In May 2016, Johnson & Johnson’s subsidiary company, Ethicon, voluntarily recalled Physiomesh after a clinical study showed its dangers. Prior to the hernia mesh recall, surgeons used Physiomesh to repair ventral hernias after it gained FDA approval in 2010. Physiomesh’s polypropylene composite mesh patch material contains flexible filaments woven together to provide added tensile strength. While the medical community assumed it was safe for implantation, the 2015 study showed Physiomesh caused serious, unexpected adverse events. These studies prompted J&J to issue the hernia mesh recall as well as an urgent field safety notice for surgeons. In fact, the hernia mesh recall, though voluntary, affected all remaining Physiomesh products globally.
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Clinical Trial Results That Triggered Global Hernia Mesh Recall
Researchers conducted the 2015 clinical trials in order to assess various surgical mesh materials used specifically for laparoscopic hernia repair. By comparing different hernia meshes, they hoped to improved patient outcomes and reduce complications from surgical implants — more specifically, Physiomesh.
The study pulled data from two large independent hernia registries located in Germany and Denmark. Ethicon’s hernia mesh recall notice stated, “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
A closer look at the study shows 20% of Physiomesh patients experienced hernia recurrence within six months. For reference, a comparative hernia repair study states laparoscopic surgery patients typically have a 3.8% recurrence rate two years later. At the four-year mark, that hernia recurrence rate goes up to 4.9%, on average. Not only is Physiomesh’s hernia recurrence rate significantly higher, it also usually happens within months, not years.
The study also found Physiomesh patients reported a “significantly higher pain rate” after three months compared to the Ventralight group. Plus, that pain negatively impacted the Physiomesh subjects for much longer overall compared to patients implanted with Ventralight mesh patches.
Ethicon hypothesized multiple factors were to blame for Physiomesh’s unexpectedly high adverse event reports, but didn’t elaborate. These include possible faulty product characteristics as well as operative and individual patient factors. After reviewing data from the now-terminated 2015 clinical trial, J&J’s Ethicon issued a voluntary global hernia mesh recall in May.
FDA Cleared Physiomesh for Market Without Premarket Safety Tests
In March 2010, J&J requested the FDA’s clearance in order to market Ethicon’s Physiomesh surgical implant for laparoscopic hernia repair. Surgeons implant Physiomesh, which helps reinforce weakened or broken muscle tissue, to repair abdominal hernias and “bridge” other fascial deficiencies. In order to obtain the FDA’s actual approval, a device must go through a bench and animal testing program. Ethicon submitted Physiomesh to the FDA’s 510(k) program, agreeing to conduct clinical trials after the agency cleared it for market. For some surgically implanted medical devices, manufacturers must conduct clinical trials before applying for FDA approval. These tests help establish a medical product’s safety and efficacy before the FDA approves it for sale to U.S. consumers. Shockingly, less than 1% of all surgically implanted medical devices go through rigorous safety testing required to gain FDA approval.
Surgical hernia mesh patches that actually do gain FDA approval are typically bench-tested for:
- thickness
- pore size
- burst strength
- device weight
- tensile strength
- device stiffness
- suture pullout strength
- burst strength
- tear resistance
The 510(k) clearance (or Premarket Notification) report, however, allows the FDA to classify the device using “substantially equivalent” competing products. And while Physiomesh met all criteria required for market release, Johnson & Johnson didn’t conduct any human clinical safety trials. Instead, the company compared it to others legally marketed and sold to consumers in its 510(k) premarket submission letter.
Revision Surgery Requirements for Anyone Affected by the Hernia Mesh Recall
Surgery is the only way to repair ventral hernias, so anyone affected by the 2016 hernia mesh recall requires re-operation. Many already needed one revision surgery due to hernia recurrence within a year of implantation, hopefully using different mesh materials. For those unfamiliar with mesh implant repairs, when the abdominal hernia re-opens, it’s called a recurrence. Unfortunately, each subsequent hernia repair attempt can be far more painful and harder to do than the previous revision surgery.
According to The British Hernia Centre, “the chances of success actually diminish with each successive attempt at repair.” Because every surgery generates new scar tissue, additional recurrences could lead another hernia to format each subsequent incision site. Each additional revision surgery also increases the patient’s nerve damage risks, which can cause lingering pain and discomfort after healing. Significantly, hernias never go away on their own, and they usually only grow larger and harder to repair over time.
Plaintiffs Sue Ethicon Over Alleged Physiomesh Injuries
It’s true that surgeons can use hernia mesh patches to reinforce the abdominal wall better than just using sutures alone. But they also “can irritate nerves and carry a slightly higher risk of infection,” according to the Wall Street Journal.
The American Hernia Society’s president, Dr. B. Todd Heniford, stated: “Doctors may often say it’s just a hernia, but this is not a 100% benign procedure, and we need to help patients weigh the potential risks and benefits of surgery and say no if they need to.”
When surgical mesh patches break loose, twist or fragment after implantation, they can cause severe health complications and internal injuries. Florida resident Joanne Quinn required revision surgery after her Physiomesh hernia implant failed, causing her serious, chronic abdominal pain. Even after Quinn’s surgeon tried unsuccessfully to remove the mesh patch material, she continues to suffer from:
- diminished bowel mobility
- bowel obstruction
- severe pain from internal bowel adhesions involving mesh fragments
And Quinn isn’t the only one suing Ethicon for injuries allegedly caused by Physiomesh before its 2016 hernia mesh recall. Lawsuits are now underway from plaintiffs who blame their intestinal fistulas and other life-threatening injuries on Ethicon’s allegedly defective Physiomesh.
What You Can Do
If you were affected by the 2016 Phyiomesh hernia mesh recall, we can help you get the justice you deserve. Get started with your free claim review online now to tell us about your injuries. Once you’ve submitted your information, an attorney will call you to discuss your financial compensation options and potential next steps.
Related: How the FDA’s Polypropylene Ruling Affects Hernia Patients
Mandy Voisin
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.