Guest guest Posted September 2, 2006 Report Share Posted September 2, 2006 Kathynye@... wrote: From: Kathynye@...Date: Sat, 2 Sep 2006 10:53:28 EDTbreast implant news:New Plastic Surgery Device Keeps Breast Implants in PlacePR Web (press release) - Ferndale,WA,USAAs cosmetic surgery patients select larger and larger breast implants the long term risk for implant displacement increases. A new ...INSERT: In Re: to news story aboveSubj: Toxic Discovery Date: 9/1/2006 5:43:44 PM Eastern Standard Time From: kathy@... Bad news is that their "mesh sling" most likely would mask a rupture which would most likely make one "bottom out". Silicone Snake Oil at its finest! We wonder what the "sling" is made of?????? If one has to have a "sling" to keep your implants in place then HELLO - "can you not see the problem"."Stupid is as stupid does. "Quote from Forrest Gump - 1994__________________________________Implantable prosthesis for positioning and supporting a breast implant 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.(SCROLL BELOW TO READ THE REST OF THE PATENT...)Agent: Patzik, & Samotny Ltd. - Chicago, IL, USInventor: E. Class: 623008000 (USPTO), (Intl Class) Brief Patent Description - Full Patent Description - Patent Application Claims PRIOR APPLICATION DATA [0001] This application claims priority to U.S. Patent Application Ser. 60/599,512, filed on Aug. 6, 2004. FIELD OF INVENTION [0002] The present invention relates to an implantable prosthesis for positioning and supporting a breast implant within a patient and a method of positioning and supporting the breast implant within the patient using the implantable prosthesis. BACKGROUND OF INVENTION [0003] The American Society of Plastic Surgeons reports that breast augmentation procedures increased seven-fold in the ten-year period between 1992 and 2002, increasing from 32,607 procedures in 1992 to 225,818 procedures in 2002. Overall, it has been estimated from breast implant sales data that anywhere between 1.5 to more than 2 million women in the United States alone have breast implants. An estimated 70-80% of breast augmentation procedures were performed for cosmetic purposes while the remaining 20-30% were performed for reconstructive purposes. [0004] Implants are positioned within the chest in one of three positions: (1) implant over the pectoralis major muscle and under the breast tissue (subglandular); (2) implant partially under the muscle (partial submuscular); and (3) implant completely under the muscle (submuscular). The subglandular placement puts the implant directly behind the breast tissue and mammary gland and in front of the pectoralis major muscle. This placement requires the least complicated surgery and yields the quickest recovery. The downsides of this placement are increased chances for capsular contracture, greater visibility and vulnerability for the implant. This is because only the skin and breast tissue separate the implant from the outside world. Depending on the amount of available breast tissue, the implant may be seen "rippling" through the skin. [0005] Partial submuscular placement involves placing the implant under the pectoralis major muscle. Because of the structure of this muscle, the implant is only partially covered. This alternative reduces the risk of capsular contracture and visible implant rippling, but recovery time from this positioning is typically longer and more painful because the surgeon has to manipulate the muscle during surgery. Also, because of increased swelling, the implant may take longer to drop into a natural position after surgery. Completely submuscular placement puts the implant firmly behind the chest muscle wall. The implant is placed behind the pectoralis major muscle and behind all of the supporting fascia (connective tissue) and non-pectoral muscle groups. This placement has even longer recovery time, potential loss of inferior pole fullness, and involves a more traumatic surgical procedure. [0006] Regardless of location of the implant, in the case of breast augmentation the surgery is carried out through an incision placed to minimize long-term scarring. The incision is made in one of three areas: (1) peri-areolar incision; (2) inframammary fold incision; and (3) transaxillary incision. The peri-areolar incision enables the surgeon to place the implant in the subglandular, partial submuscular or completely submuscular position, with the implant being inserted, or removed, through the incision. Like the peri-areolar incision, the inframammary fold incision provides for all three placement types and both insertion and removal of the implant through the incision. The incision is made in the crease under the breast, allowing for discreet scarring. Once the incision is made, the implant is inserted and worked vertically into place. [0007] The transaxillary incision is made in the armpit. The incision is made in the fold of the armpit and a channel is cut to the breast. The implant is inserted into the channel and worked into place. Like the peri-areolar and crease incisions, the armpit incision can be used for implant placement anywhere in the breast. If a complication occurs that requires revision or removal of the implant, the surgeon will likely have to make a peri-areolar or inframammary fold incision to revise the position of the implant. The transaxillary incision is rarely reused because it is difficult to work on an implant from what is really a remote site. Visibility inside the breast is extremely limited for the surgeon with a transaxillary incision without the use of a fiber optic endoscope, which can be cumbersome in a revisional setting. In the case of reconstructive procedures, the patient's prior mastectomy incision is often used. [0008] Once the incision is created, the surgeon must cut a path through the tissue to the final destination of the implant. Once that path has been created, the tissue and/or muscle (depending on placement) must be separated to create a pocket for the implant. When deciding where to cut the pocket in the breast, the surgeon must predict what the breasts will look like when the implants are filled. [0009] Presently, there are very few techniques to reliably maintain the position of implants placed as part of cosmetic or reconstructive surgical procedures. Implant malposition may be the result of several factors, including poor surgical technique, i.e. the implant pocket is too big or too low; implant weight; or lack of soft tissue support. In addition, in reconstructive patients cancer treatments, such as chemotherapy, weaken the soft tissue and surgery, in general, interrupts the natural anatomic plains of the soft tissue. These factors are more profound in patients who have lost massive amounts of weight. Such situations typically provide extremely poor soft tissue support and the inability of the usual support structures within the breast, such as the inframammary fold, to support the weight of the implant. [0010] Patient studies have demonstrated an 8-12% incidence of implant malposition severe enough to incur removal of the implant within 5 years. Over time, implants can be displaced medially resulting in symmastia (as is seen in FIG. 1), laterally resulting in implant excursion into the axilla of the chest cavity, or inferiorly resulting in "bottoming out" (as is seen in FIG. 2). [0011] Symmastia is commonly referred to as "bread loafing" and is commonly seen in patients who have subglandular implants. With this condition, the implant pockets actually meet in the middle of the chest, giving the appearance of one breast 2 (FIG. 1), instead of two. The condition is most often related to technical error by a surgeon attempting to create too much cleavage in the patient or using an overly wide implant. Lateral displacement results in the implant moving into the armpit, especially when the patient is lying flat on her back. Lateral displacement is most common with submuscular placement when muscle is inadequately released medially and is the most under-recognized implant displacement problem. [0012] Inferior displacement or "bottoming out" is described as a lengthening of the distance from the nipple to inframammary fold. This type of displacement results from a lowering of the inframammary fold during surgery or an inadequacy of soft tissue support required to maintain the implant weight. FIG. 2 shows a breast implant 4 that has bottomed out after sub-muscular placement within the patient. FIG. 2 also shows the proper location of an implant 6 that has not bottomed out. Bottoming out of implants may be exacerbated by a failure to wear a bra, activities resulting in excessive "bouncing" of the implants, excessively large implants, and/or extreme weight loss. Once these problems are established, classical repair techniques have had limited effectiveness, with high rates of displacement recurrence. [0013] The traditional method of correction for implant malposition has utilized the scar tissue "capsule" as the strength of the repair. In most desciptions, the capsule is allowed several months to "mature" at which point the patient is taken to surgery, a section of the scar capsule excised or imbricated on itself and the remaining capsule closed using non-resorbable sutures. [0014] The problems with this method are numerous. First, the scar capsule is often attenuated making adequate "bites" of capsule impossible. Second, the capsule is itself distensible so the factors which initially acted on the pocket can result in rapid recurrence. Finally, and most obviously, in nearly all cases the implant is replaced once the repair is complete--once again putting strain on the repair especially in the case of bottoming out. Some authors have advocated the use of percutaneous bolsters 8 (seen in FIGS. 3 and 4) placed to buttress the repair and take pressure off the internal repair. These bolsters may limit direct implant pressure but leave unattractive scars on the skin due to the tension. For medial malposition, the use of a Thongbra.RTM. (a bra designed to apply pressure over the sternum) or bolsters placed to secure the medial breast skin to the underlying sternum have had limited success. SUMMARY OF INVENTION [0015] The present invention comprises an implantable prosthesis for positioning a breast implant within a patient, where the prosthesis comprises a sheet of prosthetic material configured to form a receiving area for receiving the breast implant, and comprising at least a first tissue affixation region. The first tissue affixation region is adapted to attach the implantable prosthesis to soft tissue surrounding the breast implant or a boney structure within the patient, such as the periosteum of the chest cavity, with a first suture or by conventional or endoscopic tacking. Preferably, the sheet of prosthetic material is of a porous nature to facilitate tissue in growth and secure fixation of the implantable prosthesis to the patient. The outer surface of the prosthetic material is composed of polytetrafluoroethylene, silicone, or another suitable chemically inert material. [0016] In one preferred embodiment of the present invention, a biocompatible landing overlays the prosthetic material, the landing adopted to communicate with and support the breast implant. The landing is composed of a pad overlaying the receiving area, the pad being composed of polytetraflouroethylene, silicone, or any other suitable chemically inert material. The landing pad is affixed to the sheet by stitching, a biocompatible, inert adhesive, or any other suitable means of attachment. In another preferred embodiment, the receiving area comprises the fibers of the porous sheet of prosthetic material and the landing comprises coating the fibers with polytetraflouroethylene, silicone, or any other suitable chemically inert material. [0017] The present invention also comprises a method of maintaining the position of a breast implant with an implantable prosthesis, the method comprising: providing a sheet of prosthetic material comprising a front surface configured to form a receiving area for receiving the breast implant, and providing at least a first tissue affixation region adapted to facilitate fixation of the implantable prosthesis to the patient. The sheet of prosthetic material is provided with an outer surface composed of a biocompatible material comprising polytetrafluoroethylene, silicon, or another suitable, chemically inert material. [0018] The method further comprises cutting an incision in a patient, the incision adapted to provide a point of insertion for the breast implant, the method further comprising rolling the implantable prosthesis up and inserting the prosthetic through the incision, wherein the incision is a peri-areolar incision or an infra-mammary incision. The first end of the sheet of prosthetic material is sutured to an area of soft tissue surrounding the breast implant. The implantable prosthesis is then unfurled, positioned, and affixed to the patient at the first tissue affixation region with a suture or by conventional or endoscopic tacking. The sheet of prosthetic material is preferably a porous mesh to facilitate tissue in growth to securely hold the implantable prosthesis in place. BRIEF DESCRIPTION OF DRAWINGS [0019] FIG. 1 shows a front elevation view of malpositioned breast implants exhibiting symmastia; Continue reading...Full patent description for Implantable prosthesis for positioning and supporting a breast implantBrief Patent Description - Full Patent Description - Patent Application ClaimsClick on the above for other options relating to this Implantable prosthesis for positioning and supporting a breast implant patent application.### How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. (i.e. mesh sling for breast implants) 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Implantable prosthesis for positioning and supporting a breast implant or other areas of interest.###Previous Patent Application:Aspheric lenses and lens familyNext Patent Application:Graft ligament anchor and method for attaching a graft ligament to a boneIndustry Class:Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor###FreshPatents.com Support | Advertise on FreshPatents.com:Design/code © 2004-2005 Freshpatents.com. Website Terms and ConditionsPatent data source: United States Patent and Trademark OfficeInformation published here is an abstract for research/educational purposes.Complete official applications are on file at the USPTO and may contain additional data/images.FreshPatents.com is not affiliated with or endorsed by the USPTOThank you for viewing the Implantable prosthesis for positioning and supporting a breast implant patent info.IP-related news and infoAbove research provided by Toxic Discovery_________________________________________Kathy L. ley-ston, R.N.Executive DirectorToxic DiscoveryColumbia, MO. 65203Phone: (573) 817-2090Fax: (573) 445-4700kkjohnston@... 'INFORMED CONSENT BEGINS WITH INFORMED INDIVIDUALS" Fw: New Plastic Surgery Device Keeps Breast Implants in Place Download this press release as an Adobe PDF document.As cosmetic surgery patients select larger and larger breast implants the long term risk for implant displacement increases. A new mesh sling keeps breast implants from moving too low on the chest or into the woman’s armpit and replaces a longstanding procedure which is prone to failure.Munster, IN (PRWEB) August 31, 2006 -- Keeping breast implants in place is the goal of a new surgical procedure invented by an Indiana plastic surgeon. Dr , a board certified plastic surgeon and member of the American Society of Plastic Surgeons, became frustrated with the number of women he was seeing with older breast implants which had become displaced over time.“These women didn’t need a breast lift,†said , “It was their implants that had dropped not their breast tissue.†This condition, commonly know as bottoming out, was making women less satisfied with their breasts and their implants. Bottoming out can be due to the weight of an implant pulling on weakened tissues or can be the result of poor implant placement during the initial procedure. “The first woman I saw for this problem had had her implants placed by one of the most prominent plastic surgeons in Chicago so I guess the lesson is it could happen to anyone and at any time after the implants are placed,†said .When patients experience bottoming out, they often complain that one breast sits higher on their chest than the other due to uneven implant pocket formation. In more advanced cases, the nipple appears to sit too high on the breast and in the worst scenario, patients may become concern that their nipple might “pop out†when wearing a bra or bathing suit top. “The problem, “said ,†is not that the nipple sits too high, it’s that the implant sits too low.â€Traditional techniques for repair of bottoming out have involved a procedure known as a capsulorrhaphy in which the scar capsule supporting the implant is brought together to close off the pocket where the implant sits. “Unfortunately, sewing weak tissues together and then replacing the implant which caused the initial stress is a setup for failure,†said . Studies have reported over 50% failure rates for capsulorrhaphy.’s technique uses a patented mesh sling to support and bear the weight of the implant. “General surgeons have used mesh for years to repair hernias elsewhere in the body, “he said, “to some degree this is just a hernia of the breast.†The mesh not only closes off the defect caused by the stretched tissue but, acts as a scaffold for new scar tissue. “Once the scar tissue has grown into the mesh, the chance of recurrence becomes very small.†said . This process occurs within about two weeks. Patients report the mesh feels much like the implant does and after a few weeks most are back to their normal activities.A second group of implant related problems is also well suited for mesh repair. “I see patients frequently who’s implants fall into their armpits when they lay back, “ said , “unfortunately, few plastic surgeons examine their patients in this position so often they aren’t even aware there’s a problemâ€. The same mesh sling placed vertically can be used to close off this “lateral displacement†giving patient back the cleavage they enjoyed initially after their surgery.To date, has used his mesh sling on over 30 breasts and has received rave reviews by patients treated. Unlike the older capsulorrhaphy procedure, no patients treated with the mesh have had recurrent bottoming out. Word of the new device has spread and patients have traveled to Indiana from Minnesota, Florida, Texas, California and all throughout the Chicagoland/Northwest Indiana area specifically for the mesh technique. “Given the option of mesh or losing their implants, many patients will gladly make the trip,†said. For additional information about implant displacement and the mesh sling contact Dr via www.ariasurgery.com.About Dr E. , MD:Dr is a board certified Plastic Surgeon in private practice in Munster, Indiana. Dr specializes in breast and body cosmetic procedures especially revisional plastic surgery. He is the patent holder for the mesh breast sling. More information on Dr is available on his practice website www.ariasurgery.com or by phone at (219) 924-3377.Contact: Murnane(219) 924-5006Trackback URI: http://www.prweb.com/dingpr.php/TWFnbi1GYWx1LUluc2UtTG92ZS1JbnNlLVplcm8= We, should have guessed it was from the, PS's Society. Why didn't he, state they rupture, an are faulty also? Gigi- LawrenceAnd are the slings made from silicone also????And if those implants have been in for several years, are they going to rupture when the doctors start "messing around" with them??? Sounds like a prescription for disaster to me!!CarolynCarolyn=====================================================Australia clamp on teen breast implantsGulf Daily News - Manama,BahrainSHOCKED by an apparent rise in the number of teens seeking breast implants, Botox injections and nose jobs, the leader of Australia's most populous state has ...Overheard in New York: Strippers and Breast ImplantsNational Ledger - Apache Junction,AZ,USABy Jo Anne Way. Overheard in New York was first noted here on Monday by Cris Bergman. As I had never heard of the Overheard in New ...============================================================Subj: Sarcoidosis Date: 8/31/2006 2:43:27 AM Eastern Standard Time From: saxony01@... CINDY FUCHS-MORRISSEY <cfuchsmorrissey@...> wrote: From: CINDY FUCHS-MORRISSEY <cfuchsmorrissey@...>Date: Wed, 30 Aug 2006 19:32:19 -0700 (PDT)~Please post~Hi. I would like to network with women who have been exposed to breast implants and have been diagnosed with sarcoidosis. Also, I would like to know the company and lot numbers if this is known as well. Thank you. Fuchs-seyFuchssey@...cfuchsmorrissey@... ==========================================================Subj: Annex A - All Dow & MDL claimants should read this. Here's the link. Date: 9/2/2006 9:04:08 AM Eastern Standard Time From: saxony01@... ALL Dow and MDL claimants should read Annex A of the DCSettlement page. It is worth printing out for reference.[link=www.dcsettlement.com/resources/ANNEX%20A%20to%20SFA%20-%20FINAL.5-26-04.pdf]Annex A [/link]'Annex A' includes all the criteria and exclusions necessary for BI Class Action Settlements, and Dow has the same criteria as the MDL. Every claimant should have this. This has a rundown of the disease criteria - even if you have a lawyer, you should be reading this so you can keep up with what you need or don't have. A good lawyer should do that, but I suspect some do and some don't. And it surely can't hurt for you to know where you stand. There are some twists and knowledge of how the claims office interprets some of this that an attorney should know and can help you with, but these are the basics. Any woman who wants to can represent herself in these claims, with the proper information. It is not easy - I hired an attorney even though I am an attorney -- I was too sick and overwhelmed with all of it when I started my claim. And I am too close to my own case. However, even if you hire an attorney, you should read this. A good attorney will welcome an educated client - if you are courteous and reasonable, 'partnering' with your attorney on your claim will help both you and your attorney. And, Annex A is the "Bible" if you are pro se (representing yourself). Second, there are other sections in Annex A - a list of doctors who only used one type of implant, so if you had any of these docs, your proof of manufacture (POM) will be easier. It also has the requirements for POM.Also has the list of settlement determined attorney's fees. Messages in this topic (1) Reply (via web post) | Start a new topic Quote Link to comment Share on other sites More sharing options...
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