A quantum leap in patient safety

World premiere at German Surgeons' Congress: "Titanized" breast implants!! The "titanization" of silicone implants reduces the foreign body reaction and thus the risk of reoperation by a considerable margin. Approximately 70,000 women have their breasts augmented in Germany every year.



Nürnberg/Munich . What Hollywood stars have been doing for decades has been practised in Germany for quite some time as well: cosmetic surgery. Most of the big names in the entertainment industry have made use of these methods in one way or another to help nature along. One of the most frequent cosmetic operations is aesthetic breast augmentation or complete breast reconstruction, for instance following cancer surgery. Around 70,000 women in Germany have received silicone breast implants for these reasons. In the US the figure is around 250,000 per year. In spite of many advances seen in recent years, the risk of a foreign body reaction to silicone implants in the human body remains. In extreme cases of so-called capsular fibrosis, the encapsulated, deformed and hardened implants have to be removed and replaced. The implants used to date all consist of a smooth or texturized silicone shell filled with a silicone gel or a saline solution. Those filled with saline solution have one decisive drawback: The breast may cool down considerably in winter, for instance during skiing. Smooth silicone implants may shift or get turned around. There is currently a consensus among the experts that texturized silicone shells filled with silicone gel are preferable. However, one fact has not changed: The shell is made of the plastic silicone!



For this reason, physicians and patients alike have for years been demanding development of a biocompatible material that would solve the foreign body reaction problem once and for all. As a matter of fact, such a material has been known for a long time: titanium! Titanium has been scientifically recognized as a biocompatible material for decades now. It is readily accepted by the human body and is tolerated over the longer term as well. Thousands of hip and knee joints as well as dental prostheses made of titanium are implanted every year. Wherever natural flexibility is required, e.g. in reinforcement of soft tissues or in vascular implants, plastic is the material that is used. Plastics have established a solid reputation for their usefulness in many fields of modern medicine. Despite the successful use of pure plastic implants, surgeons are still searching for a physiologically tolerable implant material due to the residual risk of a foreign body reaction, although the consequences are not always as dramatic as in capsular fibrosis.



The echo in European medical circles was understandably jubilant when GfE-Medizintechnik in Nürnberg announced a completely new composite material at last year's Congress of the German Surgeons' Association: "titanized plastic." In this new composite material, the plastic substrate is given a very thin coating of titaniumæ really only a few atomic layers thick. This titanium layer is so thin that it remains as flexible as the plastic. The titanium atoms are chemically bound to the plastic, so that the layer cannot be detached. This revolutionary techniquehas for the first time combined the advantages of both implant materials: the excellent physiological tolerance of titanium and the natural flexibility of plastic. A decisive advantage of titanization is that body tissues are only in contact with the biocompatible titanium and accept the titanized implants for the life of the patient.



That may sound simple, but as is frequently the case in science, the development of the titanization technology was a genuine engineering challenge. With the objective of developing biocompatible implant materials, the FORBIOMAT Research Project was launched in 1996 by the Bavarian Research Association for Biomaterials. The industrial partner on this research project was the parent company of GfE-Medizintechnik , the traditional company GfE-Gesellschaft für Elektrometallurgie in Nürnberg. Die GfE has been working in the fields of metals, ultrathin coatings and high-tech materials for nearly a century. Examples of their work include the titanium coatings of hip implants they have been supplying for a number of years now to well-known medical companies. The company was quite simply a logical choice when the Bavarian Government set out to find an experience, innovative partner in the material sciences field. And the effort paid off in the end, because one of the results of this project was the revolutionary titanization technology of GfE and the physiologically compatible composite material "titanized plastic."



This new composite material is already showing what it can do in the field of hernia surgery. This is the most frequently performed medical operation of all. Half of the approximately 250,000 patients who undergo this operation every year receive a so-called mesh implant to reinforce the defective connective tissues. The mesh material had previously been made of polypropylene. Since the middle of last year, the first product made of "titanized polypropylene" has been on the market under the product name <TiMESH> and has seen widespread use all over Europe. Over 60,000 TiMESH units were sold the first year and used very successfully in major European clinics. This comes as no surprise to Prof. Dr. Ferdinand Köckerling, who contributed to the development of TiMESH,: "In modern hernia surgery there are two things we need: as little foreign material as possible and material that is as biocompatible (tissue-compatible) as possible. That is what our patients demand." Professor is the Senior Physician of the Surgical Clinic and Centre for Minimally Invasive Surgery in the Hannover Clinics, Siloah, and is one of Europe's leading specialists in the field. GfE's titanized mesh material satisfies the needs of the medical experts in an ideal manner: TiMESH extralight is the lightest mesh implant material on the market, weighting 16g/m_. Thanks to titanization, the body tolerates and incorporates it in an optimal manner.



Europe's surgeons, and the success of the new mesh implants have encouraged GfE Medizintechnik in their intentions to apply their titanization technology to more plastics in addition to polypropylene, for example silicone. In the fields of aesthetic breast augmentation and reconstruction, patients and physicians have been looking for more biocompatible silicone implants for years. The company is presenting the world's first titanized breast implant a the 120th Congress of the German Surgeons' Association. The implant product bears the name <TiBREEZE> and comprises a titanized silicone shell. It is texturized and filled with a cohesive silicone gel. "In our development of TiBREEZE we based our work on state-of-the-art scientific knowledge. We are proud of the quantum leap in patient safety represented by the GfE titanized breast implants," says Helmut Fricke, General Manager of GfE-Medizintechnik, clearly convinced that the titanized breast implants will be a major success.



Further products made of "titanized plastic" were also introduced for the first time at the Congress: "titanized suture material <TiGOOD>. This biocompatible suture material for skin closure and implant fixation in soft tissues, e.g. in hernia mesh, reduces the foreign body reaction and therefore accelerates the healing process. This is very important from the point of view of the patient, since it results in a cosmetically optimized skin suture. The mesh implant TiMESH will also be available in new variants for other surgical applications.




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