As hernia mesh lawsuits continue to mount against Ethicon, Inc. and other device makers, researchers from the Washington University in St. Louis School of Medicine are calling for a standardized system of package labeling to better inform doctors of the risks associated with the implants.
Their study, published online last month in the Journal of the American College of Surgeons, analyzed labeling guidelines and 510(k) requirements across a range of common hernia mesh products regulated by the U.S. Food & Drug Administration (FDA). They also conducted a literature review to understand recommended guidelines for mesh products.
“We found that food labels undergo critical scrutiny and detailed specifications, yet medical devices are not subjected to similar guidelines,” the study authors wrote.
The paper noted that:
“While standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines. There is an extreme underreporting and lack of consistency of clinically important mesh properties,” the study authors concluded. “Standardized packaging labels will provide accessibility of these properties and aim to bring standardized terminology into practice. With an increase in access to important properties, this can facilitate intraoperative decision making on a case-by-case basis.”
The majority of hernia mesh lawsuits currently pending in U.S. courts involve Ethicon’s Physiomesh products and C-Qur devices marketed by Atrium Medical Corp.
Ethicon’s Physiomesh implants are made from non-absorbable polypropylene (plastic) filaments that are woven into fabric. Each side of the mesh is then covered with an absorbable film coating intended to help the patch incorporate into the body and reduce inflammation. However, plaintiffs claim that this configuration actually prevents incorporation and increase the odds that a patient will experience serious complications, including hernia recurrence and the need for revision surgery.
In May 2016, Ethicon announced a worldwide market withdrawal of its Physiomesh Flexible Composite Mesh product, after unpublished data from two European hernia registries suggested that these devices were associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
Earlier this year, all federally-filed Physiomesh lawsuits were centralized in a multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia. More than 300 cases were pending in that litigation as of November 15, 2017.
Hernia mesh lawsuits involving Atrium’s C-Qur implants have been centralized in the U.S. District Court, District of New Hampshire, where more than two dozen cases were pending as of November 15th.
C-Qur hernia mesh is constructed with an Omega-3 barrier coating, which Atrium claims will reduce the risk of adhesion formation between the mesh and the intestines and allow for better fixation of the device to the abdominal wall. However, plaintiffs allege that this configuration actually encourages an inflammatory response that promotes the formation of bowel adhesions, impedes proper abdominal wall fixation, and causes additional severe complications.