Surgeons consider hernia mesh the “gold standard” of care. Each year, surgeons perform about 800,000 hernia repairs. The majority are mesh repairs. However, mesh implants have been shown to lead to complications — some brands more than others. Injured patients have filed hernia mesh lawsuits claiming the surgical mesh caused organ perforation, serious infections and painful scars called adhesions. Some underwent more surgeries to remove the implant, according to court documents. Many say they were unaware of the possible side effects and complications.
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 misrepresenting the quality and safety of hernia mesh
- Negligently designing and marketing unsafe hernia mesh
One allegation is that mesh manufacturers failed to adequately test 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 (FDA) 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.
Kugel Hernia Patch Litigation
C.R. Bard was one of the first companies to be named in surgical mesh litigation and offer settlements. In 2011, Bard settled about 2,000 Kugel Hernia Patch cases for $184 million. Lawsuits claim a defective memory recoil ring on these mesh products broke while inside patients causing bowel and intestinal damage.
When C.R. Bard and its subsidiary, Davol Inc., first introduced the Composix Kugel patch, it became a popular synthetic mesh for repairing hernias. However, patients began to report that the Kugel implant caused dangerous side effects like bowel obstruction, bowel perforation, fistulas, adhesions and infections due to the metal ring inside the mesh patch that was prone to breaking.
Bard and Davol began recalling the devices in 2005. Since then, thousands of patients and their families in the U.S. have filed personal injury and wrongful death lawsuits against the manufacturers. The companies also face lawsuits from international patients, including some in Canada and Germany.
Kugel Patch Recalls
Davol first recalled some types of the Composix Kugel hernia patches in late 2005. Each recall notice cites a potential for the memory recoil ring to break and possibly lead to bowel perforation and chronic enteric fistula. All of the recalls were Class I, meaning the defect associated with the use of the Kugel mesh patch could likely cause serious health consequences, including death.
The first recall was issued on Dec. 22, 2005, to all international Kugel patch clients. The same recall letter was delivered to U.S. customers on Dec. 27, 2005. On Jan. 5, 2006, an updated letter was issued. Davol issued a third letter on March 24, 2006, expanding the recall.
Davol issued a second wave of recalls on the Kugel patches in early 2007, extending the recall to include two more models presenting the same risk of a ring break. Customers were notified by letter on Jan. 10, 2007. According to the letter, there had been six reports of ring breaks between 2004 to 2005 — four of which caused complications. These reports include one incidence of ring migration, one incidence of abdominal pain and two incidents of bowel perforation. In the other two cases, the surgeon noted the ring was broken but did not implant it into the patient.
Kugel patches recalled in 2005, 2006 & 2007:
- Bard Composix Kugel Mesh X-Large Patch Oval with EPTFE, 8.7” x 10.7”
- Bard Composix Kugel Mesh X-Large Patch Oval with EPTFE, 10.8” x 13.7”
- Bard Composix Kugel Large Oval, 5.4” x 7”
- Bard Composix Kugel Oval, 6.3” x 12.3”
- Bard Composix Kugel Large Circle, 4.5”
- Bard Composix Kugel Mesh X-Large Patch Oval with EPTFE, 7.7” x 9.7”
- Bard Composix Kugel Hernia Patch Large Oval with EPTFE, 5.4” x 7”
- Bard Composix Kugel Hernia Patch Large Circle with EPTFE, 4.5”
Kugel Patch Lawsuits
After the recall was released, many patients and families of patients who had experienced complications from the Kugel hernia patch implant began suing. These cases made headlines for about a decade as thousands were filed against C.R. Bard and Davol for personal injury and wrongful death. The cases vary and include individual and multidistrict litigation suits in state and federal courts.
When several hundred to several thousand federal court cases identify the same defendant over the same issue, the U.S. Judicial Panel on Multidistrict Litigation can request the cases be transferred to one judge and tried as a group. On June 22, 2007, more than 150 federal cases were consolidated into a multidistrict litigation (MDL) heard by U.S. District Court of the District of Rhode Island Judge Mary M. Lisi. At that time, only 60 state court cases had been filed. As the years passed, that number swelled to more than 3,000 cases against Bard and Davol in federal and state courts. The Kugel patch has also been a subject in courts in other countries, including in Canada where a judge approved a $1,375,000 settlement for a class action suit in February 2014.
Kugel Patch Bellwether Trials & Settlements
Judge Lisi selected four bellwether cases under MDL-1842, more commonly known as “In re Kugel Mesh Hernia Patch Products Liability Litigation,” to be tried and serve as test cases. The results of bellwether trials are used to shape how the rest of the MDL cases are heard or settled.
The first of these cases was decided on April 14, 2010, when the jury ruled in favor of the defendant. The jury found the plaintiff had not fully proven his injuries were a direct result of the Kugel patch implant. In the second bellwether case, Thorpe v. Davol, the jury ruled in August 2010 in favor of the plaintiff and ordered a $1.5 million award. In this case, Christopher Thorpe argued he developed an abscess and fistula as the result of a Kugel hernia patch he received in November 2008.
Christopher Thorpe was awarded $1.5 million after developing an abscess from using a Kugel Patch.
In the summer of 2011, before the remaining two bellwether cases went to trial, C.R. Bard and Davol came to an agreement with about 2,000 plaintiffs in the MDL and settled for $184 million without admitting liability. Of the 2,233 actions filed under the MDL, six remained pending as of March 2017. The MDL remains open, and attorneys are still accepting injury or death cases related to the Kugel hernia patch.
Atrium C-Qur Hernia Mesh Litigation
On October 11, 2016, hernia mesh lawyers filed a motion to consolidate C-QUR hernia mesh lawsuits pending in federal courts across the country under an MDL.
“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. In December 2016, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal cases against Atrium Medical Corp. over its C-Qur mesh products into an MDL in the District of New Hampshire. At the time, the litigation consisted of13 actions pending in seven districts. The panel was also notified of eight related actions pending in eight districts. As of March 2017, 24 cases remained pending under MDL-2753 IN RE: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation.
All of the cases allege that defects in Atrium’s C-Qur mesh products incite an allergic or inflammatory response that causes severe complications.
The lawsuits claim:
- C-Qur mesh was defectively designed or manufactured
- Atrium knew or should have known of the alleged propensity of C-Qur mesh to result in an allergic or inflammatory response
- Atrium failed to provide adequate instructions and warnings with the mesh
The panel selected the District of New Hampshire as the appropriate transferee district for the MDL because seven of the actions on the motion to consolidate, as well as a number of state court cases, were pending in the district, and Atrium is headquartered there. The panel chose the Hon. Landya B. McCafferty to preside over the litigation, which is in the very early stages of the MDL process.
Ethicon Physiomesh Hernia Lawsuits
A handful of Ethicon Physiomesh lawsuits have been filed in federal courts. Ethicon, a Johnson & Johnson company, 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. Physiomesh is also 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.
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 intra-abdominal adhesions and mesh bulging. Some patients had hernia recurrence within one year.
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
Toxic Hernia Mesh Plastic
Some studies and lawsuits say one of the problems with certain 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 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 a 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.