ST. LOUIS – A woman who underwent hernia repair surgery in 2012 in Poplar Bluff is suing the manufacturers of a mesh product claiming it was defective and caused her permanent injuries.
Callie Cooper filed suit against Davol Inc. and its parent company, C.R. Bard, over its Composix Kugel hernia mesh on May 31 in U.S. District Court for the Eastern District of Missouri.
According to the complaint, Cooper had surgery to repair an umbilical hernia by Dr. Kean Griffith at Poplar Bluff Regional Medical Center on Sept. 18, 2012. Nine months later she underwent surgery by a different surgeon, Dr. Darin Minkin, to remove the mesh that had "retracted" and was no longer covering hernia defect. It had come up anteriorly toward the skin underneath the wound, the complaint states.
Cooper, represented by Adam M. Evans and C. Brett Vaughn of the Hollis Law Firm in Prairie Village, claims she continues to experience complications and will likely require additional surgeries to repair damage.
Among the allegations in Cooper's complaint are that the defendants were aware "of the high degree of complications and failure rate" of the Composix Kugel, which is produced in varying sizes, many of which had been recalled in 2005 due to a faulty memory recoil ring.
The suit claims that incidents including ring migration, intestinal fistulae bowel perforation and even death had been reported during that time period. It further claims that the Food and Drug Administration had investigated in 2006 and concluded, among other things, that the manufacturers "failed to provide full information which they knew regarding numerous Composix Kugel complaints."
"Defendants have concealed and/or failed to disclose to the public all of the serious risks and all of the potential complications associated with the product, so as to ensure continued and increased sales and profits and to the detriment of the public, including Plaintiff.," the suit claims.
Cooper seeks a jury trial, as well as unspecified compensatory and punitive damages and attorney fees.