Hernia Mesh Class Action Lawsuit
Hernia Mesh Class Action Lawsuit
Hernia Surgical Mesh is used to strengthen tissues and lessen the chance of a hernia recurrence. Use of such meshes have been on the rise since the 1980’s and are critical in a significant number of hernia repairs.
A hernia is caused when a tissue, organ, or intestine is forced through a weak spot in the surrounding connective tissue or muscle. They often occur along the abdominal wall and are prone to recurrence and repeat injury.
Despite its widespread use, some types of hernia mesh can have side effects. Both Physiomesh and C-Qur mesh have received lawsuits alleging damage to the abdomen, intestines, and bowels. These side effects can require additional surgeries to mitigate.
Hernia patients who have required surgery using these meshes are filing lawsuits against the manufacturers Atrium and Ethicon. These suits allege that these companies designed dangerous or defective products and failed to warn about the potential complications properly.
What are some possible complications from Hernia Mesh?
Patients requiring hernia revision surgery and receiving a hernia mesh can suffer from the following side effects:
- Abdominal wall tears
- Adhesions of mesh material to their bowels
- Perforated intestines or bowels
- Bowel resection
- Intestinal fistulae
Why are some hernia meshes causing problems?
Polypropylene plastic makes up both of the meshes made by Ethicon (Physiomesh) and Atrium (C-Qur). Polypropylene is the same material used for many transvaginal mesh products, which has lead to as many as 100,000 personal injury lawsuits.
Physiomesh is coated by a material used to prevent inflammation and adhesion called by Monocryl. Patients have alleged that the absorbable material is not suitable for implantation.
The C-Qur mesh, unlike Physiomesh, is coated with an Omega-3 fatty acid fish oil. It is possible that this oil can cause some patients to experience allergic reactions.
Both C-Qur and Physiomesh were approved through the FDA’s 501(k) clearance program. This program does not require clinical trials with human patients if the manufacturers can demonstrate enough similarity with other products on the market.
Which Hernia Mesh products have been recalled?
Physiomesh by Ethicon
Ethicon, a Johnson and Johnson subsidiary, issued a voluntary withdrawal of their hernia mesh product Physiomesh, as of July 2016. Ethicon cited a higher risk than other brands of recurrence and subsequent surgery.
C-Qur by Atrium
Atrium issued a Class 2 FDA recall in July 2013 for its C-Qur mesh product. Over 95,000 devices have been involved. The recall was in response to concerns that the mesh’s coating could stick to the package lining. This would happen if exposed to a high level of humidity and could lead to an increased risk of infection in the patient.
In October 2012, the FDA had sent warning letters to Atrium for failure to address sterility and infection complaints on their C-Qur mesh product. There had been thirty-five complaints made after finding human hair in the mesh.
The FDA has also filed a lawsuit against manufacturer Atrium for the poor quality control at their New Hampshire facility. This forced Atrium to stop both production and distribution of C-Qur.
3DMax, Ventralex ST, and Composix Kugel Mesh by C.R. Bard
Both the 3DMax hernia mesh and Ventralex hernia patch, manufactured by C.R. Bard were approved through the FDA’s 510(k) program. So, similar to C-Qur, they did not have to go through human clinical trials.
3DMax is is another polypropylene mesh. Within two months of approval, Bard recalled numerous mislabeled devices. The 3DMax device has generated complaints of pain and revision surgery.
The Ventralex hernia mesh is a self-expanding patch used to repair smaller defects. In October 2011, CR Bard issued an “urgent” Class 2 FDA recall for the hernia patch.
CR Bard’s Composix Kugel mesh has been recalled at least three times and spawned thousands of lawsuits. Bard has settled more than 3,000 Kugel lawsuits for $184 million.
Notable hernia mesh lawsuits
The Ethicon Physiomesh lawsuits are currently being consolidated in Florida. With over 300,000 of the mesh implants sold, Physiomesh can allegedly cause abdominal abscesses, infection, and intestinal fistulas.
The lawsuit was originally filed by Matthew Huff, who had an abdominal wall hernia corrected with Physiomesh in 2013. Within two years he required revision surgery for the infection and abscesses.
The manufacturer Atrium also faces similar personal injury lawsuits. These suits have been consolidated in New Hampshire. The lawsuit alleges that Atrium convinced medical professionals the product was safe despite knowing the risks that it was biologically incompatible with patients. Additionally, it is also alleged that Atrium failed to properly notify the FDA and medical community of adverse events and using “stealth recalls.”
James Brown filed a lawsuit against Atrium in January 2017 for their C-Qur mesh product. He was implanted with the device for a hernia repair in December 2013. Afterward, he continued to suffer from pain. In 2016, Mr. Brown had additional surgery to remove the mesh. Doctors discovered scarring in the surrounding tissue and that he suffered from a “foreign body giant cell reaction.”
What is alleged in the Hernia Mesh Lawsuits?
- Creating an “unreasonably dangerous and defective product”
- Unreasonable risk of severe adverse reactions
- Being responsible for the necessity of surgical removal
- Selling a product that did not perform as intended to a reasonable degree
- Failure to warn patients and medical professionals of the risks
Who can file a Hernia Mesh Lawsuit?
- If you have undergone a laparoscopic hernia repair surgery that used hernia mesh
- The surgery took place on January 1st, 2008 or later
- You have received, or have scheduled, hernia revision surgery
What Expenses Can Recovered?
The lawsuits can provide compensation for the following:
- Pain and suffering
- Medical bills
- Loss of wages