As Physiomesh Lawsuits Mount, Study Investigates Efficacy of Mesh Hernia Repair

Published on October 24, 2016 by Sandy Liebhard

A new study suggests that the benefits associated with mesh-based ventral incisional hernia repair may be offset by the potential for mesh-related complications.

Ventral incisional hernia repair is performed to fix a hole that appears in the abdominal wall at the site of a prior surgical incision. In 2012, roughly 190,000 inpatient abdominal wall hernia repairs were performed in the U.S. alone. Prosthetic mesh products, such as Ethicon, Inc.’s Physiomesh Flexible Composite Mesh, are used in at least half of these procedures. However, researchers writing in the October 2016 issue of JAMA point out that the benefits of mesh for reducing the risk of hernia recurrence or the long-term risks of mesh-related complications are not known.

For their study, they analyzed data involving   3,242 Danish patients who had elective incisional hernia repairs from January 2007 to December 2010. A comparison of mesh repairs (either open or laparoscopic) versus open surgeries without mesh revealed that the mesh patients had a lower risk of hernia recurrence at five-year follow-up. However, the cumulative incidence of mesh-related complications was higher ( 5.6 percent for patients who underwent open mesh hernia repair and 3.7 percent for patients who underwent laparoscopic mesh repair) compared to the complication rate among those who underwent non-mesh repair (0.8 percent).

Hernia Mesh and 510(K)

“Mesh implantation prevented the need for subsequent reoperation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use,” the authors of the paper wrote. “This observation, however, should be interpreted with caution because of the risk of selection bias. Larger, more complicated hernias are likely to be repaired with mesh, and small, simple hernias with little likelihood of long-term problems tend to be repaired without mesh.”

The report also points out that the majority of hernia mesh products currently on the U.S. market were cleared for sale via the Food & Drug Administration’s (FDA) 510(k) clearance protocols. This process allows a product to come to market without the benefit of human clinical trials, so long as a manufacturer can prove that a device is “substantially equivalent” to a previously approved product.

“Thus, 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 paper states. “This highlights the need for more long-term studies of mesh repair using high-quality registries such as the one in Denmark.”

Ethicon Physiomesh Withdrawal

Ethicon’s Physiomesh Flexible Composite Mesh product was among the hernia devices that received clearance through the FDA’s 510(k) program. Ethicon voluntarily withdrew the product from the market in May 2016, after data from German and Danish registries indicated that “recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.” The company was not able to determine the reason for these issues, and said that the higher rates seen with Physiomesh could be due to product factors, as well as operative and patient characteristics.

A number of Physiomesh lawsuits have been filed in U.S. courts on behalf of individuals who allegedly experienced hernia recurrence and other complications due to the withdrawn hernia mesh. Plaintiffs claim that Physiomesh is made from materials that are not inert and that react to human tissues, placing patients at risk for chronic pain, infection, hernia recurrence, adhesions, intestinal blockage, mesh migration, mesh contraction and repeated surgery.

The first Physiomesh case is expected to go to trial in January 2018.