By Bruce Freedman, M.D., Vice President of Clinical Development, TELA Bio
It’s 2021: surgeons can perform operations on patients while not even in the same room. Despite the incredible advancements and innovations like robotic surgery and creating anatomical planes for prosthetic placement we’ve seen over the few decades, synthetic mesh continues to be used by surgeons for many hernia repairs. Though, the standard of care for years and not without their utility, synthetic mesh materials can cause discomfort and potentially long-term complications. Thousands of lawsuits have been filed, but the use of synthetic mesh continues to prevail. It’s time for us, as an industry, to reevaluate the material we’re implanting into patients and understand that we now have, a plethora of hernia mesh options at our disposal.
Complications Are Long-Term
Because of the strength it lends to hernia repair and low cost, synthetic mesh material has been accepted as the industry standard for decades. Unfortunately, there are significant drawbacks and risks, and data is beginning to emerge that shows that the long-term outcomes of synthetic mesh may not be as good as once believed.
A 2019 study by Felix Heymann from University Hospital Aachen in Germany found that polypropylene meshes used for hernia repair trigger foreign body reactions. This response and sustained inflammation can result in some patients’ issues such as stiffness, abdominal pain, fistulas, and hernia recurrence. The stiff, synthetic mesh can also rub against nerves or muscles and cause chronic irritation.
Synthetic mesh can also adhere to the surrounding tissue, nerves, and organs, especially when inserted against the viscera. To minimize this risk, mesh manufacturers have added protective coatings to their products. However, these coatings eventually dissolve, leaving patients exposed to potential downstream complications.
One of the most common patient complaints from the use of synthetic meshes is chronic pain severe enough to decrease their quality of life. The exact rates of this condition are difficult to determine due to the challenges in defining and reporting individual pain levels. However, most surgeons have accepted that chronic pain affects between 12% to 15% of hernia repair patients, although some estimates are much higher.
Litigation Is Growing
A number of patients who have experienced failed hernia surgeries or complications due to synthetic mesh are filing lawsuits at a rapid rate, seeking compensation to help cover medical bills and lost wages. The largest hernia mesh lawsuit amount to date is $184 million paid by C.R. Bard to settle roughly 3,000 cases in 2011. Now, in 2021, there are still more than 13,000 lawsuits that have been filed in Rhode Island alone.
Cheaper Isn’t Always Better
Like most things in business, mesh selection by hospitals often comes down to cost. Hospitals are tasked to stay within budget and synthetics are, by far, the most cost-effective option. With more than 800,000 inguinal hernia and 350,000 ventral hernia procedures performed each year in the U.S. alone, 90% of which require the use of mesh, and more expensive mesh options can add up. However, despite the upfront savings, synthetic mesh can actually be more costly in the end when one includes the cost downstream complications such as mesh infections requiring removal, severe contracture, erosions, and other complications requiring additional surgeries, not to mention poor patient satisfaction and lawsuits.
We Have Alternatives
It’s clear that synthetic meshes, while inexpensive, have significant drawbacks, mostly due to the amount of permanent plastic in them and the body’s foreign body response. Luckily, patients and surgeons have a number of options.
Biologic mesh, sourced from animals or humans, is the most natural option and addresses many of the drawbacks of posed synthetic mesh. However, biologic mesh is expensive and may stretch over time.
A newer category of hernia repair materials, called “reinforced tissue matrix,” like OviTex from TELA Bio features the benefits of a more natural repair, reducing the foreign body footprint. Composed of 95% natural, biologic material and reinforced with either permanent or resorbable synthetic suture material, this option is available without the need for large amounts of synthetic. It is also easy for surgeons to use and available in multiple configurations that can be tailored to the various types of hernias patients experience.
In the end, there is no one, singular option that is best for every individual patient, and selecting the right hernia repair material plays a critical role in a successful surgical outcome. Hospitals need to be open to innovation and more advanced materials and surgeons should be encouraged to discuss these options with their patients and decide together on the best path forward. With aging populations and obesity rates on the rise, we are only going to see an increase in hernia repairs.