What Hernia Surgery Patients Need to Know about Defective Hernia Mesh Patches
Hernia surgery has evolved in recent years from the traditional procedure that involved stretching the weakened tissue to close the opening in the abdomen to correct a protrusion of an organ, tissue, muscle or other structure, with the stretched tissue being stitched together. The more common approach to hernia surgery now involves employing a hernia mesh patch to keep the protruding structure in place. While the use of abdominal hernia mesh has become a common practice, more than a 100,000 of these medical devices have been recalled because of serious flaws that can cause permanent debilitating injuries.
The Composix Kugel Mesh® hernia repair patch is one type of abdominal hernia mesh that was approved for use by the FDA in 1996 and manufactured by Davol, Inc., a subsidiary of C.R. Bard, Inc. The abdominal mesh is inserted and placed between the intestines and the stomach lining in order to retain the intestines in their original position. Serious issues with the abdominal hernia mesh patch began to be reported in 2002 according to the FDA.
This patch is implanted in the abdomen through an incision. The large and extra-large versions of the patch began to create problems because the medical devices were failing and causing serious injuries. The devise is comprised of dual layers of mesh which are surrounded by a plastic memory recoil spring. The device is implanted into the abdomen by folding and inserting the memory coil, which is designed to open once implanted so that the device is flat against the opening and reinforces the tissue while the body heals.
When these abdominal mesh patches began to fail and cause complications in 2002, the manufacturer initially claimed the issues were linked to errors by the surgeons who implanted the defective medical devices. However, over time it became apparent that the defective medical devices were failing at the place that the memory coil was welded. The memory recoil spring, which is used to open the device during insertion, may fail when under pressure once it is implanted in the abdomen.
The two largest versions of the abdominal mesh were recalled in December 2005, with the recall being expanded to include additional lots and models of the product between December 2005 and March of 2006 and in January 2007. The covered Composix Kugel Mesh hernia repair patch models and lots are subject to a Class 1 recall by the FDA, which is the most stringent type of FDA recall based on evidence that the defective medical product may cause serious injuries or fatalities.
If you have been implanted with a defective abdominal patch you may suffer serious complications including chronic intestinular fistulae, bowel perforations and other serious hernia surgery repair complications. When the Composix Kugel Mesh defective hernia mesh repair medical product fails, it can have sharp edges that cut through surrounding organs and cause a variety of other intestinal and migration-related injuries.
These injuries can cause serious debilitation and even be life-threatening. If you have suffered this type of serious injury, our experienced personal injury lawyers may be able to help you seek critical financial compensation including costs of revisionary surgery and other medical costs, lost wages from time off work, compensation for future lost income, pain and suffering, diminished quality of life and other damages.
Although you might have received a recall notice from the manufacturer of Composix Kugel Mesh, many individuals are unaware that they were implanted with this defective medical device. If you had hernia surgery that included implantation of abdominal surgical mesh, you should contact an experienced defective medical products attorney if you are experiencing the following symptoms:
- Persistent abdominal pain
- Abdominal distension
- Intestinal fistula
- Tenderness at the implantation site
- Bowel perforation
- Changes in bowel movements
There are medical screening procedures that can be utilized to determine if your symptoms are a product of defective abdominal mesh including barium swallows, x-rays and reverse imaging CT scans. Our law firm is evaluating lawsuits based on a range of legal theories, such as the manufacturer's failure to conduct proper testing and quality control before placing the defective medical device on the market. An investigation by the FDA also revealed that the manufacturer of this defective abdominal mesh allowed it to remain on the market long after the company was aware of serious problems with the medical device.
The Kugel Mesh Patch® was implanted in approximately 750,000 hernia repair surgeries per year. The manufacturer continued to implant these defective medical devices in many patients despite their awareness of problems with the device. Our experienced Georgia personal injury attorneys at are available to answer your questions and provide aggressive legal representation to those who have been injured by defective abdominal surgical mesh during hernia repair surgery.
Put Our Law Firm's Over 37 Years of Experience to Work For You
Our Georgia personal injury attorneys at Montlick and Associates have been representing those who suffer serious injuries or wrongful death for over thirty years throughout all of Georgia and the Southeast, including all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.