Abstract: A soft prosthetic implant, for example, a breast implant, having a shell filled with a fluid. One or more components of the soft prosthetic implant receive a unique identifier for traceability during the manufacturing process. The unique identifier is placed on one component, such as a patch molded-in-place with a shell to form a soft prosthetic implant. Information about the respective components, as well as process parameters, can be stored on the unique identifier for later reference. The unique identifier may be a two-dimensional printed label or laser-etched characters, or may be a three-dimensional embossed or indented region. The unique identifier may be a separate label attached to the respective component, or may be formed in the component, such as with embossing.

Abstract: The present invention relates to a breast prosthesis having at least one contact surface which is intended for contact on a body surface, with the contact surface having at least one means by means of which air circulation and/or an exchange of air can be achieved between the contact surface and the body surface.

Abstract: A fluid-filled prosthetic implant having a shell comprising a matrix material and an additive distributed in the matrix material.

Abstract: A tapered sleeve is provided that includes a hydrophilic coating on an inner surface. In use, the device is typically removed from sterile packaging and soaked to activate the lubricous properties of the coating. An implant (e.g., a pre-filled silicon breast implant) is introduced into a large end of the sleeve and extruded into a surgical pocket of minimal access incision size through a small-sized end of the device.

Abstract: An implantable prosthesis for use in positioning a breast implant comprising a sheet of a prosthetic material configured to form a sling-shaped receiving area for receiving and supporting the breast implant. The surface area of the implantable prosthesis contacting the breast implant comprises a biocompatible or chemically inert material to prevent abrasion of or reaction with the breast implant. The implantable prosthesis of the present invention can be used during corrective procedures to reposition and support a malpositioned breast implant or during reconstructive or cosmetic procedures at the time the implant is first positioned within the patient. The prosthesis is used with implants in the partial sub-muscular, completely sub-muscular, and sub-glandular position and is used to prevent medial, lateral and inferior displacement of the implant.

Abstract: A soft tissue expander includes an expandable cover, a base, an adjustable central portion and a connecting member joined to side portions and extending across the central portion to determine the width of the expander.

Abstract: A reconstructive breast prosthesis suitable for implantation into a void in a breast following a lumpectomy procedure in which a body of tissue is excised from the breast, the reconstructive breast prosthesis including an implant body at least generally configured to assume an implant shape corresponding to the shape of the body of tissue excised from the breast and an implant shape retaining structure adapted to maintain the implant body in the implant shape, the reconstructive breast prosthesis having an overall density which is less than the density of the body of tissue excised from the breast.

Abstract: An implantable prosthesis for use in periareolar mastopexy. The prosthesis may constructed of a prosthetic or biological mesh material, or a biodegradable/resorbable material, and may be either annular or frusto-conical in shape. An aperture of the prosthesis is sized to surround an areola upon implantation. The prosthesis may include a plurality of teeth, extending outwardly from a top surface of the prosthesis, and canted generally towards an apex of the prosthesis. The implantable prosthesis permits a resorbable, rather than a nonresorbable suture to be used in the periareolar mastopexy procedure.

Abstract: Methods are provided for making materials suitable for implantation in a mammal. The methods include the steps of providing a base material having a desirable surface topography, such as a polyurethane foam, contacting the base member with a silicone-based fluid material to form a coating, and allowing the coating to set to form a silicone-based structure suitable for implantation in a mammal. The base material may be removed from the coating.

Abstract: Described herein are material compositions including various textures which when implanted in a mammal encourage an optimal biological response.

Abstract: Compositions of cross-linked polyvinylpyrrolidone (PVP) are disclosed that are generally in the form of an elastic, hydrophilic, water-insoluble viscous cohesive mass of material that has many important medical uses including uses as a filler for implants. The present invention also involves a process for producing such compositions.

Abstract: A reduced weight implantable prosthesis, including, an outer surface shell for encapsulating the prosthesis, a gel mixture comprising a mixture of a cohesive gel and micro-spheres for filling the shell, one or more inner volumes internal to the shell which do not contain the gel mixture; and wherein the gel mixture contains less than 60% by volume of micro-spheres mixed into the cohesive gel.

Abstract: An implantable device for use in tissue and ligament repair comprising at least one knitted section and at least one single continuous fiber traversing the at least one knitted section, the at least one single continuous fiber forming a plurality of traverses extending through the at least one knitted section. The implantable device may comprise at least one single continuous silk fiber. The implantable device is suitable for use in a variety or reconstructive or support applications such as breast reconstruction, mastoplexy, breast augmentation revision, breast augmentation support, standard breast augmentation, chest wall repair, organ support, body contouring, abdominoplasty, facial reconstruction, hernia repair, and pelvic floor repair.

Abstract: The present invention provides methods of making covalently crosslinked vinyl polymer hydrogels having advantageous physical properties, and covalently crosslinked vinyl polymer hydrogel compositions made by such methods, as well as articles of manufacture comprising such covalently crosslinked vinyl polymer hydrogel compositions. The physical properties of the produced hydrogels can be adjusted by varying controlled parameters such as the proportion of physical associations, the concentration of polymer and the amount of radiation applied. Such covalently crosslinked vinyl polymer hydrogels can be made translucent, preferably transparent, or opaque depending on the processing conditions. The stability of the physical properties of the produced vinyl polymer hydrogel can be enhanced by controlling the amount of covalent crosslinks.

Abstract: Compositions of cross-linked polyvinylpyrrolidone (PVP) are disclosed that are generally in the form of an elastic, hydrophilic, water-insoluble viscous cohesive mass of material that has many important medical uses including uses as a filler for implants. The present invention also involves a process for producing such compositions.

Abstract: A breast implant includes an implant shell having an outer surface and defining a first fluid reservoir, and a porous membrane overlying the outer surface of the implant shell and defining a second fluid reservoir. The breast implant includes a filling tube having a first conduit in communication with the first reservoir and a second conduit in communication with the second reservoir. The breast implant includes an injection dome coupled with the filling tube and having a first fluid chamber in communication with the first conduit and a second fluid chamber in communication with the second conduit. The injection dome includes an upper end having an injection cover, a lower end including a support base, the first fluid chamber located adjacent the injection cover, the second fluid chamber located adjacent the support base, and a diaphragm dividing the first and second fluid chambers from one another.

Abstract: A prosthetic breast form that is worn external to the human body to simulate a missing breast or portion thereof has a fabric pouch that defines an outer shape that approximates a breast shape or portion thereof, and that further defines an inner compartment; and a filler disposed within the inner compartment, the filler comprising a free flowing blend of clustered fiber filler, filler beads and weighting beads that are intermingled, where the weight of the filler is between approximately 1.25 ounces and 40 ounces. This abstract is not to be considered limiting, since other embodiments may deviate from the features described in this abstract.

Abstract: The invention provides systems and methods for tissue expansion. A tissue expander may have an implant portion which may be used to expand the tissue. A delivery/drainage system may be also be provided, which may be in fluid communication with a pocket surrounding the tissue expander. Various port configurations may be provided that may provide access to the implant portion and/or the delivery/drainage system. The tissue expander may advantageously help prevent or treat infection, or check the state of the pocket surrounding the tissue expander.

Abstract: Tissue expanders and their methods of use.

Abstract: A structure of breast augmentation pocket comprises a biocompatible liquid pocket, wherein a biocompatible liquid and a plurality of hollow silicone gel particles in the forms of large, small circles, or various shapes are filled inside. The silicone gel is applied with colors to form recognizable silicone gel such that the silicone gel particles are readily recognized and then cleaned away in case of rupture of the biocompatible liquid pocket. The silicone gel particles are hollow with the same average density as that of the biocompatible liquid so as to be suspended in the biocompatible liquid, whereby a touch feeling more similar to that of real tissue is provided because of the combination of biocompatible liquid with silicone gel particles. With good biocompatibility with non-dissolvability, the silicone gel particles neither lead to immune reactions nor cause any possible sequelae.

Abstract: An irrigation device is adapted to be placed into the body with and at the same time as a breast implant. The device delivers irrigation solution and/or antibiotic gels through small holes directly to the anterior (valve side) surface of a saline filled breast implant. The remaining implant surfaces, breast pocket and underside of the breast tissue will be likewise irrigated at the same time. By placing irrigation solutions and/or antibiotic gels directly onto the surface of the filled breast implant, bacterial biofilms will be targeted directly and eradicated, thereby reducing the incidence of capsule contracture and infection. The device is inserted with the breast implant, irrigates its surface and surround pocket when filled, and is removed with the breast implant fill tube at the end of the procedure.

Abstract: A breast implant (1) having a flexible, but impermeable casing (2) and with an electrically conductive filling (3) is provided with an internal electrode (4) and an external electrode (5), with the electrodes being connected to a resistance or impedance measurement device integrated in a transponder (6). In case of perforation of the casing (2), if filling (3) escapes, then the electrical contact between the electrodes (4) and (5) is completed, and a drop in resistance or impedance is registered by the measurement device. In suspicious cases, the implant could be inspected of the measured resistance or impedance values with an external transmitter-receiver unit (13 or 14) and dangerous damage to the breast implant could be determined.

Abstract: A device includes a tissue expanding portion and an enclosure positioned on a surface of the tissue expanding portion. The enclosure includes an enclosure wall and a drug formulation pocket defined by the enclosure wall.

Abstract: A device for intraoperative sizing of a human female breast during resizing and/or shaping of the breast composes: a (a) substantially hemispherical, rigid, cup-shaped foraminous body, i.e., a foraminous cup, defining a desired size and shape of the breast; and (b) a rim member to which the foraminous cup is affixed.

Abstract: The present specification provides compositions useful as dermal fillers and methods using such compositions to treat a condition of skin.

Abstract: The invention relates to an implantable combination comprising a barrier (12), and a macromolecular bio-compatible material (14). The barrier (12) is porous to allow moieties of the macromolecular bio-compatible material (14), when implanted, to be exposed through the barrier, whereby the surface of the barrier is experienced by the body as an essentially non-foreign object. It also relates to an implant made from a barrier material and a bio-compatible material, the implant being suitable as e.g. a breast implant.

Abstract: The invention relates to a soft-tissue implant for use in the medical field which has an antibacterial effect. The soft-tissue implant, which may for example be a breast implant, has at least one antibiotic substance bound to the implant surface in first and second configurations that release the antibiotic substance, after implanting in an animal body, at short term and long term release rates. The first and second configurations are each present at one or more common surface locations. The soft-tissue implant has an antibacterial effect that prevents or reduces the deposition of bacteria and the formation of bacteria-containing biofilms.

Abstract: The field of the present invention relates to a novel method for producing tissue or organ in a mammal by implanting in vivo a novel three dimensional biodegradable scaffold. The novel three dimensional biodegradable scaffolds overcome the barrier of developing large organs with tissue engineering.

Abstract: A surgical implant namely a tissue expander or adjustable implant having a synthetic mesh loosely attached to the surface. The mesh is elastic in all directions and the implant adjustable or expandable. The expandable implant is filled to an over filled volume into the surrounding tissue until a new capsule forms. At this stage the volume of the implant is reduced leaving the supporting capsule with the mesh at a larger volume. The volume of the implant is then reduced thus rendering a tension free capsule around the implant. The filling tube of the adjustable implant is then removed leaving the adjustable implant in position. Alternatively the tissue expander may be removed and a new implant placed in the expanded tension free pocket.

Abstract: A silicon breast implant injector for augmentation mammaplasty which includes a hollow tube and a plunger. The hollow tube has a barrel which has one end tapered to form a first arched barrel connecting to an inverse second arched barrel which in turn is connected to an ejection opening formed at the same diameter as the second arched barrel but into a short inflexible length tube. The plunger can push a silicon breast implant s held in the hollow tube through an incision into patient's submammary pocket. Coupled with a smooth connection between the first arched barrel and the second arched barrel, push resistance can be reduced, and thus can smoothly, quickly, easily and safely move the silicon breast implant into the submammary pocket.

Abstract: Implantable prosthesis, components of prosthesis, and methods of making same are provided. The methods generally include the steps of providing an implant shell, applying a curable fluid composition to the shell to form a coating thereon and applying a particulate component to the composition. The composition is a mixture, for example, an emulsion, containing a silicone-based elastomer dispersion and droplets of a suspended leachable agent. After the elastomer is stabilized and cured, the particulate component and leachable agent are removed, resulting in an implantable member having a porous, open-cell surface texture designed to be effective in reducing incidence of capsular formation or contraction.

Abstract: An implantable tissue expander is provided for supporting a body tissue. The tissue expander includes an implantable support member that is externally positioned with respect to the body tissue to be shaped. The support member includes a first end and an opposing second end. The first end includes a first fastener configured to be inserted into the body tissue to secure the first end to a first portion of the body tissue. The second end includes a second fastener configured to be inserted into the body tissue to secure the second end to a second portion of the body tissue. The support member includes a biasing element configured to exert a tension force at each of the first end and the second end to shape the body tissue.

Abstract: An implant for marking an area within a living body includes a matrix material and a marking material. The implant is formable to fit the shape and size of a cavity in the human body. The implant is configured to support tissue surrounding the cavity and to allow in-growth of fibrous tissue into and replace at least a portion of the matrix material.

Abstract: A biodegradable cover or coating for a breast implant includes a biodegradable cover or coating over the breast implant and contains one or more drugs for delivery at the surgical site, particularly for treating or preventing infection, pain, inflammation, capsular contracture, scarring or other indication or complication associated with breast augmentation or breast reconstruction.

Abstract: A method for implanting a breast implant into a subject, the method includes: providing a sterile, flexible, elastic biodegradable bag sized to contain the breast implant; providing a sterile breast implant; inserting, using sterile handling, the sterile breast implant into the sterile bag to form a sterile breast implant assembly; closing the bag to fully enclose the implant within the bag; and implanting in a sterile manner the sterile breast implant assembly into the subject. A sterile bag, which may be provided in a kit, preferably for use with the method includes first and second chambers connected by a channel for moving a breast implant from the first chamber through the channel to the second chamber without directly touching the implant. An incision dilator may also be included with the kit or separately provided for use in a preferred embodiment of the method.

Abstract: The present specification generally relates to multifunctional polyethylene glycol-based crosslinking agents, hydrogel compositions comprising a matrix polymer crosslinked with such crosslinking agents, and methods of treating a soft tissue condition using such hydrogel compositions.

Abstract: A breast implant system includes a shell, a viscous material for substantially filling the shell, and a plurality of bio-medical units affixed to at least one of the shell and the viscous material. A bio-medical unit of the plurality of bio-medical unit includes a wireless power harvesting module, a functional module, and a wireless communication module. The wireless power harvesting module is operable to generate a supply voltage from a wireless source. The functional module is operable to perform a function when activated and powered by the supply voltage. The wireless communication module is operable to facilitate wireless communication with the functional module.

Abstract: An implantable tissue expander for supporting a body tissue including a support member positioned with respect to the body tissue and adapted to expand to a support configuration, in the support configuration, the support member shaping the body tissue.

Abstract: A reduced weight implantable prosthesis, including an outer surface shell for encapsulating the prosthesis, a gel mixture comprising a mixture of cohesive gel and micro-spheres for filling the shell, one or more inner volumes internal to the shell which do not contain the gel mixture; and wherein the gel mixture contains less than 60% by volume of micro-spheres mixed into the cohesive gel.

Abstract: A breast implant system is provided comprising a plurality of chambers including one or more first fluid chambers (1) and one or more second fluid chambers (2). The first fluid chamber (1) forms part of a breast implant (10), whereas the second fluid chamber (2) may also form part of the breast implant or may be implanted remote from the breast implant. The first and second fluid chambers are interconnected so as to allow exchange of fluid between the first and second chambers, thereby causing the shape and, depending upon the specific embodiment, also the volume to change accordingly.

Abstract: A self supporting breast implant includes a generally cone shaped partially absorbable medical mesh support member and a silicone shell defining a hollow core that is preferably filled or partially filled with a silicone gel. The support member is made of a polypropolene/poliglecaprone monofilament and may be attached to a patient's tissue by sutures or by absorbable hooks.

Abstract: A self supporting breast implant includes a generally cone shaped partially absorbable medical mesh support member and a silicone shell defining a hollow core that is preferably filled or partially filled with a silicone gel. The support member is made of a polypropolene/poliglecaprone monofilament and may be attached to a patient's tissue by sutures or by absorbable hooks. A textured outer surface or shell is formed around the relatively smooth implant or inner shell and the inner shell is reduced in size to provide a small space between the inner shell and the outer shell to eliminate or at least minimize the adverse effects of capsular contraction.

Abstract: A fluid-filled soft prosthetic implant having a shell with a reinforced shell wall. The soft prosthetic implant may be for breast reconstruction or augmentation, or to restore the normal appearance of soft tissue in the buttocks, chin, calf, etc. The implants may be reinforced using several methods: reinforcement of the shell wall, non-homogeneous gel-filling, or both. At least a portion of the perimeter region desirably has a shell wall thickness greater than the average shell wall thickness of either the anterior face or the posterior face. The added material at the perimeter region strengthens that area in which a large percentage of implant ruptures occur. The reinforced perimeter also helps prevent the implant from collapsing or folding, which can cause undesirable rippling or wrinkling visible through the patient's skin. The remainder of the shell will desirably have a nominal wall thickness to retain the overall softness and supple feel of the implant.

Abstract: A medical implant assembly and method having a medical implant, e.g. a breast prostheses, affixed to a biological interface. The biological interface is comprised of a dermal material with capsular contracture inhibiting properties so that once the medical assembly is inserted into the host, the biological interface, which is intimately coupled to the implant, prevents/reduces capsular contracture formation around the implant.

Abstract: A medical implant to be accommodated in a human body is disclosed. The medical implant includes porous silicon with bubbles of different sizes, and a silicon film enclosing the porous silicon. Also, the medical implant includes porous silicon balls with bubbles and a silicon film enclosing the porous silicon balls. Cushion and weight of the implant can be properly adjusted so as to maintain the cushion at a level similar to that of cellular cells of the human body and to shorten a recovery time. Plural grooves or through-holes are provided on a surface of the implant, and thus body fluid smoothly flows through the grooves or through-holes to improve the affinity of the implant against the cellular cells.

Abstract: A surgical procedure for breast augmentation includes the steps of preparing a pocket for receiving a breast implant; applying a semisolid including at least one therapeutic agent to at least one of the pocket or the breast implant; and inserting the breast implant in the pocket. An implant kit includes the implant and the semisolid with one or more additives.

Abstract: Graft materials and devices for surgical breast procedures, as well as methods of making graft devices are described.

Abstract: A preformed, seamless, three-dimensional, anatomically contoured prosthetic device for reinforcing breast tissue and supporting a breast implant includes a flat back wall, a concave front wall and a curved transitional region between the flat back wall and the front wall defining a smoothly curved bottom periphery. A concave receiving space is defined by the back wall and the front wall for at least partially receiving and supporting the breast implant therein. The three-dimensional prosthetic device is free of wrinkles, creases, folds or seams, which may have otherwise caused potential tissue irritation, bacteria hosting, infection and palpability problems.

Abstract: A tissue marking implant includes a matrix material and a dye marker. The implant, which can be formed entirely of bioresorbable material such as a collagen foam, is sized and shaped to replace excised tissue. The implant supports surrounding tissue upon implantation, while allowing for in-growth of fibrous tissue to replace the implant. According to various alternative embodiments, the implant is elastically compressible, or can be formed from self-expanding foam or sponges, and can be implanted through a cannula or by injection, as well as by open procedures. The implant can carry therapeutic and diagnostic substances. The dye marker leaches from the implant such that a surgeon, upon subsequent surgical intervention, visibly recognizes the tissue marked by the dye marker.

Abstract: Disclosed herein is an implantable prosthesis for breast augmentation or reconstruction procedures. The prosthesis comprises a biocompatible and biodegradable fabric structure comprising one or more individual yarns comprised of sericin-extracted native fibroin fibers, wherein the yarns are intertwined to produce the fabric structure. The fabric structure extends in at least a first dimension and has at least a first surface that is adapted to engage and support natural breast tissue and/or a prosthetic breast implant in a patient. Also disclosed are methods of supporting breast tissue or a breast implant in a patient by inserting the prosthesis between the skin of the patient and the breast tissue and/or implant within the patient.