Stern Law Handling Medtronic Hernia Mesh Cases

Stern Law’s skilled product liability attorneys are currently taking cases involving hernia repair with Medtronic mesh. If you have or a loved one has been injured following implantation of Medtronic mesh, contact Stern Law, PLLC, today to see if you might have a claim for damages.

What is Medtronic Mesh?

Medtronic, formerly known as Covidien, manufacturers an array of synthetic polyester and polypropylene mesh products designed for repair of hernias. Hernias occur when a wall of tissue or muscle becomes weak and allows internal organs to protrude through. Sometimes this can be caused by heavy weight lifting or during pregnancy or child birth. Hernias are most common in the abdomen but can also develop in other areas of the body. In addition to often causing a visible bulge on the body, hernias can result in ongoing pain and discomfort.

Some of Medtronic’s most well-known hernia repair products include:

Paritex™ Composite Mesh – Synthetic polyester mesh designed for repair of inguinal and ventral hernias. Introduced in 1999, Parietex™ Composite mesh comes in several shapes and sizes, depending on the hernia size and the area where the hernia is located. It can be used during laparoscopic or open hernia repair surgery and is intended to be a permanent implant.

Surgipro™ Mesh – Mesh constructed of polypropylene multifilament fibers. It comes in several sizes, depending on the hernia size and the area where the hernia is located, and can be used during open or laparoscopic hernia repair. Surgipro™ mesh is intended to be a permanent implant.

Parietex™ Plug and Patch System – Synthetic polyester mesh designed for repair of hernias in the groin area. The plug in the Parietex™ Plug and Patch System is a flat, round piece of mesh that is folded into a cone-like shape and inserted through a small incision near the hernia site. The plug fills in the hernia defect, and then the patch, or flat sheet of mesh material, is fixed over the top of the plug.

All of Medtronic’s mesh products are intended to reinforce the weakened muscle or tissue wall, while pushing the protruding organs back into place. But Medtronic mesh products can lead to many complications, resulting in serious injuries.

Medtronic Mesh Injuries

Numerous patients who have undergone surgery to repair a hernia using Medtronic mesh experience postoperative complications related to the mesh implant. Because we have worked on medical device litigation for decades at Stern Law, we have unfortunately seen a wide range of mesh injuries. Complications can range from minor infections only requiring a round of antibiotics to major medical problems requiring multiple surgeries. Regardless of seriousness of injury, all our Medtronic clients’ lives have been affected by these dangerous products.

The most common injuries from Medtronic hernia mesh implants we have seen in our practice include:

Chronic pain – Many patients who come to us with mesh complaints report being in constant pain. The pain is often localized to the site of the mesh implant, sometimes with pain radiating out to the limbs.
Infection – Up to 8 percent of patients who have hernia repair surgery using mesh reported developing infections post operatively. The infection can be simple, requiring a round of antibiotics, but it can sometimes be severe, necessitating further surgical procedures to clean out the infected tissue.
Adhesions – Adhesions are intense buildups of scar tissue that result in tissue sticking to internal organs. The mesh implant tends to cause a large amount of scar tissue formation, which often leads to painful adhesions. Though adhesions frequently carry no noticeable symptoms, they can cause pain or make any subsequent surgeries more complicated by making it difficult to isolate organs and healthy tissue during a surgery.
Bowel Obstruction – A bowel obstruction is a blockage of the large or small intestine. After surgery to repair a hernia using mesh, inflammation and scar tissue can build up and cause the intestine to become closed off. In addition, the mesh can adhere to the intestines, causing intestinal incarceration. Bowel obstructions impede normal digestive function by preventing stool from moving all the way through the intestines. This leads to a number of serious and painful problems. Bowel obstructions must be repaired with additional surgery.
Mesh tearing – Patients have reported their mesh implants tearing after surgery, potentially leading to recurrence of the hernia or other bodily injury. Mesh tearing usually requires a repeat hernia repair surgery.
Mesh erosion and perforation – Hernia mesh has been reported to erode into or perforate surrounding tissue and organs, causing pain, illness, and infection. In severe cases, mesh erosion or perforation can lead to nerve damage. In most cases, mesh erosion and perforation require additional surgery.
Mesh folding – Hernia mesh has a tendency to fold into itself after implantation. This folding results in mesh failure and recurrence of the hernia, as well as increased risk for scar tissue formation and damage to surrounding tissue and organs. Mesh folding typically requires a repeat hernia repair surgery.
Mesh migration – In some cases, the mesh implant will move positions inside the body or “migrate” to another area of the body where it is not containing the hernia and has the potential to damage surrounding tissue and organs. Mesh migration usually requires a surgery to remove the existing mesh and repair the hernia again.
Mesh shrinkage – The material that comprises the mesh has been known to contract or shrink into itself in the months following implantation. When this occurs, the mesh can become detached from the tissue holding it in place, leaving the patient vulnerable to migration and resulting problems. Mesh migration will usually require a repeat hernia repair surgery.
Intestinal fistula – An intestinal fistula is an abnormal hole or opening in the gastrointestinal tract that allows contents of the stomach or intestines to leak out. Hernia mesh can cause these fistulas through intense inflammation and pressure or by eroding through or perforating the intestines. These fistulas cause pain, diarrhea, nausea, dehydration, and malnutrition.
Spermatic cord injuries – In men, particularly those undergoing repair of inguinal hernias with mesh, hernia 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), which renders men unable to have children. Some men must also undergo removal of their testicles if the spermatic cord injury is too advanced to repair safely.
Testicular ischemia – Men who have hernia mesh implanted, especially in the inguinal area, can develop a blood loss to the testicles due to the mesh cutting off regular blood flow. 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 Medtronic hernia mesh require surgery to remove the original mesh and readdress the existing hernia. But the design of the mesh makes that incredibly complicated, if not impossible.

Medtronic mesh has many pores, much like a window screen, which encourages rapid tissue ingrowth. The ingrowth is supposed to create a stronger reinforcement around the hernia, but it makes dissection and removal extremely tedious. The process of scar tissue growth and embedment within the mesh starts immediately and can be complete in about 30 days. Doctors then have to tackle the highly difficult task of trying to timely intervene and safely separate the mesh from the patient’s tissue. In many cases, the mesh can never be fully removed, and patients will always have pieces of it stuck inside their bodies.

Hernia Mesh Alternatives

Though some doctors approach hernias with “watchful waiting,” the only real way to treat a hernia is to repair it through surgery. Some factors like weight and digestive health can contribute to hernias, but changing those behaviors will not actually treat a hernia. If left untreated, hernias can become more painful and can cause serious problems, like intestinal obstruction and intestinal strangulation.

During the last two decades, mesh has become an incredibly popular technique for repairing hernias. But it is not the only way to repair hernias, and our lawyers argue it is not the safest way. To understand the alternatives, it helps to first learn 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.

Surgeons have the option to repair hernias using techniques other than mesh. They can use sutures, and the patient’s own fascia (fibrous tissue), tendons and ligaments. During these surgeries, they 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 tissue prevents many of the foreign body reactions patients struggle with and avoids other mesh complications altogether. Additionally, if the hernia reoccurs, or another complication occurs, 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. If scar tissue formation is advanced, mesh might never be able to be fully removed, which limits a surgeon’s repair options and inhibits a patient’s potential for total recovery.

Why do Doctors Use Hernia Mesh?

Why do doctors repair hernias with mesh if it causes so many problems? While the answer to this is nuanced, we do know that manufacturers played a huge role in the start and continuation of surgeons’ use of mesh in their patients. The vast majority of the information surgeons receive about mesh comes from the manufacturers.

Manufacturers paid for and conducted studies attempting to prove that mesh repair surgeries result in a lower rate of hernia recurrence than traditional hernia repair methods. These studies usually did not last long enough to capture all the injuries patients developed and did not accurately portray all of the injuries observed. Upon study completion, manufacturers distribute written information to doctors, invite doctors to seminars, and perform site visits to boost their product image and convince doctors that mesh is the gold standard for hernia repair. They market mesh as less invasive, requiring shorter recovery time, and having a higher rate of success. They even train doctors and participate in patient surgeries to help doctors implant the mesh.

Part of the allegations Stern Law includes in mesh lawsuits are failure to warn doctors about the risks associated with mesh use and failure to provide doctors with updated information about risks and reported complications.

FDA Information and Action Regarding Mesh

Though it is aware of the propensity for postoperative complications, the Food and Drug Administration (FDA) has taken little to no action with regard to hernia mesh implants.

In April 2017, the FDA issued a statement addressing hernia mesh, in which it reported on the most common adverse events following hernia repair with mesh. The FDA stated pain, infection, hernia recurrence, adhesion, and bowel obstruction were the most common complications associated with hernia mesh, but it also minimized these injuries by noting that the same complications occur with all mesh surgeries, with or without use of mesh.

In the same statement, the FDA went on to say it had received many reports of complications related to hernia mesh, but that the Administrations had concluded recalled mesh products were the main cause of several of these complications. Interestingly, while patients continue to experience serious mesh complications, only a few hernia mesh products have actually been recalled or withdrawn from the market.

Ventralex™ ST

The Ventralex™ ST patch is manufactured by Davol Inc., a subsidiary of C.R. Bard, Inc., and is a round patch of polypropylene monofilament fibers that have been woven into mesh. Doctors use Ventralex™ ST patches for intraabdominal repair of umbilical, epigastric, and other small ventral hernias.

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.

Physiomesh™

Physiomesh™ is a composite mesh knitted from polypropylene and polydioxanone fibers. It is manufactured by Ethicon, Inc., a subsidiary of Johnson & Johnson, for repair of ventral hernias.

In May 2016, Ethicon voluntarily pulled Physiomesh™ from the market, after data from two studies showed a high rate of hernia recurrence and repeat surgery, compared to other hernia treatment products. In carrying out this withdrawal, Ethicon issued an Urgent Field Safety Notice to medical facilities nationwide, notifying doctors of Physiomesh™ complications and the related product recall.

Composix Kugel™

Composix Kugel™ hernia patches are manufactured by Davol Inc. 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.

Only two of these recalls or withdrawals were due to reported medical complications, and patients have are continuing to experience real problems related to mesh implants. Our clients are reporting the same injuries with other hernia mesh implants, including Medtronic implants. Even though the FDA will not take strong action regarding Medtronic’s surgical mesh products, we will. The best way for you to protect your rights is to pursue an individual claim against the manufacturer of the mesh.

Current Hernia Mesh Litigation

Right now, the 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 first hernia mesh MDL formed in 2007 in the U.S. District Court for the District of Rhode Island, centralizing 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.

Most recently, an MDL formed to centralize hernia mesh lawsuits filed against the manufacturer Atrium Medical Corp. in the U.S. District Court of New Hampshire. There is also an active application to form an MDL for hernia mesh lawsuits filed against Ethicon, Inc. Litigation of these cases is in its early stages, so no settlement negotiations have yet taken place.

What Can I Recover in a Medtronic Mesh Lawsuit?

At Stern Law, we know your Medtronic mesh injuries have changed your life, and we want to help you receive the compensation you need to move forward. When you file a claim for damages against Medtronic, you can recover for the various ways you have been harmed. This includes claims for the following types of damages:

Lost wages, if you missed work or cannot currently work because of your hernia mesh injuries;
Lost future wages, if you will not be able to return to work;
Past medical bills for treatment related to your hernia 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 hernia mesh injuries.

When you hire Stern Law, we will help you calculate the full extent of your economic and noneconomic damages to maximize the amount you and your family recover.

What are the Next Steps?

When you are considering a lawsuit against a large corporation like Medtronic, it can be difficult to know where to begin. At Stern Law, we make the process as easy as possible. When you call our office, you will already be on your way to securing the justice you deserve. In that first call, you can speak with one of our seasoned medical device lawyers, who will explain the litigation process.

Some of the steps we can take for you include:

Obtaining a detailed account of your surgeries and injuries;
Ordering medical records for your original hernia operation, as well as any further treatment or surgery;
Determining product identification, or the name of your exact mesh implant, as well as the name of the manufacturer (if not Medtronic);
Consulting with medical experts and industry experts to obtain support for your claim;
Determining where your case should be filed and against whom;
Drafting and preparing a petition for filing.

Building a successful hernia mesh claim takes time and hard work, and it is never too early to start. Contact us today to ease your stress and begin working toward a resolution for you and your family.

Contact Stern Law, PLLC

The legal team at Stern Law, PLLC, has the knowledge, skills, and compassion you need on your side during this stressful time. Our attorneys have more than 30 years’ experience in product liability law and understand what it takes to win. Contact our office by calling (844) 808-7529, and schedule your free consultation today.