Listing a study does not mean it has been evaluated by the u. It manufactures tissue repair products for reconstructive, urogynecologic and orthopedic surgeries. Comparison of permacol tm and strattice tm for the repair of abdominal wall defects. Lifecell 0608001 strattice 6cm x 8cm pliable reconstructive tissue matrix designed to reinforce tissue where weakness exists and for repair of damaged or ruptured soft tissue membranes. In general, i think strattice is a very useful product, but i dont believe its use is always necessary for achieving your goals. The surgeon does not think it was an allergic reaction. Recurrence of diaphragmatic hernia after thoracoscopic. The strattice was placed in an intraperitoneal, underlay fashion using vertical mattress no. Strattice reconstructive tissue matrix perforated surgical mesh device description strattice reconstructive tissue matrix perforated strattice tm or the surgical mesh is a surgical mesh that is derived from porcine skin and is processed and preserved in a patented phosphate buffered aqueous solution containing matrix. Jun 01, 2018 the complaint pdf was filed by evelyn menjivar in the u. Lifecell strattice reconstructive tissue matrix demonstrates high success rate in treating complex ventral hernias in landmark study.
Lifecell corporation lifecell has recently become aware of serious adverse events in certain breast reconstruction procedures in which strattice tm was used. Intermediate risk patients and early complications. The serious adverse events reported were not a result of a malfunction of or defect in the strattice surgical mesh, but are related to improper breast reconstruction surgical technique. It was reported to lifecell that surgeon removed infected mesh from patient and used a 16x20 lifecell device for hernia repair. This unique new surgical product is developed using a porcine dermis, which is strong, sterile and flexible. At 1, 3, 6 and 12month time intervals, rats in each group were sacrificed and the mesh was excised. Lifecell manufactures biologic mesh including alloderm and strattice hernia meshes. Accessgudid strattice reconstructive tissue matrix bps m328con10060 small curved shape for strattice, bps contour 1. Specifically, the strattice reconstructive tissue matrix was cleared under k082176 as ltmbps surgical mesh for use as a soft tissue patch to. Surgeon noticed that the device had dissolved about a week later and was no longer apparent. The area looked inflamed and free of infection, but was irrigated with antibiotics. Story in sarasota heraldtribune february 6, 2012 james fico had a problem. The purported benefits of strattice compared to allodermease of use, reduced risk of disease transmission, and improved graft strengthmake strattice an appealing substitute both for alloderm and for more traditional synthetic meshes reimbursement in 2008, cms provided reimbursement for stratticetm under hcpcs. Branchburg, new jersey is a noncrosslinked porcinederived acellular dermal ma.
Complications in immediate breast reconstruction using strattice. The extrusion was noted at inframammary fold incision site. Full incorporation of strattice reconstructive tissue matrix in a reinforced hiatal hernia repair. Parastomal reinforcement with strattice full text view.
Indications include repair of hernias andor body wall defects which require the use of reinforcing or bridging material. Class 3 device recall strattice reconstructuve tissue. Lifecell informed users that additions would be made to the products instructions for. Patient underwent subsequent debridement of tissue, fascia, and strattice, treatment for fistula, and wound vac therapy. For more information, please see the instructions for use ifu for all strattice rtm products. Full incorporation of strattice reconstructive tissue matrix. Strattice reconstructive tissue matrix rtm, strattice rtm perforated, strattice rtm extra thick, and strattice rtm laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. To report an adverse reaction, please call allergan at 1. Lifecell manufacturers both strattice, which you correctly identify is a porcine pig product, and alloderm is human cadaver skin. District court for the eastern district of new york on may 16, indicating that the composix kugel hernia patch, the strattice. Strattice mesh archives mesh medical device news desk.
Please visit a few qualified surgeons with excellent reputations for revision surgery. For strattice rtm laparoscopic, refrain from using excessive force if inserting the mesh through the. Strattice reconstructive tissue matrix laparoscopic strattice tm or the surgical mesh is a surgical mesh that is derived from porcine skin and is processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. Lawsuit filed over problems with kugel, strattice and. Lifecell tissue matrices have been used to treat surgical, trauma and burn patients for over ten years. Oct 15, 2012 lifecell has introduced a new tissue matrix support product they have named strattice. Once the mesh was secured in place, the wound was irrigated, and the midline fascia was closed using figureeight no. Parastomal reinforcement with strattice prism the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Lifecell corporation lifecell issued a field safety notification on 23 jun 2015 informing users of serious adverse events in certain breast reconstruction procedures in which strattice tm was used. Is strattice a good option for a possible revision. Alloderm hernia mesh and dangerous medical devices. The implant was replaced and a new strattice device was placed. Strattice recontructive tissue matrix products allergan.
Nov 18, 2015 the objective of this study is to assess longterm outcomes of stratticebased breast reconstructions in multiple breast surgery centres across the uk. Have you sustained injuries due to a defective medical device or surgical implant. Faq strattice reconstructive tissue matrix tm restora. Strattice rtm, strattice rtm perforated, strattice rtm extra thick, and strattice rtm laparoscopic are available by prescription only. Adoption of the strattice surgical mesh may serve as a method of differentiation for hospital services. Strattice internal bra read more lifecell is a company that produces a dermal matrix that has been used now as the gold standard in breast cancer reconstruction with tissue expanderssilicone implants. Strattice tissue matrix regenerates and continues to reinforce over time strattice tissue matrix provided a reinforced repair up to 38 months postimplantation as demonstrated in histopathologic results. Chest wall reconstruction with strattice in an immunosuppressed patient. The number of adhesions, surface area, mesh thickness and tensile strength were determined, and immunohistochemical analysis performed. I have used strattice in over 300 patients in the past 8 yearsreally since its launch by lifecell. A few years later, the manufacture started marketing their products to promote the use for hernia mesh repair surgerys and abdominal reconstruction.
Pdf complications in immediate breast reconstruction using. Class 3 device recall strattice reconstructuve tissue matrix. By clicking accept you understand that you are directing. Across the country, patients have suffered debilitating injuries after undergoing hernia surgery with alloderm mesh products. Lifecell s strattice mesh products are derived from porcine skin, but those who received these mesh implants report many of the same complications as others whose repairs involved other mesh implant products.
Strattice tm was introduced in the united states in february 2008. Critical analysis of strattice performance in complex. Strattice provides internal breast support upland, rancho. It has a special processing that removes all the cells and proteins that our body can react to so when it is placed it is essentially a sheet of proteins mainly collagen. Pdf complications in immediate breast reconstruction. This device is designed to perform as a surgical mesh for soft tissue. Strattice reconstructive tissue matrix, lifecell, branchburg, nj, usa along with a nissen fundoplication. The complaint pdf was filed by evelyn menjivar in the u.
Strattice reconstructive tissue matrix upland, rancho. Absorbable mesh is cheaper, and can be used without drains. Strattice is an expensive biologic material that requires drains. Several types of synthetic polytetrafluoroethylene, polypropylene, dacron and biological strattice, alloderm, surgisis, permacol matrices, both allogeneic and xenogeneic, have been applied for the reinforcement of hiatal hernia repair. Lifecell strattice mesh lawsuit hernia mesh attorneys. Sep 03, 2012 the objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh strattice. The sarasota heraldtribune here reports on the north port mans basketballsize hernia that protruded from his belly for more than five years. Critical analysis of strattice performance in complex abdominal wall reconstruction. It was reported that a very obese patient had a previous abdominal wall repair with a synthetic mesh that became infected and was explanted. Pictures nameoftheproducts stratticereconstructivetissuematrix. Use of strattice mesh in paraesophageal hernia surgery. Postoperative care recommendations strattice reconstructive. Sterile and pliable, strattice tm is derived from porcine tissue, which.
The structural properties minimize tissue attachment to the mesh. Full incorporation of strattice reconstructive tissue. Tissue reinforcement with strattice reconstructive tissue. Pdf comparison of permacol tm and strattice tm for. Strattice reconstructive tissue matrix surgical mesh device description strattice reconstructive tissue matrix strattice tm or the surgical mesh is a surgical mesh that is derived from porcine skin and is processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. Strattice was used as an underlay graft in all patients. Lifecell introduced alloderm back in the early 1990s and marketed it for use in dental surgery, reconstructive surgery, and skin grafts for burn injury patients. See safety informationand full instructions for use.
Aug 09, 2012 the high recurrence rate has led to the use of mesh reinforcement of the crural repair 3,4. Strattice reconstructive tissue matrix used in the repair. A sterilized, surgical mesh that is derived from porcine skin, and is processed and preserved in a patented aqueous phosphatebuffered solution containing matrix stabilizers2 a tissue patch designed to reinforce soft tissue where weakness exists, and for the surgical repair of damaged or ruptured soft tissue membranes2. Galaflex is an example of a mesh that would be ideal for use to make an internal bra to support dropped out implants. The strattice tissue matrix was inserted into the pocket with its hypotenuse running along the border of the pmm. Strattice tissue matrix is a sterile, structurally intact biological tissue matrix derived from porcine dermis. Strattice offers great benefits to women who have lost their natural breast shape over the course of years to ptosis or from an older breast. Specifically, the strattice reconstructive tissue matrix was cleared under k082176 as ltmbps surgical mesh for use as a soft tissue patch to reinforce soft tissue where weakness exists and for. Pdf chest wall reconstruction with strattice in an. Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. Lifecell corporation, one millennium way, branchburg, nj 08876 strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
Strattice mesh complications lawyer law offices of oeb. Strattice reconstructive tissue matrix is a surgical mesh used by plastic surgeons to reinforce weakened tissue in breast augmentation and revision surgery. Lifecell, the makers of strattice, has a directory of surgeons in your area that use strattice regularly. The b6 year old female subject active smoker more than 1 pack per day underwent a bilateral nipple sparing mastectomy with direct to implant reconstruction with silicone implants and adm acellular dermal matrix lifecell devices on b6 2014. Recurrence of diaphragmatic hernia after thoracoscopic repair. To report an adverse reaction, please call allergan at. Recurrence of diaphragmatic hernia after thoracoscopic repair with strattice patch, alemayehu h et al. The supplier of strattice tm, lifecell, also supplies alloderm regenerative tissue matrix, a product which has been used breast cancer reconstruction since 2002. It may help surgeons mask the implant and recreate breasts that are more natural looking and feeling than those made possible by traditional breast implant reconstruction techniques.
Find information for healthcare professionals on strattice reconstructive tissue matrix, intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. What are the possible complications associated with a breast. Surgical notes indicates the concern for fistula development. Strattice reconstructive tissue matrix product offerings. Pdf comparison of permacol tm and strattice tm for the. Strattice reconstructive tissue matrix used in the repair of.
This will be a casecontrol study comparing women who have had an immediate implantbased breast reconstruction with strattice case or without control. You are correct in that alloderm and strattice can both be used to help buffer the tissues of the breasts in order to conceal implant rippling. The objective of this study is to assess longterm outcomes of strattice based breast reconstructions in multiple breast surgery centres across the uk. Reconstructive tissue matrix following correction of severe breast deformity robert cohen, md, facs paradise valley, az case summary a combination of pocket correction, repositioning of the right pectoralis major muscle, inferior and superomedial fold correction that was reinforced with strattice reconstructive tissue matrix, and. This dermal graft protects and supports the breast implant in cancer patients, and it can likewise be used to correct the position of breast. These are both dermal products, one from humans and the latter from pigs, that are used mostly in breast reconstruction but have recently been used more frequently for cosmetic breast revision cases. Strattice reconstructive tissue matrix bps m328con10060. What are the possible complications associated with a. Potential adverse events are those typically associated with the surgical mesh materials andor their implantation procedures including, but not limited to, infection, foreign. The placement of the mesh and method of fixation are believed to be crucial to the success of the graft.
Accessgudid strattice reconstructive tissue matrix m32810200020 strattice reconstructive tissue matrix, 10 x 20, firm. Strattice reconstructive tissue matrix with an implant. Lifecell is an allergan subsidiary based in new jersey. Strattice instructions for use, lifecell corporation, 2015. Sep 27, 20 in general, i think strattice is a very useful product, but i dont believe its use is always necessary for achieving your goals. Breast reconstruction outcomes with and without strattice. On b6 2011, it was noted that the bioa mesh had disintegrated along with partial lifecell device disintegration. He did comment that this particular patient is a very poor healer. Strattice reconstructive tissue matrix m32810200020. On b6 2014, the surgeon performed a bridge repair with strattice in which the strattice was underlay secured to the rectus using transabdominal 20 pds suture. Strattice tm consists of a terminally sterilized sheet of processed porcine dermal matrix. Pdf introduction immediate breast reconstruction ibr is becoming increasingly popular.
With the introduction of strattice tissue matrix contour pieces, today a strattice tissue matrix contour 2 could be used. Strattice tm reconstructive tissue matrix is a soft, natural product from lifecell that is designed to reinforce weak tissue. Artia reconstructive tissue matrix specifically surgeries1,2. Postoperative skin and soft tissue infections can be managed without explantation of mesh.
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