If you underwent surgery to repair a hernia using surgical mesh and have developed postoperative injuries, you might have a claim for damages against the mesh manufacturer. The attorneys at Stern Law, PLLC, can help you understand your rights and determine whether you can file a lawsuit.
Types of Hernias
A hernia occurs when internal organs, most often the intestines, protrude through a weakened wall of muscle or tissue. 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
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.
What is Hernia Mesh?
One of the ways doctors repair hernias is through use of surgical mesh. The mesh is usually made of synthetic polypropylene or polyester material and is used to reinforce the weakened muscle or tissue wall, while pushing the protruding organs back into place. By design, scar tissue will grow into the holes of the mesh, creating stronger protection for the organs. Unfortunately, however, many mesh devices cause problems for patients.
Hernia Mesh Injuries
Numerous patients who have undergone surgery to repair a hernia using mesh experience subsequent problems related to the implant. Polypropylene is essentially a plastic material, the kind you find in carpet backing. When mesh is introduced into human tissue, the patient has an immediate foreign body response, which triggers pain and inflammation. The patient’s body understands there is something unnatural present and works to trap it from the rest of the body by building scar tissue and sending out a strong immune response. Injuries can range from more minor infections to those requiring multiple additional surgeries.
With our extensive experience in mesh litigation at Stern Law, we have unfortunately seen a wide range of mesh injuries. Complications from hernia mesh can greatly interfere with quality of life and result in continuous need for medical treatment and repeated surgeries.
The most common injuries from 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 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.
How Do I Know What Mesh I Have?
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.
Hernia Mesh Recalls and FDA News
Dozens of corporations manufacture mesh for hernia repair, and most of them have several lines and products available to treat hernias. While numerous mesh products have been marketed for hernia repair, and only a few have been recalled or withdrawn from the market. Most of those taken off the market were voluntarily withdrawn by the manufacturers after reports of complications or after discovering an issue with the product. Voluntary withdrawals such as these are not technically considered “recalls,” and manufacturers fight to make that distinction.
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. 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.
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.
Physiomesh™ is one of the most widely known products in the hernia mesh litigation, in large part because of Ethicon’s withdrawal of the product. Stern Law is alleging Ethicon sold Physiomesh™ in a defective and unreasonably dangerous condition and failed to warn patients and doctors of all the potential side effects associated with the product.
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 another 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.
Hernia Mesh Alternatives
Unfortunately, the only 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 treat a hernia. And while the herniated tissue can often be manipulated and pushed back in, it will always come back out without surgical repair. If left untreated, hernias can become more painful and can cause serious complications, like intestinal obstruction and intestinal strangulation.
Mesh has become an incredibly popular technique for repairing hernias, but it is not the only way, and our lawyers argue it is 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 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? There is not a simple answer to this question, but we know a large reason surgeons started to and continue to us mesh is rooted in the information disseminated to them by the mesh 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. Sometimes, recurrence happens 10 years after the original surgery, and those issues were not addressed in the studies.
Upon study completion, manufacturers distribute written information to doctors, invite doctors to seminars, and perform site visits to tout their products 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.
Hernia Mesh Settlement News
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.
Why Choose Stern Law for Your Hernia Mesh Claim?
When you have been injured by a medical device, like hernia mesh, you need an experienced product liability lawyer fighting for your legal rights. With more than 30 years’ experience in the field of product litigation, the attorneys at Stern Law are ready to help you and your family.
When you sign with Stern Law, we will immediately begin investigating your claim to give you a timely determination about whether we can file a lawsuit on your behalf. Before we can proceed with a lawsuit, we have to acquire what we call “product identification.” This means we need to know the exact brand and manufacturer of every client’s mesh implant. But people often do not know the exact name of the product used in their surgeries, and in some cases, are not entirely sure they even have mesh implants. If you are not sure what kind of implant you have, you do not need to worry; We will find out that information for you.
Upon entrusting your case to Stern Law, you can count on our firm to quickly order medical records from your original hernia repair surgery, including 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.
Once we have identified what kind of mesh implant you have, we can begin obtaining records that document the full extent of your injuries. We want to make sure we build the strongest case possible for you, and we have a reputation for achieving results. We undertake our entire investigation of your claim without ever asking for money up front. And in the event we cannot file a lawsuit for you, you never have to worry about receiving a bill from us.
What Can I Recover in a Hernia Mesh Lawsuit?
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 claim for damages against the manufacturer of hernia mesh, you can recover for 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 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 receive.
What are the Next Steps?
If you or a loved one had hernia repair surgery using mesh and developed a postoperative injury, contact Stern Law, PLLC, today to talk to one of our attorneys. During your call, you will be able to schedule a free consultation with a seasoned product liability lawyer, who will explain the litigation process and the services we provide. When you hire our firm, your attorney will prepare your case by:
- 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;
- 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.
Stern Law Offering Free Hernia Mesh Claim Review
When you’re trying to hire a lawyer for a product liability lawsuit, it can be difficult to know where to begin, but at Stern Law, we make the process as stress-free as possible. In your first call to our firm, you’ll be able to schedule a consultation with one of our skilled surgical mesh attorneys, who will listen to your story and help you understand your options.
We know our clients have already endured costly treatment and revision surgeries because of their hernia mesh injuries, and they are struggling under the weight of costly medical bills. That’s one of the reasons we offer free case consultations. Your initial call or meeting with our firm is completely free, and we will investigate your claim without ever asking for money up front. If our investigation concludes we cannot pursue a claim for you, you never have to worry about receiving a bill from us.
Additionally, if we conclude we can pursue a claim on your behalf, we will generally advance the costs of doing so. Most people cannot afford the expenses associated with litigating a product lawsuit, so we assume that financial risk for you and contract our cases on a contingency fee basis. That means we only get paid if you get paid. If you do not receive a money award from your lawsuit, you will not owe us anything.
Especially in the circumstances of hernia mesh, when you are potentially filing a claim against a major medical corporation, the process can seem intimidating. But when you hire Stern Law, you can rest easy knowing we have the resources and experience to bring you the justice you deserve. We take on the biggest corporations and don’t shy away from complex cases because we firmly believe in the justice of holding medical device manufacturers accountable. Together, we can make the industry safer for people in the future and secure the compensation you deserve.
Contact Stern Law, PLLC
At Stern Law, PLLC, we know how your medical device injuries have affected your life. Our legal team has the knowledge and skills you need on your side during this stressful time. Our experienced attorneys can achieve the just result you deserve, starting with a confidential consultation at no cost to you. Contact our office today by calling (844) 808-7529, and schedule your free consultation with one of our compassionate product liability attorneys.