Composix Kugel mesh patches are manufactured by Davol. Davol is a subsidiary of the parent company C.R. Bard. There are currently hundreds of Bard Kugel hernia mesh lawsuits pending in different courts. Davol Inc. is located in Rhode Island. C. R. Bard was purchased by Becton Dickinson in December of 2017. C. R. Bard is now known as Bard Medical which is a division of BD. Bard’s principal offices are now in New Jersey.
- Kugel Hernia mesh 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.
- These patches contain a “memory recoil ring.”
- Unfortunately, these memory recoil rings often buckled or broke causing very serious and extremely painful complications.
- Hernias are painful and often require treatment to prevent further medical harm.
- One of the options currently available to doctors in the surgical treatment of hernias is the use of mesh patches such as Kugel mesh.
- There is currently no Kugel recall but there have been a number of Kugel hernia mesh recalls in the past.
- In 2011, there was a settlement of 2,600 Kugel hernia mesh lawsuits for $184 million. These lawsuits were Multidistrict Litigation in RI Federal Court.
Update – 4/08/2022- Over 5,000 Bard / Davol hernia mesh lawsuits have settled in 2022 in Rhode Island State Court. Cases are settling in batches. The 2nd Bard bellwether trial is underway in the MDL in Federal Court for the Southern District of Ohio.
Kugel Hernia Mesh Lawsuit update
Kugel hernia mesh lawsuits are currently being filed in the following places:
- Rhode Island state court -Kugel cases may be file in a consolidated state court proceeding for hernia mesh manufactured by Bard/ Davol.
- Federal Court- A Kugel mesh lawsuit can be filed in the consolidated Multi District Litigation (MDL) pending in the Southern District of Ohio. There are over 15,000 Bard / Davol hernia mesh lawsuits pending in the Southern District of Ohio as of 2/15/22. mdl-statistics-kugel-hernia-mesh-lawsuit Many of these pending lawsuits are Kugel hernia mesh lawsuits.
- Various State courts- There may also be a limited number of multi-million dollar damage cases filed as individual lawsuits in various state courts across the United States. (Individual lawsuits tend to be cost prohibitive unless damages far exceed a million dollars.) (Any individual lawsuit filed in Federal Courts would be transferred to the MDL in Ohio.)
Kugel hernia mesh which is often misspelled as “Kugle” mesh is not to be confused with other Composix Surgical mesh for ventral hernias manufactured by Bard / Davol such as:
History- Circa 2011, Kugel Mesh Multi District litigation
- There was previously a consolidated Kugel hernia mesh litigation pending in Rhode Island Federal Court.
- Thousands of victims filed lawsuits against Bard / Davol In federal courts.
- These cases were consolidated into a multi district litigation. The multi district ligation was named: “In re Kugel Mesh Hernia Patch Products Liability Litigation, Case No.: MDL No. 1842”
- 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”). Mary M. Lisi Mary M. Lisi Chief United States District Judge,
- This Kugel MDL was disbanded / closed in 2017. The MDL had been open for a 10 year period,
184 million settlement of 2600 cases pending in RI Federal Court in 2011
- In 2011 Bard settled approximately 2600 Kugel lawsuits that were pending in the MDL in the District of Rhode Island for a total of $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.” About Lawsuits
- Bard Davol had previously recalled many different types of Composix Kugel Mesh patches.
- Victims received an average of $70,000 each.
- After the mesh settlement, the Kugel MDL in federal court was disbanded in 2017.
- Despite the Kugel hernia mesh settlement and the disbanding of the lawsuit, it is not too late to file a Kugel hernia mesh lawsuit in 2020.
The Current Rhode Island Bard / Davol State Court Proceedings:
- Cases against Bard/ Davol are currently being filed in Rhode Island State Courts in front of the Honorable Justice Vogel.
- In 2017, the Providence Superior Court “set up a multi-case management coordinated proceeding for cases primarily involving Davol/ C.R. Bard Composix Kugel Hernia Patch.” IN RE: DAVOL/ C.R. BARD HERNIA MESH PROCEDURAL ORDER NO. 1
- To this date, many Kugel cases are being file in Rhode Island State Courts.
- Rhode Island has a long lasting, protracted and extended statute of limitations for Bard hernia mesh victims.
- In the Bard Davol lawsuit in Rhode Island the CK patch was described as: “Composix Kugel Hernia Patch: The Composix Kugel Hernia Patch is constructed of two layers of small pore, heavy weight, unsuitable polypropylene that is stitched to layer of ePTFE with one or two PET ring(s) sewn in between. Class 1 Device Recalls of this patch were required in 2005, 2006, and 2007 due to the defective and dangerous nature of this product. The FDA classified all of the recalls as Class 1 Device Recalls. This means that the FDA found there is reasonable chance that the patches could
cause serious health problems or death.” MASTER LONG FORM COMPLAINT AND JURY DEMAND- IN RE: DA VOL/ CR. BARD HERNIA MESH
MESH MULTI—CASE MANAGEMENT
- As of 2/19/22, 0ver 5,000 of these lawsuits have been settled in RI state Court. More bard settlements are expected in the future.
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.
Modified Kugel patch (MK Patch)
The MK Patch by Bard,is widely known as the Modified Kugel Patch. “The Bard® MK™ hernia repair technique is a minimally invasive, tension-free technique that can be completed through a small 4-6 cm incision and minimal requirement of fixation. It is a preperitoneal repair performed through an open, anterior approach that can be completed using local or regional anesthesia.” Bard Medical The MK patch is manufactured by Bard medical. The purpose of the MK patch was to correct the allegedly defective design of the Kugel Patch. However, the Modified Kugel Patch proved to be plagued by problems causing complications in victims and leading to hernia mesh lawsuits.
“Modified Kugel Hernia Patch: The Modified Kugel Patch is constructed of layer of small pore, heavyweight, unsuitable polypropylene that includes PET ring, and additional layers of the above-noted mesh, Which act as positioning pocket and positioning strap, along with separate flat, pre-shaped onlay piece of small pore, heavyweight, unsuitable polypropylene mesh. Mesh Patch Complications.” MASTER LONG FORM COMPLAINT AND JURY DEMAND, IN RE: DAVOL/ CR. BARD HERNIA MESH MESH MULTI—CASE MANAGEMENT
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 from other medical issues.
- 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.
- 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.
2005 Kugel recalls
As far back as late 2005, C.R. Bard’s subsidiary Davol issued a number of recalls related to the Composix Kugel mesh patch product that it manufactured. It had been discovered that problems were occurring with the minimally invasive surgeries in which the Composix® Kugel Mesh Patches (“CK Patch”) was used. There were a number of reports of the plastic memory ring used in the device splintering into smaller pieces that would then migrate away from the original surgical site. This led Davol to recall the mesh.
2007 Kugel recalls
A second recall was issued in 2007 for similar problems related to these medical devices. In January 2007, the total number of Composix Kugel Mesh devices the company had recalled had soared above 100,000. By this time, the FDA had gathered reports that indicated that some 34 memory rings on these devices had broken, with 21 of these incidents causing serious injury. One incident actually resulted in death.
Once it had been discovered that this flaw existed in the memory recoil ring, which allowed it to break or buckle during placement, the company’s recall notices were expanded upon and issued multiple times. In all cases, the FDA classified these recalls as Class I. Again, this recall level for medical devices indicates that they are potentially defective and dangerous and could possibly lead to extremely serious health issues or even the death of the patient involved.
FDA Class 1 recall
The FDA – the United States Food and Drug Administration – classified this recall as a Class I, which is the highest level that the FDA uses for its recalls. This designation provided evidence of just how seriously the agency took the potential danger these implanted devices represented to the American public. This mesh product was created to serve as a patch and had a so-called “memory recoil ring” that was designed to permit the surgeon to insert the patch through a relatively small incision in the abdomen. However, it was later discovered that this ring could break or buckle after it was placed in the body, resulting in intense pain and complications that had the potential of being life-threatening.
Reported problems and recommendations
- 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.
Many victims have been desperately searching the internet for searches about: hernia mesh failure symptoms, hernia mesh infection, hernia mesh problems years later.
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 Kugel hernia mesh lawsuit, so it is important to discuss the matter with a qualified attorney as soon as possible.
Health Risks Caused by Bard Hernia Mesh Implants and patches
Based on a careful analysis carried out by the Food and Drug Administration that looked that the scientific literature and adverse event reports for such medical devices, the most frequently occurring adverse event for hernia repair operations are infection, pain, organ adhesion, hernia reccurrence, bowel obstruction, abdominal obstruction, fistulas, bleeding, tissue perforation and seroma. Any of these could result in considerable discomfort and danger for the patients involved.
Hernia mesh lawsuit against Bard allegations
In the ck patch lawsuit filed by CHARLES A. EATON and WANDA EATON against DAVOL INC. and C. R. BARD INC., the Plaintiff’s alleged the following:
- “The CK Patches, like the one implanted in Plaintiff Charles Eaton, at the time they left the possession of Defendants were inherently dangerous for their intended use and were unreasonably dangerous products which presented and constituted an unreasonable risk of danger and injury to Plaintiff as follows:
- The CK Patch was sold in a defective condition by design and manufacture;
- The CK Patch as designed and manufactured was unsafe to Plaintiff;
- The CK Patch as designed and manufactured was unreasonably dangerous to Plaintiff;
- The CK Patch did not perform safely as an ordinary consumer/patient, like Plaintiff, would expect;
- The CK Patch as designed and manufactured was unsafe for its intended use;
- DAVOL and BARD failed to warn the end user about the dangers and risks of the product;
- DAVOL and BARD knew the component parts of the CK Patch as implemented through design and/or manufacture could cause injury to the end user;
- Failing to implement an adequate, safe and effective “memory recoil ring” and/or its interaction with the mesh of the CK Patch to withstand the foreseeable stresses they would be subject to within the intra-abdominal space;
- Failing to avoid shrinkage, contraction and degradation of the CK Patch and/or its components;
- Failing to avoid migration of the CK Patch and/or its components from the initial site of the hernia repair surgery;
- Any other acts or failures to act by DAVOL or BARD regarding the studying, testing, designing, developing, manufacturing, inspecting, producing, advertising, marketing, promoting, distributing, and/or sale of CK Patches for hernia repair surgery as will be learned during discovery.” Eaton v. Davol Inc. Case Number: PC-2017-0735, complaint. Providence Superior Court.”
Unfortunately, many victims mispell Kegel mesh as Kugle hernia mesh.
Bard Defective Device Lawsuits
This is not the first time that Bard has encountered legal troubles and liability regarding its medical devices. It has a very poor safety record when it comes to such products. For instance, a state court in California awarded a woman $3.6 million after she demonstrated to the court’s satisfaction that Bard’s Avaulta Plus implant had caused her serious injury. These implants were later removed from the market, but the damage had already been done.
Many devices of questionable safety manufactured by this company are still available on the market, regardless of the fact that they may be dangerous. A number of lawyers have pointed out in court that Davol Bard has sold a large number of plastic mesh devices over the years in which they used a type of plastic that the plastic manufacturer indicated was not safe for implantation in humans. In documents presented in court, emails from within the company itself revealed discussions in which executives warned their coworkers not to tell plastic manufacturers they were using this particular plastic material in the medical devices they were manufacturing for placement in human beings.
In fact, in spite of the warnings it had received from these plastic manufacturers, Davol / Bard continued using the material in its vaginal mess devices and hernia repair meshes. They were technically able to do this because the mesh itself had been cleared for use through the FDA’s 510(K) system, which frequently permits medical manufacturers to place medical devices on the market without actually conducting human tests regarding their safety or efficacy. There are quite a few defective products manufactured by Bard / Davol that can result in problems, including:
• 3D Max
• Composix EX
• Perfix Plug