Stern Law Answers Your Questions About C.R. Bard Mesh

If you underwent surgery to repair a hernia using a C.R. Bard, Inc., mesh implant and developed subsequent complications, you might be eligible to file a lawsuit. The experienced product liability attorneys at Stern Law, PLLC, can investigate your potential claim and help you understand your rights.

Hernia Causes and Treatment

A hernia occurs when internal organs or tissue protrude through a weakened wall of muscle or tissue. Hernias are associated with weakened muscles because of a preexisting muscle condition, aging, or continual strain on the abdomen or groin, resulting from lifting heavy objects, chronic coughing, enduring pregnancy and child birth, being overweight, or straining because of constipation. Gender can also play a role in the likelihood of certain hernias.

Hernias are most common in the abdomen but can also develop in other areas of the body. They often cause pain and discomfort, in addition to creating a visible bulge on the patient’s body. Types of hernias generally include:

Umbilical – Hernia near the belly button
Ventral – Hernia in the abdominal wall
Inguinal – Hernia in the groin area
Femoral – Hernia in the inner thigh area
Hiatal – Hernia in the chest and diaphragm area
Epigastric – Hernia between the chest and belly button
Incisional – Hernia at the site of a previous surgical incision

The standard treatment for a hernia is surgical repair to push the herniated tissue back in place and create a stronger muscle wall to prevent the hernia from coming back. Surgeons will often use mesh implants to try to accomplish this, and many of those implants are manufactured by Davol Inc. Davol is a subsidiary of C.R. Bard, Inc., which is headquartered in New Jersey and marketed simply under the name Bard.

Davol / C.R. Bard Hernia Mesh Products

Composix Kugel™

Composix Kugel™ hernia patches are manufactured by Davol. They are round pieces of mesh woven from monofilament polypropylene and designed for repair of most hernias.

In 2005 through 2007, Davol voluntarily recalled various lots of its Kugel™ patches after finding out that the recoil rings around the patches were prone to breaking or buckling, causing several painful complications to patients. In doing so, Davol issued notices to doctors and hospitals informing them of the possible complications and need to discontinue use of the products.

Kugel™ is a widely known hernia mesh product. It was the subject of numerous lawsuits in the early and mid-2000s, and plaintiffs were successful in achieving settlements. Stern Law is still taking and litigating these cases.

The first hernia mesh Multidistrict Litigation formed in 2007 in the U.S. District Court for the District of Rhode Island. Hernia mesh litigation is expansive because of the volume of mesh products and number of manufacturers involved. In litigations of this size, the parties will usually try to form Multidistrict Litigations (MDLs). An MDL is essentially a consolidation of cases in one federal court. Unique MDLs can be formed for each manufacturer, based on the number of lawsuits filed against that manufacturer.

The Rhode Island MDL centralized lawsuits filed against the manufacturer Davol Inc., regarding its Kugel™ hernia mesh patches. In 2011, Davol (through its parent corporation, C.R. Bard, Inc.) settled more than 2,000 of these cases for $184 million.

3DMax™ Mesh

3DMax™ Mesh is a trademarked surgical mesh product manufactured by Davol Inc. The mesh is constructed of polypropylene monofilaments. Polypropylene is a thermoplastic polymer that can be strung into fibers and knitted together to form a piece of mesh. The 3DMax™ Mesh is used for repair of hernias that result from soft tissue weakness. This particular brand of mesh is primarily used in the inguinal, or inner groin, area of the body.

Davol designed its 3DMax™ Mesh to be placed during a laparoscopic procedure, in which the surgeon makes a small incision near the hernia site and places the mesh to reinforce the weakened tissue causing the hernia. This procedure is thought to be less invasive than a standard hernia repair operation.

PerFix™ Plug

The PerFix™ Plug is a piece of mesh constructed of polypropylene monofilaments. The polypropylene is essentially a plastic material that, when strung into fibers, can be woven together to form a porous sheet of material (mesh). Davol manufactures the PerFix™ Plug for repair of hernias in the groin area of the body.

Resembling a flower, the PerFix™ Plug is inserted by its inner “petals” through a small, 4 to 5 cm incision near the hernia site. The plug fills in the hernia defect, and then an “onlay,” or flat sheet of mesh material, is fixed over the top of the plug to reinforce the weakened wall of tissue around the hernia. An entire hernia operation using the PerFix™ Plug can take 25 minutes or less to complete.

Ventralex™ ST

The Ventralex™ ST patch is another product doctors have been using for surgical repair of hernias. Ventralex™ ST is manufactured by Davol Inc., and is round patch of polypropylene monofilament fibers that have been woven into mesh. Medical doctors use the Ventralex™ ST patches for intraabdominal repair of umbilical, epigastric, and other small ventral hernias.

The Ventralex™ ST is one in a line of Davol’s mesh products containing its registered Sepra® technology. Sepra® technology is described as a “hydrogel barrier” on one side of the mesh patch that purportedly minimizes tissue attachment to the mesh and provides internal protection during the healing process. The hydrogel barrier initially swells upon implantation and is resorbed within about 30 days following the patient’s surgery.

In 2011, Davol issued a voluntary recall of the product because of mislabeling. The Ventralex™ patches come in several sizes, and Davol found out that a batch of its medium-sized patches had been packaged in pre-printed cartons for its small-sized patches. Davol corrected the problem and placed the product back into the market. Though this recall did not involve safety of the product itself, Stern Law joins law firms across the country in alleging this mesh product is not safe for implantation.

Ventralight™ ST

The Ventralight™ ST is also constructed of polypropylene monofilaments that are strung into fibers and knitted together to form a piece of mesh. Ventralight™ ST is manufactured by Davol Inc., and is designed for laparoscopic repair of hernias.

Surgeons can order Ventralight™ ST mesh in a large sheet or can create customized shapes and sizes to repair several kinds of hernias in various locations of the body. The Ventralight™ ST is another in Davol’s line of mesh products to feature its registered Sepra® technology hydrogel barrier on one side of the mesh.

C.R. Bard Mesh Injuries

Numerous patients who have undergone surgery to repair a hernia using Bard mesh have experienced subsequent problems related the mesh implant. Injuries can range from relatively minor infections to complications serious enough to require multiple additional surgeries. The most common injuries from Bard mesh implants we have seen in our practice include:

Infection – A significant percentage of our Bard mesh clients report developing an infection after their hernia repair surgeries. The infection can be simple, requiring a round of antibiotics, or it can sometimes be severe, necessitating further surgical procedure to clean out the infected tissue.

Chronic pain – Bard mesh can cause chronic pain, partly because of the foreign body reaction taking place in the body. Some of our clients are in such intense pain that they can no longer go to work or enjoy their usual activities.

Adhesions – Adhesions are thick formations of scar tissue that stick to the mesh and to nearby tissue and organs. When adhesions occur, patients can experience pain and a tugging sensation. Adhesions can lead to nerve entrapment and pressure on the mesh, causing the mesh to buckle or break. These scar tissue buildups also make removal of the mesh extremely difficult.

Mesh tearing – Bard mesh can tear during or after implantation, which can leave a patient susceptible to other complications. If the mesh tears, the patient will need an additional surgery to remove the mesh and readdress the hernia.

Mesh erosion and perforation – Bard mesh, particularly the memory coil ring, can break, fray, or unravel, and perforate a nearby organ. Perforation leads to serious injury and will need to be repaired through surgery. The Bard mesh can also erode or degrade, causing pain, infection, and tissue/organ damage.

Mesh folding – Bard mesh can roll or fold on itself, despite the memory coil ring. When this happens, the patient will experience pain and often recurrence of the hernia. It also can cause the mesh to become detached and move out of position. Folding generally must be corrected with another operation.

Mesh shrinkage – Bard mesh has a high rate of contraction or shrinkage after it has been implanted in the body. When the mesh shrinks, it can move out of place and allow the hernia to return. Mesh shrinkage is also associated with intense pain and a pulling sensation.

Mesh migration – Sometimes Bard mesh can migrate or change positions inside the body. This can occur either because the mesh has contracted or because the mesh sutures have snapped. Migration can lead to many issues, including pain and perforation. Migration must be addressed through an additional surgery.

Bowel Obstruction – A bowel obstruction is a blockage of the large or small intestine. After surgery to repair a hernia using Bard mesh, inflammation and scar tissue can form and close off the bowel. The mesh can also adhere to the intestines, causing intestinal bowel incarceration. When a patient has a bowel obstruction, normal digestive function is impeded because stool cannot travel all the way through the intestines. This leads to a number of serious and painful problems. Bowel obstructions must be repaired with additional surgery.

Intestinal fistula – An intestinal fistula is leaking of stomach or intestinal contents due to an abnormal hole or opening in the gastrointestinal tract. Hernia mesh like Bard mesh can cause these fistulas through intense inflammation and pressure on the intestines or by mesh erosion through or perforation of the intestines. These fistulas cause pain, diarrhea, nausea, dehydration, and malnutrition.

Spermatic cord injuries – In men, particularly those undergoing repair of inguinal hernias with Bard mesh, the mesh can adhere to, perforate, or entrap the spermatic cord. This leads to pain, interference in sexual function, and in severe cases, azoospermia (a total lack of sperm in ejaculate fluid). The loss of sperm leaves these men unable to have children. If the injury to the spermatic cord is extreme and cannot be repaired in isolation, the affected man could end up undergoing a procedure to remove his testicles.
Testicular ischemia – When men have Bard mesh implanted, especially in the inguinal area, they can develop a blood loss to the testicles. This blood loss is due to mesh constriction and mesh cutting off regular blood flow to all areas of the body. Some men have testicular shrinkage associated with this complication, and some men end up requiring removal of the testicles.

Several injuries that can develop from implantation of hernia mesh require surgery to remove the original mesh and readdress the existing hernia. Unfortunately, due to the design of the mesh material, removal is extremely difficult and sometimes impossible.

The porous nature of hernia mesh encourages rapid tissue embedment, which makes dissection and removal tedious and complicated. Some mesh manufacturers claim their products contain technology that prevents tissue from becoming too attached, but in reality, the tissue ingrowth process is still a major issue when a patient needs to have the mesh removed. The process starts immediately and can be complete in about 30 days, making it difficult for doctors to timely intervene and safely separate the mesh from the patient’s tissue. In some cases, the mesh can never be fully removed.

Hernia Mesh Alternatives

The best way to treat a hernia is, unfortunately, a surgical procedure. While factors in a patient’s control, like weight and digestive health, can contribute to hernias, resolving those issues will not resolve the hernia. Even when a patient can manipulate and push the herniated tissue back in, it will always bulge out again without surgical repair. If left untreated, hernias can become more painful and can cause serious complications, like intestinal obstruction and intestinal strangulation.

Prosthetic implants, like Bard mesh, have become an extremely commonplace treatment for hernias, but they are not the only way to surgically treat hernias, and our lawyers argue they are not the safest way. To understand the alternatives, it is best to start by learning about the two different ways hernia surgeries can be performed:

Open surgery – Open surgery involves a long incision around the hernia site. The surgeon will open up the skin and fat and create a hole in the muscle down to the hernia, then push the herniated tissue back in place and reinforce the muscle/tissue wall. All types of hernias – big and small – regardless of location can be repaired using this method.

Laparoscopic surgery – Laparoscopic surgery is often regarded as a less invasive option that involves a smaller incision. The surgeon will place a balloon or gas into the body through the small incision, which will expand to create room for the surgeon to work. The surgeon will then repair the hernia using a camera and surgical tools to pull the hernia back and reinforce the muscle/tissue. Smaller hernias are usually best suited for repair using this technique.

Aside from mesh, surgeons have the option to repair hernias using sutures, and the patient’s own fascia (fibrous tissue), tendons and ligaments. They can essentially sew the muscle back together or use the patient’s own tissue, tendons, and ligaments to create a stronger wall above the herniated tissue so that it will not bulge back through.

Using the patient’s own natural body tissue prevents many of the foreign body reactions patients struggle with following mesh implantation and avoids other serious mesh complications entirely. Moreover, if the hernia reoccurs, or the patient develops another complication, the surgeon can resolve those issues without having to worry about whether he will be able to remove mesh that might have become completely encapsulated with scar tissue. This alternative provides a safer method of treatment for patients and an easier course of treatment for both patients and doctors, should complications arise.

How Do I Know What Mesh My Surgeon Used?

In order to file a lawsuit against a mesh manufacturer, a person must be able to prove he or she had one of that manufacturer’s products. Many times, patients who undergo hernia repair surgery do not know the exact name of the product used, and in some cases, are not truly sure whether the surgeon used mesh at all. Surgeons typically spend time with the patient explaining the procedure to be performed and the projected results, rather than discussing the individual instruments they will use. For this reason, few of our clients know what product they have when they first contact us.

When you sign up with Stern Law, we do that work for you by immediately ordering your medical records from your original hernia repair surgery. Included in our records order, we request copies of the intraoperative notes and implant reports from the day of your surgery. Those records will usually contain a product sticker or lot number that identifies the specific brand and manufacturer of your mesh implant. We call this sticker or lot number “product identification.”

Once we have identified what brand of hernia mesh you had implanted, we can get to work building a solid case against that particular manufacturer, which will include ordering additional medical records, hiring experts, determining the best place to file your claim, and preparing filing documents.

Compensation for Bard Hernia Mesh Injuries

At Stern Law, PLLC, we understand how these injuries affect your life, and we are dedicated to obtaining the compensation you deserve. When you file a hernia mesh claim for damages against C.R. Bard, you can recover for all of the ways you have been harmed. This includes claims for the following types of compensation:

Lost wages, if you missed work or cannot currently work because of your Bard mesh injuries;

Lost future wages, if you will not be able to return to work;

Past medical bills for treatment related to your Bard mesh injuries;

Future medical bills, if you will need additional treatment for your injuries; and

Compensation for the physical and mental pain and suffering you have incurred and will incur as a result of your Bard mesh injuries.

Your Stern Law team will analyze all your injuries, both economic and noneconomic, to make sure we capture the full extent of your damages and maximize the recovery you receive.

Contact Stern Law, PLLC

If you’re suffering from a Bard mesh complication, you need the best legal representation on your side. Our lawyers have more than 30 years’ experience fighting for victims of medical device injuries. When you hire Stern Law, you can rest easy knowing we have the resources and experience to bring you the justice you deserve. Our attorneys know how to achieve the results you need while giving you the time and attention you deserve. We take on the biggest corporations and don’t shy away from complex cases because we firmly believe in holding manufacturers accountable, finding ways to assist people in rebuilding their lives, and making the medical device industry safer for people in the future.

Helping people has been Stern Law’s passion for decades, and we are ready to help you and your family today, starting with a confidential consultation at absolutely no cost to you. If you had surgery to repair a hernia using Bard mesh and are suffering from a mesh injury, contact our office today by calling (844) 808-7529, and schedule your free consultation with one of our dedicated product liability attorneys.