Recalled Kugel Hernia Patch Subject of Vaginal Mesh Injury Lawsuit

On April 26, an Illinois resident filed a vaginal mesh injury lawsuit alleging the Composix Kugel patch she received caused her severe complications. The case is proceeding in the U.S. District Court, District of Minnesota (DMN), where the plaintiff hopes to recover compensatory and statutory damages.

The woman’s vaginal mesh lawyer is charging defendants and Composix Kugel mesh manufacturers Davol and C.R. Bard with negligent design and manufacture of a surgical device, which allegedly caused the Illinois plaintiff to incur bodily injuries and financial losses due to the defective nature of the product. The claim joins scores of others in the Kugel Mesh Hernia Patch Products Liability Litigation (MDL-1842) overseen by United States District Judge Lisi.

Kugel mesh hernia patch recalled by FDA

Based on growing reports of transvaginal mesh complications involving weld defects in the recoil rings of the Composix Kugel mesh, Davol recalled several sizes of its patches in December 2005 under a Class I recall notice. The mesh was authorized by the FDA as a Class II medical device through the agency’s 510 k “fast track” process, in which rigorous pre-market testing isn’t required as long as the device is deemed to be “substantially similar” to another already on the market.  The Composix Kugel Patch was recalled due to a defective memory recoil ring that could fracture under pressure leading to migration, intestinal fistulae, bowel perforation, and in more dire scenarios, death.

According to court documents, in March of 2006 and again in January of 2007, the Class I recall on the Kugel Patch was broadened to include additional sizes and lots of the defective hernia mesh product.  Although not part of the official vaginal mesh recall, Davol’s Composix Kugel Patch does contain the faulty memory recoil ring.

Allegations made in vaginal mesh injury lawsuit

The claimant asserts that she was never made aware by the defendants of the potentially defective and dangerous nature of its recalled product, when she was implanted with their patch on July 1, 2006 to address her ventral hernia defect. She received the 14 x 18 cm Kugel Composix oval hernia patch but did not learn about the possibility of future complications with the recoil ring until well after Bard’s and Davol’s FDA recall of the product. A Class I recall is reserved for products and medical devices that the FDA deems may lead to life-threatening problems to patients.

In August 2011, the plaintiff’s Kugel Composix oval hernia patch failed, according to the complaint, requiring immediate removal. The woman had surgery to extract her hernia patch at Rush University Hospital in Chicago in 2007, and alleges that she has since incurred substantial physical pain and emotional trauma following the mesh failure. Her lawsuit charges Davol and C.R. Bard with negligence, intentional infliction of emotional distress, failure to warn and breach of implied and express warranties, as well as misrepresentation by omission. Her lawyer claims that representations were made with the intent to defraud and deceive the plaintiff and her physicians and that due to the defendants’ misrepresentations and oversights, the claimant has suffered and will continue to suffer injury, harm, and economic losses.

Honorable District Judge Lisi, who is overseeing the multidistrict litigation involving the recalled vaginal mesh, clarified that the MDL would include alleged design defects associated with additional Bard/Davol hernia repair products.