Hernias occur when internal tissues bulge out of the body through a weak muscle, usually in the groin. Around 1 million Americans have hernia surgery every year.
In most surgeries, mesh patches are used to plug the hernia and prevent it from returning — but they do not always work.
It is very common for the body to reject synthetic mesh implants. Even low-level inflammation can cause pain, excessive scar-tissue growth, adhesions, or hernia recurrence.
About a decade ago, manufacturers started selling hernia mesh implants with coatings they claimed were anti-inflammatory.
Instead, more than 15 lawsuits claim the coatings can actually trigger allergic reactions, inflammation, infections, and other major complications that require revision surgery.
In May 2016, Johnson & Johnson recalled Ethicon Physiomesh in Europe and Australia after a massive study linked it to higher rates of hernias returning and needing another surgery.
Physiomesh was withdrawn without a recall in the U.S., which is why the FDA did not issue warnings, but that did not stop lawsuits.
One lawsuit was filed last week by a woman from Florida. She needed another surgery when her hernia returned less than four months after Physiomesh was implanted in her body.
Physiomesh is a patch woven from plastic-like fibers that is laminated between two layers of Monocryl (polyglecaprone).
Her lawyers say the coating is promoted to prevent or minimize inflammation and adhesions, but instead it “prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response.”
Those same allegations have been raised in at least 14 lawsuits involving another type of hernia mesh — Atrium C-QUR — which is coated in fish oil (Omega-3 fatty acid).
The fish oil coating is advertised as an “anti-adhesion barrier” to prevent scar-tissue sticking organs together during the healing process, a common problem after hernia surgery.
Last year, researchers published a case report of a 61 year-old woman who had an inflammatory reaction to fish oil-coated hernia mesh. Very few studies have investigated the safety of hernia mesh coated in active agents, the researchers warned.
The FDA approved C-QUR in 2006 without clinical trials because it was “equivalent” to other hernia mesh implants on the market, although it was — and still is — the only one coated in fish oil.
Likewise, Ethicon Physiomesh was approved through the same process in 2010. Its “equivalent” product was Ethicon Proceed Surgical Mesh, which does not have a Monocryl coating.