Hernias are painful and require treatment to prevent further medical harm. One of the options available to doctors in the surgical treatment of hernias is the use of mesh patches. Composix® Kugel® mesh patches are manufactured by Davol, a subsidiary of parent company C.R.Bard. It is used primarily for hernia surgery, particularly for laparoscopic ventral hernia repair. The product is inserted into place through a small incision in the abdomen and is meant to remain in place as a permanent repair.
Kugel Mesh Multi District litigation
Composix® Kugel® Mesh patches were manufactured and designed by C.R. Bard. Bard is a subsidiary of Davol Inc. located in Rhode Island. These patches contained a “memory recoil ring”. Unfortunately, these memory recoil rings often buckled or broke causing very serious and extremely painful complications. Thousands of victims filed lawsuits against Bard Davol In federal Courts. These cases were consolidated into a multi district litigation. These cases were consolidated into a multi district ligation named: “In re Kugel Mesh Hernia Patch Products Liability Litigation, Case No.: MDL No. 1842” This MDL is otherwise known as: “In re Kugel Mesh Hernia Patch Products Liability Litigation, MDL No. 1842, No. 07-MD-1842-ML (D.R.I.)”
According to the Presiding Judge of the MDL, the Honorable, Mary Lisi: “The MDL involves claims surrounding allegedly defective hernia repair patches designed and manufactured by Davol, Inc. (“Davol”), Bard Devices, Inc. (“Bard Devices”), and C.R. Bard, Inc. (“Bard,” together with Davol, the “Defendants”). /s/ Mary M. Lisi Mary M. Lisi Chief United States District Judge, June 5 , 2012
2011 Global Settlement of MDL for 184 million
In 2011,Bard “reached an agreement to settle Kugel hernia mesh lawsuits brought by about 2,600 people who experienced severe internal injuries caused by problems with their hernia repair patches, with an average payout of about $70,000 for each plaintiff.” https://www.aboutlawsuits.com/kugel-hernia-mesh-settlement-charge-19288/ Bard paid 184 million to settle the product liability lawsuits. Bard Davol had previously recalled many different types of Composix Kugel Mesh patches.
Kugel Cases still being filed in 2018
After the settlement, the Multi District litigation was disbanded. Most of these cases are currently being filed in Rhode Island State Courts in front of the Honorable Justice Vogel.
History of Composix Kugel Mesh Patches
The Kugel mesh patch was approved for use by the U.S. Food and Drug Administration, FDA, in 1996. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the hernia. The ring can break or bend when it is under pressure or when it changes position. The end can then protrude out of the mesh and perforate the bowel. This condition is called chronic enteric fistulae. Various sizes of the device were recalled in 2005, 2006, and 2007. Some models of the product were recalled due to reports of serious injuries that occurred because of the patch breaking inside the patient. Patients continue to experience and report medical problems due to Composix Kugel mesh patches.
Mesh Patch Complications
There are a number of medical complications that can occur from the use of mesh patches including Composix Kugel mesh patches. Some of these complications include:
- Bowel obstruction
- Abdominal fluid
- Intestinal perforation
- Pelvic inflammatory disease, PID
- Ring migration
- Abdominal pain, tenderness, and distention
As the body heals, new tissue grows around and on the mesh implant. In some cases, the ring itself is pushed out of place and protrudes through the abdominal wall. In other cases, an infection may develop which can become severe. When a problem arises, additional surgery is required to assess the extent of damage and correct the situation.
Treatment of Complications
Complications from the use of mesh patches must be treated as quickly as possible to avoid further damage from occurring. The doctor must properly diagnose the medical issue to determine the cause. Complications from mesh implants can sometimes have similar symptoms as
Adequate medical treatment other medical conditions. A CT scan or other tests are necessary to make a proper diagnosis. In most cases, the only viable treatment for a complication due to mesh implant is through additional surgery.
Is removal of mesh implants possible?
Removal of the original mesh implant is not usually possible because internal tissues have already begun to attach to it and grow around it. This can cause a more difficult surgery, and more mesh materials may be required to patch the area. When a patient is noted to have any symptoms associated with a mesh patch product it is necessary to perform an examination to determine what treatment is needed.
Adequate medical treatment for defective hernia patch
Only once the extent of damage is determined can adequate medical treatment be rendered. Some patients may have extensive internal damage such as a tear in the intestine. Others may have a recurring hernia, and still, others may have a complete bowel obstruction. If the damage has caused an infection, the patient could be in serious condition and in some instances the injuries could lead to the patient’s death.
Recalls and settlement
Composix Kugel mesh patches are manufactured in a variety of types and sizes. Some of these have been recalled over the years. Various sized patches were recalled by Bard Davol Inc. The products included in a recall in January 2007, are product code 0010202 large oval, and product code 0010204, large circle. Additional codes that were also recalled include 0010206, extra large oval, 0010207, extra large oval, 0010208 extra large oval and 0010209, oval.
Bard provided information to immediately discontinue use of products with specific codes and lot numbers. The company redesigned the product to improve the integrity of the ring. They increased the ring strength by four times, increased the overlap at the joint and made changes to the size of the ring itself.
Many victims have been desperately searching the internet for searches about: hernia mesh failure symptoms, hernia mesh infection, hernia mesh problems years later.
Many people are asking the following question to google:
- How long does it take for hernia mesh to heal?
- What is hernia mesh made out of?
- Is the mesh used for hernia repair safe?
- Can a hernia mesh be removed?
- How long does it take to recover from laparoscopic inguinal hernia surgery?
Additionally, instructions for proper use are included with the product and are designed to remind doctors of the proper way to fold the patches for use. The proper technique is supposed to help reduce the risk of complications. As a result of reported problems with the products, Davol issued recommendations to doctors to identify patients in which the product was used, advise patients of the recall and evaluate and examine patients for symptoms that could be related to the recalled products.
Litigation History and Current Status
Patients have reported many various types of problems and complications associated with the use of mesh patches in their hernia surgeries. One of the most important considerations is that patients or their doctors were not properly warned of the potential of problems that could occur and therefore were not able to make intelligent decisions about their medical treatment. In some cases, the company received reports of injuries but did not take any action to resolve the problem. There continue to be reports of injuries from the use of Composix Kugel mesh patches that are still on the market. Many of these products continue to be used for hernia surgeries even though defects have been reported.
How to Take Legal Action against Davol and C.R. Bard
If you have experienced serious complications due to the use of a Composix Kugel mesh patch may be entitled to compensation. A lawsuit may be filed against C.R. Bard because they failed to warn about potential injuries and/or because they knew about the potential for injuries but did not take any action to prevent further injuries from occurring.
Patients must provide medical documentation about the use of a mesh patch in their original hernia surgery and also medical details regarding the occurrence of complications and treatment of them. The patient and his or her physician should also report the medical complications to the U.S. Food and Drug Administration, FDA, through their MedWatch reporting program. The law limits the time to file a lawsuit, so it is important to discuss the matter with a qualified attorney as soon as possible.