In May 2016, Johnson & Johnson subsidiary company Ethicon voluntarily recalled all Physiomesh hernia repair patches sold across the globe. But why? A European hernia surgery study found significantly higher recurrence rates in Physiomesh patients than competing mesh repair products. Shortly after reviewing these hernia surgery study results, Ethicon issued an Urgent Field Safety Notice to surgeons and healthcare providers. While the medical community applauded Ethicon’s move, several hernia surgery studies published years earlier show Physiomesh’s faulty device design issues. At least one study found 1 in 5 Physiomesh patients suffered hernia recurrence within six months after surgical implantation. Since 2010, surgeons implanted Physiomesh into thousands of hernia patients. Now, those patients need expensive and painful hernia surgery again to replace their faulty Physiomesh.
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Hernia Surgery Clinical Trials: Physiomesh Patients Reported Higher Pain Levels, Recurrence Rates
Researchers published the study that spurred the 2016 Physiomesh recall online in July 2015, nearly one year before Ethicon acted. The study pulled laparoscopic repair surgery data from two large independent hernia patient registries located in Germany and Denmark. Researchers discovered 20% of Physiomesh patients experienced hernia recurrence within six months after placement. For reference, a comparable 2003 study showed average recurrence rates at 3.8% two years after undergoing laparoscopic hernia surgery. Four years post-laparoscopic surgery, the average recurrence rate rose to 4.9%, according to the 2003 study results. Contrast that against what researchers called “unacceptably high recurrence rates” affecting 10% of open inguinal surgical repair patients. If 10% is “unacceptably high,” the 20% recurrence rate for Physiomesh is understandably shocking.
What’s more, the July 2015 hernia surgery study found Physiomesh patients experienced a “significantly higher pain rate” after implantation. When compared against the Ventralight subject group (which experienced zero recurrences), Physiomesh patients suffered measurably significant pain three months later. Even more worrying is the fact that researchers terminated this 2015 hernia surgery study early due to “safety reasons.” It states, “Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH (Physiomesh) system associated with significantly greater hernia recurrences and postoperative pain… This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.”
Other Physiomesh Hernia Surgery Studies Showing Additional Health Risks
Below, we’ll outline additional Physiomesh studies which highlighted the dangers associated with the now-recalled device’s faulty design.
October 2013 Physiomesh Study: Significantly Higher Inflammation, Bleeding
Researchers conducted the first Physiomesh study using porcine subjects back in 2013. Surgeons implanted Physiomesh in five animals and Ventralight, its closest mesh competitor, into another five subjects for observation. Researchers wanted to compare hernia surgery results between both products as well as complication rates.
After 14 days, the Physiomesh hernia surgery subjects exhibited significantly more inflammation, fibrosis, and hemorrhage complications than the Ventralight group.
August 2015 Hernia Surgery Study: Mesh Shrinkage, Weakening; Painful Scarring
This 2015 study compared three new composite meshes for ventral hernia repair: Physiomesh, Omyra and Hi-Tex Endo-IP. Among all three, Physiomesh weakened the most after 90 days, making it more prone to tearing and fracturing. In addition, researchers noted that “fractioning of the Physiomesh® coating over time led to an increase in interfilamentary granuloma formation.” This response caused painful abdominal scarring among some Physiomesh patients. Finally, Physiomesh showed “only minimal to no abdominal wall adherence” – which puts patients at risk for hernia recurrence.
August 2016 Hernia Surgery Study: Seromas Present in 83% of Subjects
In this 2016 study, researchers compared Physiomesh, Ventralight and one other “new composite mesh” brand used for ventral hernia repairs. Unfortunately, 83% of Physiomesh subjects developed seromas (fluid build-up areas beneath the skin). (Seromas can develop just below surgical incision sites or wherever surgeons remove tissue for weeks afterward.) This caused poor tissue integration issues, which subsequently increased migration, fracture and device failure risks.
Ethicon Didn’t Conduct Clinical Trials for Physiomesh
Ethicon rushed Physiomesh to market via the FDA’s controversial 510(k) clearance program. As a result, subsequent European clinical trials found Physiomesh hernia surgery dangers American patients weren’t warned about before surgical implantation. In June 2017, judges approved a motion to consolidate all failure to warn lawsuits against Ethicon under MDL 2792.
What You Can Do
If you or someone you love needs revision surgery to replace defective Physiomesh, you may be entitled to financial compensation. Since the only way to fix this problem is through more expensive, painful hernia surgery, you may have a case. Get your free hernia claim review online now in just minutes to see if you may qualify for legal assistance. An experienced attorney will call you to review your claim and compensation options shortly after you submit your information.
Related: Hernia Recurrence Risks: Which Type of Mesh Implant Is Safest?
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.