Busting a Gut is No Laughing Matter

Most everyone knows of someone who has had an abdominal wall hernia repaired. They are very common, especially the groin variety in men, where there is a more than 1 in 4 chance of developing a groin hernia in their lifetime. The causes of abdominal wall hernias are varied and they can be classified as either acquired or congenital. Acquired hernias can develop because of improper lifting or because of sports-related activities. They can also develop from the inactivity of a sedentary lifestyle that leads to obesity. Some hernias result from previous abdominal surgery, which results in a weakened abdominal wall, or perhaps from the creation of an ostomy. There are those caused by excessive coughing or sneezing and, for those who might not want to admit it, from constipation or straining on the toilet. Other hernias are congenital, some of which may be relatively benign like umbilical (belly button) hernias, or they can be life threatening like congenital diaphragmatic hernias (CDH) where the contents of a newborn’s abdomen pass into the chest and can inhibit lung growth. CDH affects about 1,600 newborns in the U.S. each year. This devastating condition has an alarming 50% survival rate. Recently, to help raise awareness, the U.S. Senate designated April 2016 as the National Congenital Diaphragmatic Hernia (CDH) Awareness Month, which has the support of CHERUBS, The Association of Congenital Diaphragmatic Hernia Research, Awareness and Support. Globally, 147 babies will be born with CDH every day and over 700,000 babies have been born with CDH since January 1, 2000.[1] Congress stepped up to blow the horn, but it didn’t offer up any research money, as that is left to the non-profit organizations.

The one thing that all types of hernias have in common is that surgery can be a very effective treatment, and in the case of CDH, surgery is the only possible treatment. Groin hernia surgery alone accounts for an astounding 20 million procedures worldwide[2] and it

for about 70-75% of all abdominal wall hernia surgeries. Watchful waiting is a viable strategy for groin hernias if there are no symptoms, but there is a high likelihood that pain will develop enough to warrant surgery in most patients within 10 years. Hernias cause pain, either because the abdominal contents can become trapped or even strangulated after passing through a weakness in the wall. Despite the large numbers of groin hernia patients, largely men, there are resource constraints that limit access to surgery, especially in low- and middle-income countries. The limited resources could be due to the lack of adequately trained surgeons, but more often, it is the lack of monetary resources necessary to purchase the costly materials used in surgery.

Hernia surgical technology has come a long way from the time of 13th century Italy when the hernia sac was incised, the resultant cavity stuffed with lint, and the wound treated with arsenic powder[3]. In groin hernia surgery today, most surgeons reinforce the weakened abdominal wall with a synthetic or biologic mesh prior to closing the defect. Surgeons have plenty of options with about 250 products to choose from in the U.S. The most commonly used type is a flat knitted polypropylene (PP) mesh. There are now other more exotic synthetic meshes available in the form of plugs and other alternative 3D shapes. Biologic products are made from cow, pig, or human cadaver tissue. A piece of flat mesh typically costs about $80-$100 per piece in the U.S., $100 in Ecuador, and $125 in Uganda. Incredibly, a 16 × 20–cm piece of biologic mesh can cost up to $10,099[4], which can be more than the reimbursement rate that the hospital receives for the surgery itself.

What happens to those patients in countries where “an estimated 2.4 billion people live on less than $2 (in U.S. dollars) per day, and a large proportion of health care costs are paid out of pocket”[5]? In these countries, there is an effort to find creative alternatives to offset the high cost of materials. One solution, supported by randomized clinical trials, is to use readily available low-cost mosquito netting which costs less than $1 per piece. It is made from 100% polyethylene (PE), compared to the standard industry made PP mesh, and it has a similar looking knitted construction. One drawback of PE is its lower melting point, compared to PP, which puts limitations on the sterilization cycle, but these have now been overcome with adjustments to the temperature of sterilization. In a comparative study of PP mesh vs. mosquito netting in the treatment of groin hernias in Ecuador, it was found that mosquito netting yielded a low complication rate and it also proved to be cost-effective.[6]

Given the alarming growth in the cost of health care in the U.S., as a percentage of GDP, mosquito netting sounds like an interesting option for hernia mesh repair here. Unfortunately, there is little or no chance that will happen. First, the FDA regulatory costs to get it approved for use would be a show-stopper for any vendor considering its sale. Second, with such low prices, there is no money to be made, so no company is going to invest in a distribution channel to make it happen. Maybe out-of-the-box thinking is required. For example, can you imagine letting hospitals purchase sterile hernia mesh, of the mosquito netting variety, from Amazon? Why not? It would require the FDA to look itself in the mirror and see they are part of the problem regarding innovation in health care delivery. Let’s get creative and remove some of the regulations that make health care so expensive and then redirect some of the excessive wasteful spending to developing solutions for underfunded programs like newborns with CDH.

In less-developed countries, the medical device industry has left it to the non-profit sector to sort these things out, because of this industry’s lack of a profit motive. Non-profit organizations, like Operation Hernia, have stepped in to fill the gap to help those patients without access to surgery. Of course, the Amazon strategy might not work outside the U.S. Let’s just hope that the Zika virus threat doesn’t soak up the supply of mosquito netting or drive up its price. That would cause a breech in Operation Hernia’s strategy, for sure.

[1] http://www.cherubs-cdh.org/research/cdh-statistics

[2] Lofgren, J, et al. A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair. N Engl J Med 2016; 374:146-53.

[3] McCluskey, DA, et al. Groin Hernia-Anatomical and Surgical History. Arch Surg. 2006;141(10):1035-1042.

[4] Galandiuk, S, Allen D. Should We Not Strive for a Balance Between Procedure Fee and Overall Cost? Arch Surg. 2009;144(6):496-497.

[5] Lofgren, J, et al. A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair. N Engl J Med 2016; 374:146-53.

[6] Shillcutt, SD, et al. Cost-Effectiveness of Inguinal Surgery in Northwestern Ecuador. World J Surg 2013; 37:32-41.