ABOUT HERNIA MESH LEADS AND
SIGNED RETAINERS

1. What Is a Hernia Mesh Implant?

A hernia mesh implant is a medical procedure involving implantation of a loosely woven plastic or biological material through laparoscopic or open surgery. The surgery is performed to repair a hernia or revision of a previously implanted hernia mesh implant. It is considered as the most common elective abdominal wall procedure performed by surgeons.

2. What is a Hernia?

Hernias occur due to weakness in the abdominal wall. When part of a person’s tissue or intestine pushes through the abdomen wall, complications can arise. Hence, options to repair the hernia involve implanting plastic or biological mesh to add enforcement to the abdomen to prevent protrusion.

3. What Are the Different Types of Hernia Mesh Implants?

Hernia mesh implants can be used on the following types of hernias:

• Abdominal: Hernias located along the walls of the abdomen.
• Inguinal: Hernias located in the groin area and are the most common type.
• Incisional: Hernias at the site of a previous injury or surgery and are the second most common type.
• Umbilical: Hernias usually occurring around the belly button.
• Hiatal: An abdominal hernia in the upper part of the stomach.
• Femoral: Hernias located at the upper thigh, around the outer groin or labia (these hernias are more common in women).

4. Types of Hernia Mesh Complications

Tens of thousands of reports of problems suffered from patients implanted with hernia mesh products exist. Many originate from recalled hernia mesh products.

• Extreme abdominal pain. Hernia mesh implants may cause abdominal pain and is a common category of problems. This could be a sign of adhesions, bowel obstruction, nerve damage, or some type of infection.
• Leg, Groin, and Testicular Pain. Many patients experience extensive leg, groin, and testicular pain due to hernia mesh. Some patients have experienced numbness in the testicular area and have had one removed. These could occur from inguinal hernias being repaired with mesh.
• Painful Sex and Erectile Disfunction. Mesh implants could cause pain during sexual intercourse as the mesh interferes with the spermatic cord. This has resulted in removal of the testicles for some patients. The occurrence of erectile disfunction due to hernia mesh from inguinal hernia among men, especially from mesh repairs, is also a potential issue.
• Infection. There are different reasons for hernia mesh implants causing infections. Staphylococcus is the most common pathogen involved with infected mesh implants. Chronic mesh infections require removal of the mesh because antibiotics and mesh-saving surgeries are not sufficient. MRSA can also be found in infected implants.
• Bowel Obstruction. Inguinal hernia repair is among the most common type of hernia mesh revision. Small bowel obstruction is a specific problem to laparoscopic inguinal hernia repairs.
• Adhesions. Laparoscopic procedures from abdominal surgery increases the risk of adhesions due to mesh implants. Abdominal adhesions occur when fibrous tissue develops between abdominal tissues and organs, or fistulas between the mesh and organs. Ethicon removed their Physiomesh hernia mesh implant from the market due to this complication. Adhesions to the bowel could also occur.
• Migration. Hernia mesh could migrate to the abdominal viscera or into the sigmoid colon after inguinal revision surgery. Migration may occur due to inadequate securing of the mesh (“mechanical migration”) or when the body has an inflammatory reaction to the mesh (“secondary migration”). The Atrium C-Qur Edge and Ethicon Physiomesh may be more prone to migration issues, according to law suits.
• Perforation of bowel or intestines. After hernia mesh implantation, it could puncture or perforate the bowel or intestines. Additionally, it could do the same to the abdominal wall or other organs. When this occurs, fecal matter and bacteria may drift into the abdominal cavity causing peritonitis and sepsis. Sepsis may be fatal.

5. Hernia Mesh Implant Recalls

Below are some of the product recalls over the past few years.

5a. 2005 – 2006 Hernia Mesh Implant Product Recalls

On December 22, 2005, Davol, which is a subsidiary of C.R. Bard, had a Class I recall of its Composix Kugel Mesh. In fact, six versions were recalled.

The reason was the memory recoil ring could break, which could possibly cause bowel perforation. The manufacturer discontinued the mesh product on March 31, 2012 and indicated replacing them with the Ventrio or Ventrio ST products as an option.

5b. 2010 Hernia Mesh Implant Recalls

Due to nonconforming material or component, Ethicon initiated a Class 2 Recall of its Polymeric Surgical Mesh on October 18, 2010.

According to the FDA, Ethicon instructed medical facilities “immediately remove the recalled product from their inventory and return it according to the instructions provided.”

5c. 2013 Hernia Mesh Implant Recalls

On July 19, 2013, Atrium Medical Corporation initiated a Class 2 Device Recall of its C-QUR Edge Mesh products. The reason provided was the mesh could adhere to the packaging once exposed prolonged conditions of high humidity. Hence, the C-QUR product is still being sold at time of publication of this page, yet some attorneys believe the FDA should issue a Class 1 recall of the product.

Notably, the FDA issued a warning letter to Atrium Medical Corporation due to its failure to properly address several complaints regarding infections related to the C-QUR mesh. The letter also mentioned that the company looked to be ignoring a number of sterility complaints; at least 35 individual complaints of human hair discovered in the mesh were supposed to be sterile.

5d. 2015 Hernia Mesh Implant Recalls

On February 11, 2015, EXP Pharmaceutical Services Corp initiated a Class 2 Device Recall of its PhysioMesh Flexible Composite Mesh. Apparently, the manufacturer failed to register as a medical device establishment or establish its own quality system and depended upon its vendors that were registered for quality control.

5e. 2017 Hernia Mesh Implant Recalls

On November 22, 2017, Atrium Medical Corporation initiated a Class 2 Device Recall of some of its ProLite Mesh patches. This was due to incorrect configuration of packaging where the wrong product code was placed inside the pouch of packages.

5f. 2018 Hernia Mesh Implant Recalls

On February 23, 2018, Sofradim Production initiated a Class 2 Device recall of its Versatex Monofilament Mesh 50 x 50 cm.

Due to patient reports of abdominal hernia recurrence following hernia repair, Versatex added the risks of using the mesh implant with its Instructions for Use to make surgeons aware of the issue.

6. Hernia Mesh State Trials and Federal Bellwether Trials

There are several federal trials under the multidistrict litigation classification. Below are some of them.

6a. Johnson & Johnson/Ethicon Physiomesh Products Liability Litigation MDL 2782

Hernia mesh claims against Ethicon, a subsidiary of Johnson & Johnson, deal with its Physiomesh implants. These have been consolidated under MDL 2782 in the U.S. District Court, Northern District of Georgia.

Generally, claims against Johnson & Johnson and Ethicon assert certain Physiomesh hernia mesh implants were defectively designed, manufactured, and labeled.

Specifically, Plaintiffs have asserted the Physiomesh products cause serious complications due to multi-layer coating that prevent proper incorporation of the mesh. Additionally, it has been alleged the mesh does not adequately prevent normal abdominal pressure, which has caused herniations to recur through the mesh.

6b. Atrium Medical C-QUR Products Liability Litigation MDL 2753

Multidistrict litigation for Atrium Medical Corp. C-QUR Mesh Products Liability Multidistrict Litigation docket number 2753. This is being held at the United States District Court, District of New Hampshire. For a list of individual cases as of May 31, 2019, go here.

Specifically, these cases allege the fish oil coating used caused several complications. More details assert detachment of the implant resulted in adherence and adhesions to organs. Additionally, patients supposedly experience extreme abdominal pain and subsequent hernia recurrence that required one or more surgeries and removing the mesh implant.

There are reports that doctors and medical facilities have stopped implanting the mesh implant because of high rates of infections, bowel obstructions, and allergic reactions to the coating on the C-QUR product. Also, it could be difficult to explant once the device attaches to the bowel.

6c. Davol/C.R. Bard Polypropylene Hernia Mesh Products Liability Litigation MDL 2846

There are many hernia mesh cases underway in Rhode Island state court. Currently, MDL 2846 against Davol/C.R. Bard is progressing in United States District Court for the Southern District of Ohio, Judge Edmund A. Sargus presiding.

Like many hernia mesh implant manufacturers, the FDA allowed Davol/C.R. Bard to sell many of its mesh products under a 510(k) avenue of approval. That means the manufacturer represented its products were similar to already approved products in the marketplace.

Previous mesh injury cases demonstrated that the manufacturer hid their intent to use plastic made from Chevron Philips that was not suitable to be implanted in humans.

Over $1.1 billion in awards and settlements has been paid to various vaginal and hernia mesh claimants, but most have not yet settled. Meanwhile, there are estimates that over 50,000 hernia mesh lawsuits are pending in federal, state, and local courts.

C.R. Bard settled over 2,600 lawsuits filed in Rhode Island multidistrict litigation for $184 million due to complications from its Kugel Hernia Mesh product.

One notable state court plaintiff victory against C.R. Bard occurred in April 2018. In that case, a New Jersey jury awarded $33 million in compensatory damages and $35 million in punitive damages. According to Law360, the jury felt punitive damages were warranted because the manufacturer “acted maliciously or in wanton and willful disregard to the rights of plaintiff Mary McGinnis and her husband” from her debilitating injuries.

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