In 2007, the FDA issued a Class 1 recall for the Composix Kugel Mesh Patch, a medical device inserted to repair ventral (incisional) hernias. The FDA later updated the degree of its warning, as the product’s defects have potential to result in serious and adverse health consequences, including death.
The Kugel Mesh Patch was designed to repair hernias resulting from the thinning or stretching of scar tissue that forms after surgery. Surgeons implant the device behind the area through a small incision. A “memory recoil ring” holds the mesh together for insertion and then unfolds once it reaches the correct spot.
The plastic ring, however, may break under the stress of placement in the intra-abdominal area. For patients experiencing this, the following symptoms may surface:
• Tenderness at the implant spot
• Bowel perforation
• Chronic intestinal fistulae
• Nausea and vomiting
• Unexplained or unusual intestinal symptom like bowel obstruction, distention, fecal vomiting, or constipation.
Yearly, 750,000 patients undergo hernia repair surgeries in the U.S. Lawsuits filed against C.R. Bard and parent company Davol allege the manufacturer was aware of the hernia patch’s defects but allowed the product to enter the market and be implanted into patients.
Nevertheless, unlike similar product transvaginal mesh that can be removed through multiple revision surgeries, this type of hernia surgical patch should ideally remain in the patient. Although the memory ring can be taken out, removing the mesh poses far more risks than leaving it in. Patients given this product, as a result, require continual medical attention.
After The Recall
Since the 2007 recall, Davol and C.R. Bard informed hospitals and doctors about the defective hernia patch, advising them to stop implantation and to update all patients who received the mesh. Nevertheless, even years later, patients are just finding out they were implanted with the Kugel Mesh and are now seeking compensation for the medical monitoring it requires.
If you’re just now finding out a doctor inserted the Kugel Mesh for a hernia procedure, seeking medical attention and legal advice is recommended. To pursue your claim and receive compensation for injuries, pain and suffering, and future medical attention, have Trantolo & Trantolo’s experienced attorneys examine your case.