Hernia Mesh Complications, Recent Recalls Alarm Canadian Doctor

Published on May 9, 2017 by Sandy Liebhard

Complications associated with the use of hernia mesh have become “endemic,” according to one Canadian physician concerned that such products are being overused.

“I’ve seen pictures of it in the bladder, I’ve seen mesh in the stomach,” Dr. John Morrison, president of the Canadian Hernia Society, recently told CTV News. “The mesh can erode into other organs over a period of time.”

Dr. Morrison often removes malfunctioning hernia mesh as part of his practice. His comments came less than a year after Health Canada announced a recall for Ethicon, Inc.’s Physiomesh Flexible Composite Mesh products after they were associated with an unusually high rate of complications. Since 2000, 12 brands of hernia mesh have been recalled in Canada, while such devices have been tied to 185 reports of serious injury, including three deaths.

According to Dr. Morrison, 10% to 20% of hernia mesh patients are left with chronic pain. Patients who continue to experience pain more than three months after implantation should consult with their doctor. He also told CTV News that individuals preparing to undergo hernia repair surgery should ask their doctor if they intend to use mesh, what type of hernia they have, and why the mesh is necessary.

Physiomesh Market Withdrawal

Ethicon withdrew Physiomesh Flexible Composite Mesh from the global market in May 2016, after unpublished data from two European registries suggested that the hernia mesh was associated with higher average recurrence and revision rates compared to other devices used in laparoscopic ventral hernia repair. The company was unable to determine the cause of the problems but noted that it could be due to product characteristics, as well as operative and patient factors.

Unlike Health Canada, the U.S. Food & Drug Administration (FDA) has not declared the Physiomesh market withdrawal an official recall. However, hospitals were asked to return any unused Physiomesh patches included in the market withdrawal to Ethicon. The company indicated that it would not seek to return the affected products to the market.

U.S. Physiomesh Litigation

Court documents indicate that at least 18 Physiomesh lawsuits have been filed in U.S. courts on behalf of individuals who developed adhesions, perforations, infections, mesh erosion and other debilitating complications due to an allegedly defective hernia patch.  In March, plaintiffs filed a Motion with the U.S. Judicial Panel on Multidistrict Litigation seeking the transfer of all federally-filed Physiomesh claims to a single U.S. District Court for the purposes of coordinated pretrial proceedings. The Motion argued that the litigation could eventually grow to include hundreds of similar cases and asserted that consolidation of the federal docket would promote greater judicial efficiency. However, Ethicon is opposed to centralization, holding that the lawsuits are too individualized to warrant the creation of a multidistrict litigation.

The JPML will hear oral arguments on the matter during its May 25th Hearing Session in San Antonio, Texas.

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