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Hernia Mesh Used for Hernia Repair

In recent decades, hernia repair surgeries using hernia mesh have increased dramatically. 1 Accompanying this increase in use, there has also been an increase in problems with meshes once they are inside a person’s body. Some types of hernia mesh have been recalled due to these problems.

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Suffering complications after hernia mesh surgery?

Hernia mesh is a type of surgical mesh. Surgeons can use surgical mesh in an attempt to help support weakened or damaged tissue. 2

Most surgical mesh products are made from animal tissues or synthetic materials. Some surgical mesh is absorbable, some is nonabsorbable, and some is a combination of both. 3

Nonabsorbable mesh is meant to be a permanent implant. Absorbable surgical mesh provides temporary support and gradually breaks down. 4

Hernias

If you notice an unusual bulge around your groin, pelvis, or abdomen, you may have a hernia. A hernia is a weakening of muscle or connective tissue inside the abdomen that then bulges or tears. 5

This weakened area may allow a part of the intestines, a digestive organ, or fatty tissue, to slip through the weakened muscle or connective tissue, forming a bulge. A hernia can cause significant pain and possibly lead to other medical problems. 6

Both men and women can develop hernias. In addition, people of all ages can develop hernias.

Hernias can develop because of weakness in a person’s abdominal wall, pressure against the abdomen, or strain on the abdominal wall. Possible causes of hernias include: 7

  • Obesity.
  • Congenital defect.
  • Poor nutrition.
  • Smoking.
  • Heavy lifting.
  • Overexertion.
  • Chronic coughing or sneezing.
  • Diarrhea or constipation.

Most hernias (80 percent) occur near the inner groin. These are called inguinal hernias. 8

Hernia Types and Symptoms

Other types of hernias include: 9

  • Femoral, in upper thigh or outer groin.
  • Umbilical, around the naval.
  • Incisional, along a previous surgical incision.
  • Ventral, in the general abdominal area or ventral wall.
  • Hiatal, inside the abdomen, along the upper stomach or diaphragm.

Symptoms of hernias may include: 10

  • A bulge near the groin or in the abdomen.
  • Pain while lifting something.
  • Dull ache or burning sensation in the abdomen.
  • A nonspecific feeling of fullness.
  • Nausea and constipation.

Hernia Repair with Mesh

Hernia repair procedures are common. In fact, surgeons perform more than one million hernia repairs in the United States annually. 11

The most common hernia repair procedures are for inguinal hernias — roughly 800,000 per year. Another 200,000 hernia repairs a year are for other types of hernias. 12

Sometimes hernia repairs are done laparoscopically. This means the surgeon makes a few small incisions in the abdomen and then inserts specialized surgical instruments through the incisions to fix the hernia.

A surgeon can perform laparoscopic hernia repair with mesh or without surgical mesh.

Sometimes hernia repairs involve more extensively opening a patient up during surgery. This is called open repair. In these situations, the surgeon makes a larger incision near the hernia itself and works directly inside the person’s body, as opposed to using a scope to visualize during laparoscopic surgery, to repair the weakened area.

Surgeons can also perform this type of hernia repair with mesh or without surgical mesh.

Hernia Mesh Complications

Following hernia repair procedures, patients may experience complications. Common hernia mesh complications include: 13

  • Pain.
  • Infection.
  • Hernia recurrence.
  • Adhesion.
  • Bowel obstruction
  • Tissue perforation.

Other possible hernia mesh complications include: 14

  • Mesh movement, or migration
  • Mesh contraction or shrinkage

When people report significant hernia mesh complications to the U.S. Food and Drug Administration (FDA), the agency may scrutinize the reports for signs of recurring problems. In some cases, as a result of FDA or company investigation, hernia device manufacturers have recalled defective mesh products and removed them from the market. 15

Hernia Mesh Failure Symptoms

One of the most significant hernia mesh failure symptoms is hernia recurrence. The hernia repair itself might be fine, but the mesh can bulge and expand causing new abdominal wall swelling. 16

When serious hernia mesh failure symptoms such as this occur, surgery may be necessary. 17

Another possible hernia mesh failure symptom is pain. Although some initial pain is expected following any surgery, significant pain that lasts for weeks or months may indicate additional surgery or other procedures are necessary. 18

Hernia Mesh Reactions

Some patients experience an adverse reaction to the mesh itself. Your body may react to the hernia mesh the way it would to other foreign objects. Inflammation, pain, and irritation are possible. 19

Another hernia mesh failure symptom could be nerve irritation. If a nerve got caught in or became irritated by the mesh during surgery or due to mesh migration, a patient might experience prolonged and chronic pain. 20

According to the Cleveland Clinic, patients should not have to live with pain that lasts for months following hernia repair surgery. Different surgical and nonsurgical procedures may help to alleviate pain: 21

  • Mesh removal is one surgical possibility.
  • Neurectomy, which involves surgically removing a nerve or part of a nerve, may be indicated.
  • PRP (plasma-rich protein) injections may ease nerve pain.
  • Nerve ablation is a nonsurgical procedure that uses electrical currents to lessen nerve pain.
  • Other kinds of pain management are also available.

When you experience prolonged hernia mesh complications, consult your doctor about possible solutions. You may also want to get a second opinion if you have any concerns about those recommendations. 22

Hernia Mesh Recalls

The FDA collects medical adverse event reports through its Manufacturer and User Facility Device Experience (MAUDE) database. In recent years, people have reported hernia mesh complications and significant adverse events.

In addition to infection, recurrence of hernia(s), and pain, additional reported complications reports include: 23

  • Adhesion, “scar-like tissue that sticks tissues together.”
  • Obstruction, when the large or small intestine is blocked.
  • Perforation, a hole that forms in nearby organs or tissues.

Because of increasing numbers of adverse events linked to some hernia mesh devices, some manufacturers have publicized hernia mesh recalls for specific models of their hernia mesh. These models are no longer on the market. 24

Types of Hernia Mesh

Many different types of hernia mesh exist. Some types of hernia meshes that are currently being investigated by lawyers include, but are not limited to:

Atrium

  • C-QUR Mesh.
  • C-QUR Edge.
  • C-QUR Edge Mesh V-Patch.
  • C-QUR Lite Mesh V-Patch.
  • C-QUR V-Patch Mesh.
  • C-QUR OVT Mesh.
  • C-QUR RPM Mesh.
  • C-QUR TacShield.
  • C-QUR Mosaic.

Bard

  • 3DMax Mesh.
  • Mesh (Flat).
  • Composite (Composix) Mesh.
  • Composix E/X Mesh.
  • Composix Kugel Hernia Patch.
  • Marlex Mesh.
  • Modified Kugel Hernia Patch.
  • PerFix Mesh.
  • Sepramesh IP Composite Mesh.
  • SpermaTex Mesh.
  • Ventralex Patch.
  • Ventralex ST Mesh.
  • Ventrio.
  • Ventrio ST.
  • Visilex.

Covidien

  • Parietex Surgical Mesh.
  • Parietex Composite Mesh.
  • Parietex ProGrip Mesh.

Ethicon

  • Physiomesh Flexible Composite Mesh.

Genzyme

  • Sepramesh IP

You can find out if a particular brand of hernia mesh has been recalled by visiting the FDA’s Medical Device Recall website.

You can also search the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database to read any reported adverse events linked to specific hernia mesh products.

If you search the MAUDE database, you may discover that people have reported problems with a particular model of hernia mesh. Those hernia mesh models may still be on the market, and surgeons may continue to use those products for hernia repair procedures.

Hernia Mesh Lawsuits

Many patients who have undergone a hernia repair procedure and experienced severe medical complications in recent years have filed hernia mesh lawsuits. You do not have to wait for manufacturers to announce hernia mesh recalls in order to pursue legal action due to hernia mesh complications.

Currently people have brought hernia mesh lawsuits across the country against different hernia mesh manufacturers. Hundreds, if not thousands of cases, have been filed against the same hernia mesh manufacturers.

Because the underlying facts and issues in dispute are similar, if not uniform, across all plaintiffs with the same hernia mesh against a particular hernia mesh manufacturer, this is what is known as a mass tort litigation.

Mass tort cases are often combined into what is called a multidistrict litigation (MDL) in federal court or a multicounty lawsuit (MCL) in state courts. In recent years, several medical device manufacturers have faced or are facing mass tort litigations in federal or state court related to their allegedly defective hernia meshes.

One of these manufacturers is Ethicon, Inc. (Johnson & Johnson). Hernia mesh cases against Ethicon have been combined into an MDL being overseen in the Northern District of Georgia. That MDL number is 2782. 25

In that litigation, people claim that Ethicon’s Physiomesh Flexible Composite hernia mesh led to severe complications, such as: 26

  • Herniation through the mesh.
  • Recurrent hernia formation and/or rupture.
  • Deformation of the mesh.
  • Failure of the mesh to adequately incorporate into tissues.

Another manufacturer facing hernia mesh lawsuits is Atrium Medical. Those cases have been combined into a multidistrict litigation being overseen in the District of New Hampshire. That MDL number is 2753. 27

In that litigation, people have claimed that defects in Atrium Medical’s C-QUR meshes “incite an allergic or inflammatory response that causes severe complications.” 28

Identifying Current Hernia Mesh Litigations

If you want to find out if a particular hernia mesh manufacturer is facing a federal multidistrict litigation, you can visit the U.S. Judicial Panel on Multidistrict Litigation’s (U.S. JPML’s) website.

You can also see if there are any multicounty lawsuits (MCL) filed in state courts related to your particular hernia mesh manufacturer.

People across the country are also filing hernia mesh lawsuits against hernia device manufacturers right now. You can also check the U.S. JPML website or search state courts for new litigations to see if those lawsuits become part of newly designated multidistrict litigations related to hernia mesh products.

Hernia Mesh Lawsuit Settlement Amounts

Sometimes hernia mesh lawsuits end up in court and jurors award money to plaintiffs. Other times, hernia mesh manufacturers agree to settle with plaintiffs outside of court.

$184 Million Settlement in Hernia Mesh Case

Past hernia mesh lawsuit settlement amounts include a win for people who were harmed by defective hernia mesh.

In 2011, C.R. Bard Inc. was facing more than 3,000 lawsuits in both state and federal court. The company resolved most hernia mesh claims that had been consolidated in the multidistrict litigation in Rhode Island.

The company agreed tentatively to a hernia mesh settlement amount of $184 million. 29

Plaintiffs had claimed they suffered serious injuries because Bard’s Composix Kugel surgical mesh patches were defective. According to the lawsuits against Bard, the Kugel patches did not work the way they were supposed to and Bard failed to properly test the Kugel patch’s design before marketing the device, allowing for patients to experience horrible adverse events.

The plaintiffs claimed they developed terrible medical complications, including but not limited to: 30

  • Abscesses (pockets of pus).
  • Fistulas (abnormal tunnels or connections between two areas inside the body).

  1. U.S. Food & Drug Administration. (2018, February 4). Medical Devices. Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  2. Ibid.
  3. Ibid.
  4. Ibid.
  5. Cleveland Clinic. (2017, March 1). Laparoscopic Surgery for Hernia Repair. Retrieved from https://my.clevelandclinic.org/health/treatments/6905-laparoscopic-surgery-for-hernia-repair
  6. U.S. Food & Drug Administration. (2018, February 4). Medical Devices. Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  7. U.S. Food & Drug Administration. (2018, February 4). Medical Devices. Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  8. Cleveland Clinic. (2017, March 1). Laparoscopic Surgery for Hernia Repair. Retrieved from https://my.clevelandclinic.org/health/treatments/6905-laparoscopic-surgery-for-hernia-repair
  9. U.S. Food & Drug Administration. (2018, February 4). Medical Devices. Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  10. Cleveland Clinic. (2017, March 1). Laparoscopic Surgery for Hernia Repair. Retrieved from https://my.clevelandclinic.org/health/treatments/6905-laparoscopic-surgery-for-hernia-repair
  11. U.S. Food & Drug Administration. (2018, February 4). Medical Devices. Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  12. Ibid.
  13. Ibid.
  14. Ibid.
  15. Ibid.
  16. Deerenberg, E.B., et al. (2016, September 30). Mesh expansion as the cause of bulging after abdominal wall hernia repair. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5061296/
  17. Ibid.
  18. Cleveland Clinic. (2017, March 10). How You Can Get Relief From Groin Pain After Hernia Repair. Retrieved from https://health.clevelandclinic.org/can-get-relief-groin-pain-hernia-repair/
  19. Ibid.
  20. Ibid.
  21. Ibid.
  22. Ibid.
  23. U.S. Food & Drug Administration. (2018, February 4). Medical Devices. Hernia Surgical Mesh Implants. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
  24. Ibid.
  25. United States Judicial Panel on Multidistrict Litigation. (2017, June 2). In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation. Transfer Order. MDL No. 2782. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2782-Initial_Transfer-05-17.pdf
  26. Ibid.
  27. United States. Judicial Panel on Multidistrict Litigation. (2016, December 8). In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation. Transfer Order. MDL No. 2753. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2753-Initial_Transfer-12-16.pdf
  28. Ibid.
  29. Shrestha, B. (2011, July 1). Bard Offers $184M To Settle Patch Suits. Retrieved from https://www.law360.com/articles/255403/bard-offers-184m-to-settle-hernia-patch-suits
  30. Ibid.