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Material sciences & engineering

ADM/MESH/Implants

The below content has been supplied directly by innovators/industry and does not imply endorsement from iBRA-NET.

01

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Motiva Flora® Tissue Expander (two-stage anatomical saline fill) is the first device of its kind that comes with an integrated Radio Frequency Identification (RFID) port. An air wound coil containing RFID technology embedded in the needle stop is activated externally, allowing surgeons to achieve an exact localisation of the injection site through an LED indicator on the ergonomic port Locator. It has no magnets, allowing for MRI scanning during the expansion process. Traditional tissue expanders have magnetic ports that create significant safety issues, substantial signal losses, and distortion on MR images and are labeled “MR Unsafe”.

 

References:

  • Mungunchimeg Bayasgalan, Alexandre Mendonça Munhoz, Frank G Shellock. Breast Tissue Expander With Radiofrequency Identification Port: Assessment of MRI Issues. AJR Am J Roentgenol. 2020 Jul;215(1):159-164. doi: 10.2214/AJR.19.22492. Epub 2020 May 14.

03

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Exa-flex is a unique bi-layer membrane obtained through the processing of bio-secure bovine pericardium. Developed exclusively for use in breast reconstruction surgery, the Exa-flex membrane is processed using a proprietary process which allows the extraordinary characteristics of the natural pericardium to be preserved. Exa-flex ensures a rapid integration with each of the two layers carrying out a specific task in the integration process; Fibrous layer: is highly porous, it accepts the cells and together with the matrix components collaborates with cytokines and growth factors for immediate regeneration and early neoangiogenesis. Compact layer: gives support to the matrices. The Exa-flex Pocket for elective use in immediate pre-pectoral breast reconstruction is designed to revolutionise the surgical procedure. When the membrane is rehydrated it allows anterior coverage of the implant in around 60 seconds, without the time-consuming adaptive procedures which involve surgical delays, risks of accidental damage to the breast prosthesis and greatly reduces the relative risk of contamination. The pre-formed mesh is re-hydrated, with the smooth side (intended to receive the prosthesis) facing the operator. The anterior surface of the implant is placed on the membrane, by drawing the double purse-string, the “petals” are fixed in a few seconds to the back side of the prosthesis. By tying off the purse-strings; thanks to the drapability of the material and to the mesh configuration, The Exa-flex Pocket fully covers the anterior surface and partially the posterior surface of the prosthesis without any unnecessary excess material. The assembly is ready to be positioned, even without the need of sutures for fixing to the chest wall; the high superficial friction coefficient provided by the fibrous side in contact with the skin flap ensures considerable grip.

 

References:

  • Semprini G1, Cattin F, De Biasio F, Cedolini C, Parodi PC. The bovine pericardial patch in breast reconstruction: a case report. G Chir. 2012 Nov-Dec;33(11-12):392-4.

  • Uppara Mallikarjuna, Minahil Mujahid, Richard Pilkington, M Shaheer, Pervaz Mujahid, A cellular bovine pericardium in implant-based breast reconstruction: A systematic review of the literature. European Journal of Plastic SurgeryAugust 2017, Volume 40, Issue 4, pp 265–270

  • Hugh Logan Ellis, Oluwatosin Asaolu, Vivien Nebo, Abdul Kasem, Biological and synthetic mesh use in breast reconstructive surgery: a literature review. World J Surg Oncol. 2016; 14: 121

02

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CELLIS® Breast is manufactured using an exclusive process based on our high experience with tissue acellularisation, this process preserves the essential qualities of the best porcine dermis. Elemental Healthcare offer a complete range of solutions for both pre- and sub-pec reconstructions and the Cellis matrix provides strength and flexibility conforming to a variety of implants and patient anatomy. Cellis is preservative-free and non-crosslinked which ensures that the collagen is kept native and allows for fast remodelling (in 3 months) and quick revascularisation of the reconstructed tissue which minimises adverse reactions and complications. CELLIS BREAST POCKET for pre-pectoral breast reconstruction, is a unique 3D pocket shape which hosts the ideal combination of meshed and non-meshed material to provide flexibility and strength. The 3 finger-like, solid mesh areas provide additional strength and prevent over-expansion. CELLIS BREAST MESHED for pre-pectoral breast reconstruction, provides maximum coverage with minimal material and specific borders for easy and secure fixation. CELLIS BREAST for sub-pectoral breast reconstruction is designed with fenestrations to help fluid drainage and offers strength and reliability in an easy to handle matrix with a quick hydration process.

 

References:

04

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Fortiva 1mm Perforated is an Acellular Dermal Matrix derived from Porcine. It is licensed throughout Europe for Breast Reconstruction meaning it can be used in both Sub-Pectoral (Dual Plane) Reconstruction and Pre-Pectoral Reconstruction. It comes in four sizes: 8x16cm, 10x16cm, 16x20cm and 20x25cm. With the cost savings ranging up to £900 per breast in Sub-Pectoral reconstruction, and up to £3,300 per breast in Pre-Pectoral (based on list pricing of current products). RTI Surgical is currently running two studies in the UK: - A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction (APPeaR). - MAP-BRA - RTI is proud to be the first ADM to follow the credo of iBRA's "No innovation, without evaluation" by placing Fortiva into MAP-Bra prospective cohort study which will look at the effectiveness of Fortiva in Sub-Pectoral and Pre-Pectoral implant based reconstruction, by comparing clinical and patient reported outcomes from the NIHR funded iBRA study. RTI surgical is one of the worlds largest suppliers of tissue with more that 8 million biologic implants having been processed through RTI’s proprietary validated sterilisation processes with zero confirmed incidence of implant-associated infection. PFM Medical are out sole distribution Partner in the UK

05

SurgiMend® PRS Meshed is unique; it is an expandable acellular dermal matrix derived from foetal bovine dermis, which provides up to twice the initial coverage once fully hydrated. The first MHRA approved ADM solution for pre-pectoral implant based reconstruction. Strong and flexible enough to meet the needs of plastic and reconstructive surgeons. Sterile and ready to use ensuring critical and costly theatre time is optimised. SurgiMend® PRS Meshed is indicated for plastic and reconstructive surgery, including specifically pre-pectoral breast reconstruction. The matrix is used to support and stabilize the breast implant, ensuring it is held in the correct position on the chest wall. It minimises unwanted movement as SurgiMend® PRS Meshed conforms to the surface of the breast implant more completely than fenestrated or solid products. SurgiMend® PRS Meshed is made from exactly the same bovine dermis we produce our sub pectoral PRS products from and works in harmony with your patients own tissues providing dependable support – without any detrimental inflammatory response.

Key Advantages: The ideal solution to pre-pec implant based reconstruction. High in type III collagen. Hydrates quickly. No detrimental inflammatory response. Classified as a category 4 non irritant by the World Health Organisation. Excellent handling characteristics with the strength to control and support the implant. Mesh expansion up to ~18cm x 22cm. Rapid revascularisation to support tissue building. Easily conforms to round or anatomical breast implants. It has been available since 2018 with over 1700 pieces implanted in the UK only (as of December 2019).

 

References:

  • 440 Consecutive immediate, implant-based, single-surgeon breast reconstructions in 281 patients: a comparison of early outcomes and costs between SurgiMend fetal bovine and AlloDerm human cadaveric acellular dermal matrices. Butterfield JL Plast Reconstr Surg. 2013 May;131(5):940-5

  • Initial experience with the use of foetal/neonatal bovine acellular dermal collagen matrix (SurgiMendTM) for tissue-expander breast reconstruction Ohkuma R, Buretta KJ, Mohan R, Rosson GD, Rad AN Journal of Plastic, Reconstructive & Aesthetic Surgery (2013) 66, 1195e1201

  • A Head-to-head Comparison between SurgiMend and Epiflex in 127 Breast Reconstructions. Eichler C, Vogt N, Brunnert K, Sauerwald A, Puppe J, Warm M Plast Reconstr Surg Glob Open. 2015 Jul 8;3(6):e439.

06

TIGR Matrix - strong when needed, gone when you don't. The ideal matrix material for breast reconstruction and support. TIGR Matrix is the world's first long-term resorbable, 100% synthetic mesh, made from materials that have been in clinical use since the 1970's (lactide, glycolide, trimethylene carbonate). It's unique technology consists of dual degradation and full resorption. Over time TIGR Matrix degrades and the support load is gradually transferred to the newly regenerated tissue during the remodeling phase, resulting in new supportive and protective functional tissue. TIGR Matrix is rapidly integrated into the surrounding tissue by deposition of new collagen and the formation of new blood vessels. Specifically designed for soft tissue repair and used by surgeons world-wide in reconstructive surgery. TIGR Matrix is strong whilst remaining soft and pliable, ideally when preforming implant based breast reconstruction, either sub-pectoral or pre-pectoral and for support to breast tissues in secondary breast augments and mastopexy patients. The untwisted multifilament fibers allow new tissue to integrate fully through the porous structure as well as in-between each fiber. Clinical data shows extremely low complication and implant loss. TIGR Matrix is easy to use and handle and can be cut and trimmed where required. The multifilament structure allows suturing even into the corners.

 

References:

  • Pompei, S., Evangelidou, D., Arelli, F., Ferrante, G. The use of TIGR Matrix in breast aesthetic and reconstructive surgery. (2018) Clin Plast Surg. 45(1):65

  • Hallberg, H., Lewin, R., Elander, A., Hansson, E. TIGR Matrix surgical mesh - a two-year follow-up study and complications analysis in 65 immediate breast reconstructions. (2018) J Plast Surg Hand Surg. 52(4): 253.

  • Sharma, S., Van Barsel, S., Barry, M., Kells, R.M. De novo experience of resorbable woven mesh in immediate breast reconstruction post-mastectomy. (2016). Eur J. Plast Surg. 40(1): 17-22.

07

B-Lite® the first and only Lightweight Breast Implants in the world. Up to 30% lighter than conventional implants – B-Lite® implants reduce the stress and strain on the breast soft tissue, and maintain the shape and appearance of the breast in the long term. The uniquely lightweight B-Lite® series has revolutionised the world of breast implants and is considered one of the most significant developments in the industry over the last 30 years. To achieve this, B-Lite® combine proven materials with breakthrough technology: the standard silicone gel filling is enhanced with special microspheres and is designed to reduce the effects of gravity. The result is an implant that combines comfort with sustainable aesthetics; less ptosis, atrophy, rippling and patient discomfort. When compared to conventional implants, patients with B Lite implants also experienced less post-operative surgery pain, required less analgesia, had shorter recovery times and faster return to normal activities. The microsphere design also enables improved imaging on mammography and ultrasound. The B-Lite® series implants have been available since January 2019 and are currently manufactured in round and anatomical shapes with a microtextured POLYtxt® surface.

 

References:

  • Govrin-Yehudain, Jacky et al: Lightweight Breast Implants: A Novel Solution for Breast Augmentation and Reconstruction Mammaplasty, Aesthet Surg J. 2015 Nov; 35(8): 965–971. doi: 10.1093/asj/sjv080

  • Gunter Germann, Jacky Govrin, Chris Inglefield, Nikolaus Raab, Dauro Reale, Philip Turton. Post-Market Survey 2017; G&G; Data on file.

  • Govrin-Yehudain, Matanis Y, Govrin-Yehudain J.Aesthetic Surg J. 2018.oct;38(10):1092-1096;doi 10.1093/asj/sjy071