Mesh Benefits Partly Offset by Complications at 5 Years

Miriam E. Tucker

October 19, 2016

WASHINGTON, DC — In patients undergoing elective incisional hernia repair, the use of mesh is associated with a lower risk for reoperation related to recurrence, but that benefit is partially offset by mesh-related complications than can occur up to 5 years after surgery, new research shows.

This does not mean that mesh should not be used, said Dunja Kokotovic, MB, from the Center for Surgical Science at Zealand University Hospital in Køge, Denmark.

"We still recommend the use of mesh because it does reduce the risk of recurrence," she told Medscape Medical News.

Other studies have shown that hernia-repair recurrences are often more technically difficult because of scarring, which also raises the risk for complications. "We still believe the mesh is beneficial, but we just have to inform our patients of the possible complications," Dr Kokotovic said.

Findings from a nationwide Danish registry — the largest and longest-term study to investigate the use of mesh in hernia repair — were presented here at the American College of Surgeons Clinical Congress 2016 and published simultaneously in JAMA (2016;316:1575-1582).

All patients who underwent elective hernia repair in Denmark from 2007 to 2010 were included in the analysis.

Of the 3242 patients, 1119 underwent open mesh repair, 1757 underwent laparoscopic mesh repair, and 366 nonmesh repair. Median follow-up ranged from 59 to 62 months.

Mean age in the cohort was 58.5 years, and 1720 (53%) of the patients were women.

At 5 years, rates of reoperation related to recurrence were significantly lower for patients who underwent open mesh repair or laparoscopic mesh repair than for those who underwent nonmesh repair (12.3% vs 10.6% vs 17.1%).

However, during those 5 years, the risk for mesh-related complications increased continuously. Of the 1050 patients (32% of the cohort) who required subsequent abdominal surgery, 5.6% required open mesh hernia repair and 3.7% required laparoscopic mesh repair. Open mesh hernia repair was an independent risk factor for long-tem complications, compared with laparoscopic mesh repair (hazard ratio, 2.36; P = .01).

Of the mesh-related complications, 1.4% were considered major, such as bowel obstruction, perforation, and bleeding, and 3.5% were deemed "clinically important complications," such as surgical-site or sinus tract infection, fistula, seroma, nonhealing wound, and pain. Mesh removal was required in 1.6% of the patients.

A search of the registry revealed one risk factors for mesh-related complications: larger mesh size.

It's not about mesh vs not mesh. It's about the overall health outcomes balanced against each other.

One limitation of this study is potential selection bias; it was not a randomized trial, said session discussant David Soybel, MD, from the Milton S. Hershey Medical Center in Pennsylvania.

The number of patients receiving nonmesh repairs accounted for just 11% of the total study population, and the reasons mesh was not used were not available.

"Beyond the message that long-term follow-up is necessary, I think we shouldn't automatically think that mesh is bad. This is a nuanced discussion," said Dr Soybel. "How can we make these patients truly comparable?"

And a randomized clinical trial is needed to assess the cost aspect, he told Medscape Medical News.

"Whenever you decide to do something to optimize one variable, there will be unanticipated consequences," he explained. "It's always going to be a trade-off, and the way you make those decisions is by taking into account all the relevant conditions. It's not about mesh vs not mesh. It's about the overall health outcomes balanced against each other."

A slightly different take is presented by Kamal Itani, MD, from the VA Boston Health Care System in Massachusetts, in an editorial accompanying the published results (JAMA. 2016;316:1551-1552).

"These data suggest that the risk–benefit ratio of mesh is not as clear as previously thought," he explains. "This calls into question the current practice of liberal use of mesh, even for repair of small hernias, when mesh is the norm for all incisional hernia repairs of any size. This finding supports previous calls to reconsider the use of mesh for smaller hernia defects."

Dr Itani also points out that the mean mesh size in the laparoscopic group was almost twice that of the open group, despite similar-sized hernia defects. It is likely that the larger mesh used for the laparoscopic hernia repair contributed to fewer recurrences in small- and medium-sized hernias, but at the expense of an increased risk for complications, he suggests.

"It is clear that larger hernia defects are more prone to recurrence and require larger mesh size, and larger-sized mesh is more prone to complications. As such, larger defects are not necessarily best suited for laparoscopic repair," he concludes.

In their publication, Dr Kokotovic and her colleagues point out that in the United States, demonstration of long-term safety is required for drugs but not for some devices, such as hernia meshes. Most meshes in the United States are approved by the US Food and Drug Administration through the 501(k) mechanism, which requires only that they be similar to products already on the market; clinical trials that demonstrate efficacy and safety are not required.

"The complete spectrum for 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," the researchers point out.

"This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark."

Dr Kokotovic has disclosed no relevant financial relationships. One of her coauthors, Frederik Helgstrand, MD, DMSc, from the Center for Surgical Science, Zealand University Hospital, reports receiving personal fees from Bard and Etichon for educational presentations. Dr Soybel is editor-in-chief of surgery for an evidence-based, peer-reviewed information resource. Dr Itani reports serving as a research consultant to Davol in 2012 for an antibiotic-coated mesh product, and that he was principal investigator on the 2008 multi-institutional RICH observational study, for which funds were provided to his institution.

American College of Surgeons (ACS) Clinical Congress 2016. Presented October 17, 2016.


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