A recent study suggests that patients who receive Ethicon, Inc.’s Physiomesh Flexible Composite Mesh device during minimally-invasive ventral hernia repair may face a higher risk of recurrence compared to those implanted with an alternative hernia patch. The study was published in the March 2016 issue of Surgical Endoscopy, just months before Ethicon voluntarily removed this particular Physiomesh patch from the global market due to higher average recurrence and revision rates.
The study compared 25 patients implanted with the Physiomesh product during laparoscopic ventral hernia repair to 25 others implanted with another hernia patch called Ventralight. Within 6 months of hernia mesh implantation, 20% of the Physiomesh patients had suffered a hernia recurrence, while none in the Ventralight group had.
The authors of the study also observed significantly higher pain rate in the Physiomesh group after 3 months and no difference after 7 days. The pain intensity decreased significantly over time and was significantly higher in the Physiomesh group.
The study was terminated early due to safety concerns.
“Though this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system,” the authors concluded. “This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.”
On May 25, 2016, Ethicon announced that it was voluntarily withdrawing Physiomesh Flexible Composite Mesh from the global market, after unpublished data from two European hernia registries suggested that the device was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
In its Urgent Field Notice, Ethicon said it had been unable to determine the reason for the higher rates associated with Physiomesh. As such, he company not been able to issue further instructions to surgeons that might lead to a reduction in the recurrence rate, prompting it to pull the Physiomesh product from the market.
Physiomesh Flexible Composite Mesh was granted regulatory clearance in 2010, via the U.S. Food & Drug Administration’s 510(k) program. This process allows a device to come to market without human clinical trials if a manufacturer can show that it is “substantially equivalent” to a product previously approved by the agency.
The predicate product for Physiomesh Flexible Composite Mesh was a surgical patch called Proceed, which was once the subject of a recall.