C.R. Bard & Its Hernia Mesh Products

There are various types of hernia mesh products designed and manufactured by a number of manufacturers, and C.R. Bard is one of them. Some of these mesh products, however, are defective and cause injuries to patients of hernia repair surgery, including several implants made by C.R. Bard. If you have been injured by a mesh implant used for your hernia repair surgery, you may be entitled to compensation.

Mesh operation
Some mesh products are defective and cause injuries to patients of hernia repair surgery, including several implants made by C.R. Bard.

1. What is C.R. Bard?

As a worldwide leader in the hernia mesh industry, C.R. Bard depends on its hernia mesh products as a major source of the company's profits. C.R. Bard was incorporated nearly a century ago, and its focus has on been on medical devices. 1

The “C” and “R” are the initials of the company's father: Charles Russell Bard. Charles Russell Bard suffered from urinary discomfort as a side effect of tuberculosis. To address the discomfort, he used a European product, Gomenol. Eventually, in 1907, he began importing and distributing the drug. Then, in 1923, he incorporated C.R. Bard and began distributing medical devices like catheters and other urology-related medical products. Since its incorporation, the company has largely been a manufacturer and distributor of medical devices. Just before his death in 1934, Charles Russell Bard sold the company to two employees. The company continued to grow through additional acquisitions and joint ventures in the medical device industry.

By 1990, Bard manufacturing plants were in 12 states and on three continents: Europe, Asia, and Australia. Since its incorporation, the company has extended its medical products from urology-related devices to a wide range of other specialty devices related to the vascular system and cancer.

2. What hernia mesh products does C.R. Bard manufacture?

One of Bard's largest medical device product lines is its line of hernia mesh products. Bard offers the widest selections in hernia mesh and is also one of the more popular brands.

Its current product line includes

  • 3DMax
  • AlloMaxBard
  • Soft Mesh
  • Bard Mesh Sheets
  • Composix
  • Dulex
  • Kugel
  • MK Patch
  • OnFlex
  • PerFix Plug
  • Phasix Mesh
  • Phasix
  • Sepramesh IP Composite
  • Ventralex
  • Ventralight
  • Ventrio
  • Visilex
  • XenMatrix Surgical Graft

These mesh products are available as different types and classifications, from plugs to patches to coated devices to synthetic implants. Many have been successful, but a number of them have been the subject of recalls and lawsuits.

3. What are specific problems associated with some C.R. Bard hernia mesh products?

There are a number of problems associated with C.R. Bard hernia mesh products. Though many products are safe, many are defective, based on either their design or composition.

3.1 What are the design problems of C.R. Bard hernia implants?

Poor designs lead to injuries when it comes to hernia mesh products, and C.R. Bard has committed a few badly designed products. The main design defect has been the use of a memory coil ring, but there are numerous other design defects that have caused serious complications and/or injuries.

Memory Coil Ring. The memory coil ring used in Bard hernia mesh products is part of the makeup of the Bard's Kugel patches. Patches with memory coil rings can be folded so they can easily be inserted into the abdomen. Once in the abdomen, the patch springs open and is able to lay flat over the specific area to be “fixed”. The problem with the rings: they buckle and rupture. When the latter happens, the mesh is prone to migrating or shrinking and can lead to bowel perforation and/or chronic enteric fistula.

Other Defects. Below is a list of design defects specific to particular hernia mesh products.

  • The 3DMax hernia mesh has a sealed outer edge that holds the mesh together and is supposed to prevent the mesh from cutting into patients' tissue. That edge (made up of polypropylene), however, is prone to tearing and folding over. Starting in September 2011, reports have been made of the mesh tearing. These reports were related to tears outside the body, whether it was noticed upon opening the package to tears easily being made when attempting to insert it into the body.

In addition to tearing easily, these mesh products also fold over, and when they do, they are prone to migrating. From 2007, reports have confirmed that this design folds over or buckles after implanted in the body. It can cause serious pain and other complications attributed to mesh migration.

  • The PerFix Plug is usually used to repair inguinal hernias. The plug is made of woven polypropylene, the woven aspect of which create these small pores that nerves attach to once the plug is introduced to the body. As the mesh degrades and moves through the inguinal canal, the nerves are pulled and stretched. This stretching can cause severe nerve pain that is untreatable.
  • The SepraMesh is a composite hernia mesh with an absorbable layer. Initially created by Genzyme Biological in 2005, Bard bought the license to manufacture and market the SepraMesh from Genzyme in 2010 and used the SepraMesh as the basis for its Sepra Technology (ST). ST is used on Bard's other mesh products: Ventralex ST, Ventrio ST, and Ventralight. The problem with the SepraMesh and ST is: adhesion. These products and the composite are conducive to adhering to tissue and nearby organs.

3.2 What are the problems with materials used to create the implants?

Synthetic materials make up the most of Bard's implant devices. And though most of these products' compositions are safe for human-use, there have been two specific materials that have lead to injuries in patients: (1) expanded Polytetrafluoroethylene (ePTFE); and (2) Polypropylene.

ePTFE. Bard combined ePTFE with a heavyweight mesh in an effort to create a product of maximum stability. There were two problems with this design. First, the heavyweight is too heavy and exceeds the abdominal wall. Complications include fibrosis, infection, and stiffening of the mesh. ePTFE is a plastic coating that absorbs into the body and causes infection and increases the risk of

Polypropylene. Polypropylene is another plastic that had been used in many of Bard's products. Polypropylene can be purchased from different manufacturers. Bard purchases its polypropylene from Phillips Sumika. Phillips Sumika had provided a Material Safety Data Sheet -- as required by Occupational Safety and Health Administration (OSHA) -- advising purchasers that polypropylene should not be used for permanent implantation in the human body. 2 Since 2011, however, Phillips Sumika Polypropylene Company has been shut down. 3 The polypropylene material, however, was still used in Bard's hernia mesh products. Complications include but are not limited to

In addition to materials not suited for the body, these two materials are predisposed to erosion. Once implanted, polypropylene begins to degrade. Pieces of the plastic can crack and/or break off. This erosion can cause serious pain and other complications, like nerve damage in anyone or spermatic cord damage in men.

4. Which Bard products have been subjected to recalls?

In 2002, doctors started reporting abdominal problems with patients who had a CK Patch implant. Then, in 2003, the first reports of the memory coil rings featured in these patches breaking started to roll in. By December 2005, Bard Davol became aware of the increase in reports and initiated a Corrective and Preventive Action to investigate the complaints. Soon thereafter, the first set of FDA recalls were made.

Davol, Inc., as a subsidiary of C.R. Bard, has had three sets of recalls. First, on December 22, 2005, a Class 1 Device Recall was made for the following:

  • Z-0524-06 - Composix® Kugel Mesh X-Large Patch Oval With EPTFE, 8.7” X 10.7” Code: 0010206. 5
  • Z-0525-06 -Composix® Kugel Mesh X-Large Patch Oval With EPTFE, 8.7” X 10.7” Code: 0010206. 6
  • Z-0762-06 – Composix® Kugel Oval, 6.3” X 12.3” For Hernia Repairs Product Code: 0010209. 7
  • Z-0760-06 – Composix® Kugel Large Oval, 5.4” X 7” For Hernia Repairs Product Code: 0010202. 8
  • Z-0761-06 – Composix® Kugel Large Circle, 4.5” For Hernia Repairs Product Code: 0010204. 9
  • Z-0526-06 – Composix® Kugel Mesh X-Large Patch Oval With EPTFE, 7.7” X 9.7” (19.6cm X 24.6cm) Code: 0010208. 10

Then, on January 10, 2007, additional units were recalled. This recall included the following:

  • Z-0359-2007 - Composix® Kugel Hernia Patch Large Oval with ePTFE, 5.4” x 7”. 11
  • Z-0360-2007 - Composix® Kugel Hernia Patch Large Circle with ePTFE, 4.5”. 12

These Bard Composix Kugel Hernia Patches are also known as CK Patches. Davol acquired these patches from Surgical Sense Inc. Surgical Sense, Inc., had been marketing them for many years. After Davol acquired the product, it designed the CK Patch with two layers of polypropylene mesh, a layer of ePTFE, and a PET memory recoil ring in between the polypropylene layers. All of these mesh products were approved through the FDA 510(k) clearance process.

The CK Patches line was eventually discontinued in full after all the recalls.

5. Which Bard products have been or are the subject of lawsuits?

When patients are victims of defective medical devices, lawsuits often follow. Oftentimes, these kinds of lawsuits that could involve a number of people with the same or similar allegations are combined into multi-district litigation (MDL). Consolidation of like cases streamlines the process, which benefits all parties involved. There are more than a handful of Bard products that have been subject to lawsuits and MDLs, both of which have already been settled and those that are currently in litigation.

5.1 To date, has C.R. Bard settled any cases?

In 2011, C.R. Bard settled more than 2,600 lawsuits in a Rhode Island multi-district litigation for its Kugel Hernia Mesh product that were recalled between 2005 and 2007. The settlement was in the amount of $184 million.

5.2 To date, what hernia mesh lawsuits are pending?

At present, there are more than 1,500 Bard hernia mesh lawsuits pending in Rhode Island state court (Rhode Island is Bard's subsidiary Davol's home state). 13

The number in federal courts is much less: as of April 2018, there were about 98 cases. 14 On April 10, 2018, several law firms together filed a motion to consolidate most Bard hernia mesh cases filed in federal courts throughout the country. If the Bard Hernia Mesh MDL is established, it could include the following Bard hernia mesh products:

  • 3DMax
  • 3DMax Light
  • Composix
  • Composix LP
  • Marlex / Bard Mesh
  • PerFix Plug
  • PerFix Plug Light
  • Sepramesh
  • Ventralex
  • Ventralex ST
  • Ventralight ST
  • Ventrio
  • Ventrio ST
  • Composix Kugel
  • Kugel
  • Modified Kugel
  • Composix EX.

6. When should you seek legal counsel to file a claim against C.R. Bard?

You want to seek legal counsel if (1) you have had hernia repair surgery with a product manufactured by C.R. Bard; and (2) you have suffered injuries or complications after that surgery, whether the injuries were immediately or years after the surgery. You should know that as a victim of a defective hernia mesh product, you have rights. Two of those rights include the right to hire a personal injury attorney and the right to file a claim or lawsuit for compensatory damages.

At Shouse Law Group, we have years of experience in personal injury cases, including injuries caused by defective medical devices. We will thoroughly review your case and provide you with an honest assessment of what your options are. Contact us today at (855) 396-0370 to learn more.

References

  1. C.R. Bard, Inc. About C.R. Bard, Inc.
  2. MatWeb Material Property Data. Phillips Sumika Marlex Polypropylene Homopolymer, Fiber Grade.
  3. Id.
  4. Baylon, Karen et al. Past, Present and Future of Surgical Meshes: a Review. Membranes 2017, 7(3), 47; doi: 10.3390/membranes7030047.
  5. FDA Class 1 Device Recall Bard. Z-0524-06. February 22, 2006.
  6. FDA Class 1 Device Recall Bard. Z-0525-06. February 22, 2006.
  7. FDA Class 1 Device Recall Bard. Z-0762-06. February 22, 2006.
  8. FDA Class 1 Device Recall Bard. Z-0760-06. February 22, 2006.
  9. FDA Class 1 Device Recall Bard. Z-0761-06. February 22, 2006.
  10. FDA Class 1 Device Recall Bard. Z-0526-06. February 22, 2006.
  11. FDA Class 1 Device Recall Davol Composix Hernia Patch. Z-0359-2007. January 10, 2007.
  12. FDA Class 1 Device Recall Davol Composix Kugel Hernia Patch. Z-0360-2007. January 10, 2007.
  13. In re: Davol, Inc./C.R. Bard, Inc. Polypropylene Hernia Mesh Products Liability Litigation. MDL Docket No: 2846. Case NJ/2:18-cv-02533. Document 12. Filed 05/03/18.
  14. Id.

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