Once again a defective hernia mesh is making news. This time it’s Physiomesh™, manufactured by Johnson & Johnson’s subsidiary Ethicon. Ethicon joins both Atrium and Bard Davol who are currently fighting legal battles over their dangerous surgical mesh products. Atrium’s C-Qur Hernia mesh was recalled in 2013, though their legal consequences continue to this day. Bard Davol manufactured a number of recalled mesh products, including the ill-fated 3DMax and Kugel hernia repair patch.
Among these companies, Physiomesh™ has earned the distinction of mounting lawsuits in both the United States and Canada. However, all hernia mesh products are currently undergoing investigations for causing serious injuries, which may require patients to undergo hernia repair surgery.
Surgical mesh products are typically used to repair ventral hernias, in which an organ or other tissue enters a muscle cavity. This happens when the abdominal wall is weak, sometimes from a previous surgery or a birth defect.
Depending on their use and placement within the body, surgical mesh products may be referred to as hernia mesh, surgical mesh or transvaginal mesh. Manufacturers tailor products to different medical problems, but the underlying technologies – and risks – are similar.
The mesh technology was first introduced more than half a century ago as an alternative to suture repair. These devices are meant to repair larger areas and to strengthen the weakened tissue.
The basics haven’t changed, though device makers seem to continuously add to the list of recalled and defective surgical meshes. There are two kinds of mesh products and a handful of technical considerations, such as weight, flexibility and biocompatibility, or the toxic effects a product might have on a person’s biology.
Surgical mesh is either synthetic, or derived from animal tissue. Animal-derived meshes are absorbable and are intended only to strengthen the patient while the body repairs itself. In contrast, synthetic meshes can be non-absorbable, and thus permanent.
Even after 50 years, it is not clear that mesh repair is better than suture repair. A 2014 review in The Journal of the American Medical Association: Surgery (JAMA) found that mesh technologies could reduce recurrence, but are more likely to result in surgical site infections. Mesh repairs were also more likely to cause seromas, which are fluid pockets that may require draining.
Risk and Reward
With such inconclusive benefits, the risk of a defective device hardly seems worth it. When these meshes fail, the hernia can recur, often worse than before.
Some common complications are even more critical than a hernia itself. According to the FDA: “Pain, infection, recurrence, adhesion, obstruction and perforation are the most common complications associated with recalled mesh.” Perforation carries a serious risk of fatality, especially in Parastomal hernia cases.
In non-fatal cases, reports document years of discomfort and even excruciating pain. These symptoms can lead to expensive tests and unnecessary treatment, all without addressing the actual problem. Meanwhile, patients have reported the pain to their doctors as, “rated 10 out of 10.”
Hernia Mesh Falls Short
While the pain some surgical mesh products cause may be a perfect 10, it is clear that these medical devices have a long way to go toward being perfect themselves. And that responsibility lies squarely on the manufacturers and distributors of these products.
In the United States, there are more than 1 million hernia repair operations per year. Depending on the hernia type, around 90 percent of repairs are now done with mesh. With so many people suffering, the stakes are too high to allow corporations to push unproven products with minimal benefits.
Perhaps this next bout in the courtroom will give Ethicon and its competitors some much-needed motivation to improve their products and place a greater value on the patients who receive them.