants removed after 20+ years in vivo.

Mechanical analysis of explanted saline-filled breast implants exposed to betadine pocket irrigation

Background: Because of concerns that exposure to povidone-iodine (Betadine) may lead to early breast implant failure, the Food and Drug Administration announced in 2000 that any contact between implants and Betadine is contraindicated. The evidence cited by the Food and Drug Administration primarily referred to Betadine added to saline implant filler solution and not to povidone-iodine used for pocket irrigation. Objective: Thirteen explanted Mentor saline solution-filled devices that had been exposed to Betadine pocket irrigation during implantation were studied for any loss of implant shell integrity. Methods: The 13 explants had been in place 1 week to 55 months, and none had intraluminal Betadine exposure. Twelve of the 13 explants were intact when removed, and one had leaked through the anterior valve. All were examined for any signs of patch-shell delamination. The mechanical properties of tensile strength, percent elongation, force-to-break, tear resistance, and patch bond strength were also measured. Results: No shell delamination or disruption of the sealing patch bond was found in any of the 13 explants placed in Betadine-irrigated pockets. In addition, the measured mechanical properties of the explants exceeded American Society for Testing and Materials requirements, with the exception of the textured explants (n = 2), which failed to meet the minimum elongation standards. Conclusions: We found no evidence of patch or shell delamination in Mentor implants that had extraluminal contact with Betadine irrigation and were later explanted. We believe that the lower mechanical properties of the two textured implants are probably related to the texturing process rather than to Betadine pocket irritation. (Aesthetic Surg J 2002;22:438-445.)

Microbial growth in saline breast implants and saline tissue expanders.

The subject of microbial growth within the saline medium of prosthetic breast implants has been one of great controversy in recent years. Although several articles have described microbial growth within the tissue surrounding implanted breast prostheses, few have attempted to determine the possibility of such contamination of the luminal saline. The authors studied the intraluminal saline medium of a series of explanted breast prostheses with the objective of identifying any microbial contamination. Over a 6-month period, a consecutive series of saline-filled breast implants and tissue expanders were removed from 37 patients. Under the supervision of a microbiologist, saline extracted from each implant was subjected to bacterial and fungal cultures, Gram staining, and acid-fast staining. A total of 24 saline-filled breast implants were removed from 15 patients, and 32 saline-filled tissue expanders were removed from 22 patients. The average length of implantation was 28.1 months for the implants and 7.1 months for the expanders. None of the saline within the implants or expanders within our series displayed any evidence of microbial contamination. These results suggest that microbial contamination of the luminal saline of prosthetic breast implants is an extremely unlikely event.

Augmentation Mammaplasty with Saline-Filled Textured Implants: Review of 9 Years' Experience and Results of Patient Survey

Introduction: In June of 2000 the FDA approved saline-filled breast implants as safe prosthetic devices based on results of clinical testing presented by the manufacturers. The corresponding author has been using saline-filled implants since 1992. It was decided to review his experience and assess the incidence of postoperative complications as reported by the patients and to identify factors related to their satisfaction. Materials and Methods: A survey was mailed out to a cohort of 460 patients. The survey included questions pertaining to possible postoperative complications and the patient's overall satisfaction. Overall, 207 surveys were returned after 2 mailings. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) software. Results: The patient's age at the time of surgery ranged from 18 to 62 years, with a mean of 33.8 years. Follow-up time ranged from 6 months to 102 months postoperatively, with a mean of 37.2 months. Forty-two out of 193 patients were smokers. Implant volumes ranged from 180 to 800 mL, with an average of 380 mL. Implant types used were McGhan (55.5%), Mentor (40.5%), and Microcell (4%). All implants had surface texturing. Most of the implants (90.7%) were placed in a submuscular position. Sixty-five percent of the patients preferred a transaxillary approach, whereas 35% preferred the periareolar approach. Discussion: Capsular contracture remains one of the main factors affecting patient satisfaction. Implant volume and position had no significant effect on the risk of developing capsular contracture. Furthermore, the volume of an implant did not have a significant impact on the risk of developing pain, loss of nipple sensation, or wrinkling. In this study, a significant number of patients reported wrinkling (44.4%) and alteration of nipple sensation (40.6%), which reflects the fact that this is a subjective patient-reported result. Overall satisfaction rate reported was 96.6%.

Immediate breast reconstruction with saline-filled implants: no interference with the oncologic outcome?

The possible adverse effects on cancer control due to immediate breast reconstruction have been addressed recently for both silicone-filled implants and flap reconstruction. To evaluate those possible effects after immediate breast reconstruction with saline-filled implants, 49 patients reconstructed with saline-filled breast implants at the Jules Bordet Cancer Institute were studied. Selection was only based on the possibility to find a matched patient. These patients were matched with a control group of 49 matched women with breast cancer treated in the same center by mastectomy without any type of breast reconstruction. The two groups were comparable according to age at diagnosis (within 3 years), year of diagnosis (same year), stage of the tumor, histology, and nodal status. The only difference between the two groups was that radiation therapy was applied to some of the patients who were not reconstructed (due to tumor location). The results show, in terms of local recurrences, distant metastasis, and deaths, no significant difference between the two groups, even for the irradiated patients, within a mean follow-up period of 72 months (range, 24 to 108) months.