Patent Publication Number: US-2013231743-A1

Title: Hybrid breast implant

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Application Ser. No. 61/671,992 filed Jul. 16, 2012, U.S. Provisional Application Ser. No. 61/602,300 filed Feb. 23, 2012, and U.S. Provisional Application Ser. No. 61,548,993 filed Oct. 19, 2011, the entire disclosure of each of which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     A breast implant is commonly used to correct shape or volume deformity of the breast due to breast removal following cancer or to correct size and asymmetry. Examples of breast implants available in the United States include silicone gel-filled implants and saline-filled implants. However, silicone gel-filled implants and saline-filled implants diverge from an ideal implant. 
     Relative to saline implants, silicone gel-filled implants can offer superior feel; however, silicone gel implants have a higher capsular contracture rate and should be removed if ruptured. Further, a  1992  United States Food and Drug Administration (FDA) moratorium on the use of silicone gel-filled implants negatively impacted the perception of their safety. Restraints on approval of silicone gel implant devices and alternative implant filling materials still exist. 
     Saline-filled implants (also referred to herein as saline implants) have been FDA approved and have an excellent safety record spanning  30  years. On the other hand, saline-filled implants may feel less natural than silicone gel implants, and surface rippling can be problematic. If a saline-filled implant leaks, the subject&#39;s body absorbs the saline, and the volume of the saline-filled implant decreases. The amount of saline leakage can be substantial, sometimes to the point of being substantially free of saline. In this circumstance, the empty or nearly empty shell can be removed and replaced. 
     Due to regulatory overview by the FDA, introducing a breast implant in the United States can be fraught with enormous expense of time and money due to compliance with FDA requirements, which can involve extensive clinical trials and reporting occurring over the course of years. Typically, review of previously unapproved materials in, for example, breast implants can be a leading factor in the regulatory approval delay for an implant. 
     Materials and implants that overcome the above issues would be well-received by those skilled in the art. 
     SUMMARY OF THE INVENTION 
     Disclosed herein is an implant comprising: a first container; and a plurality of members disposed in the first container. 
     Further disclosed herein is a process of making an implant, the process comprising: attaching a member to a second container; and inserting the second container in a first container. 
     Additionally disclosed is a method of using an implant, the method comprising: disposing the implant into a subject; and adjusting a volume of a fluid in the implant. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The following descriptions should not be considered limiting in any way. With reference to the accompanying drawings, like elements are numbered alike: 
         FIG. 1  is a cross-section of a breast implant having free-floating closed members; 
         FIG. 2  is a cross-section of a breast implant having free-floating open members; 
         FIG. 3  is a cross-section of a breast implant having open members attached to other members; 
         FIG. 4  is a cross-section of a breast implant having members attached to a container; 
         FIG. 5  is a cross-section of a breast implant having free-floating members interposed between an inner container and outer container; 
         FIG. 6  is a cross-section of a breast implant having members attached to an inner container; 
         FIG. 7  is a partial cross-section of a breast implant having members attached to other members; 
         FIG. 8  is a cross-section of a breast implant having members attached to an inner container and outer container; 
         FIG. 9  is a cross-section of a breast implant having an anatomical shape with an inner container disposed closer to an inferior portion of an outer container; 
         FIG. 10  is a cross-section of a breast implant having an anatomical shape with an inner container disposed closer to an inferior portion of an outer container; 
         FIG. 11  is a cross-section of a breast implant having semi-shell members attached in layers to an inner container; 
         FIGS. 12 and 13  are cross-sections of a breast implant having semi-shell members partially attached to an inner container; 
         FIG. 14  is a cross-section of a breast implant having free-floating open members after evacuation of air from the implant with an outer container and members collapsed; 
         FIG. 15  is a cross-section of a breast implant having free-floating closed members in response to introduction of a fluid; 
         FIG. 16  is a cross-section of a breast implant having open members attached to an inner container after evacuation of air from the inner container; 
         FIG. 17  is a cross-section of a breast implant having open members attached to an inner container showing introduction of a fluid into the inner container via a filling tube; 
         FIG. 18  is a cross-section of a breast implant having semi-shell members attached to an inner container with a filling tube and also having a seal disposed on an injection site of an outer container; 
         FIGS. 19 and 20  show cross-sections of an implant having members attached and in fluid communication with an inner container; 
         FIGS. 21 ,  22 , and  23  show cross-sections of the implant of  FIGS. 19 and 20  during various events associated with filling the implant with a fluid; 
         FIGS. 24 and 25  are cross-sections of a valve and needle for injection of a fluid into a breast implant; 
         FIG. 26  shows a cross-section of members disposed on an inner container of an implant; 
         FIG. 27  shows a cross-section of members disposed on an implant that has projections radially disposed on an inner container of the implant; 
         FIG. 28  shows a cross-section of an implant having a plurality of nested containers and members; 
         FIG. 29  is a cross-section of an implant showing optional containers disposed in an inner container; 
         FIG. 30  is a cross-section of a member having an injection patched attached thereto; 
         FIG. 31  shows a cross-section of an implant having members disposed in an inner container and interposed between the inner container and an outer container; 
         FIGS. 32 and 33  are cross-sections of implants with an inner container having projections; 
         FIG. 34  shows variations of a surface of an inner container; 
         FIGS. 35 through 39  show cross-sections of an implant with an outer container surroundingly disposed about nested inner containers arranged such that an inner container includes projections; 
         FIG. 40  is a cross-section of an implant with members disposed in an inner container and surrounded by a fluid inside an outer container; 
         FIG. 41  is a cross-section of an implant having nested inner containers with openings and projections and that are disposed in an outer container and having valves independently attached to that to the inner and outer containers; and 
         FIG. 42  is a cross-section of an implant having nested inner containers having a single valve attached thereto and also openings and projections that are disposed in an outer container such that all chambers are in fluid communication with each other. 
     
    
    
     DETAILED DESCRIPTION 
     A detailed description of one or more embodiments of the disclosed apparatus and method are presented herein by way of exemplification and not limitation with reference to the Figures. 
     Disclosed herein is an implant such as a breast implant or other tissue implant that uses biologically safe materials. Such materials have gained approval from the United States Food and Drug Administration (FDA) as of the date of this application. An implant constructed of these materials has a feel that emulates that of biological tissue. The inventor has discovered that a breast (or other tissue) implant herein that contains these biologically safe and compatible materials prevents surface rippling of the implant as well as obtains an effective fluid viscosity that mimics that of natural breast tissue. Further, the disclosed implant can be efficiently manufactured at a low relative cost. Moreover, the implants herein are volumetrically compressible. That is, the implant can be evacuated prior to implantation so that the implant can be implanted in a substantially fluid-free state or that partially contain a fluid (e.g., a liquid, solid, or gas). The compact size of the implant can thus eliminate pressure on a mastectomy incision and skin flaps. After implantation, the implant can be filled with a desired volume of fluid. Moreover, the implant can be adjusted to a suitable volume multiple times over the lifetime of the implant. 
     As shown in  FIG. 1 , in an embodiment, an implant  100  includes an outer container  101  and a member  102  disposed in the outer container  101 . Particularly, a plurality of members  102  can be disposed in the outer container  101 . The surface of the member  102  can be closed as shown in  FIG. 1 ; such a member  102  can be referred to as a closed member. Alternatively, the surface of the member  201  can be open as shown in  FIG. 2 ; such a member  201  can be referred to as an open member. In another embodiment, the implant  100  can contain a combination of a closed member  102  and an open member  201 . As will be discussed more fully below, an aperture  202  in the open member  201  allows a fluid to flow in or out of the open member  201  and can decrease motional perturbations of the implant  100 . Additionally, closed members  102  can also impede fluid flow. In this manner, the motion of the fluid in an implant herein behaves similar to natural, healthy breast tissue. The aperture  202  can allow fluid communication from the exterior of the member  201  to the interior of the member  201 . In some embodiments, the members  102  and  201  can be free-floating in the outer container  101 . As used herein, “free-floating” refers to a member unattached to a surface of a container (e.g., an outer container or inner container). According to an embodiment, the outer container  101  includes an opening  103 . The opening is sealed with a patch having a valve once the members have been disposed. The members  102  or  201  can be inserted inside the outer container  101  through the opening  103  or the outer container  101  can be formed around the members  101  or  201 . Unless otherwise specified or indicated, when “member” is used for the remainder of this document, “member” includes both open members  102  and closed members  201 . 
     The pressure of the closed members  102  can be different than the pressure of the outer container  101 . Consequently, depending on the wall thickness of the closed members  102  and the outer container  101 , the closed members  102  can have a higher compressibility than the outer container  101 . Alternatively, the outer container  101  can be more compressible than the closed members  102 . Thus, the closed members  102  can feel harder than the outer container  101 , or the outer container  101  can feel harder than the closed members  102 . As a result, the overall tactile feel and appearance of the implant herein can obtain the desired rigidity, projection, and surface morphology by selection of the relative pressure and compressibility of the closed members  101  and outer container  101 . 
     In certain embodiments, the members  102 ,  201  can be attached to various objects of the implant. In an embodiment, a member  301  is attached to another member  302  and disposed in the outer container  101  as in  FIG. 3 . Some of the members  301 ,  302  can be attached to each other to form a mass of attached members. In another embodiment, a member can be detached from any other member. In a further embodiment, a plurality of masses of attached members (i.e., multiple groups of masses that are not connected to one another) can be disposed in the outer container  101 .  FIG. 4  shows an embodiment where a member  401  is attached to the outer container  101  by an attachment  402 . In an additional embodiment, the members  401  can be attached to themselves and to the outer container  101 . 
     As shown in  FIG. 5 , an implant  500  includes an outer container  501  and an inner container  502  disposed in the outer container  501 . A member  503  can be interposed between the inner container  502  and the outer container  501 . A member  503  can be detached from other items or can be attached to another other item of the implant  500 . In an embodiment, a member  601  is attached to the inner container  502  ( FIG. 6 ). As shown in  FIG. 7 , a member  701  can be attached to another member  702  between the inner container  804  and the outer container  802 . In an embodiment, a member  801  can be attached to the outer container  802 , and a member  803  can be attached to the inner container  804 . According to yet another embodiment, a member can be attached to the outer container, the inner container, another member, or a combination comprising at least one of the foregoing. In an alternative embodiment, a member is unattached to (i.e., detached from) the outer container, the inner container, another member, or a combination comprising at least one of the foregoing. 
     In a further embodiment, a member can be disposed in the inner container either attached or detached to another item including the inner surface of the inner container. In addition, a member can be interposed between the outer container and the inner container, and a member can be disposed in the inner container. 
     As in  FIG. 9 , the implant can have an anatomical shape, for example, a shape of a human breast. To achieve the anatomical shape, the inner container  901  can be disposed proximate (i.e., in closer proximity) to the inferior portion of the outer container  902  than the superior portion of the outer container  902  as shown in the cross-sectional view from the ventral side of the implant  900  in  FIG. 9 . Moreover, the number of members  903  interposed between the outer container  902  and the inner container  901  can be greater in the superior portion of the outer container  902  than the inferior portion of the outer container  902 . In an embodiment, the inner container  901  can be disposed proximate to the anterior portion of the outer container  902  and further from the posterior portion of the outer container  902  as shown in  FIG. 10 , which is a cross-section along line A-A of the implant  900  in  FIG. 9 . Other positions of the inner container  901  within the outer container  902  are contemplated to produce a shape of the implant in an anatomical shape. The position of the inner container  901  can be determined by the number of the members  903  in a region between the inner container  901  and the outer container  902 . 
     The shape of a member can vary and can be any shape that provides an obstruction to abrupt fluid flow in the implant. In an embodiment, the cross-sectional shape of a member is circular, ellipsoidal, crescent, irregular, cubic, tetrahedral, conical, a truncated version thereof, or a combination thereof. According to an embodiment, the members are semi-shells. Semi-shells can have a portion of the surface missing from a closed member or open member, and semi-shells are not merely a member with an opening for fluid flow as an opening is described herein. Exemplary semi-shells include hemispheres and other partial ellipsoids including partial spheroids and partial spheres and can also be partial cubes and tetrahedral or other multi-sided structures as well as cylindrical and tubular shapes and the like. In a non-limiting embodiment, as shown in  FIG. 11 , an implant  1100  includes semi-shell member  1101  attached to an inner container  1103 . The semi-shell  1101  has a base that can be fully attached to the inner container as in  FIG. 11  or partially attached to the inner container  1103  as in  FIG. 12 , which shows a base  1202  of semi-shell  1201  partially detached from the inner container  1203 . With reference again to  FIG. 11 , a semi-shell member  1101  can be disposed in a first layer on the surface of the inner container  1103 , and another semi-shell member  1102  can be in a second layer that is disposed on the first layer. A semi-shell ( 1101  or  1102 ) can also have an opening  1105 . Although, openings (such as  1105  in  FIG. 11 ) are not shown in  FIG. 12 , members  1201  can include an opening. As shown in  FIG. 13 , the placement of the semi-shell members  1201  on the inner container  1203  can be any configuration that allows fluid to bafflingly flow in the outer container  1205 . The semi-shell members  1201  can be disposed so that the closed portions of the semi-shell members  1201  face one another or such that the closed portion faces an open portion of an adjacent semi-shell member  1201 . The distance between adjacent semi-shell members  1201  can be any distance. In an embodiment, semi-shell members  1201  can be spaced apart so that they do not contact one another when the implant is filled with a fluid. In another embodiment, semi-shell members  1201  can be spaced apart so that they contact one another when the implant is filled with a fluid. In a further embodiment, semi-shell members  1201  can be spaced apart so that adjacent semi-shell members can be nested such that a portion of their walls overlap.  FIG. 13  also shows a filling tube  1204  through which a fluid can be disposed in the inner container  1203 . A patch  1206  is disposed on and seals the outer container  1205 . The patch covers an aperture that is used to fill the outer container  1205  with a fluid. 
     The size of a member is about 1 millimeter (mm) to about 70 mm, specifically about 5 mm to about 60 mm, and more specifically about 10 mm to about 50 mm. As used herein, the “size of a member” refers to the greatest linear dimension of the member. According to an embodiment, different sizes of members are used inside the implant, or the size of the members are substantially the same. As used herein, “substantially the same” refers to a tolerance of 5%. When different sizes of members are used, the members may pack at a higher number density (relative to a uniform size of members being used) inside the implant with smaller members filling gaps between larger members. 
     In an embodiment, a member includes a wall and a void disposed within each member such that each member is hollow. In another embodiment, a member is a solid without a void. A member can contain pores disposed in the wall or solid portion thereof. The pores can be connected or detached from one another. In an embodiment, the member has open cell pores to communicate fluid through the pores. In some embodiments, the member has closed cell pores that can provide a spring-like restoring force if the member is compressed and then decompressed due to a fluid (liquid, gas, or solid) inside the closed pores. In a non-limiting embodiment, the member is an FDA-approved testicular implant. Such testicular implants have an outer elastomeric shell (e.g., silicone) and are filled with a fluid (e.g., saline). 
     The wall thickness of the member can be from about 228 micrometers (μm) (0.009 inches (in.)) to about 535 μm (0.021 in.), and specifically about 254 μm (0.010 in.) to about 457 μm (0.018 in.). In some embodiments, the wall thickness can be that of an FDA-approved testicular implant or saline-filled breast implant. Moreover, the wall thickness in a member can be different at different regions of the member. In an embodiment, the member can have an ellipsoidal shape with the wall thickness being thicker at the ends of the ellipsoid and thinner in the middle region of the ellipsoid or have any variation of wall thickness throughout the member. 
     According to an embodiment, the member has an opening. The opening can be any shape (e.g., round, ellipsoidal, polygonal, and the like) and any size to allow fluid to pass into or out of the member from a container within which it is disposed (e.g., an outer container or inner container in an embodiment where the member is respectively disposed in the outer or inner container). The opening can have a size from about 0.01 mm (e.g., a substantially linear slit in the member) to about 10 mm, and specifically about 0.01 mm to about 4 mm. Here, “size” refers to the largest linear dimension of the opening, which can be any shape, e.g., circular, ellipsoidal, polygonal. The member can have more than one opening. Exemplary members have one opening, two openings, and the like. An upper limit to the number of openings is not limited as long as the member remains operable to baffle fluid flow in the implant. In an embodiment, the number of openings is less than 1000, specifically less than 50, and more specifically less than 10. In another embodiment, a member is closed and free of an opening that allows fluid communication from the exterior of the member to the interior of the member. Instead of having fluid communicate through the closed member, the closed member can be solid or have a void. The void in the closed member can be filled with a fluid, for example, saline, silicone gel, or other fluids described herein and those known in the art. In another embodiment, an implant includes an open member, a closed member, or a combination comprising at least one of the foregoing. 
     As discussed above, a member can be attached to the outer container, inner container, another member, or a combination comprising at least one of the foregoing. The attachment can be an adhesive (e.g., a biocompatible adhesive such as silicone glue), a physical attachment (such as a polymeric tether, suture, clip, and the like), or a combination comprising at least one of the foregoing. Additionally, instead of individual members being attached to each other or the inner or outer container, the member can be manufactured as a single aggregate of members, or the inner or outer container having members attached thereto can be manufactured as a single item. In an embodiment, members attached to one another can be attached in various geometric patterns. In particular, a plurality of members can be connected in a honeycomb shape. The honeycomb of members can be attached to, for example, the inner container. 
     The members can be attached to the entire exterior surface of the inner container. In some embodiments, a portion of the surface of the inner container can be exposed and not attached to a member. Likewise, either a portion or the entire interior surface of the outer container can be attached to a member. 
     The number of members inside the outer container can be from one up to as many members as the volume of the outer container can hold without rupturing or adversely affecting the structural integrity of the outer container. For example, for a 300 cubic centimeter (cc) (300 milliliter (mL)) outer container, one to about 30 closed members each having a volume of about 10 cc (10 mL) can be disposed in the outer container. In an embodiment, the number of open members disposed in the outer shell can be greater than or equal to the number of closed members due to the ability of the open members to be compressed. In an embodiment, the outer container is flexible (as described below) and expandable such that the volume of the members disposed in the outer container is about 1 volume percent (vol %) to about 120 vol %, specifically about 25 vol % to about 110 vol %, more specifically about 50 vol % to about 90 vol %, based on the nascent volume of the outer container. As used herein, “nascent volume” refers to the volume of an object before stretching of the object occurs. 
     Although various figures herein show one inner container, the number of inner containers is not so limited. Moreover, multiple inner containers can be disposed in the outer container. In an embodiment, an inner container can be disposed in another inner container, to create nested inner containers. According to another embodiment, an outer container can include nested inner containers, a further inner container disposed external to the nested inner containers, and a member. 
     In a non-limiting embodiment, the member is flexible so that the shape of the member under compression can change to accommodate forces exerted on the member or the outer container of the implant. Alternatively, the member can be relatively rigid so that the member provides structural integrity and support to the shape of the implant. 
     According to an embodiment, the outer container, inner container, and the member are a same or different material, and each can be a medical grade elastomer so that the outer container, inner container, and member are flexible, resilient, and biocompatible. Exemplary material for the outer container, inner container, and member include silicone or other relatively inert or biocompatible materials for soft tissue replacement, particularly vascular grafts, breast implants, or testicular implants. Additionally, the outer container, inner container, and member can be an elastomer such as polyisobutylene-based thermoplastic elastomer, poly(ethylene terephthalate) (PET), poly(tetrafluoroethylene) (PTFE), polypropylene (PP), polyurethane (PU), or a combination comprising at least one of the foregoing. Further, the elastomer can be a thermoplastic elastomeric biomaterial, for example, polystyrene-b-polyisobutlyene-b-polystyrene (SIBS). In another embodiment, the outer container is an FDA approved saline breast implant. In yet another embodiment, the outer container is an FDA approved saline implant modified with the features as described herein, for example, having an opening for disposal of a member therein. 
     In an embodiment, a member is disposed in the outer container as a closed member. A member has a wall and an internal void. According to an embodiment, a fluid can be disposed in a closed member. This fluid can be introduced into the member through a perforation in the wall. A patch can seal the perforation on the surface of the member. According to an embodiment, the fluid is introduced into the member by inserting a filling tube or syringe needle into the wall, creating a perforation. In a member having an opening, the fluid can be disposed in the member via the opening, and the opening sealed such that flow does not flow from the interior to the exterior of the member. Alternatively, the member can be made with a perforation or a valve for disposing the fluid. The patch adheres to the surface of the member by an adhesive such as a silicone-based glue or other biocompatible sealant. The patch can be the same or different material as the member. Moreover, the pressure inside the member can vary depending on the amount of fluid disposed in the member. As a result the volume of fluid disposed in the member and the wall thickness, the flexibility and compressibility of the member are variable and can be selected based on the desired fluid properties and aesthetic preferences for the implant. 
     The outer container or inner container can include a valve (for filling such a container with a fluid) such as a valve that allows reversible insertion of a tube (e.g., a filling tube). The tube can extend from inside the container (inner or outer container) to outside the outer container. The end of the tube disposed in the container can be, for example, straight or tapered. The end of the tube external to the implant can have an injection port for introducing a fluid that flows through the tube into the outer or inner container. An exemplary valve includes those that are used in adjustable breast implants sold under the trade name Spectrum Implant and Becker 50-50 Implant available from Mentor Corp. In an embodiment of the implant having such a valve, the implant can be filled post-implantation at least up to one year before removal of the filling tube. After the filling tube is removed, the implant is sealed by the valve. 
     The filling tube can be made of metal, non-metal, or a combination thereof, such as stainless steel or plastic. In an embodiment the filling tube has a blunt end so that the member or inner container is not damaged by the filling tube. Damage to the member or inner container can cause, for example, leakage or shape deformation. Alternatively, a blunt syringe needle can be used to introduce a fluid into the implant with due care so that the member or inner container is not damaged. 
     In a method of preparing an implant, an outer container can be provided. The outer container can be formed to have a valve, filling tube, opening for disposal of a member or inner container, or a combination comprising at least one of the foregoing. According to an embodiment, an inner container can be provided and formed to have a valve, filling tube, or a combination comprising at least one of the foregoing. 
     In an embodiment, a process of making an implant includes disposing an elastomer on a mandrel. For example, the mandrel can be dipped in a liquid elastomer or a liquid elastomer can be coated on the mandrel. The elastomer is cured and removed from the mandrel to produce a member. The mandrel can include protrusions that are not coated by the elastomer so that the cured elastomer has holes due to the protrusions. As an alternative, the member can be cut to produce the openings in the member. In a further embodiment, the member is produced by extruding an elastomer using an appropriate die, or the member can be formed in a mold to produce solid or hollow members. 
     A member can be attached to another member via an adhesive and inserted into the outer container through the opening in the outer container. In another embodiment, a member can be attached to an inner container, which is inserted into the outer container. In yet another embodiment, a member can be inserted into the outer container and attached thereto. In a further embodiment, a member is a semi-shell, and the base of the member is attached to the inner container or the outer container either partially or completely. After disposal of the member or the inner container in the outer container, the opening of the outer container can be sealed, for example, with a patch. 
     In an embodiment, an inner container having a filling tube is disposed in the outer container and the filling tube is disposed through a valve that is disposed in the outer container so that the filling tube extends from the internal portion of the inner container, through the outer container, and external to the outer container for fluid communication with the inner container. 
     According to an embodiment, the implant is useful as a breast implant, including implantation as a tissue expander or for augmentation. A method of using the implant includes disposing the implant into a subject, and adjusting a volume of a fluid in the implant. The implant can include an outer container; an inner container disposed in the outer container; a member attached to the inner container; and a tube removably disposed in the inner container and extending from the inner container, through the outer container, and terminating outside of the body of the subject. Adjusting the volume comprises transmitting fluid, through the tube, among the inner container and a source external to the subject. After achieving a selected volume of the implant, the tube can be removed. 
     As shown in  FIG. 14 , to insert the implant  1300  into the subject, the implant  1300  having an outer container  1301 , members  1302 , and a filling tube  1303  can be evacuated through the filling tube  1303  to compress the outer container  1301  and members  1302 . Such compression creates a smaller volume of the implant  1300  to insert into the subject so that a smaller incision can be made to accommodate insertion of the implant  1300 . Similarly, for an implant having an inner container, the inner container  1501  can be evacuated through a filling tube  1502 , which extends from inside the inner container  1501  to outside the outer container  1503  as in  FIG. 16 . 
     The outer container, inner container, and member are flexible and elastic such that they can withstand compression and can be initially configured in an original shape. Upon compression, they obtain an intermediate shape in response to a compressive force. When the compressive force is released or through introduction of a fluid, they obtain a terminal shape in response to removal of the compressive force. The compressive force is, for example, due to evacuation such that the pressure inside the implant is below ambient pressure. The terminal shape can be that of or similar to the original shape. In an embodiment, upon removal of the compressive force, the members provide a restoring force to the implant so that the implant expands toward the terminal shape. 
     The size of the implant is adjusted by introducing a fluid (e.g., saline) into the implant. In the implant shown in  FIG. 14 , a fluid is disposed in the outer container  1301  through a filling tube  1303  that also can be attached to an injection port (not shown) for later adjustment of the fluid. That is, in an embodiment, as shown in  FIG. 15 , the implant  1400  includes an outer container  1401  and members  1402 . An opening in the outer container  1401  through which members  1402  are inserted into the outer container  1401  is sealed with a patch  1403 . A filling device, for example a syringe needle  1404 , can be inserted through the patch  1403  to dispose fluid in the implant  1400 . After fluid has been disposed in the outer container  1401 , the syringe needle  1404  can be removed, and a patch (not shown) can be disposed over the injection site to seal the outer container  1401 . 
     With reference to  FIG. 17 , an implant  1600  having open members  1601  attached to an inner container  1602  disposed in an outer container  1603  is evacuated ( FIG. 16 ) and then implanted into a subject. The outer container  1603  is filled with a fluid (not shown). A filling tube  1604  extends from inside the inner container  1602 , through the outer container  1603 , and outside the body of the subject. The filling tube  1604  has a detachable plug  1605  connected to the end disposed in the inner container  1602  and an injection port  1606  at the end of the filling tube  1604  external to the subject&#39;s body. A hole  1607  near the detachable plug  1605  allows fluid communication through the filling tube  1604  among the inner container  1602  and the injection port  1606 . A filling device  1608  can connect to the injection port  1606  for fluid sourcing and exchange with the implant. The filling device  1608  can be manual or automated. The filling tube  1604  traverses a primary valve  1609  disposed on the outer container and a secondary valve  1610  disposed on the inner container  1602 . Fluid is introduced into the inner container  1602  to adjust the implant  1600  to a desired volume, and the filling tube  1604  is removed from the implant  1600 . Removal of the filling tube  1604  can be achieved by pulling on the filling tube  1604  with an amount of force effective to seat the detachable plug  1605  in the secondary valve  1610  and to detach the plug  1605  from the filling tube  1604 . The filling tube  1604  is pulled from the outer container  1603  through the primary valve  1609 . In this way, the primary valve  1609  seals the implant  1600 , and the secondary valve  1610  seals the inner container  1602 . 
     In an embodiment, the members are open members. When the outer container is filled with the fluid, the volume of the outer container increases from the compressed state. Likewise, the member (due to its opening) fills with the fluid that is introduced into the outer container. In this way, the member reverts to its pre-compressed, original shape or size or a substantially similar shape or size. 
     In another embodiment, as shown in  FIG. 18 , an implant  1700  is inserted into a subject and includes an outer container  1701 , an inner container  1702  disposed in the outer container  1701 , a first layer of semi-shell members  1703  disposed on the inner container  1702  and having openings  1704  for fluid transmission, and a second layer of semi-shell members  1705  disposed on the first layer of semi-shell members  1703 . The inner container  1702  and members ( 1703 ,  1705 ) are inserted into the outer container  1701  through an opening  1708  that is then sealed with, for example, a patch  1707 . A filling tube is inserted into an aperture  1708  in the patch  1707 , and the outer container  1701  and members ( 1703 ,  1705 ) are filled with a fluid. Thereafter, the filling tube is removed from the outer container  1701  and the aperture  1708 , and the aperture  1708  is sealed with a seal  1709  (e.g., a patch or plug). A duct  1710  interconnects the outer container  1701  and the inner container  1702 , and a filling tube  1711  traverses the duct  1710 . The filling tube  1711  extends from inside the inner container  1702  to the outside of the outer container  1701  to be disposed outside the subject&#39;s body. The filling tube  1711  includes a detachable plug  1712  that is disposed in the inner container  1702  to seal the inner container  1702  in response to removal of the filling tube  1711  from the implant  1700 . Thus, the filling tube  1711  is removably disposed in the duct  1710 . A valve  1713  seals the inner container  1702  in response to the detachable plug  1712  being seated in the valve  1713  when the filling tube  1711  is removed. 
     In an exemplary embodiment, as shown in  FIGS. 19 and 20 , an implant  1800  includes an inner container  1802  disposed in an outer container  1804 . A member  1806  is disposed and attached to the inner container  1802 . The inner shell  1802  and member  1806  can be molded as a single item or can be made separately with the members  1806  being attached to the inner shell  1802  in a separate process. Fluid channels  1808  connect the member  1806  to the inner container  1802  so that fluid can flow therebetween. The member  1806  can have various shapes as described herein for members. A filling tube  1810  is disposed in the inner container  1802  and extends through and beyond the outer container  1804 . A duct  1812  can optionally be disposed between the inner container  1802  and the outer container  1804  through which the filling tube  1810  can extend to connect the inner container  1802  to a fluid source (not shown). A patch  1814  is disposed on the surface of the outer container  1804  to seal the outer container  1804 . 
     As shown in  FIG. 20 , the implant  1800  can collapse in response to evacuation of its contents, including air or a liquid, for example. The members  1806 , inner container  1802 , and outer container  1804  are flexible so that evacuation of, for example, the inner container  1802  through the fill tube  1810  causes the implant  1800  to collapse. Such collapse is advantageous in the insertion of the implant  1800  in a patient. 
     In an embodiment illustrated in  FIGS. 21 ,  22 , and  23 , prior to insertion in a subject (e.g., a breast surgery patient), an outer container  1904  of an implant  1900  is filled (e.g., fully or partially filled) with a fluid  1902  (e.g., saline) via a syringe  1908  (or other implement configured to dispose a fluid in the outer container ( 1904 ). An inner container  1906  has a filling tube  1910  disposed therein to dispose fluid or evacuate the inner container  1906 . Upon insertion of the implant  1900  into the subject, the inner container  1906  is filled with a fluid  1912  via filling tube  1910  ( FIG. 19B ). The amount of the fluid  1912  can be less than the volumetric capacity of the inner container  1906  so that in a subsequent procedure (which can occur several months or years after the initial implantation of the implant  1900 ) the implant  1900  can be expanded to a larger volume by addition of additional fluid  1912  injected via syringe  1914  into port  1916  of filling tube  1910 . Similarly, the volume of the implant  1900  can be reduced by extraction of some of the fluid  1912  in the inner container  1906  via filling tube  1910 . After final adjustment of the size of the implant, the filling tube  1910  can be removed from the implant  1900 . 
     According to another embodiment, an implant is inserted into a subject and has a primary tube removably disposed in the outer container to transmit fluid to or from the outer container. Members are disposed in the outer container, and the implant also has a primary valve disposed on the outer container to seal the outer container in response to removal of the primary tube. A secondary tube is removably disposed in the outer container and the inner container to transmit fluid among the inner container and the same or another fluid source disposed external to the outer container. A secondary valve is disposed on the outer container to seal the outer container in response to removal of the secondary tube, and a tertiary valve is disposed on the inner container to seal the inner container in response to removal of the secondary tube. Using the primary and secondary tubes, the volume of the outer container, members, and inner containers can be adjusted with addition or removal of a fluid to a desired volume. 
     As shown in  FIG. 24 , a breast implant can have a self-sealing valve  58  that includes a sealing aperture  54  and a tube  52  through which filling tube  60  can be inserted (instead of, e.g., an injection site patch  1814  as in  FIG. 19 ). The self-sealing valve  58  can be part of an outer container patch or can be part of the outer container of the implant. 
     Beyond the self-sealing valve  58 , other valves can be used with the implant. Examples of such valves include a check valve, duckbill valve, diaphragm valve with an external or internal plug, reed valve, leaf valve, cross slit valve, or the like. The valve prevents the fluid from exiting the implant. The valve can be integrally formed with an outer or inner container during a manufacturing process. 
     The outer container provides a shield against loss of the fluid into a patient after implantation of the implant. Further, if fluid leaks from the outer container, the loss of volume of fluid would be finitely inconsequential. Without being bound by theory, for an embodiment in which the fluid contains a small amount of silicone gel, none or substantially none of the silicone gel would leak from the implant herein since the silicone gel attaches to the internal surface of the outer container and the external surface of the members or an inner container. 
     The fluid used to fill the inner container, outer container, and member is non-corrosive and is compatible with the materials of construction herein as well as biological tissue or biological fluids. The fluid can have different hydrophobic or hydrophilic properties from those of the inner container, outer container, and member. The volume of the fluid inside the outer container of the implant is about 1% to about 120%, specifically about 5% to about 80%, more specifically about 5% to about 30% of the nascent volume of the outer container. Moreover, the volume of the fluid contained within the outer container enhances mobility of the members and inner container disposed in the outer container while dampening motional disturbances of the fluid due to, e.g., a movement or impact of the outer container when implanted into a subject. The volume of the fluid in the outer container is about 5 cc to about 500 cc, specifically about 5 cc to about 200 cc, and more specifically about 5 cc to about 150 cc. In an embodiment, the volume of the fluid is determined based on the volume of the outer container, volume of the members and inner container, and consideration of aesthetic parameters. The volume of the fluid introduced into the implant is selected by such factors as reduction of rippling of the breast implant or optimization of the shape of the breast implant as well as volume adjustment to correct asymmetry so that both breasts after implantation appear to be of the same size, either during insertion or post-operatively such as by a detachable injection port attached at an end of a filing tube that is external to the subject&#39;s body. 
     By selection of the ratio of the volume of the members and the inner container to that of the fluid in the outer container, the effective viscosity of total medium (the member, inner container, and fluid) can be controlled and varied to form a breast implant that exhibits a highly realistic, aesthetically pleasing appearance. The volumetric amount of the members and the inner container in the fluid is about 10 vol % to about 95 vol %, specifically about 20 vol % to about 90 vol %, and more specifically about 40 vol % to about 80 vol %, based on the total volume of the members, inner container, and fluid. 
     The fluid is biocompatible and can be bio-absorbable. The fluid used in the outer container, inner container, and member can be the same or different. Exemplary fluids include saline, silicone, polyvinyl pyrrolidone hyaluronic acid, polyacrylamides, polysaccharides, dextran, hydrogel (e.g., methylcellulose hydrogel), povidone, triglycerides, cellulose, derivatives of the foregoing, or a combination comprising at least one of the foregoing. 
     In certain embodiments, an implant  2000 , as in  FIG. 26 , can have various members disposed in an outer container  2002 . The implant optionally can include an inner container  2018 . Exemplary members include a member  2004  with no opening (e.g., a testicular implant pre-filled with a fluid or a solid, elastomeric member); a member  2006  having an opening  2008  disposed on its surface for fluid communication with the outer container  2002 ; a semi-shell member ( 2010 ,  2012 ,  2014 , wherein some of the semi-shell members open towards each other as in  2010 ; some of the open shell members abut one another as in semi-shell members  2012 ; some of the open shell members point in a same direction as in semi-shell members  2014 ); a member  2016  in fluid communication with the inner container  2018 , and the like. Combination of the members ( 2004 ,  2006 ,  2008 ,  2010 ,  2012 ,  2014 ,  2016 ) can be used together. Additionally, a valve  2020  can be disposed on the inner container  2018  and outer container  2002  to admit fluid and to seal each container. 
     With reference to  FIG. 27 , in an additional embodiment, the implant  2000  includes projections  2022 . The projections  2022  can be finger-like in that they are radially disposed on the surface of the inner container  2018 . The projections  2022  can have a length of about 2 mm to about 25 mm, and specifically about 2 mm to about 20 mm. The transverse cross-sectional shape of the projections  2022  can be any shape including circular, polygonal, oval, star, and the like. The largest linear dimension in the transverse cross-section can be about 2 mm to about 15 mm, and specifically about 2 mm to about 10 mm. Furthermore, the projections  2022  can have a hollow space (continuous with the interior of the inner container  2018 ), can be solid without such a space, or a combination thereof. The projections  2022  and the inner container  2018  can be molded in a single piece or can be made separately with the projections  2022  being later attached to the inner container  2018 . Alternatively, during manufacture of the inner container, the projections  2022  can be made by placing the inner container  2018  in a mold having a plurality of through holes disposed in the mold surface and pressurizing the inner container  2018  with a gas in order to expand portions of the inner container  2018  through the holes in the mold, producing the projections  2022 . In an embodiment, the projections  2022  can be softer and more elastic than the inner container  2018  so that the projections have a floppy effect in a fluid inside the outer container  2002 . In one embodiment, an exterior surface (e.g., a tip) of a projection  2022  is attached to the interior surface of the outer container  2002 . 
     Referring to  FIG. 28 , according to yet another embodiment, an implant  2100  includes nested containers such as outer container  2102 , inner container  2104 , and intermediate container  2106 . Although three nested containers ( 2102 ,  2104 , and  2106 ) are indicated, the number of nested containers is not limited thereto. Furthermore, the inner container  2104  or the intermediate container  2106  can have an opening  2108  (an aperture, perforation, slit, and the like) disposed therethrough to allow fluid communication between the container ( 2106  as shown in  FIG. 21 ) and a surrounding container ( 2102  as show in  FIG. 21 ). In an embodiment, a member  2110  can be disposed between any two containers ( 2102 ,  2104 , and  2106 ) or the interior of the inner container  2104 . 
     As previously mentioned, the implant can have members disposed in an inner container.  FIG. 29  shows a breast implant  105  with an inner container  104  that contains a member  107 . Members  107  can have pores  108  for flow of fluid  110  inside the inner container  103 . Alternatively, the member can be closed without permitting communication of fluid between the interior and exterior of the member  108 . Such closed members can contain fluid or can be solid. 
     Also as previously indicated, a member can be made of various materials and have various shapes. As shown in  FIG. 30 , a member  310  (e.g., a testicular implant) has a shell  312  (e.g., a shell with a hollow internal space) and contains a sub-fluid  314 . The sub-fluid  314  is introduced into the member  310  through a perforation in the shell  312 . A patch  316  seals the perforation on the surface of the shell  312 . According to an embodiment, the sub-fluid  314  is introduced into the member  310  by inserting a filling tube or syringe needle into the shell  312 , creating a perforation, or the shell  312  is made with an opening or a valve for sub-fluid introduction. The patch  316  adheres to the surface of the shell  312  with an adhesive such as a silicone-based glue or other biocompatible sealant as above. The patch  316  can be the same or different material as the shell  312  of the member  310 . Moreover, the pressure inside the member  310  can vary depending on the amount of sub-fluid  314  introduced. As a result, the flexibility and compressibility of the member  310  is variable. 
     In another embodiment, the member is a solid body without a hollow internal space. 
     The number of members inside a container of the implant herein can vary from one up to as many members as the volume of a container can hold without rupturing or adversely affecting the structural integrity of the container (e.g., an inner, intermediate, or outer container). Since the container herein is flexible and expandable, the volume of the members inside the container can be about 1% to about 120%, specifically about 25% to about 110%, more specifically about 50% to about 90% of the volume of the container before any expansion of the container beyond it nascent volume. 
     The shape of the members can vary. In an embodiment, the cross-sectional shape of the members is circular, ellipsoidal, crescent, irregular, or a combination thereof. The shell of the member is flexible so that its shape under compression can change to accommodate forces exerted on the container of a breast implant. Alternatively, the shell is rigid so that the members provide further structural integrity and support to the shape of the breast implant. 
     In some embodiments, the inner and outer containers of an implant independently can contain members. In a non-limiting embodiment, as shown in  FIG. 31 , an implant  2200  includes an inner container  2202  disposed in an outer container  2204 , a filling tube  2206  traversing the outer container  2204  and disposed in the inner container  2202 , members  2208  interposed between the outer container  2204  and the inner container  2202 , and members  2210  having openings  2212  disposed in the inner container  2202 . It is contemplated that any type of member described herein can be used in either of the inner  2202  or outer  2204  containers. 
       FIG. 32  shows a breast implant  320  with an inner container  322  and outer container  324 . The inner container  322  has projections  326  protruding from a surface thereof. Projections  326  can be made separately from (and subsequently attached to) the inner container  322 , or the inner container  322  can be made integrally with the projections  326  as a single item. The breast implant  320  also has a filling tube  328  to fill a space  330  of the inner container  322 . The inner  322  and outer  324  containers can have a different pressure from each other such that a pressure differential exists at the surface of the inner container  322  that separates the space  330  from an interstitial space  332  between the inner container  322  and outer container  324 . A patch  334  is disposed on an external surface of the outer container  324  to cover and seal a perforation, which allows transfer of fluid or members into the outer container  324 . The breast implant  320  can contain a fluid, and different fluids can be disposed in the inner  322  and outer  324  containers. As depicted in  FIG. 33 , the breast implant  320  can have the interstitial space  332  filled with, e.g., a gel  336  while the space  330  is filled with a different fluid, e.g., saline. The different fluids in the space  330  and interstitial space  332  can contribute to a more natural feel and also contribute to moderation of fluid motion in the breast implant  320 . Again, the pressure and volume can differ between the inner  322  and outer  324  containers to satisfy a patient&#39;s needs. 
     As previously described, the surface of an inner container can have various surface contours (e.g., projections) or members attached thereto.  FIG. 34  shows possible variations of a surface of a container. A surface of the container  340  can be substantially smooth over a portion of the surface or be smooth in a portion with a distribution of projections or members over some portion of the surface. The surface of a container  342  can have projections  350  that have a base  352  that is the largest size of the projection. A container  344  can have projections  354  that have a base  356  that is smaller than a larger portion  358  of the projection  354 . Members  360  (open or closed) can be attached to the container  346 . Additionally, semi-shell members  362  can be attached to the container  348 . These surfaces can have an opening to communicate fluid therethrough or can be a continuous surface without an opening. Any combination of the foregoing surface features can be used. 
     The implant can have nested inner containers as, e.g., in  FIGS. 35 through 40 ,  42 , and  43 . In a particular embodiment shown in  FIG. 35 , the implant  150  has an outer container  152 , inner container  154  (also referred to as an intermediate container) with projections  156 , and inner container  158  that is substantially smooth. The intermediate container  154  is interposed between the outer container  152  and inner container  154 . Further, the inner container  158  is equipped with a filling tube  160  for disposal of fluid therein independent of fluid volume in spaces  162 ,  164 . Fluid can flow between intermediate container  154  and outer container  152  through an opening  166  in intermediate container  154 . In an embodiment, an implant  150  can have several intermediate containers  170  that have openings  174  distributed on the intermediate containers  170 ,  172 . A patch  176  attached to the outer container  152  can seal an opening therein that is used for provision of a fluid into the outer container  152 . 
     In an embodiment as shown in  FIG. 37 , the implant  180  has an intermediate container  186  interposed between an inner container  182  and an outer container  184 . The intermediate container has openings  188  and members  190 , which are disposed in the in the intermediate container. A member  190  can have an opening  192 . The opening  192  in the member  190  can open to a space  194  external to the intermediate container  186  or to a space  196  internal to the intermediate container  186 . Thus, fluid can communicate into the member  190 . For a member that has openings  192  that connect the internal space  198  of the member  192  to the spaces  194  and  196 , fluid can communicate between space  194  and  196  via internal space  198  of member  190 . As a result, fluid flow in the implant  180  is baffled to a great extent such that the implant  180  achieves a more realistic feel and appearance of natural biological tissue when implanted into a subject. As in the embodiment shown in  FIG. 38 , the implant  180  is similar to that shown in  FIG. 37 . Here, two intermediate containers  210 ,  212  are interposed between inner  182  and outer  184  containers. Intermediate containers  210 ,  212  have projections  214 ,  216  that project from one another in opposing radial directions. In addition, the intermediate containers  210 ,  212  are displaced from one another by distance D. It is contemplated that the distance D can be any value, e.g., from 0.1 mm to 50 mm, without limitation. The spaces  218 ,  220 ,  222 ,  224  can be independently filled to attain distinct volumes of fluid. In an embodiment, the space  222  can be filled via an opening (not shown) that is subsequently sealed with a patch  226 . Thus, the spaces  218  through  224  can be different volumes of fluid, different fluids, and attain different pressures as selected.  FIG. 39  (and its corresponding inset) indicates that intermediate containers  230 ,  232  can be attached to one another at connector  234 . The connector  234  can be of the same material as the inner  182  or outer  184  container or can be a different material. Further, the connector  234  can be springy or rigid such that the intermediate containers  230 ,  232  are maintained from each other at some distance, which can, but does not have to, vary along the circumferential direction of the intermediate container  230 . The connector  234  can be a partition between a space  240  (among intermediate containers  230 ,  232 ) and opening  242 . Opening  242  communicates and buffers fluid flow between spaces  244  that occur between containers  182 ,  184 ,  230 ,  232 . Further, projections  248 ,  250  can be disposed on the surfaces of intermediate containers  230 ,  232 . It should be noted that opening  242  baffles while maintaining fluid flow radially among spaces  244  while projections  248 ,  250  can baffle non-radial, angular flow of fluid within spaces  244  such that abrupt motion or “sloshing” of the fluid in the implant  180  is decreased. 
     As shown in  FIG. 40 , an implant  260  includes an outer container  262  and an inner container  264 , which may be free-floating or not. The inner container  264  includes projections  266  from a surface thereof. The projections  266  can be formed as a structural feature of the inner container  264  such that a nascent shape of the inner container has the projections  266 . Alternatively, the projections can be a result of force applied on the inner container by a fluid in the inner container  264  or by conforming around members  268  disposed in the inner container  264 . A member  268  can be closed or open. An open member can have an opening  270  to communicate fluid between an internal space  272  of the member  268  and the inner container  264 . The members  268  can be attached to one another or to the inner surface of the inner container  264 . The implant  260  can contain different fluids in the outer container  262 , inner container  264 , and members  268  (in the case of closed members). In an embodiment, a space  274  between the outer container  262  and the inner container  264  can be filled with, but not limited to, gel, while the inner container  264  and members  268  can be filled with, e.g., saline. Filling tube  276  traverses the outer container  262  and terminates in inner container  264  for filling or removing fluid in the inner container  264  or members  268 . 
     With reference to  FIG. 41 , an implant  280  includes an outer container  282 , a free-floating inner container  284 , and nested intermediate containers  286 . The inner container  284  can be free floating and contain members  288  disposed therein as well as projections  294  on its surface. A combination of closed or open member  288  can be attached to one another or to the inner surface of the inner container  284 , or the members  288  can be free-floating. Openings  290  in the intermediate containers or inner container  284  communicate a fluid between spaces  292 . The nested intermediated containers can be concentric or may be disposed asymmetrically with respect to one another or the inner  284  or outer container  282 .  FIG. 42  shows an implant  296 , similar to the implant  280  in  FIG. 41 . Implant  296  includes an inner container having opening  298  therein for fluid communication among members  288 , and spaces  292 . 
     The implant herein closely approximates natural, healthy breast tissue, particularly with respect to the hydrodynamic properties of the implant filled with a fluid. According to Pascal&#39;s law a change in pressure applied to an enclosed fluid is transmitted undiminished to every point of the fluid and the walls of a containing vessel. R. A. Serway,  Physics,  413 (Saunders 1990). To decrease the transmission of the pressure change through the fluid to the walls of the implant, a member can be disposed along the fluid communication path in the implant to obstruct the transmission of the motion and absorb energy from the travelling wave. Thus, the amplitude of the disturbance at a wall of the implant diminishes through the implant due to the baffling effect of the members. Moreover, for the implants herein with an elastic wall (e.g., the outer or inner container, which can flex, bend, or otherwise deform under a pressure change), the amount of disturbance at the elastic wall and corresponding displacement of the elastic wall decreases due to inclusion of such a baffling member in the fluid communication pathway. Consequently, the implant herein occasions an effective fluid viscosity that well-approximates that of natural, healthy breast tissue. In addition, the inclusion of, for example, the semi-shell members attached to an inner container advantageously affect the fluid motion of the breast implant and aesthetic presentation of the implant. 
     Moreover, the implants use biologically safe materials. Such materials have gained approval from the United States Food and Drug Administration (FDA), and the implant constructed of these materials has a feel that emulates that of biological tissue. Surface rippling is diminished or eliminated in the implants herein. Further, the disclosed implant can be efficiently manufactured and at a low relative cost. 
     Since FDA approved materials can be used in the construction of the implants herein, the need or length for further regulatory approval studies may be greatly reduced. In addition to the saline-filled members and inner container, no additional filling material is introduced for the breast implant although the embodiments are not limited thereto. Saline as well as other lubricants can be added between the outer container and the members and inner container. Consequently, the disclosed breast implant has enhanced safety factors. Moreover, a filler such as a coil, tube, or rod of elastic polymer material (e.g., polystyrene, silicone, polyurethane, polyimide, and the like) also can be disposed with the members or inner container in the outer container for further baffling or shaping purposes of the implant. 
     Breast implants of conventional filling materials (saline and silicone gel) can have a limited lifetime. An end of life of such implants can result from rupture of the outer shell of the implant. Rupture of a saline implant can result in nearly total deflation of the implant, i.e., near complete loss of the saline. Rupture of the silicone gel implant can result in migration of the silicone gel out of the shell, which can result in encasement of the silicone gel by the subject&#39;s body, e.g., so-called capsular contracture of the silicone gel. Rupture of an implant can require another surgery to replace the implant or evacuate the leaked filling material, e.g., silicone gel. Moreover, saline-filled implants can have an unnatural feel. The hydrostatic properties of the saline fluid can distort the outer shell as the tissue surrounding the implant moves the implant. Such disturbance of the implant can increase the leak rate of the implant. As noted above, an embodiment of the breast implant disclosed herein does not suffer from these problems. In an instance where the fluid in the outer container is, e.g., silicone gel, the members can diffuse the fluid evenly (e.g., see  FIGS. 19 and 23 ). Also, less gel is used to fill the outer container. If the outer container ruptures, such gel adheres to the members disposed in the outer container. Consequently, there is less likelihood of gel leaking out of the outer container. 
     The tactile feel of the breast implant herein is superior to a conventional breast implant since the breast implant herein is filled with members in a fluid that provide a consistency more closely approximating normal breast tissue. Thus, the breast implants herein move with a motion similar to breast tissue. Additionally, the fluid lubricates the members that support the outer container. As a consequence, the breast implant has a low probability of fold flaw failure and rupture due to rippling. 
     While one or more embodiments have been shown and described, modifications and substitutions may be made thereto without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the present invention has been described by way of illustrations and not limitation. Embodiments herein can be used independently or can be combined. 
     All ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other. The suffix “(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including at least one of that term (e.g., the colorant(s) includes at least one colorant). “Optional” or “optionally” means that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where the event occurs and instances where it does not. As used herein, “combination” is inclusive of blends, mixtures, alloys, reaction products, and the like. All references are incorporated herein by reference. 
     The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. “Or” means “and/or.” It should further be noted that the terms “first,” “second,” and the like herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The modifier “about” used in connection with a quantity is inclusive of the stated value and has the meaning dictated by the context (e.g., it includes the degree of error associated with measurement of the particular quantity). The conjunction “or” is used to link objects of a list or alternatives and is not disjunctive, rather the elements can be used separately or can be combined together under appropriate circumstances.