Hernia Mesh Lawsuits: Ethicon, Bard Under Fire Over Severe Complications
Thousands of hernia patients have filed product liability lawsuits over severe side effects and complications linked to a variety of hernia mesh patches, including models manufactured by market leaders Ethicon, a subsidiary of global giant Johnson & Johnson, and Bard.
Hernia Mesh Litigation: Can You File A Lawsuit?
Today, nearly 60,000 patients and families are currently pursuing hernia mesh lawsuits, citing alleged product defects as the cause of life-threatening complications, from debilitating infections to internal adhesions that require immediate surgical intervention. Numerous patients claim to have undergone multiple revision procedures, experiencing repeated pain and trauma, while incurring thousands of dollars in medical debt.
Dozens of medical device manufacturers have been implicated, with industry luminaries like Endo International paying out hundreds of millions of dollars in settlement agreements. The hernia mesh litigation today, however, is centered around two manufacturers in particular:
- Bard / Davol (formerly C.R. Bard)
- Ethicon (a subsidiary of Johnson & Johnson)
Neither of these companies are strangers to legal trouble. In fact, both manufacturers have entered into multi-million dollar settlement agreements to resolve hernia mesh litigation in the past. Yet the lawsuits keep coming.
Ethicon Physiomesh Lawsuits
In 2016, Ethicon issued a global product withdrawal for its Physiomesh Flexible Composite Mesh, a hernia mesh patch. As the company explained, a review of data from two safety databases maintained in Europe found evidence that patients implanted with a Physiomesh patch were far more likely to suffer a hernia recurrence and/or require a revision surgery than people who received competitor mesh products.
Product liability lawsuits followed soon after. In their complaints, injured patients accuse Ethicon of releasing a defective product to the market, concealing evidence of the mesh’s alleged risks from medical care providers and the public. Over 500 Physiomesh lawsuits are now consolidated in the US District Court for the Northern District of Georgia, where District Judge Richard W. Story is guiding the litigation through pre-trial proceedings.
In Atlanta, plaintiffs who have filed federal mesh lawsuits will be allowed to pool their resources, including knowledge, to better prosecute their individual cases. This legal mechanism, known as Multi-District Litigation, makes it possible for hundreds or thousands of similar lawsuits to be “centralized” in a single court, increasing the efficiency of litigation and, in many cases, encouraging settlements.
Alongside Physiomesh lawsuits, our experienced product liability attorneys are also investigating potential claims involving a range of other Ethicon mesh products:
- Prolene– a synthetic mesh used in the treatment of hernias, stress urinary incontinence and pelvic organ prolapse
- Prolene Hernia System (PHS)
- Prolene 3D
- Proceed – a polypropylene mesh designed for the repair of hernias
New lawsuits have called the safety of these mesh products in question. If you or a loved one suffered injuries after receiving an Ethicon-made hernia mesh, contact our medical device lawyers now for a free consultation.
Bard Mesh Lawsuits & Settlements
Rhode Island-based manufacturer Davol, a subsidiary of C.R. Bard, has also come under fire for selling allegedly defective hernia mesh products:
- Composix E/X
- Composix Kugel
- Sepramesh IP
- Ventrio ST
- PerFix Plug
Several of these products were recalled due to serious safety concerns. For example, many of the company’s Composix Kugel mesh patches were recalled between 2005 and 2007, after it was discovered that a key component of the device could break during implantation.
Nearly 3,000 patients filed suit over the mesh, saying the product’s alleged defects had led to serious injuries, including internal organ perforations and costly revision surgeries. According to Law360, C.R. Bard offered the plaintiffs, whose claims had been consolidated in a Rhode Island federal court, $184 million to resolve their lawsuits.
How Hernia Repair (Should) Work
Surgical mesh products have become a staple in operating rooms around the country, allowing surgeons to seal open wounds, strengthen surgical incisions and reinforce weak muscle walls.
Mesh devices have become especially popular in the treatment of hernias, a medical condition in which internal organs begin to poke through compromised layers of muscle or body tissue, leading to tenderness, pain and discomfort.
Without treatment, herniation can lead to permanent tissue damage, as pieces of internal organ are pinched off and starved of oxygen and vital nutrients. To solve the problem, surgeons often turn to hernia mesh patches. Instead of stitching the hernia closed, physicians take a swatch of woven mesh material, often made from industrial plastic materials, to patch openings in the muscle wall.
Alleged Defects Lead To Severe Complications
But thousands of patients say that many of the world’s most popular hernia mesh products are defective. In lawsuits and FDA reports, tens of thousands of patients describe horrific complications after receiving a hernia mesh implant. Many patients claim to have undergone multiple mesh implantations, with each device failing in new and debilitating ways.
Medical researchers have discovered the truth of these complaints. In a 2016 study for the Journal of the American Medical Association, a group of Danish researchers found that, while patients who receive a mesh appear to be less likely to experience hernia recurrence, that potential benefit is offset by an increase in mesh-related complications. Among 3,242 patients, the team discovered complication rates up to 5.6% in people who had undergone open mesh surgeries.
Moreover, the rate of complication increased steadily over the course of five years. In short, the longer you have a mesh implant, the more likely you are to experience a severe complication.
Hernia Mesh Side Effects & Revision Procedures
And these aren’t minor mesh complications. In their lawsuits, patients describe chronic pain, life-threatening infections and perforations of the bowels, among other serious side effects:
- fistula – in which a mesh product eats through body tissues, creating abnormal passageways between organs
- rejection and aggressive immune system reactions – in which the body rejects a mesh implant as a “foreign invader”
- shrinkage and migration – in which the implant detaches from its site of implantation and moves to other places inside the body
- internal organ perforation
- bowel obstruction
- adhesion – in which the mesh becomes stuck to internal organs, usually the intestines, allowing scar tissue to develop
- seroma – in which fluid builds up around the site of surgery
Hernia mesh complications have forced thousands, if not millions, of patients to undergo invasive and expensive revision surgeries. Alongside the expense and trauma of enduring yet another procedure, additional revision operations also increase the risk for further complications, a fact that can compound the pain and suffering a patient must face.
Find More Information In A Free Consultation
Help is available. Did you or a loved one experience serious complications after receiving a hernia mesh implant? Were you forced to have another surgery to fix the problem? Our experienced mesh litigation team is here to fight for your best interests.
You may be entitled to file a personal injury lawsuit and pursue substantial financial compensation. In a successful lawsuit, you may be able to secure compensation for your medical expenses, both past and future, along with any lost wages. In addition, most product liability lawsuits claim significant damages for pain and suffering, including emotional trauma. To learn more about your legal options, contact our attorneys now for a free consultation. You can learn more about your rights at no charge and no obligation.
November 27, 2018 – World Champion Hurdler Speaks Out On Hernia Mesh Complications
One of England’s biggest athletes lost five years of his career to severe hernia mesh complications. In a new story for BBC Sport, world champion hurdler Dai Greene is speaking out about the “minimally invasive” procedure that nearly ruined his Olympic dreams.
Greene says he was sold a lie – the dream of a small medical implant that could have him back on his feet within weeks. In reality, the hernia mesh implant he received for an inguinal hernia in the spring of 2013 left Greene suffering from severe pain. Greene doesn’t remember being told any warnings about the implant.
He underwent a series of operations to fix the problem. Ultimately, a team of German surgeons learned that Greene’s mesh had frayed inside the body, becoming entwined with nerves in his pelvis. “That’s why anytime I was moving I was in loads of pain,” Greene says, “because there was something just constantly pressing on my nerves.”
Complications from the surgeries meant Greene missed out on the 2016 and 2017 seasons. He also lost lucrative sponsorship deals. While Greene is now back to running (he won the British athletics championships this year), his experience echoes through hundreds of product liability lawsuits filed in America over hernia mesh implants.
November 14, 2018 – Scottish Vet Describes Horrific Hernia Mesh Complications
A Scottish veteran has come forward publicly to describe the severe complications he experienced after undergoing a hernia mesh procedure in 2014, according to the Sunday Post. David Foulkes says hernia mesh has left him crippled by pain and unable to walk without a cane. The veteran, who served two tours in the Gulf War, has been repeatedly passed over by medical professionals unwilling to entertain the idea that his problems are due to the mesh.
“Nothing prepared me for the hell I’ve been left to face from the ‘simple hernia operation’ that reduced me to a shell,” Foulkes says, describing agony so extreme that liquid morphine is unable to control his physical pain. Foulkes has gone to great lengths to stem the pain, but to no avail. In 2016, he had a testicle removed, but says the operation has done nothing to ease his suffering.
Foulkes’ disclosure comes as Scottish parliamentarians struggle to avert a crisis in their country. Scots remember well the scandal surrounding transvaginal mesh, and fear that hernia mesh could prove a greater challenge. Scotland was the first country to outlaw transvaginal mesh. Now, members of parliament including Neil Findlay are considering similar measures for hernia mesh.
To learn more, click here.
October 11, 2018 – As Many As 30% Of Hernia Mesh Patients May Experience Severe Complications
A new report from the BBC’s Victoria Derbyshire investigative program suggests that up to 170,000 UK patients may have experienced severe hernia mesh complications. Using new data, the program’s investigative team discovered that between 12% and 30% of hernia mesh patients may experience complications. The numbers in America are even more shocking. With up to 900,000 hernia mesh repairs performed every year in the United States, an estimated 270,000 American patients could experience hernia mesh complications every year.
August 27, 2018 – Atrium Medical Faces Over 700 C-QUR Hernia Mesh Lawsuits
Over 700 product liability lawsuits have been filed against Atrium Medical Center, a manufacturer of the C-QUR line of hernia mesh patches. The cases, consolidated in the United States District Court of New Hampshire, accuse Atrium of manufacturing a defective and dangerous hernia mesh product. In their lawsuits, plaintiffs claim to have suffered severe injuries after being implanted with one of Atrium’s C-QUR mesh products.
August 13, 2018 – Federal Panel Consolidates Bard Polypropylene Hernia Mesh Cases In Ohio Court
The Judicial Panel on Multi-District Litigation has consolidated dozens of lawsuits filed against C.R. Bard and its subsidiary Davol Inc., transferring all federally-filed cases involved polypropylene hernia mesh products to the United States District Court of Ohio. Chief Judge Edmund A. Sargus has been appointed to preside over the consolidated litigation. 53 hernia mesh lawsuits are included in the initial transfer order, with around 70 “tag-along” actions also expected to make their way to the Columbus federal court in the coming weeks.
June 8, 2018 – Study: Partial Hernia Mesh Removal Increases Risk Of Infection, Reoperation 300%
Researchers at Carolinas Medical School have found a strong link between partial hernia mesh removal procedures and poor patient outcomes. “We feel that complete mesh excision […] should be performed whenever possible,” states Dr. Angela Kao, who presented the results of her study at the 2018 meeting of the International Hernia Congress. Studying data from 29,000 hernia procedures, Dr. Kao and her colleagues discovered that, when compared to complete mesh removal, partial mesh excision led to a 280% increased risk of surgical infection and a 340% increased risk for a procedural intervention.
May 29, 2018 – Florida Couple Files New C.R. Bard Hernia Mesh Lawsuit
A Florida couple has filed a new lawsuit against C.R. Bard, Inc. and its subsidiary, Davol, Inc., accusing the businesses of manufacturing and marketing a defective hernia mesh product. In their complaint, filed in the U.S. District Court for the Middle District of Florida, the couple blames the Ventralex hernia mesh for intense pain, abdominal deformities and other damages.
April 23, 2018 – Study Finds Major Deficiencies In Hernia Mesh Labeling
The majority of hernia mesh products aren’t labeled with critical device information, according to a new study out of Washington University in St. Louis. Few mesh products, the researchers found, advertise important features like pore size or resorption time, in their external packaging. The study’s authors, Dr. Jeff Blatnik and medical student Lindsey Kahan, say industry and regulatory officials should be working toward standardized labels that would allow surgeons to make quicker, more-informed decisions.
April 17, 2018 – New Jersey Jury Slams C.R. Bard With $68M Damages In Transvaginal Mesh Lawsuit
C.R Bard must pay $68 million in compensation to a woman from South Carolina who suffered severe injuries due to the medical device manufacturer’s pelvic mesh products, according to a jury in the New Jersey Superior Court. Announcing their decision on April 12, jurors for the court found Bard liable for manufacturing and marketing two pelvic mesh patches with design defects that rendered them unreasonably dangerous. The products in question hailed from Bard’s Avaulta and Align lines of pelvic mesh.
March 26, 2018 – Bard 3DMax Lawsuit In New Jersey Loses On Appeal
An appeals court in New Jersey has rejected efforts to revive a hernia mesh lawsuit filed against C.R. Bard. In a decision rendered on March 19, 2018, the New Jersey Superior Court’s Appellate Division held that none of the plaintiff’s three expert witnesses could adequately demonstrate that Bard’s 3D Max mesh product is defective.