Hernia mesh is becoming an increasingly popular method to repair hernias of all types. According to a recent market report on OpenPR.com, a hernia is a “protrusion of an organ through a weak spot in the surrounding connective tissue.” Additionally, that same report says that the use of hernia repair mesh is a consistently growing market.
“Globally, the market is growing steadily and it is anticipated to show an exponential growth reaching approximately $8.5 billion in 2022,” the report states.
There are several types of hernias, such as inguinal, incisional, and femoral, many of which can be repaired laparoscopically rather than using open surgery. The laparoscopic procedures usually involve using some sort of implanted mesh intended to bridge the gap in a hernia.
Hernia mesh, however, could result in worse injury than the hernia itself.
Johnson & Johnson’s Ethicon released a hernia mesh device in 2010 using the 510(K) fast-track approval method, called Physiomesh. Its approval was based on being “substantially equivalent” to the PROCEED Surgical Mesh, described as a “unique macroporous design and partially absorbable tissue-separating barrier support safe and comfortable healing” and “stronger than the abdominal wall” on J&J’s website. It is also described as having “improved potential not to harbor bacteria that can lead to infection.”
However, the complaints filed regarding Physiomesh highlight the device’s contrast to its predecessor, not its equivalency.
The complaints include reports of pain due to its lack of incorporation; failure, rupture and deformation due to its inability to withstand normal abdominal forces following implantation; and infection due to its “impermeable” non-porous design with its five unique layers.