The Problem
Some patients that undergo hernia repair surgery suffer severe complications, which they believe were caused by the implanted surgical mesh.
Some types of hernia mesh, like Physiomesh and C-Qur mesh, can damage the intestines, bowels, and abdomen. If you have had or are scheduled to have a hernia mesh revision surgery click here
“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”
Johnson and Johnson, removed the hernia mesh due to high rates of complications. Currently, the FDA’s website still has no information on the Physiomesh recall. Ethicon continues to deny that the Physiomesh was subject to a hernia mesh recall, but does admit that they withdrew the product from the market. To date, there have been very few hernia mesh products actually recalled and hence the lawsuits. The majority of complaints that hernia mesh lawyers receive are on products that have not yet been recalled, or have simply been “pulled from the market.”
Many Patients who required hernia revision surgery are now filing lawsuits against manufacturers Ethicon and Atrium. They allege that the companies designed dangerous and defective products and failed to warn about their potential complications.
If you or a loved one required revision surgery because of side effects from hernia mesh, contact us today for a free, no-obligation legal consultation. You dont pay if we don’t win the case.
WHAT ARE SOME COMPLICATIONS FROM HERNIA MESH?
Patients can suffer the following side effects from hernia mesh:
- Perforated intestines or bowels
- Intestinal fistulae
- Bowel obstruction or resection
- Peritonitis
- Abdominal wall tears
- Abscesses
- Sepsis
- Lack of ingrowth of mesh
- Adhesions of the mesh material to the bowel
WHICH HERNIA MESHES HAS THE FDA RECALLED?
In October 2012, the FDA sent a warning letter to Atrium for their failure to address C-Qur mesh infection and sterility complaints. Thirty-five complaints were made after finding human hair in the device.
In July 2013, Atrium issued a Class 2 FDA recall of C-Qur mesh because the coating could stick to the package lining if exposed to high levels of humidity. This separation could increase 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’s Physiomesh was also recalled in July of 2016. Ethicon, a Johnson & Johnson subsidiary, voluntarily issued the recall, citing a higher risk of recurrence and revision surgery compared to other brands.
WHY IS HERNIA MESH INCOMPATIBLE WITH SOME PATIENTS?
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.
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.
WHAT ARE SOME COMMON HERNIA MESH BRANDS?
Commonly used hernia mesh manufacturers and brands include the following.
Atrium’s C-Qur
Atrium’s C-Qur is a polypropylene mesh coated in fish (Omega-3) oil. The oil is supposed to keep the mesh from attaching to tissue, but if all the lawsuits filed over this line of meshes are any indication, that is not always the case.
The FDA approved the C-Qur mesh in 2006 through the 510(k) program, which means that C-Qur did not have to undergo and pre-market studies.
In July 2013, Atrium issued a Class 2 FDA recall of C-Qur mesh because the coating could stick to the package lining if exposed to high levels of humidity, a separation that could increase the risk of infection. This recall involved more than 95,000 meshes.
C.R. Bard’s 3DMax
C.R. Bard’s 3D Max hernia mesh is a polypropylene mesh that (like C-Qur) was approved through the 510(k) program, which means it did not have to undergo pre-market studies. 3DMax was approved in October 2008. Just two months later, Bard recalled the mesh because many products were mislabeled.
Like many other polypropylene meshes, the 3DMax has generated complaints of migration, pain, and revision surgery.
C.R. Bard’s Ventralex ST
The Ventralex hernia patch is a “self-expanding polypropylene… patch that can be used to repair small ventral defects such as umbilical hernias and trocar site deficiencies.” The first Ventralex patch was approved in 2002; the most recent one was approved in 2013. Like many other mesh products, it was approved via the 510(k) program.
In October 2011, Bard issued an “urgent” Class 2 FDA recall of the Ventralex ST Medium Circle with Strap Hernia Patch.
C.R. Bard’s Composix Kugel Mesh
Bard’s Kugel hernia mesh spawned at least three recalls (in 2005, 2006, and 2007); thousands of lawsuits; and millions of dollars in settlement money and jury awards.
In 2010, a jury awarded $1.3 million to Christopher Thorpe after he experienced painful complications from his Kugel mesh. This was a bellwether trial that spurred Bard in 2011 to settle 3,000 more Kugel lawsuits for a jaw-dropping $184 million.
Ethicon/Johnson & Johnson’s Physiomesh
Ethicon’s Physiomesh was recalled in July of 2016. Ethicon (a Johnson & Johnson subsidiary) issued the recall, citing a higher risk of recurrence and revision surgery compared to other brands.
WHAT DO HERNIA MESH LAWSUITS ALLEGE?
Personal injury lawsuits accuse hernia mesh manufacturers like 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.
WHO IS ELIGIBLE FOR A HERNIA MESH LAWSUIT?
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.
WHAT COMPENSATION MIGHT THEY RECEIVE?
A hernia mesh 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.
HOW DO I FILE A HERNIA MESH LAWSUIT?
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 consultation.
We will fight to help you hold mesh manufacturers accountable. Best of all, filing a lawsuit costs nothing unless we win a jury award or settlement on your behalf.
