According to the U.S. Food and Drug Administration (FDA) there are more than one million hernia repairs done in the U.S. every year. In the old days, before a rush of medical devices hit the market, a surgeon would use some type of suture to sew up multiple layers of the abdominal wall that had torn allowing intestines to protrude through. That wall of muscle and tissue may have weakened due to an incision or compromised tissue.
But since the 1980’s, polypropylene mesh (PP) has been the first choice of doctors for hernia repairs. Today mesh is used in hernia repair more than 90 percent of the time, according to the agency. Polypropylene, a relatively inexpensive polymer plastic, sourced from the petroleum industry, is used for both pelvic and hernia repair. Between 1992 and 2010, the FDA cleared 168 applications for polypropylene surgical hernia mesh for urogynecologic use. Problems with PP mesh include mesh shrinkage and infection, chronic pain and inflammation, migration, organ perforation, bowel adhesions and nerve damage, among other problems.
That won’t slow down the mesh industry which is expected to rise to nearly $6 billion by 2019, according to forecasts. And ever hanging its hat on “innovation,” mesh makers launched what they thought was an even better version of hernia mesh.
These two new meshes are coated. Physiomesh is made by Ethicon, a division of Johnson & Johnson. C-Qur is made by Atrium Medical. Physiomesh is made of a flexible, large pore polypropylene mesh, laminated between two films of glue and Mersilene (a polyester), a heavier nonporous product. It takes up to nine months for the Mersilene and glue to be absorbed and during that time the hernia mesh reportedly does not integrate with the body. Physiomesh has hundreds of adverse events logged into the FDA’s MAUDE database, including at least 10 death reports. In many instances sepsis, or an infection of the bloodstream that originates in the bowel, caused the body to shut down with infection.
When Physiomesh was voluntary removed from the market by J&J on May 25, 2016, it issued an Urgent Field Safety Notice. Two unpublished studies found Physiomesh had higher failure rates for laparoscopic ventral (midsection) hernia surgeries than other meshes used in the German and Danish Medical Registry. The reoperation rates were higher than the average rates of comparable meshes. Defective product cases against Physiomesh Flexible Composite Mesh are consolidated in Multidistrict Litigation in the Northern District of Georgia. When Ethicon removed Physiomesh from the market, Atrium Medical sent a letter to doctors to market its C-Qur as a replacement.
Atrium Medical’s C-Qur is coated with Omega 3 fatty acids, which Atrium says is all-natural, reduces inflammation, and keeps the mesh from touching internal organ or creating scars and adhesions. But C-Qur has had so many cases of infection, rejection, erosion into organs, inflammation and mesh encapsulation, that defective product litigation is now consolidated in federal court in New Hampshire in multidistrict litigation (MDL). In 2012, FDA investigators inspected facilities that made C-Qur and imposed a permanent injunction against the companies and their officers after major violations in quality control systems were uncovered. C-Qur is still marketed by Atrium. Ethicon still sells its Physiomesh Open Flexible Composite Mesh Device, which is not included in the MDL litigation.