Recently, JAMA published a new study saying patients who underwent incisional hernia repair with hernia mesh can experience complications up to five years after surgery. Previously, the medical community assumed 3 to 4 years was the cap.
Dunja Kokotovic and her colleagues first presented their findings last year at the Clinical Congress of the American College of Surgeons. They uncovered not just the length of risk but also patients with mesh suffered more complications than those without. Some were so major that patients required additional surgeries.
The study follows over 3,000 patients who had hernia surgery. Some had mesh and others did not. Even though patients experienced a lower rate of reoccurrence with mesh, the complications far exceeded any benefits. Major complications included bowel obstruction, perforation, and bleeding. Other serious complications included pain, non-healing wounds, infections, fluid buildup and organs fused together (fistulas). The larger the mesh showed an increased risk of complications.
Out of the 3,242 study participants, 1,050 required subsequent abdominal surgery.
Continual Safety of Hernia Mesh
Doctors perform over 800,000 yearly hernia repairs. This means doctors should still check patients even years after the initial surgery.
“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic said.
In their study, Kokotovic and colleagues think these complications could have been avoided with more pre-trial data. They blame the lack of data on the FDA’s 510(k) premarket notification clearance process. This process can fast-track drugs without companies fully testing them.
“Demonstration of long-term safety is required for drugs in the United States but not for some devices, such as hernia meshes, which are not subject to similarly strict documentation,” Kokotovic wrote in her study. “Thus, the complete spectrum of the risks and benefits of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization.”
Hernia Mesh Suits
At The Michael Brady Lynch Firm, we urge a patient who suffered complications after a hernia mesh surgery to file suit against mesh manufacturers. When a manufacturer does not warn you about faulty mesh, they should be held liable.
Mesh manufacturers Atrium for its C-QUR Mesh and Johnson & Johnson’s Ethicon for its Physiomesh face thousands of hernia mesh lawsuits. Contact us today for a free consultation.