Kugel Mesh Lawsuits Still Coming In

Providence, RIIt’s been some time since Kugel mesh has been in the news. The mesh, manufactured by Davol Inc. and its parent company Bard, has been around since first approved by the US Food and Drug Administration (FDA) in 1996. Mesh has also, over time, become the preferred method for repair of abdominal hernias. However, what seems to have driven the Kugel Mesh litigation parade is the adoption of placement methods through small incisions, with mesh tightly coiled for insertion, then expanded into place through the deployment of a “memory coil ring.”

This type of surgery is less invasive, allows for speedier healing and requires reduced time in the hospital, freeing up beds. And yet, for a number of Kugel patients the outcome has been anything but satisfactory, with the memory coil ring allegedly breaking in some cases, with the mesh allegedly migrating in others.

The lawsuits keep coming. One of the more recent filings occurred earlier in the spring. Plaintiff Casey N. Oppenheim filed an action against Davol Inc. and C.R. Bard Inc. in Rhode Island District Court March 7 of this year (Case No. 1:2014cv03859). Specifics of the complaint are not yet available - but it is telling that lawsuits are still coming in.

A compelling commentary as to just what can happen with migration or similar complication inherent with Kugel Mesh was recently outlined in the February 2014 issue of The American Surgeon. A case study conducted by Takehiro Okabayashi, MD and colleagues at Kochi Health Sciences Center in Japan focused on the plight of a 58-year-old female patient who underwent surgery for repair of an abdominal hernia using the Kugel mesh system.

According to the study, the patient underwent laparoscopic incisional hernia repair with Bard Composix Kugel Patch (expanded polytetrafluoroethylene mesh) under general anesthesia. Approximately four years after laparoscopic incisional hernia repair, the patient was readmitted to the hospital.

This mesh migrated and impacted the colon

Subsequent examination discovered that the mesh, over time, had migrated from its original insertion point and wound up eroding into the transverse colon - a finding further supported through the use of colonoscopy, which revealed “mesh-like material protruding through [the] transverse colon wall.

“Mesh migration often results in significant complications such as abdominal pain, bleeding, infection, and fistula,” the study authors concluded. “Therefore, [an] operation [made necessary for] removing the mesh, performing partial resection of the transverse colon, anastomosing the bowel, and then repairing the hernia without mesh.”

The study authors acknowledged that use of mesh repair for incisional hernias remains a favored method of repair and is associated with reduced rates of hernia recurrence. That said, they also acknowledge that “mesh repair techniques can be associated with an increased incidence of early complications such as infection, hematoma and seroma formation.” The mesh can also migrate due to “either inadequate fixation or probably external displacing forces.” The study authors did not offer any conjecture as to what those external forces might be. Exercise, perhaps.

However, mechanical migration of Kugel Mesh can occur via the path of least resistance inside the abdomen soon after placement, or through secondary migration - described as the slow, gradual migration of the mesh following initial displacement, with erosion into adjacent tissue at a later stage.

“In conclusion,” say the study authors, “although mesh repair of an incisional hernia by laparoscopic surgery has many advantages, surgeons should be aware of the possibility of the rare but potential complication of mesh erosion.”

What this means for the patient is pain, discomfort and the potential for revision surgery with heightened complication and more time off work for healing. Little wonder that plaintiffs seek out a Kugel Mesh attorney for help in taking legal action against the manufacturer, to pursue compensation for their pain and suffering.