Composix Kugel Mesh Patch Removed from Market
The Composix Kugel Mesh Patch, a ventral hernia repair device, was removed from the U.S. market on December 22, 2005. The U.S. Food and Drug Administration and Davol, Inc., a subsidiary of C.R. Bard recalled the product because the memory recoil ring, which opens the patch after it has been inserted into the intra-abdominal space, can break. If you or a loved one has suffered injuries due to the defective Kugel Mesh product, an Kugel Mesh recall lawyer can help you recover compensation for your pain and suffering. Contact a New York Kugel Mesh Recall Lawyer today!
According to the Kugel Mesh recall notice issued by the FDA, "Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage."
As of the latest Kugel Mesh recall date, the company received 31 reports of broken rings with the defective product. If you believe that you too received damages as a result of a broken ring, Contact our New York Kugel Mesh recall lawyer right away.
What does the Composix Kugel Mesh Patch Do?
Composix Kugel Mesh Patches were designed to aid in the repair of ventral hernias caused by thinning or stretching of scar tissue that forms after hernia surgery. The purpose of the Composix Kugel Mesh Patch is to prevent the hernia from pushing through weakened tissue walls, specifically when stomach muscles are too weak for surgery to repair the hernia.
Why is the Composix Kugel Mesh Patch Dangerous?
During hernia surgery, a small incision is made and the folded patch is placed behind the hernia. The patch then unfolds and is held open by a plastic "memory recoil ring" once it is in place. However, increased stress placed on the device during certain surgical placement techniques can cause the ring to break. If the ring breaks, it can lead to bowel perforation and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Other reported cases in New York and nationwide of injury due to the breaking of the defective memory recoil ring included:
- infection
- bowel obstruction
- septic shock
- consumptive coagulopathy (blood clotting)
- memory recoil ring migration through the abdominal wall
- heart attack after surgery to repair fistulae caused by broken memory recoil ring
Following the Kugel Mesh recall, New York surgeons and hospitals were advised to cease using the defective product with codes and lots affected by the Kugel Mesh recall and to return unused units to the company. Patients who have received one of the recalled devices should seek immediate medical attention if they experience any of the following symptoms:
- fever
- tenderness at the implant site
- any other unusual symptoms potentially related to ring breakage
Which Composix Kugel Mesh Patch Products have been recalled?
On March 24, 2006, the following Kugel Mesh recall notice was issued to healthcare professionals: "Immediately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall." Contact an experienced Kugel Mesh Recall Lawyer if you have used any of the recalled products.
In December 2005, January 2006, and March 2006, the following Composix Kugel Mesh Patch product codes were recalled:
|
PC#0010206 |
Bard Composix Kugel |
Extra Large Oval |
8.7" x 10.7" |
|
PC#0010207 |
Bard Composix Kugel |
Extra Large Oval |
10.8" x 13.7" |
|
PC#0010208 |
Bard Composix Kugel |
Extra Large Oval |
7.7" x 9.7" |
|
PC#0010209 |
Bard Composix Kugel |
Oval |
6.3" x 12.3" |
|
PC#0010202 |
Bard Composix Kugel Large |
Oval |
5.4" x 7" |
|
PC#0010204 |
Bard Composix Kugel |
Large Circle |
4.5" |
Legal Help for Victims of Bard Composix Kugel Mesh Patch
If you, a family member, or a friend have had a Bard Composix Kugel Mesh Patch implantation and have suffered an injury that you believe was caused by the Bard Composix Kugel Mesh Patch, please contact a New York Kugel Mesh Recall Lawyer of Finz & Finz, P.C. at (888) FINZ-FIRM today to speak to a Kugel Mesh Recall Lawyer or fill out the Free Case Evaluation form at the right of this page.
