Composix Kugel Mesh X Large Patch
If you have ever suffered from a hernia, and received medical treatment for it, especially prior to late 2005, there is a chance that you have received a medical device which has since found to be defective. The device is known as the Composix Kugel Mesh X-Large Patch, and it was used for treating ventral, or incisional, hernias.
A hernia is a tear or breach of the abdominal wall, which is generally caused by a weakness in the wall itself. The weakness is usually congenital, and the chances of abdominal wall weakness can also increase with age. Additionally, it may occur from an event such as pregnancy, extreme weight loss, some illnesses, and surgery. Sometimes the hernia is accompanied by pain, especially when lifting or exerting oneself, and other times it can manifest itself through digestive problems. Often, however, the hernias are either asymptomatic or accompanied only by a vague feeling of pressure or discomfort.
Treatments for hernias vary, but usually involve the strengthening or reinforcing of the muscle wall with a piece of mesh. The mesh can be placed under the defect, in a posterior repair, or, less commonly, over it in an anterior repair. Sometimes staples can be used to keep the mesh in place.
The Composix Kugel Patch was inserted into the body through an incision, and was folded in order to make it easier to insert. It also had a memory recoil ring, which was intended to open the patch, and hold it in place, after insertion. However, it was found that the patch often had defective memory recoil rings, which would then break. This breakage could tear through the mesh of the patch, causing serious or even life-threatening complications such as perforation of the bowel or chronic enteric fistulae. This is a condition which involves atypical passageways between the intestines and the other digestive organs. Both the chronic enteric fistulae and the bowel perforations could lead to infection and other complications.
The Composix Kugel Mesh Patch, which was manufactured by Davol, Inc., was recalled by the FDA in a Class I recall – the most serious of all FDA recalls – beginning in December 2005 and in an expanded recall in 2007.
Some patients who have had the Composix Kugel Patch inserted may require replacement surgery; others may determine, in consultation with their surgeon, that replacement surgery poses a greater risk than leaving the Kugel Patch in place, and opt instead to remove only the broken ring. If you have had hernia surgery and believe that your doctor may have used one of these patches, consult with your doctor to determine the status of your mesh patch. Particularly if you have experienced any of the symptoms associated with the broken memory recoil ring, which include abdominal pain or tenderness, fever, or any unusual symptoms, you should have your hernia incision site evaluated.
A number of patients who have experienced issues with their Composix Kugel Mesh Patch have sought remuneration through the legal system. You, too, may be entitled to recover compensation for the pain and suffering you have endured, in addition to the medical expenses you may have incurred in undergoing additional surgery to fix the initial hernia patch. If you have a spouse or relative who has died from complications arising from a defective mesh hernia patch, you may even be eligible to bring a wrongful death suit against Davol, the manufacturer of the Composix Kugel Mesh X-Large Patch.
There are many attorneys who specialize in faulty or defective medical product litigation. Some of these attorneys may even have previous experience in litigating a case involving the Composix Kugel Mesh Patch. A little research into personal injury or medical malpractice attorneys in your area ought to afford you the confidence that you can recover damages if you have been harmed by the insertion of this brand of hernia repair patch.
Although nothing can give you back the time you spent having replacement surgery, or the quality of life that was lost during the complications following your hernia treatment, it may be possible to recover monetary damages and reimbursement of your medical bills. When someone else is at fault for a defective product, they should be held liable for the damage they cause.