Citing “rigorous research and development,” growing rates of obesity and an aging population, Hexa Research anticipates that the market for hernia repair devices – i.e., surgical mesh – will grow to $6.6 billion over the next seven years. Another source, Market Research Future, predicts that the market will reach $8.5 billion by 2022. Regardless of which figure turns out to be correct, the forecast is disturbing in light of the injuries suffered by patients who have undergone hernia repair with surgical mesh.
The Hexa report acknowledged that post-operative pain, chronic infections and injuries such as adhesion and bowel obstruction are of “growing concern,” yet synthetic materials continue to be widely employed in hernia repair because they are inexpensive and easy to obtain. However, there is a trend that appears to be growing that is also driving market growth, which is the development of what is known as “biologic” mesh. This mesh device is made from tissues taken from pigs, bovines and even human donors. Such biological materials have been available since the 1950s, but for many years, biocompatibility was a serious concern. Research over the past few decades has found ways around that issue, for the most part, although clinical research continues.
Biologic mesh offers a much lower risk of post-operative infection, and is more readily absorbed into the patient’s own tissues. On the other hand, there have been questions over its effectiveness, particularly in relationship to its higher cost. Nonetheless, in light of recent information about injuries and even deaths attributed to synthetic mesh, health insurers have been more willing to offer reimbursements for biologic mesh. This has been a factor in its increasing acceptance.
Other medical device manufacturers are exploring “hybrid,” or composite mesh. This product is intended to offer the best advantages of biologic and synthetic materials, minimizing the risks of infection and adhesion while providing greater efficacy – all at a more competitive cost. However, these hybrid mesh devices are still undergoing clinical studies.
Current companies involved in the research and development of composite mesh include Medtronic (Covidien) and Cook Medical. Medtronic’s Covidien division has been targeted in litigation over its Parietex Hernia Mesh devices, which have been implicated with numerous complications.
The company attempted to come up with an earlier composite mesh, made from polyester with a “resorbable collagen barrier,” which was supposed to prevent adhesion problems. Instead, the collagen layer would dissolve, allowing the polyester to interact with and injure patient tissues. At this point, it is unknown if such composite mesh will truly be effective in minimizing the risk of injuries associated with synthetic materials such as polypropylene.
The unfortunate fact is that the market for hernia mesh is driven not by what is good for patients, but rather the bottom line. These manufacturers have determined how many patients will be harmed by their products and how much they may have to pay out in settlements or judgments – and as is too often the case, decide that such expenses are simply part of the cost of doing business.