Hernia Mesh Lawsuit
Some patients that received hernia repair surgery have suffered severe complications, which they believe were caused by the implanted surgical mesh. This mesh is used to support the damaged tissue and help reduce the duration of hernia surgery and recovery.
Some types of hernia mesh, including Physiomesh and C-Qur mesh, can damage the intestines, bowels, and abdomen, which often requires additional surgery.
Patients who required hernia revision surgery are now filing lawsuits against manufacturers Ethicon and Atrium. Lawsuits allege the companies designed dangerous and defective products and failed to warn about their potential complications.
Hernia Mesh Complications
Patients can suffer the following complications from hernia surgical mesh:
- Perforated intestines or bowels
- Puncture of other abdominal organs
- Intestinal fistulae
- Bowel obstruction or resection
- Abdominal wall tears
- Lack of ingrowth of mesh
- Adhesions of the mesh material to the bowel
Hernia Mesh Made from Materials Not Suitable for Implantation
Physiomesh, manufactured by Ethicon, and C-Qur mesh, made by Atrium, are both made from materials that aren’t compatible with many patients’ bodies.
Physiomesh and C-Qur mesh are both made of polypropylene plastic. This is the same material used for the majority of transvaginal mesh products, which has resulted in more than 100,000 personal injury lawsuits.
Physiomesh is also coated with Monocryl, an absorbable material used to prevent inflammation and adhesion, which patients allege is not suitable for implantation.
Ethicon, a Johnson & Johnson subsidiary, recalled Physiomesh in July of 2016. They claimed the product had a higher risk of recurrence and revision surgery compared to other brands.
C-Qur mesh is manufactured by Atrium, a subsidiary of Maquet. Unlike Physiomesh, it is coated with an Omega-3 fatty acid fish oil. This oil can cause allergic reactions in some patients.
Both Physiomesh and C-Qur mesh were approved by the FDA’s fast-track 510(k) Clearance program. The 510(k) Clearance program does not require clinical trials with human patients if manufacturers can prove their products are similar enough to other products on the market.
FDA Files Lawsuit Against Atrium for Poor Quality Control
In October 2012, the FDA sent a warning letter to Atrium for their failure to address C-Qur mesh infection and sterility complaints—35 complaints were made after finding human hair in the device.
The FDA filed a lawsuit against Atrium for poor quality control at their New Hampshire manufacturing facility.
In August 2013, the product was recalled because the coating could stick to the package lining. Atrium packaged the mesh without sufficient moisture, causing the coating to separate and increasing the risk of infection.
The FDA filed a lawsuit against Atrium for poor quality control at their New Hampshire manufacturing facility, forcing the company to stop production and distribution of the C-Qur mesh.
Ethicon and Atrium Hit with Hernia Mesh Lawsuits
The Physiomesh allegedly caused an infection, two abdominal abscesses, and intestinal fistulas.
The first Ethicon Physiomesh lawsuit is scheduled for January 2018 in Illinois’ Southern District.
The lawsuit was filed by Matthew Huff, who was implanted with Physiomesh in 2013 for an abdominal wall hernia. Two years later, Mr. Huff received revision surgery. The Physiomesh allegedly caused an infection, two abdominal abscesses, and intestinal fistulas.
Atrium similarly faces personal injury lawsuits, which have been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for New Hampshire.
James Brown and his wife filed an Atrium lawsuit in January 2017 for the C-Qur mesh. Mr. Brown was implanted with the device in a hernia repair surgery in December 2013, but he continued to suffer from abdominal pain. He underwent additional surgery in January 2016 to remove the mesh. Doctors discovered he suffered from a “foreign body giant cell reaction” and scarring of the surrounding tissue.
The lawsuit accuses Atrium of convincing medical professionals the product was safe despite knowing that it was biologically incompatible with surgical patients. The complaint also alleges that Atrium failed to properly notify the FDA of adverse events and used “stealth recalls” of the product without notifying the FDA or medical community.
Personal injury lawsuits accuse Ethicon and Atrium of some combination of the following:
- Designing an “unreasonably dangerous and defective product” with an unreasonable risk of severe adverse reactions
- Selling a product that failed to reasonably perform as intended and was directly responsible for the necessity of surgical removal
- Failure to warn defendants and medical professionals of the risks associated with the mesh products
You may qualify for a hernia mesh lawsuit if you meet the following criteria:
- You underwent a laparoscopic hernia repair surgery that used hernia surgical mesh.
- The surgery took place on or after January 1, 2008.
- You had or have scheduled hernia revision surgery.
A lawsuit can help recover compensation for the following:
- Medical bills
- Lost wages (past and future)
- Pain and suffering
Though there haven’t been any settlements for Physiomesh or C-Qur mesh yet, C.R. Bard’s litigation history for their Composix Kugel Mesh offers some clues on possible compensation.
The Composix Kugel Mesh resulted in more than 3,000 lawsuits. It featured memory recoil rings that could break or buckle, causing complications like abscesses and fistulas.
In 2011, C.R. Bard offered to pay $184 million to settle 2,600 lawsuits filed in a Rhode Island multidistrict litigation.
What to Do If You Suffered Hernia Mesh Complications
If you or a loved one underwent hernia repair surgery and suffered complications from the surgical mesh, contact us for a free, no-obligation legal review.
ClassAction.com’s attorneys have recovered more than $4 billion against negligent companies, including Big Pharma, and will fight to help you hold hernia mesh manufacturers accountable. Filing a lawsuit costs nothing unless we win a jury award or settlement on your behalf.