June is being observed as ‘Hernia Awareness month’ in the US. Heightened awareness surrounding Hernia—a potentially painful condition—amongst its patients will lead to enhanced care and treatment. This article highlights the fundamental aspects of hernia, its global prevalence, current treatment options, and ongoing advancements.
A hernia is bulging of an organ, intestine, or fatty tissue through an opening or weak site in the encompassing muscle or connective tissue; one indication of hernia is an external protrusion that is observed particularly when straining or bending down. In most cases, hernias are observed near the abdominal wall but can also be found near the groin and belly button region.
Types of Hernias
Based on anatomy, there are five types of hernias which occur commonly:
- Inguinal (Groin) Hernia: in the inner groin
- Femoral Hernia: in the upper thigh/outer groin
- Ventral (Abdominal) Hernia: in the general abdominal/ventral wall
- Umbilical Hernia: at the belly button
- Hiatal Hernia: inside the abdomen, along the upper stomach/diaphragm
Inisional hernia is a subtype of ventral hernia that is caused by a surgical wound that hasn’t completely healed.
In 2015, 18.5 million people across the globe were affected by Inguinal, Femoral, and Abdominal hernias, out of which 59,800 resulted in death. The majority of hernia cases worldwide are inguinal.
Early detection is key for complete and effective treatment of hernias. The earlier the detection, the higher the availability of treatment options. Pain in the affected area, especially while bending, is one of the main symptoms of a hernia. A hernia patient may also feel burning and weakness in the abdominal region. In the case of hiatal hernias, common symptoms include persistent heartburn, difficulty in swallowing, and vomiting with soreness and discomfort.
Treatment Options for Hernia
The conventional method of treating hernia, also known as ‘open tension’ repair, is carried out in three steps:
- Expose the hernia (Open)—Surgeon makes an incision of 3" to 6" in the abdomen for accessing the tissue/organ.
- Pull (Tension)—This step involves pulling of the surrounding healthy tissue edges, further sewing using sutures.
- Closing the Repair—The exposed incision is then closed using absorbable sutures or adhesives.
This procedure is associated with pain and longer recovering times; the chances of recurrence are also higher as compared to non-tension (mesh) repair. Although mesh repair procedures are widely used to treat various types of hernias, especially in the developed countries, the open tension repair is still the treatment of choice for hernias that are small in size and easy to suture.
In this method, the protruding tissue/organ is strengthened using a piece of flexible material known as a mesh; the hernia repair mesh is held in place with the help of a fixation device.
Both open and laparoscopic techniques are used for tension-free hernia repair procedures, with the majority of these procedures being performed as open globally. Having said that, the use of laparoscopic technique is growing, especially in case of smaller hernias where using this technique is more efficient. The advantages of minimally invasive procedures include speedy recovery and lower chances of hernia recurrence.
Various types of hernia repair mesh
- Synthetic hernia repair mesh:
Synthetic hernia repair meshes include standard and composite meshes; standard meshes are made up of polypropylenes, polyesters, and expanded polytetrafluoroethylene (ePTFE). Composite meshes, which are composed of more than one kind of material, are polypropylene, polyester, or ePTFE-based mesh, coated with a layer of absorbable material that can serve as a barrier between the mesh and the intraperitoneal contents. Hybrid synthetic meshes, a relatively new category of meshes which is an amalgamation of synthetic and biological scaffolds, are going to be used as a less costly alternative to biological prosthetics. These meshes maintain their structural integrity for longer periods compared to biological meshes. Other novel synthetic meshes include 3-D meshes and Hernia plugs, which are designed to conform to the shape of the the herniated part of the abdominal wall and are mostly used in inguinal hernia repair.
- Biologic Hernia Repair Meshes:
Most biologic prosthetics are procured from either human or animal dermis (dermis-based prosthetics), porcine SIS (Small Intestinal Submucosa: SIS-based prosthetics), or bovine pericardium. The higher biocompatibility of biologic meshes results in a weak immunogenic response from the host tissue.
- Hernia Fixation Device:
Hernia fixation devices are commonly used to fixate the hernia repair mesh to the patient's tissue. They are of two types: absorbable tackers and non-absorbable tackers.
Physician preference for a mesh is based on multiple factors. The major factors include the size of the hernia, the cost associated with the repair, preference for open or laparoscopic techniques, and present complications, as well as chances of future complications based on the patient profile. A simple hernia case, less than 3 inches in size without any infections, is treated using the open technique with a standard polypropylene mesh in most cases, because of its high structural strength and low cost. In case of ventral hernia procedures, the use of laparoscopic technique is increasing in developed countries because of the associated benefits mentioned above. A procedure performed using a laparoscopic approach almost always uses a composite mesh because of an associated risk of infection due to the contact with peritoneum. In a small number of cases where the hernia is infected—less than 5%—a biologic mesh is used. Considering the high costs associated with the use of biologic meshes, advanced composite meshes (including hybrid meshes), which are suitable to treat an infected hernia and are much less costly, are expected to become the preferred choice for physicians in the coming decade.
There are cultural and religious considerations that also contribute to the choices of physicians. For instance, as of 2016, biologic Ventral Hernia Repair (VHR) meshes were not sold in Japan; this stems from a general cultural aversion to using foreign materials derived from human cadavers. In Japan, very strict regulations related to the use of biologic materials are also in place, further restricting the potential for biologic meshes in the country.
Going forward there are a number of innovative products entering the market that will improve patient and physician comfort and reduce procedural time. Bard’s Phasix ST, a hydrogel coated fully absorbable synthetic mesh that combines the strength of synthetic meshes with the tissue remodeling characteristics of biologic meshes, and TELA Bio’s OviTex Reinforced BioScaffold hybrid mesh are two promising products that will replace biologics in coming years in the treatment of infected hernias, and these are also expected to be used for complex hernias that were being performed using absorbable composite meshes. To reduce procedure time, there are self-fixating meshes entering the market. The self-fixating property of Insightra Medical’s Freedom Octomesh Ventral Hernia System facilitates the placement of the mesh without the need for sutures or hernia fixation tackers, offering surgeons an easier and faster way to position the mesh during open repair; Medtronic’s Parietex ProGrip is a similar product on the market. Companies are also trying to come up with drug eluting meshes to prevent post-operative infections.
Although there are numerous treatment options available for hernia repair, the recurrence in some cases of complex hernias can be as high as 15%. This is a cause of concern amongst physicians and manufacturers alike. Hence, favorable clinical trial data and innovation are key to maintain a stronghold in the hernia device market. On the patient side, it is important to be well aware of the procedure and seek treatment at the right time so as to avoid allowing the hernias to become infected or complicated.
DRG’s Global Hernia Repair Devices Report not only provides a view on the market dynamics but also highlights the clinical landscape and physician preference in different geographies.