疝修补设备市场分析报告 Hernia Repair Device Markets and Procedures

Hernia Repair Procedures and Specialty Equipment MarketsRures adquireret umbraculi, etiam tremulus matrimonii libere senesceret appSeptember 2010Kalorama InformationA division of MarketR38 East 29th Street Sixth FloorNew York, New York 10016212.807.2660 t800.298.5603 t212.807.2676 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited MARKETS FOR HERNIA REPAIR PROCEDURES AND SPECIALTY EQUIPMENT A KALORAMA INFORMATION MARKET INTELLIGENCE REPORT The Markets for Hernia Repair Procedures and Specialty Equipment has been prepared by Kalorama Information. We serve business and industrial clients in the United States and abroad with a complete line of information services and research publications. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-oriented executive by providing a thorough presentation of essential data and concise analysis. Author: Mary Anne Crandall Publication Date: September 2010 38 East 29thStreet New York, New York 10016 (800) 298-5699 Outside the U.S. (212) 807-2657 FAX: (212) 807-2676 www.KaloramaI E-MAIL: Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY.1 Background. 1 Scope and Methodology . 2 Size and Growth of the Market. 3 Key Issues and Trends Affecting Market. 6 Leading Competitors. 7 CHAPTER TWO: INTRODUCTION.9 Overview. 9 Types of Hernias. 10 Inguinal Hernia. 10 Indirect 10 Direct . 10 Anterior Approaches. 11 Plug-and-Patch Repair . 11 Posterior Approaches . 11 Femoral Hernia. 11 Umbilical Hernia. 12 Ventral Hernia. 12 Hiatal Hernia . 12 Risk Factors . 13 Complications of Hernia Repair Procedures . 14 World Demographics .15 Prevalence, Incidence and Mortality . 22 Insurance for the Elderly in the United States. 22 Wound Healing in Hernia Repair . 24 Hernia Wound Healing Process . 25 Defense Against Injury.25 Mononuclear Phagocyte System. 26 Inflammatory Response. 26 Wound Healing Process . 27 Primary Intention. 27 Secondary Intention . 29 Tertiary Intention.29 Delays of Hernia Wound Healing . 29 Complications of Wound Healing. 31 Table of Contents ii Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Hypertrophic Scars and Keloid Formation. 31 Contracture . 31 Dehiscence . 31 Excess Granulation Tissue . 32 Adhesions . 32 CHAPTER THREE: HERNIA REPAIR PROCEDURES AND SPECIALTY PRODUCT ANALYSIS.33 Types of Hernia Repair Procedures .33 Tension Repair.33 Open Tension-free Repair.34 Laparoscopic Tension-free Repair.34 Other Tension-Free Methods .35 Overview of Products .36 Mesh Repair.36 Product Properties.36 Polymers.36 Polypropylene.36 Polyester.37 PTFE .37 Biologics.37 Prosthetic Mesh Repairs .37 Industry Participants and Product Description .38 Bard/Davol .38 Ethicon .40 Minnesota Medical Development.41 Covidien .41 TEI BioSciences.41 LifeCell .42 Organogenesis.42 W.L. Gore .42 Cook .43 Atrium.43 Surgical-IOC .44 GfE Medizintechnik GmbH .44 B Braun Aesculap Division .45 Synovis Life Technologies .45 Nicast Ltd .45 SafeStitch Medical.46 Biomerix Corp .46 Aspide Medical.46 Tutogen Medical.46 Table of Contents iii Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited CHAPTER FOUR: ISSUES AND TRENDS.49 Advances In Hernia Repair . 49 BioMD. 50 T-Shaped Prosthesis . 51 Sports Hernia Repair . 52 Laparoscopic Hernia Repair . 52 Procedures in England. 55 Fetal Treatment of Hernia. 57 Robotics, MIS and Hernia Repair. 57 Physio Hernia Repair. 58 Hospital- Acquired Infection . 59 Kugel Recall . 60 Biotextile Hernia Implants.62 Obesity, Men and Hernia Development . 64 Implantable Electrical Stimulator . 65 PatchAssist Hernia Mesh Placement Tool. 66 Patent Analysis of top competitors. 66 CHAPTER FIVE: MARKET AND COMPETITOR ANALYSIS .69 Market Overview. 69 Market Analysis by Product Type. 72 Market Analysis by Country . 74 Competitive Analysis .76 CHAPTER SIX: LEADING MANUFACTURERS .81 Overview. 81 Atrium Medical Corporation . 82 B Braun Aesculap Division. 84 Cook Group/ Cook Medical. 86 Covidien Ltd. . 88 CR Bard/Davol . 90 Ethicon, Inc. . 94 LifeCell Corporation. 96 Synovis Life Technologies, Inc . 98 Table of Contents iv Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited TEI Biosciences .100 W. L. Gore & Associates Inc.102 APPENDIX: LIST OF MAJOR COMPANIES.105 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited TABLE OF EXHIBITS CHAPTER ONE: EXECUTIVE SUMMARY.1 Table 1-1: Forecasted Hernia Repair Procedures and Specialty Equipment Market Analysis: 2008-2012. 4 Figure 1-1: Hernia Repair Procedures and Specialty Equipment Market Analysis: 2008-2015. 5 CHAPTER TWO: INTRODUCTION.9 Table 2-1: World Population by Selected Geographical Region, 2010-2050. 16 Figure 2-1: World Population by Selected Geographical Region, 20102050. 17 Table 2-2: Estimated World Population by Age and Geographical Region, 2009. 18 Figure 2-2: Estimated World Population by Age and Geographical Region, 2009 . 19 Table 2-3: Percent Population Over 65 by Year and Region. 20 Figure 2-3: Estimated World Population by Age, 2009 and 2050 . 21 Table 2-4: Health Insurance Trends in the United States, Estimated 2009. 23 CHAPTER THREE: HERNIA REPAIR PROCEDURES AND SPECIALTY PRODUCT ANALYSIS.33 Table 3-1: Select Products and Manufacturers of Polymer and Prosthetic Mesh Hernia Repair Procedure Products .47-48 CHAPTER FOUR: ISSUES AND TRENDS .49 Table 4-1: Finished Consultant Episodes for Repair of Inguinal Hernia and % with Laparoscopic Surgery in 2008/2009. 56 Table 4-2: Selected Top Competitor Patents.67-68 CHAPTER FIVE: MARKET AND COMPETITOR ANALYSIS .69 Table 5-1: Forecasted Hernia Repair Procedures and Specialty Equipment Market Analysis: 2008-2015. 70 Figure 5-1: Hernia Repair Procedures and Specialty Equipment Market Analysis: 2008-2015. 71 Table 5-2: Hernia Repair Procedures and Specialty Equipment Market Analysis by Product Type, 2009. 73 Table of Exhibits vi Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Figure 5-1: Hernia Repair Procedures and Specialty Equipment Market Analysis by Product Type, 2009 .73 Table 5-3: Hernia Repair Procedures and Specialty Equipment Market Analysis by Region/Country, 2009 .75 Figure 5-2: Hernia Repair Procedures and Specialty Equipment Market Analysis by Region/Country, 2009 .75 Table 5-4: Hernia Repair and Specialty Equipment Market Revenues and Market Share of Leading Suppliers, 2009 .79 Figure 5-3: Hernia Repair and Specialty Equipment Market Market Share by Leading Suppliers, 2009 .80 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited CHAPTER ONE Executive Summary BACKGROUND The worldwide economic downturn produced cutbacks in hospital capital budgets and reductions in selected hospital admissions and elective surgeries. Uncertainty regarding changes in the U.S. health care system, coupled with continued severe cost constraints on global health care systems in general, have sustained this trend into 2010. Although demographics and the growing prevalence of age-related diseases and increasing obesity would appear to support resumed market growth, manufacturers are understandably concerned about the timing and magnitude of market recovery as competition intensifies for increasingly scarce health care funds. With the need to reduce the rate of hernia recurrence, as well as postoperative pain and convalescence, the treatment of hernias underwent a dramatic evolution over the past 15 years. The major advances included the introduction of the concept of tension-free hernia surgery, the use of prosthetic materials, and the development of laparoscopic techniques The development of prosthetic materials ushered in the current era of hernia surgery, allowing a tension-free repair to be performed even for the largest defects and the most difficult procedures. Tension-free mesh-based repairs (eg, Lichtenstein, plug and patch) began to increase in number in the late 1980s. More recently, with the advent of laparoscopy for general surgery, various laparoscopic techniques have been developed for hernia repair. Laparoscopic mesh-based techniques dominate the Executive Summary 2 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited inguinal hernia repair marketplace. The Lichtenstein tension-free mesh onlay repair is the most frequently performed inguinal hernia operation, with a recurrence rate of less than 1%. Although the use of laparoscopic techniques for bilateral or recurrent hernias is now accepted, the application of laparoscopy to unilateral primary inguinal hernias remains controversial During the past decade, medicine has witnessed a revolutionary change in prosthetic biomaterials for application in hernia repair. Composite mesh with absorbable and non-absorbable barriers for intraperitioneal placement, lightweight macroporous mesh and xenogeneic and allogeneic biological meshes are several of these novel materials SCOPE AND METHODOLOGY The reports geographic scope is worldwide with information for specific geographical regions； world demographics； life expectancy by country, and other general issues affecting the market. Information is presented as a worldwide overview, with special emphasis on the U.S., Europe, and other key markets. A market summary includes market analysis by product and region and a competitive analysis of leading providers. Additionally, key company profiles are included. The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study, Kalorama Information conducted interviews with more than 16 key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives. All market data pertains to the world market at the manufacturers level. The base year for data was 2009. Historical data was provided for the years 2008, with forecast data provided for 2010 through 2015. Compound annual growth rates Executive Summary 3 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited (CAGRs) are provided for 2008-2015 periods for each region and/or segment covered. Competitive analysis is provided for the year 2009. The forecasted market analysis for 2009-2015 was largely based on demographic trends, new developments, innovative technology and global expansion. SIZE AND GROWTH OF THE MARKET Worldwide, millions of dollars are spent annually on hernia repair. In 2009, sales to treat hernia repair reached $2.3 billion, increasing 15.6% from $2.0 million in 2008. See Table 5-1. A major contributing factor to growth is the aging worldwide population. An aging population coupled with other risk factors such as obesity is contributing to the rise in hernia incidence worldwide. In 2015, the hernia repair procedures and specialty equipment market is expected to reach $4.5 billion, displaying growth of 12.3% over the period. Demand for innovative product designs, less complications and the trend toward minimally invasive techniques to repair hernias are major factors expected to drive growth in the product and specialty equipment segment of this market. See Tables 1-1 and Figure 1-1. Executive Summary 4 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Table 1-1 Forecasted Hernia Repair Procedures and Specialty Equipment Market Analysis: 2008-2012 (in millions of dollars at the manufacturers level) Year Revenues Percent Change 2008 $2,120.3 21.4% 2009 2,556.0 20.5 2010 3,055.6 19.5 2011 3,556.2 16.4 2012 4,122.6 15.9 Compound Annual Growth Rate 2008-2012 18.7 % Source: Kalorama Information Executive Summary 5 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Figure 1-1 Hernia Repair Procedures and Specialty Equipment Market Analysis: 2008-2015 $2,120$2,556$3,056$3,556$4,123$0$500$1,000$1,500$2,000$2,500$3,000$3,500$4,000$4,5002008 2009 2010 2011 2012Source: Kalorama Information Executive Summary 6 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited KEY ISSUES AND TRENDS AFFECTING MARKET There are several issues and/or trends that are directly and indirectly affecting the hernia repair market. Although hernia repair has been performed for many years, technological advances in both methods and materials have had a large impact on the market recently and will continue to influence the market in the future. Some of the issues and trends impacting the market today and in the future include: Advances in Hernia Repair Sports Hernia Repair Laparoscopic Hernia Repair Procedures in England Fetal Treatment of Hernia Repair Robotics, MIS and Hernia Repair Physio Hernia Repair Hospital Acquired Infections Kugel Recall Biotextile Hernia Implants Obesity, Men, and Hernia Development Implantable Electrical Stimulator PatchAssist Hernia Mesh Placement Tool Patent Analysis Executive Summary 7 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited LEADING COMPETITORS A handful of companies are involved in the development or marketing of hernia repair procedures and specialty equipment market. The market is considered immature with development opportunity. Developing and developed markets alike have room to grow due to an aging population worldwide. Key companies such as Davol/Bard, Ethicon, and Covidien will likely maintain leading positions in the market through continued product innovation and strategic alliances and mergers. Among the competitors discussed within the study are: Atrium B Braun Aesculap Cook Covidien Davol/Bard Ethicon GfE Medizintechnik LifeCell Minnesota Medical Development Surgical IOC Synovis Life Technologies TEI BioSciences Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited CHAPTER TWO Introduction OVERVIEW A hernia is the protrusion of an organ or part of an organ through a defect in supporting structures that normally contain it. A hernia may be congenital, acquired, or traumatic. Most occur in the inguinal or femoral region； however, umbilical, ventral, and hiatal hernias also occur. A hernia is usually composed of a sac, hernial contents, and an aperture, but in some locations a sac is absent. When hernial contents can be returned to the normal cavity by manipulation, the hernia is called reducible. If the hernial contents cannot be reduced, it is called irreducible or incarcerated. Bowel present in an incarcerated hernia not only may lack adequate blood supply but may also become obstructed. This is referred to as a strangulated hernia. An immediate surgical intervention is necessary to prevent necrosis of the strangulated bowel. Introduction 10 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited TYPES OF HERNIAS Inguinal Hernia Inguinal hernia repair is one of the oldest operations ever documentedin fact, the first record of it dates prior to the Middle Ages. Today, herniorrhaphy is one of the most common surgical procedures with over 1 million performed annually and more than 80 percent were ambulatory cases. Even though hernia repair is a relatively simple procedure, repair techniques differ widely. Traditional inguinal hernia is often repaired under local anesthesia. An oblique inguinal incision on the affected side is extended through external oblique aponeurosis. The hernia sac is emptied of its contents, ligated and excised. The floor of the inguinal canal is reconstructed. Sometimes prosthetic mesh is needed to reinforce a large or recurrent defect. Repair depends on whether the inguinal hernia is indirect or direct. Indirect In an indirect hernia the peritoneal sac containing intestine protrudes through the inguinal ring and passes down the inguinal canal. It may descend all the way into the scotum. Indirect inguinal hernia, more common in male patients, originates from a congenital defect in the facial floor of the inguinal canal. Direct A direct hernia protrudes through a weakness in the abdominal wall in a region between the rectus abdominis muscle, inguinal ligament, and inferior epigastric artery. This hernia is the most difficult type to repair and appears more frequently in men. An acquired weakness of the lower abdominal wall, a direct inguinal hernia often results from straining, such as heavy lifting, chronic coughing, or straining to urinate or defecate. Prompt surgical repair prevents possible discomfort and threat of later complications. Introduction 11 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Anterior Approaches About 90% of inguinal hernia repairs in the United States and Europe utilize a prosthetic. This has driven new product development in the industry with polypropylene and polyester materials at the top of the list. The most common inguinal hernia repairs utilize anterior approaches. The Lichtenstein technique utilizes a flat polypropylene mesh placed over the inguinal floor. This repair can utilize any prosthetic, but the trend is toward lighter weight, more porous material. Plug-and-Patch Repair The plug-and-patch technique utilizes a prosthetic cone plug placed in the defect and a flat mesh placed over the inguinal floor similar to the Lichtenstein repair. The plug acts as an immediate but temporary repair, and the flat mesh helps prevent long-term recurrence. With the trend toward less dense mesh, the conical heavyweight polypropylene plug seemed headed for obsolescence. New plugs have been developed that are designed to be placed in the defect under a flat polypropylene mesh. Posterior Approaches Open approaches with a lower midline or Pfannenstiel incisions use a flat polyester mesh, but could also use any prosthetic of proper size and shape. There are several products specially designed for laparoscopic approach. These products utilize specific shapes to maximize coverage of the entire myopectineal orifice and minimize the need for suture or tack fixation. Femoral Hernia Femoral herniorrhaphy involves repairing the defect in the transversalis fascia below the inguinal ligament, as well as removing the peritoneal sac protruding through the femoral ring. The transversalis fascia is normally attached to Coopers ligament, which prevents the peritoneum from reaching the femoral ring. To repair this defect it is necessary to reconstruct the posterior wall and close the femoral ring. These hernias appear more frequently in women. Introduction 12 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited Umbilical Hernia Repair of an umbilical hernia consists of closing the peritoneal opening and uniting the fasciae above and below the defect to reconstruct the abdominal wall surrounding the umbilicus. This type of hernia, seen most frequently in children, represents a congenital defect of protrusion of the peritoneum through the umbilical ring. It may also be acquired by women after childbirth. Ventral Hernia Impaired healing of a previous surgical incision, usually a vertical abdominal one, may cause an incisional hernia. Often the result of weakening of abdominal fasciae, projections of peritoneum carrying segment of bowel protrude through fascial perforations. It is necessary to reunite the tissue layers to close the defect. After excising the old scar, the peritoneal sac is opened, the hernia is reduced, and the layers are firmly closed. If existing tissue is not sufficient for repair, synthetic mesh may be used to reinforce the repair. Incisional hernias are sometimes the aftermath of postoperative hematoma, infection or undue strain. Ventral hernias have a high recurrence rate when mesh is placed on the outside of a large repair. Through an intraabdominal laparoscopic approach, omentum can be placed over the mesh or peritoneum can be put back over the mesh. Hiatal Hernia A hiatal hernia results when a portion of the stomach protrudes through the hiatus of the diaphragm. The hiatus is the opening for the esophagus through the diaphragm, which is the chief muscle of respiration. A weakening in the hiatus permits violation of the muscular partition between the abdomen and chest. Symptoms largely are caused by inflammation and ulceration of the adjacent esophagus； resulting from reflux of gastric juices from the herniated stomach Symptoms include pain, blood loss, and difficulty in swallowing. Diagnosis is made by radiologic and endoscopic studies. Two types of hiatal hernia are commonly recognized: (1) a sliding hernia, in which both a portion of the stomach and the gastroesophageal junction slip up into the thorax so that the gastroesophageal junction is above the diaphragmatic opening, and (2) a paraesophageal hernia, in which a part of the greater curvature of the stomach Introduction 13 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited rolls through the diaphragmatic defect. Mixed hiatal hernias with features of both of these types may also occur. Sliding hernias are three to ten times more common than paraesophageal and mixed hernias combined. The incidence of hiatal hernia increases with age, and this form of hernia occurs more often in women than in men. Surgical treatment is appropriate when medical therapy fails to alleviate the problem. Surgical approach may be by the abdomen or chest, or thoracoabdominal. Each approach offers certain advantages. The abdominal approach is generally preferred. However, the better view of the hiatal region afforded by opening the chest may favor this approach. RISK FACTORS Risk factors for hernia are factors that do not seem to be a direct cause of the disease, but seem to be associated in some way. Having a risk factor for hernia makes the chances of getting the condition higher but does not always lead to hernia. Also, the absence of any risk factors or having a protective factor does not necessarily guard against getting hernia. Risk factors for hernia include: Weak muscles Injured muscles Previous surgery Age Pregnancy Obesity Smoking Weak muscles can occur for many reasons. However, there are a few causes that can directly contribute to the development of a hernia. These include muscle overuse, infections, dehydration, flu, and excessive coughing. Injury plays a part in the development of hernia as well because the muscle fibers are compromised causing them to weaken. Surgery will cause the development of hernia because the integrity Introduction 14 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited of the muscle is affected when an incision is made into the muscle. Older adults may develop hernias when muscles weaken or deteriorate due to normal aging. A chronic cough associated with lung disease can contribute to hernia development, as can straining from chronic constipation or difficulty urinating. Pregnancy may cause excess pressure on muscles especially in the abdomen. The added weight, added blood volume and pressure on all muscles during delivery may also contribute to hernia development with pregnancy. Obesity is a prevalent factor in the development of hernia. Obesity causes the abdominal wall to stretch, which causes a weakness to occur. The growing obesity problem in the United States is of great concern for the development of hernias. The link between smoking and hernia formation relates to metastatic emphysema, in which the same tobacco-induced defect in collagen formation that leads to alveolar stretching and breaking in the lung tissue also causes abnormal collagen formation in the abdominal muscles. Similarly, in patients with diverticulitis, the cause of weakness in the intestinal wall seems to carry over to a weakened abdominal wall and an increased risk of hernia. Patients with an aortic aneurysm may also have a biochemical or structural predisposition to hernia due to an underlying collagen defect. Other risk factors for hernia formation include cirrhosis with abdominal ascites and other debilitating disorders that cause decreased tissue strength and muscle mass. Smoking cessation and weight reduction in overweight or obese patients are two strategies for reducing the risk of hernia. In patients with a known predisposition to hernia formation, avoiding heavy lifting or straining might lessen the chances of hernia formation. Improving muscle tone through aerobic exercise or weight lifting does not appear to be preventive； even athletes with good muscle development and strength experience hernias. COMPLICATIONS OF HERNIA REPAIR PROCEDURES Complications of hernia surgery include those of any surgical procedure, such as infection, bleeding, and fluid collection. Infection poses an additional risk in hernia surgery； depending on the type of mesh used, the mesh itself can become infected and require removal, and the hernia re-repaired. Bacteria can infiltrate the pores of Introduction 15 Copyright 2010 Kalorama Information Reproduction without written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited nonabsorbable mesh material. Even if the mesh pores are smaller than 10 um in size, for example, a 1-um bacterium could penetrate the mesh. A 10-um white blood cell, such as a protective macrophage, however, would not be able to enter. Other potential complications of hernia surgery include enterocutaneous fistula, intestinal obstruction, wound sinus infection, deep vein thrombosis, and pulmonary problems. Due to the risk of infection, it is desirable for a nonabsorbable mesh to have a pore size larger than 15 um. For further benefit, having some pores larger than 150 um in size would allow the patients tissue to penetrate the mesh, helping to keep it in place and strengthening the repair. The wider the weave and the more holes in the mesh, the more easily tissue can penetrate and the lighter and more flexible the material. Ideally, the mesh should be made from a monofilament to prevent bacteria from lodging in the spaces created by braided fibers. To allow for contraction, mesh used for hernia repair should be bigger than the hole. WORLD DEMOGRAPHICS There are approximately 6.8 billion people living in the world today with more than 60% of these in Asia, 14% in Africa, 11% in Europe, 8% in North America, 6% in South America, and less than 1% in the Oceania region. See Table 2-1 and Figure 2-1 for the world population by selected geographical region. By 2050, the world population is expected to grow by nearly 3 billion reaching 9.4 billion worldwide. The U.S. Census Bureau estimates that nearly 130 million live births take place each year worldwide and approximately 55 million people die each year. Asia has more than 267 million people over the age of 65, or roughly 6.7% of the regions population. Europe holds the second largest region with populations over 65 with nearly 90 million people. This is followed by North America, North Africa, Latin America, and Oceanic regions. See Table 2-2 and Figure 2-2 for population by age group and sex by region for 2009. See Table 2-3 and Figure 2-3 for the percent population over the age of 65 by year and region. Introd