In 2011, Covidien, a subsidiary of Medtronic, touted its ParietexTM Composite Ventral Patch as a “clinically proven collagen film technology to minimize visceral attachment...designed for optimal abdominal wall conformability in umbilical and small ventral hernia repair.” Six years later, a patient who had received a Parietex mesh was forced to undergo revision surgery to have it removed.
According to her lawsuit involving the hernia mesh, “a CT scan of the abdomen and pelvis revealed a large fluid collection associated with the majority of the mesh...[with] a sinus tracking from this to an area that had reopened in the left lower aspect of her incision.”
The complaint further asserts that
“...symptoms of injury were caused by the Parietex Mesh defects, including but not limited to the effect of the disintegration and misshape of the Parietex Mesh on Plaintiff’s person. The physical structure of the disintegrated mesh caused trauma to the Plaintiff’s abdomen as it repeatedly came in contact with it. Furthermore, the composition of the mesh itself caused and exacerbated infection since the materials used to construct the mesh were not chemically compatible to the Defendant’s tissue.”
So much for Covidien's claim of “optimal abdominal wall conformability.”
The first Covidien hernia mesh came on to the market in 1999. This product did not undergo any testing on human subjects; instead, this mesh and subsequent models got “fast-tracked” to FDA approval under the 510(k) Premarket Notification process. Essentially, each of Covidien's hernia mesh devices won FDA approval based on data demonstrating that it was “substantially similar” to a predecessor. This process has saved medical device manufacturers and drug companies tens of millions of dollars in research and study costs – but has proven very expensive for patients who have been injured by these devices.
So far, Covidien hernia meshes have been implicated in tissue adhesion, bowel obstruction and perforation, tissue adhesion and hernia recurrence, causing severe inflammation resulting in painful infections. Patients who have undergone hernia repair with this device have required dangerous and invasive revision surgery, which often results in permanent injuries on top of the original one.
All hernia meshes have been associated with these problems. However, there are manufacturing defects that are specific to the Covidien mesh; namely, the use of polyester in its construction. This material is more likely to cause severe inflammation than polypropylene, despite the coatings that have been applied (which themselves have been linked to inflammatory response). Polyester is also less sturdy than polypropylene, creating difficulty during surgery. Beyond this, most Parietex mesh devices have unsealed edges, causing them to fray and disintegrate once they have been implanted. Once this has happened, organ perforation can result.
Significantly, the problems with polyester have been known for years. One study, published in the Journal of the American Medical Association Surgery in 1998, looked at the records of patients who underwent hernia treatments over a 9-year period. In their conclusion, the researchers stated that “polyester mesh should no longer be used for incisional hernia repair.”
That conclusion did not prevent Covidien from starting the manufacture and sale of polyester patches the following year. It is not known why this company intentionally engaged in the production of hernia mesh devices made from a product that medical science had deemed unsuitable, although minimizing production costs and maximizing profits most likely figure into the equation. Those answers will be forthcoming as lawsuits against Covidien move forward over the coming months.