As hernia mesh lawsuits mount in courts around the United States, a recent BBC investigation suggests the devices were implanted in thousands of patients with little or no clinical evidence to support their use.
The BBC analyzed data on more than 100 hernia mesh implants purchased by NHS Trusts in England and Scotland from 2012 to 2018
In most cases, these hernia mesh products were allowed to come to market without the benefit of human testing, just as long as a manufacturer could show they were similar to older, previously-approved implants. The U.S. Food & Drug Administration offers a similar program – 510(k) clearances – that also allowed hernia mesh manufacturers to avoid human trials.
While many of these devices were tested on animals, those trials only required that the mesh be left in place for a few days. A device was deemed safe for humans if the animal showed no evidence of an immune reaction.
Hernia mesh is obviously intended to remain in the human body far longer. One expert interviewed by the BBC also asserted that because animal trials can’t test for pain, they’re “completely inadequate” for devices implanted in people.
About 300 people told the BBC they had experienced adverse events – including chronic pain, infections and organ perforations – since their hernia mesh surgery. In some cases, hernia mesh complications left these patients permanently disabled.
“My kids wrote a letter saying they want their fun mum back,” a 36-year-old woman tearfully told the BBC.
“My husband said he married a wife and became a carer,” she continued. “I shouldn’t be living the life I’m living.”
While hernia mesh can sometimes be removed, many patients who contacted the BBC were told there were no surgeons trained in the procedure. Others were warned that hernia mesh revision could result in further complications.
The BBC also learned that at least one man died years after developing a post-operative infection. In a letter to his wife, the hospital acknowledged the hernia mesh he received “could have been a cause.” A chronic abdominal-wall infection was listed among the many possible causes of death.
Thousands of people in the United States have filed lawsuits for similar complications that allegedly resulted from defective and inadequately tested hernia mesh implants.
For example, more than 2,500 cases involving Ethicon, Inc.’s Physiomesh implants have been centralized in the U.S. District Court, Northerb District of Georgia. The company withdrew certain Physiomesh Flexible Composite Mesh devices from the global market in May 2016, after unpublished data from two European hernia registries suggested those products were associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
C.R. Bard, Inc. and its Davol, Inc. subsidiary are defending more than 3,500 claims involving various hernia mesh implants, all of which are pending in a multidistrict litigation underway in the Southern District of Ohio. Devices cited in those hernia mesh lawsuits include Composix E/X Mesh, Ventralex Hernia Mesh, Composix Mesh, Kugel Hernia Patch, CK Parastomal Patch, and the Modified Kugel Patch.
An additional 1,800 lawsuits involving Atrium Medical’s C-Qur hernia mesh implants have been consolidated in a third multidistrict litigation underway in the District of New Hampshire.