Hernia Mesh Lawsuits: Manufacturers May Be Liable

Cochran, Kroll & Associates is currently accepting cases involving patients who are experiencing complications due to mesh implants used in hernia repair surgeries.

Hernias are a very common medical problem, affecting thousands of people every year. A hernia is a weakness in a muscle (creating an opening) that allows an organ or tissue to squeeze through the opening. There are several different kinds of hernias, but a ventral hernia of the abdomen is the most commonly implicated in failed hernia mesh surgery.

A ventral hernia is a weakness in the muscles of the abdominal wall, creating an opening that allows other organs and tissue to squeeze through the abdominal muscles, creating a bulging appearance. The bulge is typically part of the intestine, but may also be other tissue. A ventral hernia often occurs over an incision from surgery that over time does not heal correctly.

While some hernias may not cause any harm, others require care and treatment. Frequently, surgeons perform surgery to close the opening in the abdominal wall. For most ventral abdominal wall hernia repairs, a mesh is used to close the opening in the abdominal muscle. The mesh is surgically implanted over the defect and then surgically connected to the surrounding tissue to hold everything in place. The side of the mesh that is attached to the wall is supposed to grow into the patient’s own tissue. The other side is usually coated with a substance that is supposed to keep the mesh away from the organs, such as the intestine.

Hernia Mesh Surgery Illustration

There are four basic categories of mesh materials: plastic, gortex, collagen or a composite.

The composite mesh is the most commonly used for hernia surgeries and it combines the properties of the plastic mesh on one side and the gortex or collagen mesh on the other side, insulating the intestines (and other organs) from the plastic that could cause problems, while allowing strong adhesion to the abdominal wall.

If the hernia mesh composite product fails to properly insulate the intestines from the plastic mesh, complications such as adhesions, fistulas and infections can develop requiring additional surgery.

Recent findings have shown serious complications may arise in hernia patients who have had hernia repair surgery, including those using the following brands of surgical mesh implants:

ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH

Sales of Ethicon Physiomesh Flexible Composite Mesh began in March 2010, after the FDA approved its use through a 510(k) process. A 510(k) application allows the sale of a product without clinical trials or studies that establish its safety. This sort of approval is limited to products that are “similar” to other products already on the market.

Ethicon Physiomesh

Ethicon’s Physiomesh Flexible Composite Mesh is used in laparoscopic repair of abdominal (ventral) hernias.

The polypropylene (plastic) component of the physiomesh product is laminated between two layers of poliglecaprone, a bioresorbable polymer used to form an anti-adhesion coating that acts as a barrier between the polypropylene and the patient’s organs. Utilizing an anti-adhesion coating on one side of a polypropylene mesh graft increases the risk that the graft will not incorporate into the abdominal wall, which can cause the mesh to fold, buckle and migrate, posing a threat to adjacent tissues and organs.

Poliglecaprone is the coating designed to be a protective layer but is known to cause an inflammatory response in soft tissue.

Ethicon Physiomesh diagram

When poliglecaprone-coated mesh is implanted in a patient, an inflammatory response occurs, causing complications that include pain, mesh rejection, mesh migration, organ damage, adhesions, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis and even death in some cases.

On May 25, 2016, the Ethicon Corporation issued an urgent field safety notice to withdraw its Physiomesh Flexible Composite Mesh from hospitals because of high failure rates and complications such as adhesions, fistulas and infections that resulted in pain and additional surgery.

When surgery is done with any mesh, an identifying sticker is incorporated into a patient’s medical records to show the exact product the physician implanted during surgery. Ethicon’s urgent safety notice lists the particular hernia mesh devices subject to the recall.

PRODUCT NAME PRODUCT CODE DESCRIPTION/SIZE PRODUCT LOT
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY0715R Rectangle
7.5cm x 15cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY1015V Oval
10cm x 15cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY1515Q Square
15cm x 15cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY1520R Rectangle
15cm x 20cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY1520V Oval
15cm x 20cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY2025V Oval
20cm x 25cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY2030R Rectangle
20cm x 30cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY2535V Oval
25cm x 35cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY3035R Rectangle
30cm x 35cm
All unexpired lots impacted by this voluntary product recall.
ETHICON PHYSIOMESH™ Flexible Composite Mesh PHY3050R Rectangle
30cm x 50cm
All unexpired lots impacted by this voluntary product recall.
Laparoscopic Hernia Pack PHY1515Q PROCEDURE PACK CODE ELH5 All unexpired lots impacted by this voluntary product recall.
Laparoscopic Hernia Pack PHY1515Q PROCEDURE PACK CODE ELH10 All unexpired lots impacted by this voluntary product recall.

Patients have filed law suits against Ethicon and its parent corporation Johnson & Johnson, alleging that Ethicon’s Physiomesh Flexible Composite Mesh is a dangerous and defective medical device that causes serious personal injuries such as:

  • bowel obstruction
  • hernia mesh migration
  • serious and life-threatening infections
  • adhesions
  • fistulas
  • shrinkage / contraction of hernia mesh implants
  • tearing of hernia mesh and other mesh device failures

Patients have also alleged that the coating of poliglecaprone used to make Ethicon Physiomesh Flexible Composite Mesh is responsible for many of these dangerous complications. The coating prevents the patient’s abdominal wall from absorbing the mesh. When the abdominal wall cannot absorb the hernia implant, the device can migrate (move around), causing:

  • breakage of mesh material
  • perforation of internal organs
FREE CONSULTATION FROM A HERNIA MESH LAWYER – ACT QUICKLY

Cochran Kroll and Associates has a full professional staff of paralegals, attorneys and a nurse/attorney who are evaluating cases of patients injured by Ethicon’s Physiomesh Flexible Composite Mesh.

If you have sustained injuries after surgery with hernia mesh implants, please contact our office for a free evaluation of your case. Our team will advise you of your legal options.

ATRIUM C-QUR MESH

Atrium c-qur hernia mesh

Another type of product that is commonly used for ventral hernia repair is C-Qur mesh manufactured by Atrium Corporation. This is a flexible, non-absorbable polypropylene mesh with filaments woven into a fabric and laminated.

The C-Qur mesh uses an Omega-3 fatty acid coating that Atrium claimed would prevent adhesions when first implanted. Instead, the Omega-3 fatty acid coating causes the body to initiate an immune response. This response causes pain, rashes and other serious complications.

The FDA originally approved Atrium’s C-Qur mesh in March 2006, using the 510(k) approval program. This allowed the mesh to be placed into the marketplace without rigorous safety studies because it was “similar” to another hernia patch.

Despite signs of potential problems with the C-Qur mesh design, Atrium has introduced a variety of similar products for use in hernia repair, chest wall reconstruction, and treatment of traumatic or surgical wounds, including:

  • Atrium C-Qur Mesh
  • Atrium C-Qur Mosaic
  • Atrium C-Qur TacShield
  • Atrium C-Qur V-Patch
  • Atrium C-Qur Centrifx
  • Atrium C-Qur FX Mesh (formerly C-Qur Lite)

All of these products are made with polypropylene mesh, and coated with gel made from Omega-3 fatty acids.

Many physicians have reported to the FDA various problems with the C-Qur mesh. There were so many reported complications that on October 11, 2012, the FDA issued a warning letter to Atrium Medical Corporation, noting that the company was failing to adequately address complaints related to infections associated with the C-Qur hernia mesh.

The letter also revealed that Atrium Corporation appeared to be ignoring numerous sterility complaints, including at least 35 separate complaints of human hair found in medical devices that were supposed to be sterile.

The FDA’s letter also said Atrium added additional products to their sterilization load, including the C-Qur V-Patch, without properly evaluating the additional challenges that this device may present to sterilization. Additionally, Atrium modified the temperature during the manufacturing process of the C-Qur hernia mesh without approval of the FDA.

Despite the FDA’s warning letters, requests for compliance and mounting medical studies that questioned the safety of C-Qur mesh, Atrium continued to market its C-Qur composite mesh products.

On February 3, 2015, at the FDA’s request, the US Department of Justice filed a lawsuit against Atrium for introducing adulterated and misbranded medical devices into the marketplace. Ultimately Atrium was fined $6 million for noncompliance. The FDA also issued a permanent injunction.

This stopped the manufacture and distribution of C-Qur hernia mesh. Production cannot resume until the FDA finds the manufacturing, processing, packing, holding and distribution of Atrium’s devices are in compliance. Despite this, C-Qur mesh continues to be used in surgeries nationwide.

The side effects from C-Qur composite mesh can be painful and difficult to treat and include:

  • Infection
  • Allergic reaction and rash
  • Adhesion or scar-tissue fusing together
  • Intestinal blockage
  • Mesh migration
  • Mesh shrinking
  • Bleeding
  • A hole forming in neighboring tissues or organs

In December 2016, the United States judicial panel on multi-district litigation consolidated all Atrium C-Qur hernia mesh lawsuits pending in Federal Court before U.S. District Judge Landya McCafferty in the District of New Hampshire, where Atrium Corporation is based.

YOU MAY BE ENTITLED TO COMPENSATION

If you’ve experienced complications after having surgery with C-Qur hernia mesh, call the hernia mesh litigation specialists at Cochran Kroll and Associates. We have a full staff of paralegals, attorneys and a nurse attorney to assist you and will provide a free consultation.

BARD VENTRALEX

 

The C.R. Bard’s Ventralex Hernia Patch is a composite mesh where one side is constructed of two layers of monofilament polypropylene mesh allowing tissue growth into the abdominal wall. The other side of the mesh is made of submicronic ePTFE (polytetrafluoroethlene), which is a product similar to Gortex.

In addition, the Ventralex Hernia Patch includes Sorbaflex Memory Technology designed to facilitate placement in the patient.

However, physicians are cautioned that damage to the product may cause the polypropylene to come into contact with the intestines or other organs. As a result, the inadequate design of the Ventralex Hernia Patch with the Sorbaflex Memory Technology may result in adhesions, fistulas and pain requiring additional surgery.

YOU NEED EXPERIENCED REPRESENTATION

If you’ve experienced complications following surgery to implant the Ventralex Hernia Patch you may be entitled to compensation. Contact the hernia mesh litigation specialists at Cochran Kroll and Associates for a free consultation. Our staff of paralegals, attorneys and a nurse/attorney is available to review your case.

ALLODERM REGENERATIVE TISSUE MATRIX

 

LifeCell Corporation’s AlloDerm is a collagen mesh that is manufactured from tissue harvested from human cadavers. (LifeCell also makes other mesh grafts with tissue harvested from bovine (cow) and porcine (pig) skin sources.)

Biomesh Type Products, Manufacturers
Human acellular dermis AlloDerm™, LifeCell
FlexHD™, J&J
AlloMax™, Davol
Xenogenic acellular dermis Permacol™ (porcine), Tissue Science Laboratories
SurgiMend™ (bovine, calf), TEI Biosciences
CollaMend™ (porcine), Davol
XenMatrix™ (porcine), Brennen Medical LLC (Brennenmed.com)
Strattice™ LifeCell
Porcine small intestine submucosa Surgisis®, Cook Medical
FortaGen®, Organogenesis

The manufacturer sterilely processes the tissue to remove the cells and epidermis, and then the product is freeze-dried to remove some of its elasticity, leaving a white fibrous patch. However, AlloDerm mesh has been linked to problems due to the manufacturer’s failure to warn physicians about the importance of pre-stretching the product which has been found to expand after it is implanted. With the expansion of the product after surgery, a number of painful and debilitating complications can arise.

CONTACT NURSE/ATTORNEY EILEEN KROLL TODAY

If you’ve experienced complications following a hernia surgery using AlloDerm, contact the hernia mesh litigation specialists at Cochran Kroll and Associates. You may be entitled to receive compensation. Our staff of paralegals, attorneys and a nurse/attorney will review your case and provide you with a free consultation.