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HERNIA MESH COMPLICATIONS

Recalls and warnings issued after devices linked to painful side effects.

SEE THE SIDE EFFECTShernia mesh lawsuits

You may have a case if you suffered hernia mesh complications?

hernia mesh side effects

TOP RISKS OF Hernia Mesh

Abdominal hernias are injuries that affect over 1 in 4 males and 3% of females during their lifetime. These abdominal wall ruptures are usually repaired with a surgically-implanted mesh device.

Beginning in the 1950s, doctors started replacing metal mesh implants with those made out of a strong and lightweight plastic called polypropylene. These were perfected with even lighter mesh products in the 1990s, and with coated surfaces in the last decade.

Now, over 350,000 people in the United States undergo hernia mesh implant surgeries each year.

Unfortunately, studies have revealed that both the uncoated polypropylene meshes and the coated implants pose severe health risks to patients. Many have to undergo painful removal or corrective surgeries as a result.

One of the largest makers of hernia mesh, Ethicon, recalled their Physiomesh devices from the market in May of 2016, and the FDA has warned other manufacturers of the risks. However, lawyers discovered that the companies weren't properly warning consumers of the risks.

Now, lawyers are helping those affected file lawsuits against the manufacturers, with cases growing so quickly that many have been consolidated to special federal multidistrict courts.

Assistance is available. Speak with a patient advocate today.

HERNIA MESH RECALLS

On May 25, 2016, Ethicon/Johnson & Johnson notified all operating room supervisors, chiefs of surgery and medical material management personnel that they were recalling twelve models of their Physiomesh flexible composite mesh used in hernia repair surgeries.

According to an Urgent Field Safety Notice issued by the company, the voluntary recall was issued after studies in Germany in Denmark revealed that patients with Physiomesh had higher-than-normal rates of hernia recurrence or need for corrective surgery.

The recall only involved problems associated with laparoscopic placement of the Physiomesh device. Experts also point out that the thick absorbable coating on each side of the Physiomesh prevented it from adhering to tissue, but may have also caused complications such as kidney problems.

Despite the clear language of the Field Safety Notice issued by the company, Ethicon now claims they were merely withdrawing the Physiomesh from the market in order to replace it with the Physiomesh Open.

Due to the large number of patient complaints related to the Physiomesh, several lawsuits have already been filed in federal court for those affected and lawyers are helping others investigate their claims.

top adverse events reports

MALES REQUIRING HERNIA SURGERY- 27 PERCENT
OCCURENCE RATE OF HERNIA SURGERY COMPLICATIONS - 31 PERCENT
AVG COST OF HERNIA SURGERY - $35,300
ANNUAL HERNIA SURGERIES REQUIRING MESH - 350,000

HERNIA MESH RESEARCH

Over the past decade, countless studies have examined the use of sutures versus mesh in hernia repair, as well as the possible side effects of bare polypropylene versus coated meshes. Here are a few examples:

A study of 632 hernia implant patients from Vanderbilt University published in October, 2016 revealed that 31% suffered complications within two years of their procedure.

That same month, a study from Denmark of over 3,200 patients undergoing hernia repair from 2007 through 2010 found that, although the use of mesh implants may have lower hernia recurrence rates, their use was also four times more likely to cause long-term complications.

A study from Norway published in July 2016 discovered a link between hernia mesh complications and oral infections. Doctors found that, among a group of patients with failed hernia mesh implants, all of them had the gum disease gingivitis and one-in-three had infections that had spread to the gums and teeth.

In May of 2014, a study published in the American Medical Association's Surgical Journal compared results of nearly 1,800 hernia repairs performed with sutures versus mesh implants. Researchers found that, while the mesh implants had a slightly lower risk of hernia recurrence, they also were linked to a higher risk of side effects like infection.

A 2013 study out of India noted that the severe risks of using polypropylene mesh for laparoscopic hernia repair, such as infection, organ adhesion, blockage and perforation, were present whether or not the mesh was a composite type. This, even though the composite variations are generally 15-20 times more expensive.

A study from Brigham and Women's Hospital in Boston published in 2012 comparing synthetic, composite and biologic mesh implants noted that polypropylene is "unsuitable" for placement in the abdominal cavity due to its "tendency to induce bowel adhesions."

In 2010, surgeons from Belgium first warned of the increased use of composite, or coated hernia mesh products, and the severe side effects, such as need for bowel resection and mesh removal. They particularly noted that there was no long-term data available to support their use, and that 75% of the devices had not been tested on humans prior to being sold.

HERNIA MESH Side Effects

Experts have noted an increase in the side effects related to hernia mesh products as more of these devices are made with special coatings, or doctors have begun using different procedures to implant them in the abdomen.

First, the material from which most hernia meshes are constructed, polypropylene, is also used in automotive parts, food containers, packaging and tapes. It is not designed for permanent implantation in the body and can cause damage to internal organs over time. Unfortunately, hernia mesh products made with polypropylene are sold for permanent use.

Also, with doctors performing an increasing number of hernia repairs by laparoscopic surgery, the mesh is often inserted deeper into the abdomen, where it can come in contact with the bowels or other organs.

Finally, many manufacturers have begun selling composite hernia mesh products with coatings such as Omega-3 fatty acids, that are designed to provide a barrier between the mesh and internal tissues. However, these coatings can also cause severe infections and other complications.

According to the FDA, adverse event reports for hernia mesh devices have revealed a number of severe side effects, including:

Some of the symptoms that may indicate a severe hernia mesh complication include:

If you or a loved one have experienced these or similar symptoms after receiving a hernia mesh implant, talk with a doctor about possible device failure.

hernia mesh bowel obstruction

BOWEL OBSTRUCTION

tissue adhesion hernia mesh

NAUSEA

hernia mesh internal bleeding

INTERNAL BLEEDING

infection hernia mesh

HEADACHES

Hernia Mesh BRANDS

The following is a partial list of hernia mesh brands that have been linked to patient side effects:

  • 3DMax Mesh
  • C-Qur Mesh
  • Kugel Mesh
  • Parietex Composite Mesh
  • Parietex Plug and Patch Mesh
  • PerFix Plug Mesh
  • Physiomesh
  • Proceed Mesh
  • Sepramesh
  • SurgiPro Mesh
  • Symbotex Mesh
  • Ventralex ST Mesh

Hernia Mesh Litigation

In recent years, lawyers investigating the dangers of transvaginal mesh and bladder mesh have been alarmed by the number of patients coming forward with severe side effects from hernia mesh implants.

Upon further review, it has become apparent that this $3.5 billion industry has repeatedly marketed products for surgical use in humans without proper warning or even clinical trials to measure their safety.

Most recently, the FDA has issued safety warnings regarding the C-Qur Mesh implant from Maquet/Getinge and Johnson & Johnson has issued a recall of their popular Physiomesh implant due to device failure.

The side effects of these devices can be severe and permanent, such as bowel and organ obstruction, organs growing together, and organ perforation. Often, they require painful corrective surgery.

Since manufacturers of these devices didn't properly test their products or warn patients of these risks, they may be liable for substantial compensation to victims.

Already, due to the growing number of lawsuits, cases against C-Qur mesh devices have been consolidated to a special federal MDL court, and lawyers are expected to request the same for Physiomesh claims.

If you or a loved one suffered complications after receiving a hernia mesh implant, it is important to learn your legal options. Review our Hernia Mesh Lawsuit page, or contact us today to speak directly with a lawyer at no cost.

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view sources

Baucom, R., et al. Evaluation of long-term surgical site occurrences in ventral hernia repair: implications of preoperative site independent MRSA infection. Hernia. (October 20, 2016). Retrieved from www.ncbi.nlm.nih.gov

Langbach, O. Oral, intestinal and skin bacteria in ventral hernia mesh implants. Journal of Oral Microbiology. (July 29, 2016). Retrieved from www.journaloforalmicrobiology.net

Nguyen, M., et al. Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis. JAMA Surgery. (May 2014). Retrieved from www.ncbi.nlm.nih.gov

Ramakrishna, H. Intra Peritoneal Polypropylene Mesh and Newer Meshes in Ventral Hernia Repair: What EBM Says? Indian Journal of Surgery. (October 2013). Retrieved from www.ncbi.nlm.nih.gov

Muysoms, F. Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution. Hernia. (June 2010). Retrieved from http://link.springer.com

Kokotovic, D. Long-term Recurrence and Complications Associated With Elective Incisional Hernia Repair. JAMA. (October 18, 2016). Retrieved from www.ncbi.nlm.nih.gov