Patients who received hernia mesh to repair all types of hernias filed lawsuits against mesh manufacturers. According to lawsuits, problematic hernia meshes include Atrium C-QUR Hernia Mesh and Ethicon Physiomesh Flexible Composite Mesh. Complications include infections, organ, damage, autoimmune problems, adhesions (scar tissue) and bowel obstruction that require additional surgery to repair. Hernia mesh lawyers can help these patients determine if they are eligible for compensation.
Injured patients filed hernia mesh lawsuits after they say the surgical mesh caused complications such as organ perforation, serious infections and painful scars called adhesions. Hernias occur when tissue or organs bulge through a weak spot in the abdominal muscle. Hernia repair is common — doctors perform about one million hernia repairs each year — but, studies linked certain brands of mesh to more complications than others.
Patients who received hernia mesh reported a number of adverse events and some underwent more surgeries to remove the implant, according to court documents. Hernia mesh lawyers filed lawsuits on behalf of hernia patients who claim mesh makers designed faulty hernia mesh and failed to warn patients.
Hernia mesh lawsuits accuse device makers of several counts of negligence, including:
- Manufacturing a defective product
- Failing to adequately test hernia mesh
- Failing to warn the public about the risks of mesh
- Intentionally, knowingly and recklessly concealing information about the defective mesh
- Intentionally misrepresented the quality and safety of hernia mesh
- Negligently designing and marketing unsafe hernia mesh
Surgical hernia mesh is allowed on the market without rigorous clinical trials, pre-market research or studies. The U.S. Food and Drug Administration allowed mesh makers to use the 510(k) clearance program to get their products on the market. Device makers only have to prove their products are “substantially equivalent” to other products already on the market. In some cases, these predicate devices may have been recalled or are no longer on the market because of safety concerns.
Atrium issued recalls for its C-QUR mesh in August 2013 because the fish oil coating may peel off and stick to packaging. Ethicon withdrew its Physiomesh Flexible Composite mesh from the market in May 2016 because a German and Danish registry found a higher rate of hernia recurrence and reoperation rates compared to similar meshes.
Injured patients turn to hernia mesh lawyers to help them obtain compensation for physical, financial and emotional damages. They also file lawsuits to send a message to device companies and create awareness.
Hernia Mesh Lawsuit Settlements
There are several hernia mesh litigations against different mesh manufacturers. Some manufacturers offered millions to settle cases and juries awarded verdicts. These lawsuits have many complaints in common. Lawsuits say hernia mesh has “numerous defects that create a high risk of unreasonable and dangerous injuries and side effects with severe permanent adverse health consequences.”
Current litigations include actions against Atrium and Maquet Getinge for its C-QUR Hernia Mesh line and Ethicon for its Physiomesh. These cases are still in the beginning of litigation and have not yet had trials or settlements.
C.R. Bard was one of the first companies to become involved in litigation and offer settlements for Kugel Hernia Patch lawsuits. In 2011, Bard settled about 2,600 Kugel cases for $184 million. Lawsuits claimed a defective ‘memory recoil ring’ on these mesh products broke while inside patients causing bowel and intestinal damage.
In two Kugel Hernia Patch bellwether trials, juries found the mesh products defective. In the first case, the plaintiff was unable to prove the defective design led to injuries. In the second bellwether, the jury found Bard liable for injuries and awarded the plaintiff $1.5 million.
Atrium C-QUR Hernia Mesh Lawsuit MDL
So far, there are no settlements or jury verdicts for the C-QUR hernia mesh. Nearly two dozen C-QUR hernia mesh lawsuits are pending in courts across the country. On October 11, 2016, hernia mesh lawyers filed a motion to consolidate the cases in multidistrict litigation in the District of New Hampshire before Judge Landya B. McCafferty in the District of New Hampshire.
“Plaintiffs allege that Atrium negligently designed, manufactured, marketed, labeled, packaged and sold medical devices used for hernia repair, including multiple products in a product line known as C-Qur Mesh,” according to the Motion to Transfer. “Plaintiffs also allege the C-Qur Mesh’s defective design and testing which resulted in a high failure rate and extensive complications for patients who had C-Qur Mesh implanted.”
The purpose of consolidating these cases with similar complaints is to streamline litigation. On December 8, the Judicial Panel on Multidistrict Litigation ordered the transfer of thirteen lawsuits to the District of New Hampshire.
Atrium C-QUR Design Defects
Atrium designed the mesh with an Omega 3 fatty acid (O3FA) coating made of fish oil. On the device’s brochure, Atrium claims the O3FA coating “has been shown to minimize tissue attachment to the mesh.” The coating is supposed to reduce scar tissue called adhesions, yet allow permanent fixation the abdominal wall and facilitate rehabilitation and healing, according to a report by Atrium’s parent company Getinge Group.
However, data from clinical studies links C-QUR mesh to adhesions, improper tissue fixation and more infections than other types of mesh.
“In reality, the C-Qur mesh incites an inflammatory response that promotes bowel adhesion formation, impedes proper abdominal wall fixation, and causes additional severe complications,” plaintiffs argue in court documents.
Plaintiffs claim Atrium manufactured a faulty product and failed to warn them of the risks. These lawsuits are ongoing.
Ethicon Physiomesh Hernia Lawsuits
There are currently a handful of Ethicon Physiomesh lawsuits in federal courts. Though Ethicon denied recalling the device in the U.S., it withdrew the Ethicon Physiomesh Flexible Composite Mesh from the market in May 2016. According to the Urgent Field Safety Notice, it withdrew the mesh because it had higher recurrence and reoperation rates after laparoscopic hernia repair than other meshes.
Lawsuits against Ethicon claim the material used to make Physiomesh — polypropylene plastic — reacts to human tissues and other naturally occurring body parts and fluids and adversely affects patient health.
Plaintiffs claim Physiomesh:
- Harbors infections
- Migrates in the body, damaging organs and tissue
- Perforates and abrades tissue
- Is inappropriate for use in hernia repair
- Creates an unreasonable risk of injury in patients
Ethicon Physiomesh Design Defects
Physiomesh is coated on both sides. The coating is supposed to protect organs from direct exposure to the mesh and prevent adhesions — scar tissue that forms when mesh sticks to organs or tissues. But, the coating may also prevent the mesh from properly incorporating into the body. This could lead to the mesh migrating in the body and damaging organs.
A handful of independent studies found Physiomesh performed poorly compared to other mesh products on the market. It caused more seromas (fluid buildup), scar formation, inflammation and hemorrhage compared to other meshes studied.
In one 2016 study by Dr. Kryspin Mitura and colleagues published in Surgical Endoscopy, the authors found Physiomesh caused intraabdominal adhesions and mesh bulging. Some patients had hernia recurrence within one year.
Hernia Mesh Side Effects and Injuries
Patients who filed lawsuits reported a number of adverse events. Depending on the type of hernia and location of the mesh, injuries may vary. The FDA released a Safety Communication warning the public of possible adverse events linked to hernia mesh. Hernia mesh lawyers also observed a number of injuries in patients.
- Painful sex
- Abdominal, leg, groin and testicular pain
- Autoimmune disorders
- Kidney failure
- Liver problems
- Joint aches and pains
- Mesh migration
- Seroma (fluid pocket around mesh)
- Adhesions (scar tissue)
- Bowel obstruction
- Nerve and blood vessel damage
Toxic Hernia Mesh Plastic
Some studies and lawsuits say one of the problems with hernia mesh is it is made of polypropylene, a plastic that may be toxic in the body. Though polyethylene is supposed to be safe, according to one Material Data Safety Sheet from the chemical company LyondellBasell, polypropylene is not safe for “applications involving permanent implantation into the body.”
Like hernia mesh, transvaginal mesh is also made of polypropylene. Pelvic surgical mesh manufacturers face nearly 100,000 lawsuits for filed by women who say the mesh caused severe and permanent damage requiring multiple surgeries to remove mesh.
As more surgeons practice laparoscopic hernia repair with mesh, more mesh may touch organs in the bowel. The laparoscopic intraperitoneal onlay mesh (IPOM) technique is popular with coated meshes. It places mesh inside the abdominal cavity directly against the intestines. Mesh makers began manufacturing coated mesh like C-QUR and Physiomesh to prevent polypropylene from directly touching organs.
But researchers noticed problems with migration, adhesions and inflammatory responses to these coatings.
During Donna Cisson’s 2013 transvaginal mesh trial against C.R. Bard, emails surfaced revealing the company’s Davol hernia mesh unit used plastic not suitable for human implantation. According to a Bloomberg report, the plastic’s manufacturer — chemical company Chevron Phillips — told Bard the polypropylene resin should not be permanently implanted in people. Davol told manufacturers to continue making the mesh from the Chevron Phillips plastic and agreed to cover any legal costs or damages, according to the emails.