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<h3 align="center">*** IMPORTANT ANNOUNCEMENT *** </h3>
<p align="center"><span style="color: rgb(255, 0, 0);"><strong>Johnson & Johnson announced their intention to discontinue the manufacture and marketing of EVOLENCE® products.</strong></span> </p>
<p>Patients and medical professionals who may currently be using EVOLENCE® products can be assured that they remain effective for the approved indications with a favourable safety profile. EVOLENCE® products will continue to be supported for medical inquiries and adverse event reporting, in accordance with regulatory requirements. </p>
<p>For more information please visit: <a href="http://www.evolence.com" rel="nofollow" target="_blank">www.evolence.com</a>. If you have any questions about your current treatment programme, please contact your EVOLENCE® practitioner. </p>
<p align="right"><span style="font-family: Arial; font-size: 8pt;">Reported: 3rd Nov 2009 </span></p></td></tr></tbody></table></p>
<h3>Product Summary</h3><img alt="Evolence Logo" align="right" src="https://www.consultingroom.com/uploads/Image_Directory/Product/evolence_logo.gif " /> 
<p>Launched in the UK at the beginning of 2005, EVOLENCE™ is a new, collagen-based dermal filler manufactured by ColBar LifeScience (now part of OrthoNeutrogena, a division of Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company). It was officially launched in Europe in October 2004 at the 13th EADV Congress in Florence, Italy. </p>
<p>It is intended for the correction of wrinkles, nasolabial folds, scars, atrophy from disease or trauma, defects secondary to rhinoplasty (nose surgery), skin graft or other surgically-induced irregularities and other soft tissue defects or deficiencies.</p><br />
<h3>Generic name </h3>
<p>EVOLENCE™ is supplied in a single-use syringe and is composed of 1 ml (35 mg/ml) of highly purified, cross-linked porcine collagen dispersed in phosphate buffered saline solution.</p><br />
<h3>What does it contain? </h3>
<p>The highly purified collagen in EVOLENCE™ is derived from porcine (pig) tendons. </p>
<p>Due to their high degree of compatibility with the human body’s immune system, porcine collagen materials are often used in human medicine, e.g., in heart valve replacements, implantable lenses, and surgical wound dressings. </p><br />
<h3>How is it made? </h3>
<p>Using their patented Glymatrix™ technology, they firstly break down the source material into pure collagen molecules. Then they re-create the strong, long-lasting bonds that exist in nature using a naturally occurring sugar, ribose. The result is a collagen substantial enough to fill even deep facial contours instantly but with a low viscosity making it easy to inject.</p><br />
<h3>Is a skin test required before treatment? </h3>
<p>EVOLENCE™ is natural product and due to the Glymatrix™ technology it is able to mimic the properties of the natural collagen found in the skin. Therefore, while an allergic reaction is theoretically possible, it is extremely rare so pre-testing is not required before treatment with EVOLENCE™. </p>
<p>However, patients with a history of hypersensitivity, particularly known allergies to collagen, should consult their doctor about having a skin test performed first.</p><br />
<h3>Is it temporary or permanent? </h3>
<p>EVOLENCE™ is a long lasting temporary filler, which the manufacturers claim will last at least 12 months.</p>
<p>Collagen is completely broken down within the skin over a period of months, eventually leaving no trace of the filler.</p><br />
<h3>Licenced status </h3>
<p>Medical device.</p><br />
<h3>Should be used by </h3>
<p>Trained members of the medical profession only.</p><br />
<h3>Product range </h3>
<p><em><strong>EVOLENCE™ </strong></em></p>
<p>Supplied in a single-use 1 ml (35 mg/ml)syringe . </p>
<p><em><strong>EVOLENCE™ BREEZE </strong></em></p>
<p>The manufacturers plan to extend the EVOLENCE™ product range to consist of four products that will enable the treatment of fine lines and wrinkles, the adding of fullness to lips, the shaping of facial contours, and the correcting of deep facial folds. The first of this new range, EVOLENCE™ Breeze, recommended for upper to mid dermis wrinkle correction has already obtained a CE mark for sale in Europe.</p><br />
<h3>Not to be used in </h3>
<p>EVOLENCE™ is not recommended for use in:</p>
<p>
<ul><li>the periorbital area, (around the eyes);</li><li>in pregnant or breast-feeding women, as the safety of treatment with EVOLENCE™ in these cases has not been tested;</li><li>in patients with known hypersensitivity to any collagen products;</li><li>in patients with a history of anaphylactic reactions or serious recurrent allergic reactions;</li><li>in patients undergoing or planning to undergo desensitisation injections to porcine meat products, as these injections can contain porcine collagen;</li><li>in breast augmentation or implantation into bone, tendon, ligament or muscle. </li></ul>
<p> </p>
<p>EVOLENCE™ should also be used with caution in:</p>
<p>
<ul><li>The vermilion border of the lip, as other collagen fillers have shown that overcorrection of this area has been slow to resolve due to minimal tissue stresses at this site.</li><li>Patients on immunosuppressive therapy or those with known connective tissue diseases </li></ul>
<p> </p>
<p>It is also recommended that the use of EVOLENCE™ in individual patients be limited to 10ml over a one-year period.</p><br />
<h3>Duration of effect </h3>
<p>The manufacturers claim that EVOLENCE™ will produce aesthetically pleasing results that will be visibly maintained for at least 12 months.</p><br />
<h3>Reported side effects </h3>
<p>As with any injection, patients using substances which may reduce coagulation, such as aspirin and non-steroidal anti-inflammatory drugs, may experience increased bruising or bleeding at the injection site</p>
<p>The injections produce some mild discomfort that is easily controlled with application of a local anaesthetic cream beforehand.</p>
<p>A few patients may experience mild swelling or itching for a few days after injection. </p><br />
<h3>Costs </h3>
<p>This depends on area treated and how much is required, and the practitioner doing the treatment, but price ranges are in the region of: £380 - £450 per syringe of EVOLENCE™</p><br />
<h3>Clinical results </h3>
<p>In a pre-clinical study, EVOLENCE™ 30, a lower concentration formulation of 30 mg/ml, was compared with the bovine collagen fillers Zyplast® and Zyderm® in a rabbit ear model. </p>
<p>Analysis of the size and shape of the injected implant showed that while the shape of the EVOLENCE™ 30 implant was maintained for a 12-month period, there was significant decrease of the Zyplast® and Zyderm® implants over time. </p>
<p>The superior shape preservation observed with EVOLENCE™ 30 can be explained by a combination of reduced degradation and lack of displacement of material from the injection site.</p>
<p>Furthermore, in a clinical trial, EVOLENCE™ 30 produced immediate effects on nasolabial folds equivalent to those produced by Zyplast®. However, EVOLENCE™ 30 showed extended contour correction compared to Zyplast® over an average period of 15 months.</p>
<p>Compared to Zyplast®, EVOLENCE™ was rated as having better wrinkle correction at 15 months by blinded assessors, treating clinicians, and patients participating in the trial.</p>
<p align="center"><img border="1" hspace="9" alt="Longevity of Evolence Effect Chart" src="https://www.consultingroom.com/uploads/Image_Directory/Product/longevity_evolence.jpg" /> </p>
<p align="center">(chart from ColBar LifeScience Ltd) </p>
<p align="center">Preclinical study and Clinical study report – Data on file – ColBar LifeScience Ltd. </p>
<p align="center"><img border="1" hspace="9" alt="Before and after treatment with Evolence" src="https://www.consultingroom.com/uploads/Image_Directory/Product/evolence_BandA_nasolabial.JPG" /></p>
<p align="center">Nasolabial lines on a female patient - before (left) and after treatment with Evolence™ (right). </p>

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