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Hernia Mesh Implants

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Hernia Mesh Litigation

Lawsuits involving hernia mesh implants allege that these medical devices are failing at unacceptable rates and causing serious complications such as infections, bowel obstruction, perforation of organs and chronic pain. Quite often, these complications lead to additional surgeries. These products are surgically implanted in the stomach or intestine to repair hernias by providing support to weakened tissue. Many of these mesh implants are made from synthetic materials and lawsuits claim they are defectively designed and were never properly tested.

What is the Problem with these Hernia Mesh Implants

Surgical repair for a hernia is a relatively common surgery. However, the manufacturers of these synthetic mesh implants have been marketing and promoting these products to be used unnecessarily in laparoscopic surgeries to repair smaller hernias that can often be better repaired without the use of a synthetic mesh implant. Most smaller hernias can be repaired simply with sutures that do not pose the same risks associated with hernia mesh implants. 

By 2016 synthetic mesh implants made up two-thirds of the global sales of all hernia surgical repair products. The manufacturers of these implants saw an opportunity to gain more of the market share by promoting the use of mesh implants in laparoscopic surgeries to treat minor hernias. By the end of 2016 the FDA received numerous reports of adverse events and injuries associated with these implants, including at least ten deaths.

These mesh implants consist of a polypropylene material that is coated with an absorbable film coating. The manufacturers claim that the coating makes it easier to implant into a patient’s tissues and reduces the risks of inflammation. However, lawsuits claim that the film coating is increasing the risk of infection because it prevents fluid from escaping. The fluid build-up creates an environment susceptible to bacteria resulting in dangerous infections and abscesses. There are many different “composite mesh” implants that have this type of film coating that can cause infection. The manufacturers of these products are:

  • American Medical Systems
  • Atrium
  • Boston Scientific
  • Coloplast
  • C.R. Bard/DaVol
  • Ethicon
  • Medtronic/Covidien

Ethicon Physiomesh Recall

So far at least one of these mesh products has been recalled. In June 2016, Ethicon, a subsidiary of Johnson & Johnson, recalled its Physiomesh flexible composite mesh product. This mesh product was being marketed for use in minimally invasive hernia repair surgeries. In an Urgent Field Safety Notice sent to surgeons Ethicon cited to data from two large hernia registries that showed higher than average revision rates after laparoscopic ventral hernia repair when using Physiomesh as compared to other products. Read the full Urgent Field Notice HERE. Ethicon claimed that the reason for the higher revision rates was unknown and blamed it on a “multifactorial issue (including possible product characteristics, operative, and patient factors).

In June 2017, the Judicial Panel on Multidistrict Litigation issued an order coordinating and consolidating for pretrial purposes all cases involving Ethicon Physiomesh hernia mesh implants. At the time there were close to 70 lawsuits pending which were transferred to the Northern District of Georgia. 

Atrium C-Qur Mesh

The FDA conducted several investigations into the manufacturer of another hernia mesh implant, Atrium. Atrium is the manufacturer of the C-Qur hernia mesh implant which is also the subject of current litigation. In 2012 the FDA issued a warning letter to the manufacturer because the company failed to adequately address multiple complaints relating to infections associated with the C-Qur product. Read the FDA warning letter HERE. The FDA also scolded Atrium for defects in its manufacturing process and in 2015 issued an injunction requiring the manufacturer to cease all manufacturing and distribution of C-Qur mesh implants until the FDA determined that the manufacturing and processing of the implants was in compliance. 

Lawsuits involving C-Qur hernia mesh implants claim they are defective because they contain a fish oil coating. Fish oil is not biocompatible and frequently causes rashes, rejection, allergic reactions and severe infections.  As a result, the mesh contracts and can easily fold over itself. The FDA has received many adverse event reports as a result of complications from the fish oil coating on the mesh.     

Do I Have A Hernia Mesh Lawsuit?

If you or a loved one were implanted with hernia mesh and then developed a severe infection which required corrective procedures, you may be entitled to compensation.

Protect Your Rights

If you believe you may have a lawsuit, contact us today.  There are statutes of limitations on product liability lawsuits, which could time bar your case if it is not filed in a timely manner.  Complete the form and one of our attorneys will reach out to you within 24 hours to conduct a free and confidential evaluation of your case.

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