Breast implant with corrugation

Abstract

The present application relates to a breast implant having a surface roughness and a waviness. The breast implant according to an aspect comprises: a shell constituting an outer wall; and a filler housed inside the shell, wherein an outer side surface of the shell has a convex-curved surface in contact with a tissue, and the surface shows a certain level of waviness on a filtered waviness curve 。

Description

Technical Field

[0001] This application relates to a breast implant with a corrugated shape. Background Technology

[0002] Currently, many people receive medical implants for medical or cosmetic purposes. Breast implants are used to reconstruct and enlarge the breast and can be categorized based on the filling material: saline-filled breast implants, silicone-filled breast implants, hydrogel-filled breast implants, and polyvinylpyrrolidone (PVP)-filled breast implants. To reduce side effects caused by allogeneic reactions during breast implantation, generational replacement of breast implants is underway to ensure biocompatibility. A representative example of a side effect caused by breast implants is capsular contracture, which occurs when a hard capsule forms around the implant and contracts. When capsular contracture occurs, the breast hardens, causing aesthetic damage and inconvenience.

[0003] Early first-generation silicone implants were of the "smooth" type, characterized by considerable thickness and a smooth surface. While their outer layer ruptured slowly, the high rate of silicone leakage and the resulting capsular contracture made biocompatibility difficult to ensure. Second-generation silicone implants were of the "smooth" type with a thinner outer layer. The reduced thickness of the shell decreased capsular contracture, but increased rupture of the outer layer occurred. In the third generation, to reduce silicone leakage, a multi-layered outer layer with a barrier layer was introduced, and development focused on shaping the surface to reduce capsular contracture. The initial surface shape used was a textured type with pores on the outer layer. This surface allowed the implant to be stably fixed to breast tissue after transplantation, significantly reducing capsular contracture. Various forms of breast implants have been developed to ensure a natural shape and soft touch, but recent reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of blood cancer, have strengthened the management of the safety of breast implants.

[0004] Recently, the International Organization for Standardization (ISO) has categorized breast implant surfaces into three types based on surface roughness: smooth, micro-textured, and macro-textured, and has gradually discontinued the sale of all breast implant products with macro-textured surfaces. Macro-textured surfaces are equivalent to existing textured surfaces. To address the ongoing biocompatibility issues, there is a growing focus on surface design in the breast implant technology field. Breast implant surfaces should resemble biological tissue, exhibiting minimal foreign body reaction and adhering to surrounding tissues in the correct location. Excessive reaction with surrounding tissues can cause side effects such as capsular contracture, encapsulation, and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), thus necessitating the development of suitable surfaces. Against this backdrop, extensive research is underway on breast implants with excellent biocompatibility and safety that do not cause BIA-ALCL after insertion (Korean Patent Publication No. 10-2014-0089425), but progress remains minimal. Summary of the Invention

[0005] The problem the invention aims to solve

[0006] One aspect provides a breast implant comprising: a shell forming an outer wall; and a filler housed inside the shell, wherein the shell has surface characteristics exhibiting surface roughness and a certain level of waviness.

[0007] Other objects and benefits of this application will become more apparent from the appended claims, drawings, and the following detailed description. Content not described herein is readily apparent and can be inferred by those skilled in the art or similar fields described herein, and therefore is omitted from description.

[0008] means for solving problems

[0009] The descriptions and embodiments disclosed in this application can also be applied to various other descriptions and embodiments. That is, all combinations of the various elements disclosed in this application fall within the scope of this application. Furthermore, the scope of this application is not limited to the specific descriptions below.

[0010] One aspect provides a breast implant comprising: a shell forming an outer wall; and a filler housed within the shell.

[0011] The outer surface of the housing has a convex-bent surface that contacts the tissue, and for the surface, the arithmetic mean waviness (Wa) value of the waviness curve filtered under the measurement condition of a cutoff value of 0.08 is equal to or greater than 3.00 μm.

[0012] The term "implant" in this specification is a general term for grafts or implants that can be used in sunken areas of the skin or areas depressed due to wrinkles, etc., and can be used to enhance volume for cosmetic purposes. Here, "breast implant 100" is a general term for implants that can be transplanted to a patient in breast-related surgeries and procedures, and fillers can be filled inside the shell of the breast implant. Furthermore, depending on its shape, the breast implant 100 can be round or teardrop-shaped.

[0013] The term "shell 110" in this specification refers to a structure that is the outer portion of an implant prepared to replace breast tissue, and is in the shape of a soft, thin film that can change the overall shape of the breast implant according to the flow of the filler. The shell 110 primarily functions as a pouch within the body, which can be filled with a fluid substance, namely the filler 120. Furthermore, the surface characteristics of the outermost contour of the shell adjacent to the tissue can not only affect the adhesion between the implant and the tissue, but can also be used to modulate biological responses such as inflammatory reactions.

[0014] The shell can be prepared according to methods known in the art. According to a specific example, the shell can be prepared by a method including the following steps: preparing a mandrel with certain waviness and surface roughness characteristics; preparing and curing the shell by repeatedly immersing the prepared mandrel in a pharmaceutical solution and drying it; and separating the cured shell from the mandrel, but not limited thereto.

[0015] The shell can be composed, for example, of biocompatible materials including silicon and polyester fibers, preferably of silicon materials or silicon polymer materials. However, any substance that is non-toxic to living organisms and can impart effective surface properties can be widely used without limitation.

[0016] The term "filler 120" in this specification may consist of saline solution, hydrogel, silicone, other fluids with suitable flowability, and may be supplemented with other materials or shapes (e.g., sponges) to mitigate or inhibit the flowability of these fluids, as appropriate.

[0017] In the field of breast augmentation surgery using breast implants, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is the most significant problem. This BIA-ALCL is caused by textured breast implants manufactured by Allergan, and in fact, the sale of all related silicone implant products has been suspended in Europe. Therefore, various studies are underway regarding this problem, but the relationship between the incidence of BIA-ALCL and the surface texture of the breast implant has not yet been addressed.

[0018] like Figure 1 As shown, a breast implant or the shell of a breast implant according to one embodiment has a surface roughness and may also have surface characteristics exhibiting a certain level of waviness. Furthermore, Figure 2 This diagram schematically illustrates the state of a breast implant according to one embodiment after insertion into the body. The surface of the breast implant having the above-described characteristics can be inserted in contact with any one or more tissues selected from the group consisting of thin fascia, myofascia, mammary fascia, supporting fibers, and transverse fiber thin layers.

[0019] The term "waviness 111" in this specification refers to the surface curvature of a roughness curve whose period is relatively longer than that of the breast implant surface. It is typically used interchangeably with "W" or "Wmax" and is also defined as the distance between two parallel lines taken from the cross-sectional curve according to the waviness standard length, parallel to the centerline of the cross-sectional curve, and contacting the highest peak and the deepest valley. Specifically, under measurement conditions with a cutoff value of 0.08 mm, a cross-sectional curve, i.e., a height map curve, can be obtained by recording the profile appearing on a cross-section perpendicular to the measurement surface of the breast implant along both the longitudinal and transverse directions. The waviness value can then be calculated from a curve filtered by allowing only frequencies below the cutoff frequency to pass through. Furthermore, the waviness parameter can influence the adhesion of the entire target tissue in the surrounding tissue of the inserted breast implant 100.

[0020] The surface of actual breast implants has a very complex and diverse shape, thus the measurement results can be affected depending on the measurement site. In this regard, the term "cut-off value" in this specification refers to the reference length selected by the filter when the waviness or surface roughness average is directly measured using methods known in the art, such as measurements using a stylus electromechanical measuring instrument or by three-dimensional laser scanning. Typically, 0.08 mm, 0.25 mm, 0.8 mm, 2.5 mm, 8 mm, and 25 μm are selected as reference lengths, unless otherwise mentioned; the reference length in this specification may be 0.08 mm.

[0021] The term "arithmetic mean waviness Wa" in this specification refers to the arithmetic mean height of the waviness curve. The parameter value may be as defined in accordance with ISO 25178-2:2012.

[0022] According to one embodiment, for the surface, the arithmetic mean (Wa) value of the waviness profile filtered under the measurement condition of a cutoff value of 0.08 can be equal to or greater than 3.00 μm. The arithmetic mean waviness value can, for example, be a value in the range of 3.00 μm to 7.00 μm, 3.07 μm to 7.00 μm, or 3.50 μm to 6.00 μm. Furthermore, the arithmetic mean waviness can be, for example, 3.50 to 7.00 μm, 3.50 to 6.50 μm, 3.50 to 6.00 μm, 3.50 to 5.50 μm, 3.50 to 5.00 μm, 3.50 to 4.50 μm, 3.50 to 4.00 μm, 4.00 to 7.00 μm, 4.00 to 6.50 μm, 4.00 to 6.00 μm, 4.00 to 5.50 μm, 4.00 to 5.00 μm, or 4.00 to 4.50 μm. μm, 4.50 to 7.00 μm, 4.50 to 6.50 μm, 4.50 to 6.00 μm, 4.50 to 5.50 μm, 4.50 to 5.00 μm, 5.00 to 7.00 μm, 5.00 to 6.50 μm, 5.00 to 6.00 μm, 5.00 to 5.50 μm, 5.50 to 7.00 μm, 5.50 to 6.50 μm, 5.50 to 6.00 μm, 6.00 to 7.00 μm, 6.00 to 6.50 μm. When the arithmetic mean waviness exceeds but is below the range, an overly smooth surface increases the likelihood of capsular contracture and fibrosis. When the arithmetic mean waviness temperature is above the range, there is an increased risk of BIA-ALCL.

[0023] The term “maximum height Wz of the waviness curve” in this specification refers to the arithmetic mean height of the waviness curve, and the parameter value may be defined based on the ISO 25178-2:2012 standard.

[0024] According to one embodiment, for the surface, the maximum height (Wz) value of the filtered waviness curve under the measurement condition of a cutoff value of 0.08 can be equal to or greater than 19.16 μm. The maximum height value can, for example, be a value in the range of 20.00 to 44.00 μm. Furthermore, the maximum height value can, for example, be 20.00 to 40.00 μm, 20.00 to 35.00 μm, 20.00 to 30.00 μm, 20.00 to 25.00 μm, 25.00 to 44.00 μm, 25.00 to 40.00 μm, 25.00 to 35.00 μm, 25.00 to 30.00 μm, 30.00 to 44.00 μm, 30.00 to 40.00 μm, or 30.00 to 35.00 μm. Furthermore, if the maximum height value exceeds the range, there is a risk of inducing the problems described above.

[0025] The term "surface roughness 112" in this specification refers to the short-cycle, small-amplitude irregularities on the surface of a breast implant. For example, under measurement conditions with a cutoff of 0.08 mm, a cross-sectional curve, i.e., a height curve, is obtained by recording the profile appearing in a cross-section perpendicular to the measurement surface of the breast implant along both the longitudinal and transverse directions. The surface roughness 112 is then calculated from a curve filtered to allow only frequencies above the cutoff frequency to pass through. Furthermore, this surface roughness parameter can influence the adhesion strength in localized areas of the tissue surrounding the inserted breast implant. The parameter value can be measured based on ISO 14607:2018 and calculated based on ISO 25178-2:2012.

[0026] The term “arithmetic mean roughness Ra” in this specification refers to the arithmetic mean height of the roughness curve, and the parameter value may be defined based on the ISO 25178-2:2012 standard.

[0027] According to one embodiment, for the surface, the arithmetic mean roughness (Ra) value of the roughness profile filtered under the measurement condition of a cutoff value of 0.08 can be equal to or greater than 1.00 μm. The arithmetic mean roughness value can be a value in the range of 1.09 to 2.00 μm, for example, the arithmetic mean roughness value can be 1.09 to 1.90 μm, 1.09 to 1.80 μm, 1.09 to 1.70 μm, 1.09 to 1.60 μm, 1.09 to 1.50 μm, 1.09 to 1.40 μm, 1.09 to 1.30 μm, 1.09 to 1.20 μm, 1.2... 0 to 2.00 μm, 1.20 μm to 1.90 μm, 1.20 to 1.80 μm, 1.20 to 1.70 μm, 1.20 to 1.60 μm, 1.20 to 1.50 μm, 1.20 to 1.40 μm, 1.20 to 1.30 μm, 1.30 to 2.00 μm, 1.30 to 1.90 μm, 1.30 to 1.80 μm, 1.30 to 1.70 μm, 1 0.30 to 1.60 μm, 1.30 to 1.50 μm, 1.30 to 1.40 μm, 1.40 to 2.00 μm, 1.40 to 1.90 μm, 1.40 to 1.80 μm, 1.40 to 1.70 μm, 1.40 to 1.60 μm, 1.40 to 1.50 μm, 1.50 to 2.00 μm, 1.50 to 1.90 μm, 1.50 to 1.80 μm, 1 The arithmetic roughness ranges from 0.50 to 1.70 μm, 1.50 to 1.60 μm, 1.60 to 2.00 μm, 1.60 to 1.90 μm, 1.60 to 1.80 μm, 1.60 to 1.70 μm, 1.70 to 2.00 μm, 1.70 to 1.90 μm, 1.70 to 1.80 μm, 1.80 to 2.00 μm, 1.80 to 1.90 μm, or 1.90 to 2.00 μm. This arithmetic roughness can be applied to breast implants simultaneously with the aforementioned waviness values. When the arithmetic mean roughness exceeds but is below the range, an overly smooth surface increases the likelihood of capsular contracture and fibrosis. When the arithmetic mean roughness is above the range, the likelihood of BIA-ALCL increases.

[0028] The term “maximum height Rz of roughness curve” as used in this specification refers to the arithmetic mean height of the roughness curve, and the parameter value may be defined based on the ISO 25178-2:2012 standard.

[0029] According to one embodiment, for the surface, the maximum height (Rz) value of the roughness profile filtered under the measurement condition of a cutoff value of 0.08 can be equal to or greater than 5.84 μm. The maximum height value can, for example, be a value in the range of 5.84 μm to 10.29 μm. Furthermore, the maximum height value can, for example, be 5.84 to 10.00 μm, 5.84 to 8.00 μm, 5.84 to 6.00 μm, 6.00 to 10.00 μm, or 6.00 to 8.00 μm. Moreover, if the maximum height value exceeds the range, there is a risk of inducing the problems described above.

[0030] A breast graft according to one embodiment may include a surface having at least one or more of the following characteristics:

[0031] (a) The arithmetic mean waviness Wa value in the range of 3.07 to 7.00 μm in the waviness curve filtered under the measurement condition of cutoff value 0.08;

[0032] (b) The maximum height Wz value in the range of 20.00 to 44.00 μm in the ripple curve of the filter under the measurement condition of cutoff value 0.08;

[0033] (c) The arithmetic mean roughness Ra values ​​from 1.09 to 2.00 μm in the roughness curve obtained under the measurement condition with a cutoff value of 0.08; and

[0034] (d) The maximum height Rz value in the range of 5.84 to 10.29 μm in the roughness curve of the filter under the measurement condition of cutoff value 0.08.

[0035] Furthermore, for the surface of the breast implant according to one embodiment, the skewness (Wsk) value of the filtered waviness curve under the measurement condition of a cutoff value of 0.08 is a value in the range of -0.48 to 0.41 μm, and the kurtosis (Wku) value of the filtered waviness curve can be a value in the range of 2.62 to 5.28 μm. Alternatively, for the surface, the skewness (Rsk) value of the filtered roughness curve under the measurement condition of a cutoff value of 0.08 is a value in the range of -0.21 to 0.22 μm, and the kurtosis (Rku) value of the filtered roughness curve can be a value in the range of 2.72 to 3.86 μm, but is not limited thereto.

[0036] As described above, the breast implant has both surface roughness and a certain level of corrugation. Therefore, it can improve adhesion to the surrounding tissues not only in the local area but also in a larger area, thereby significantly increasing the adhesion between the breast implant and the surrounding tissues. This can alleviate the inflammatory response of the surrounding tissues and ultimately inhibit the formation of breast implant-related anaplastic large cell lymphoma caused by breast augmentation surgery.

[0037] Furthermore, for the breast implant, techniques known in the art can be applied in a non-limiting manner to technical components other than the surface characteristics of the breast implant or shell, such as the thickness of the shell, the type and amount of filler, the type and form of adhesive patches, and the volume of the implant.

[0038] Invention Effects

[0039] In one aspect of the breast implant, the surface of the shell has a surface roughness while exhibiting a certain level of waviness. This surface characteristic can contribute to improved adhesion between the breast implant and biological tissue. Therefore, the breast implant according to this aspect can provide excellent biocompatibility and stability by reducing the formation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a known side effect. Attached Figure Description

[0040] Figure 1 This is a diagram illustrating a breast implant and its housing surface according to an embodiment.

[0041] Figure 2 This is a schematic diagram illustrating the state of a breast implant after it has been inserted into the body according to one embodiment.

[0042] Figure 3 This is a schematic diagram illustrating the process of measuring the surface roughness and waviness of the shell surface of the breast implant according to an embodiment.

[0043] Figure 4 The results show the waveform of the shell surface of a breast implant according to an embodiment under the measurement condition of a cutoff value of 0.08.

[0044] Figure 5 The results are waveforms of the shell surface of the breast implant according to the comparative example under the measurement conditions of a cutoff value of 0.08.

[0045] Figure 6 The results show the height diagram of the shell surface of a breast implant according to one embodiment under the measurement condition of a cutoff value of 0.08.

[0046] Figure 7 The results show the roughness diagram of the shell surface of a breast plant, such as a comparative example, under the measurement conditions with a cutoff value of 0.08.

[0047] Figure 8The results show the roughness diagram of the shell surface of a breast implant according to an embodiment under the measurement condition of a cutoff value of 0.08.

[0048] Figure 9 The results show the roughness diagram of the shell surface of the breast implant according to the comparative example under the measurement conditions with a cutoff value of 0.08. Detailed Implementation

[0049] The present invention will now be described in more detail with reference to embodiments. However, these embodiments are merely illustrative of the invention, and the scope of the invention is not limited to these embodiments.

[0050] Preparation Example 1. Preparation of a breast implant according to an embodiment

[0051] In this preparation example, a breast implant with surface characteristics of surface roughness and a certain level of waviness was prepared. Specifically, after preparing a mandrel shell formed of aluminum material surface-treated by sandblasting, the surface of the mandrel was coated with polytetrafluoroethylene (Teflon) to prepare a surface-treated mandrel exhibiting an arithmetic mean waviness and an arithmetic mean roughness Ra value within a specific range. Then, the shell of the breast implant was cured by repeatedly immersing the prepared mandrel in a solution and drying it. The cured shell was separated from the mandrel, and then the shell was flipped to obtain the shell of the breast implant according to this embodiment. Then, filler was filled into the inner region of the shell to prepare the breast implant according to an embodiment.

[0052] Experimental Example 1. Evaluation of surface characteristics of a breast graft according to an embodiment

[0053] In this embodiment, the surface characteristics of the prepared breast implant were evaluated, specifically, surface roughness and waviness. Specifically, such as... Figure 3 As shown, after measuring the height map (section curve) of the breast implant surface, a roughness map and a waveform map were obtained based on the measured height map distribution. The roughness map was obtained by filtering through frequencies only above the cutoff frequency, and the waveform map was obtained by filtering through frequencies only below the cutoff frequency. The surface roughness and waviness of the breast implant were then evaluated by analyzing the roughness map and waveform map. In this experiment, surface roughness and waviness were measured according to ISO 14607:2018 using a 3D laser microscope (Olympus OLS5000), and then calculated according to ISO 25178-2:2012. For the surface characteristic evaluation, measurements were performed at a cutoff value of 0.08 mm, and existing products were used as a comparison group.

[0054] 1. Ripple Evaluation

[0055] Based on the height map data Figure 4 and Figure 5 The results of obtaining waveform diagrams of the shell surfaces of the breast implant according to Example 1 and the breast implant according to Comparative Example 1 are shown. Furthermore, the results of evaluating the waviness of the breast implants according to each example and comparative example, measured in the same manner, are shown in Table 1 below.

[0056] Table 1

[0057] Example 1 5.358 31.440 0.407 2.719 Example 2 3.074 19.160 0.045 2.768 Example 3 3.789 21.684 -0.141 2.622 Example 4 4.121 24.004 -0.267 2.634 Example 5 4.888 32.638 -0.344 2.803 Example 6 5.993 43.979 1.15 5.272 Example 7 6.386 42.853 -0.481 3.296 Comparative Example 1 1.629 9.856 0.605 2.889 Comparative Example 2 7.598 61.358 0.086 5.193

[0058] (Unit: μm)

[0059] The results confirm, as shown in Table 1, that the breast implant according to one embodiment showed significant differences compared to the comparison group in terms of arithmetic mean ripple Wa value and maximum temperature Wz value.

[0060] Based on these experimental results, it can be seen that the surface of the breast implant according to one embodiment has characteristics related to waviness, i.e., surface curvature, under the experimental conditions. Specifically, in this experiment, a breast implant with an arithmetic mean waviness Wa value ranging from approximately 3 μm to 7 μm and a maximum height Wz value ranging from approximately 9 μm to 61 μm was used as the subject of the experiment.

[0061] 2. Surface roughness evaluation

[0062] Figure 6 and Figure 7 The results show height maps of the shell surfaces of the breast implant according to Example 1 and the breast implant according to the comparative example under a specific condition with a cutoff value of 0.08. Furthermore, based on the height map data, Figure 8 and Figure 9 The results of obtaining roughness maps for the shell surfaces of the breast implant according to Example 1 and the breast implant according to the comparative example are shown. Furthermore, the results of evaluating the surface roughness of the breast implants according to each example and the comparative example, measured using the same method, are shown in Table 2 below.

[0063] Table 2

[0064] Example 1 1.091 6.815 0.181 3.548 Example 2 1.468 9.01 0.037 3.404 Example 3 1.722 10.285 -0.183 3.015 Example 4 1.079 5.845 0.068 2.722 Example 5 1.465 7.607 -0.217 2.914 Example 6 1.045 6.778 0.049 3.854 Example 7 1.671 8.998 0.222 2.978 Comparative Example 1 1.095 6.448 0.146 3.063 Comparative Example 2 1.341 8.249 -0.029 3.423

[0065] (Unit: μm)

[0066] As shown in Table 2, in the breast implant according to one embodiment and the breast implant according to the comparative example, the arithmetic mean roughness Ra showed a range of about 1.04 μm to 1.72 μm, and the maximum height Rz value showed a distribution ranging from 5.84 μm to 10.29 μm.

[0067] Experimental Example 2. Preparation of a Silicon Implant Animal Model

[0068] Eight-week-old SD rats were anesthetized prior to surgery using a combination of inhalation and injection anesthesia (n=2 in each experimental group, totaling 18 rats). Before implantation, the surgical site was thoroughly disinfected with povidone-iodine, and a 3cm incision was made in the back. This incision created a pouch for implantation, into which a 2cm diameter circular implant was inserted [Examples 1 to 7 and Comparative Examples 1 to 2]. The incision was then sutured. Biopsy tissue was collected and analyzed after 16 weeks.

[0069] Experimental Example 3. FACS Surface Protein Analysis

[0070] Cells collected in Experiment 1 were washed with PBS. The resulting cells were then placed in lysis buffer. The reaction was carried out at 4°C for 1 hour while vortexing the buffer, followed by centrifugation. The supernatant was then quantified using BCA solution. 50 μg of protein was electrophoresed on a 12% gel and transferred to nitrocellulose paper, which was then blocked with 10% skim milk for 1 hour. The paper was then treated with cytokines and antibodies against various transcription factors for 1 hour, followed by washing with PBS-tween. After treatment with secondary antibodies for 30 minutes and washing, data on tumor cells, ALK-, and CD30+ were obtained using an ECL solution kit. The results are shown in Table 3 below.

[0071] Table 3

[0072] Example 1 - - - Example 2 - - - Example 3 - - - Example 4 - - - Example 5 - - - Example 6 - - - Example 7 - - - Comparative Example 1 - - - Comparative Example 2 + + +

[0073] The results confirmed, as shown in Table 3, that tumor cells, ALK-, and CD30+, which are significant ALCL-related factors, were not detected in the breast implants according to Examples 1 to 7. Furthermore, these test results were significant compared to the breast implant according to Comparative Example 2.

[0074] Experimental Example 4. Gene Expression Analysis Using RT-PCR

[0075] After carefully cutting the biopsy tissue, easy-blue solution was added for homogenization, followed by the addition of chloroform and centrifugation. 400 μl of the supernatant was mixed with an equal volume of ethanol, centrifuged, and washed with 70% ethanol. After air drying, DEPC water was added, and cDNA was synthesized after RNA quantification. Then, primers and polymerases were added for amplification. To confirm mRNA expression, the amplification products were electrophoresed using agarose gel. The results regarding Ahr cell surface proteins were obtained. The results are shown in Table 4 below.

[0076] Table 4

[0077] Example 1 + Example 2 + Example 3 + Example 4 + Example 5 + Example 6 + Example 7 + Comparative Example 1 + Comparative Example 2 +++

[0078] The results confirmed that, as shown in Table 4, the expression of Ahr cell surface protein, which is an ALCL-related factor, was suppressed and ALCL-negative in the breast implants according to Examples 1 to 7. In contrast, the Ahr expression level in the breast implant according to Comparative Example 2 was ALCL-positive.

[0079] Experimental Example 5. Collagen density analysis using MT (Masson's Trichrome) staining

[0080] Collagen density was determined after MT staining according to the manufacturer's (Polysciences, Pennsylvania, USA) guidelines. The results are shown in Table 5 below.

[0081] Table 5

[0082]

[0083]

[0084] The results confirmed that, as shown in Table 5, the collagen density in the breast implants according to Examples 1 to 7 was at a level of 52% to 58%, while the collagen density in the breast implant according to Comparative Example 1 was significantly higher than that in the examples.

[0085] The above description of the present invention is exemplary, and it will be apparent to those skilled in the art that the invention can be modified into other specific forms without changing the technical concept or essential features of the invention. Therefore, the embodiments described above are exemplary in all respects and not restrictive.

[0086] Explanation of reference numerals in the attached figures

[0087] 100: Breast grafts

[0088] 110: Shell

[0089] 111: Ripple

[0090] 112: Surface roughness

[0091] 120: Filler

Claims

1. A breast implant comprising: The shell that forms the outer wall; And the filling material contained inside the housing, The outer surface of the shell has a convex-bent surface that contacts tissue, and... For the surface in question, the arithmetic mean waviness Wa value of the waviness curve filtered under the measurement condition of a cutoff value of 0.08 mm is 3.00 μm to 7.00 μm.

2. The breast implant according to claim 1, wherein, For the surface in question, the arithmetic mean waviness Wa value of the waviness curve filtered under the measurement condition of a cutoff value of 0.08 mm ranges from 3.07 to 7.00 μm.

3. The breast implant according to claim 2, wherein, The arithmetic mean waviness Wa value is a value in the range of 3.50 to 6.00 μm.

4. The breast implant according to claim 2, wherein, For the surface in question, the maximum height Wz value of the ripple curve filtered under the measurement condition of a cutoff value of 0.08 mm is equal to or greater than 19.16 μm.

5. The breast implant according to claim 4, wherein, The maximum height Wz value of the filtered ripple curve is in the range of 20.00 to 44.00 μm.

6. The breast implant according to claim 2, wherein, For the surface in question, the arithmetic mean roughness Ra value of the roughness curve filtered under the measurement condition of a cutoff value of 0.08 mm is equal to or greater than 1.00 μm.

7. The breast implant according to claim 6, wherein, The arithmetic mean roughness Ra value is in the range of 1.09 to 2.00 μm.

8. The breast implant according to claim 2, wherein, For the surface in question, the maximum height Rz value of the roughness curve filtered under the measurement condition of a cutoff value of 0.08 mm is equal to or greater than 5.84 μm.

9. The breast implant according to claim 8, wherein, The maximum height Rz value of the roughness curve of the filter is in the range of 5.84 to 10.29 μm.

10. The breast implant according to claim 1, wherein, For the surface in question, under the measurement condition of a cutoff value of 0.08 mm, the skewness Wsk value of the filtered waviness curve ranges from -0.48 to 0.41 μm, and the kurtosis Wku value of the filtered waviness curve ranges from 2.62 to 5.28 μm.

11. The breast implant according to claim 1, wherein, For the surface in question, under the measurement condition of a cutoff value of 0.08 mm, the skewness Rsk value of the filtered roughness curve ranges from -0.21 to 0.22 μm, and the kurtosis Rku value of the filtered roughness curve ranges from 2.72 to 3.86 μm.

12. The breast implant according to claim 1, wherein, The shell is made of silicon material.

13. The breast implant according to claim 1, wherein, The tissue is selected from any one or more of the group consisting of myofascia and mammary fascia.

14. The breast implant according to claim 13, wherein, The breast fascia is a thin fascia or supporting fibers.

15. The breast implant according to claim 14, wherein, The thin fascia is a transverse fibrous thin layer.

16. The breast implant according to claim 1, wherein, The breast implant inhibits breast implant-associated anaplastic large cell lymphoma.

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