Hernia Repairs Litigation. The U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to hear oral arguments about consolidating federally filed lawsuits involving Atrium Medical Corp.’s C-Qur line of polypropylene surgical mesh for hernia repair.
Court documents indicate that at least 15 cases involving Atrium’s C-Qur line of surgical mesh products are now pending in federal courts across the country. The plaintiffs allegedly experienced severe and debilitating complications when C-Qur was used in hernia repair. If the motion is granted, the cases would be transferred to the U.S. District Court, District of New Hampshire for pretrial proceedings.
In May 2016, Ethicon, maker of Physiomesh Flexible Composite Mesh announced a worldwide withdrawal of the mesh. Data from two European health registries indicated that hernia recurrence and revision surgery rates following hernia repair were higher with the device than with comparable mesh. A number of hernia mesh lawsuits have been filed in U.S. courts on behalf of individuals who suffered injuries allegedly related to this product. In a letter to health care providers, Ethicon explained that the review of hernia procedures revealed higher rates of hernia recurrence and repeat surgery with Physiomesh than with other mesh products listed in the hernia registries, MassDevice reports.
Complications with Ethicon Physiomesh
Laparoscopic surgery is widely used in hernia repairs. Also known as minimally invasive surgery, laparoscopic hernia surgery is conducted through small abdominal incisions rather than by opening the abdomen. Small, thin instruments are inserted through the tiny incisions. The surgeon is guided by a video camera that shows the internal organs. Surgeons favor minimally invasive surgery whenever possible, because these procedures involve less post operative discomfort because of the smaller incisions; less blood loss; faster recovery times; earlier return to full activities, and smaller scars.
In a May 25 letter to health care providers, Ethicon explained that the review of hernia procedures revealed higher rates of hernia recurrence and repeat surgery with Physiomesh than with other mesh products listed in the hernia registries, MassDevice reports. Ethicon recalled the Physiomesh products following an analysis of unpublished data from two large independent European hernia registries (Herniamed German Registry and Danish Hernia Database-DHDB). Ethicon conducted the analysis of hernia recurrence and reoperation rates after laparoscopic hernia repair using Ethicon Physiomesh products. Personal injury law firm Parker Waichman notes that other Ethicon surgical mesh products have been linked to serious injuries and side effects.
Patients who have undergone hernia repair with Ethicon’s Physiomesh products allege Physiomesh is defectively designed and is manufactured using plastic materials that react to human tissues and can cause infections and complications. The plastic mesh can cut into tissues and organs and the mesh can migrate to other parts of the body and become embedded in organs. Patients also allege that Physiomesh fails to perform as expected and the hernia can recur. The patient then has to undergo repeat hernia repair surgery.
According to the recall notice, Ethicon has not been able to give surgeons further instructions that might reduce the recurrence rate and so Ethicon decided to recall Ethicon Physiomesh Composite Mesh from the market worldwide. Ethicon advises surgeons who have treated hernias with Ethicon Physiomesh to continue to monitor those patients in the usual manner.
Problems for Other Ethicon Surgical Mesh
Ethicon has faced extensive litigation over another of its surgical mesh products: transvaginal mesh devices used to treat pelvic organ prolapse and stress urinary incontinence in women. The devices provide support to pelvic organs when a woman’s pelvic structures have been weakened by childbirth, surgery, or aging. But women and their doctors have reported serious complications because of the devices’ design and the implantation technique. Women implanted with transvaginal mesh have reported complications including pelvic pain, mesh protrusion into the vagina, painful sexual intercourse, infections, urinary problems, bleeding, and recurrence of the prolapse or incontinence. One in 12 patients reportedly suffers complications from a transvaginal mesh device. The FDA plans to reclassify transvaginal mesh devices from the moderate risk Class II to the high risk Class III and make these devices subject to a more rigorous approval process.