The hernia mesh lawsuits claim the medical devices are defectively designed and the manufacturers have failed to properly warn medical providers of the serious adverse complications and device failures.
Our law firm is accepting clients who received a hernia mesh and have experienced additional surgeries, infections, bowel obstruction, organ damage, and/or chronic pain. We have been handling lawsuits against medical device companies since 1955. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
What Do We Know About the Hernia Mesh Lawsuits
Plaintiff attorneys argue that several of the hernia mesh products have been defectively designed and are causing unnecessary repairs and injuries that would not have occurred if a substitute mesh product or sutures had been utilized.
The Key Legal Issue
Many hernia mesh devices use materials that shrink, contract, harden, migrate, or fail - causing nerve damage, bowel damage, and cause the need for further surgery.
Court documents show the manufacturers of hernia mesh devices have been marketing and promoting the products for unnecessary use, such as the repair of smaller hernias that can be treated through laparoscopic surgery and stitches.
Hernia Mesh Injuries & Side Effects
Abdominal wall hernias often require surgical correction. A surgeon can typically repair a hernia without the use of a mesh product and/or the surgeon can use a material, such as a biologic mesh, that poses less risks than many synthetic products that are currently on the market.
Many of the synthetic hernia mesh products marketed since the year 2005 to the present were rushed to the market using the FDA’s 510k clearance process and were manufactured and marketed with little to no studies as to the safety of the device. Many of these devices have been silently withdrawn from the market or otherwise have been recalled.
These problematic hernia mesh devices contain design defects and undisclosed or under-disclosed risks such as: (1) use of “coatings” on the mesh product that cause adverse reactions and infections; (2) excessive mesh and tissue contraction; (3) tendency of the mesh to migrate, shrink, or turn into a hardened ball or mass; and (4) excess foreign body reaction and rejection of the mesh in the body.
The most common side effects in patients are infections, intestinal obstructions or adhesions, permanent nerve damage resulting in pain, hernia recurrence, and revision surgery to correct complications and remove or revise the mesh.
Hernia Mesh vs. Stitches
One of the big differences between using a mesh product and using sutures is that a mesh can move or shrink, and then cause bowel perforations, organ damage, obstructions, and additional surgeries. This especially is true if the mesh product is faulty or contains a polypropylene coating. If a perforation occurs, this can result in a serious infection known as sepsis.
If you have received a hernia mesh, some of the symptoms to watch for include constipation, fatigue, fever, irritable bowel, severe pain, and urinary issues. If you experience these symptoms, you should immediately report them to your treating physician. Unfortunately, hernia mesh complications can occur within days to years after the hernia mesh is implanted.
It's important for your healthcare provider to keep the hernia mesh and tissue after removing it from your body. This is an important piece of evidence in your case. Your healthcare provider can find out how to do this by contacting our office and asking for attorney Kim Adams.
Compensation in a Hernia Mesh Lawsuit
If you have sustained injuries because of a hernia mesh, we will be seeking the following damages for you:
- Past and future medical expenses that result from any injuries caused by the hernia mesh, such as the costs of the revision surgery; treatment of infections, perforations, and obstructions; and care for chronic pain.
- Past and future pain and suffering caused by the injuries, and the treatment and recovery process.
- Past and future wage loss, if any.
- Past and future loss of capacity to earn money.
- Punitive damages, if appropriate.
Hernia Mesh Lawsuit Settlement Amounts
As of this time, there have been no large mass tort settlements involving failures or injuries caused by the Physiomesh, C-QUR, or Ventralex mesh products. Generally, however, large groups of settlements do not occur until such time as a few lawsuits are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
In 2011, C.R. Bard settled 3,000 cases over its Kugel Mesh for $184 million. That device had been recalled by the FDA in 2005, 2006 and 2007. However, lawsuits against Bard and subsidiary DaVol continued to be filed for several years. In June 2017, a federal judge in West Virginia dismissed several of the cases, ruling that all claims against Bard had been settled for an undisclosed amount.
Similar to the hernia mesh lawsuits, many thousands of claims were filed against companies who manufactured a vaginal mesh medical device. This product was intended to treat women who were experiencing incontinence. Over time, the device began to erode inside the patient’s body, causing chronic pain, organ damage, and repeat surgeries. More than 100,000 lawsuits were filed against the transvaginal mesh manufacturers, resulting in $3 billion in settlements.
Attorneys Mike Papantonio and Robert Price Discuss the Hernia Mesh Implant Lawsuits
Hernia Mesh Recalls
From 2005-2007, C.R. Bard issued several recalls involving its Kugel Mesh product as a result of a problem associated with potential bowel tears.
In 2012, the FDA sent Atrium a warning over its failure to respond and address numerous complaints of infections due to the C-QUR. In 2015, a federal judge issued an injunction, prohibiting Atrium from manufacturing and distributing the product.
In May 2016, Ethicon voluntarily withdrew the Physiomesh Flexible Composite Mesh after studies determined the medical device was more likely to result in a failed hernia repair when compared to other similar products.
Ethicon mailed an urgent field safety notice to hospitals and doctors telling them to immediately return any unused products, and to stop using the product. Ethicon admitted that the design of its hernia mesh was one of the causes of the failures. At the time Ethicon issued the warning, the FDA had received approximately ten reports of fatalities associated with the Ethicon Physiomesh.
Why is a Hernia Mesh Utilized?
Each year approximately one million hernia surgeries are performed in the United States. As part of the repair, one of the devices often used is a hernia mesh, which can be made from synthetic material or animal tissue. This product is meant to reinforce the area where the hernia is protruding in order to prevent reoccurring hernias.
Hernias are caused by abdominal pressure and an opening or weakness in a muscle or connective tissue. The abdominal pressure can force an organ (such as the bowel, bladder or intestine) or fatty tissue to move through the opening or weak area.
The abdominal pressure can result from various activities, such as lifting heavy objects, diarrhea, constipation, chronic coughing and pregnancy. Obesity makes the occurrence more likely. Muscle weakness can result from poor nutrition, smoking, overexertion, or a prior surgery.
Symptoms of a hernia include abdominal pain, bulging of the skin, nausea, and vomiting.
If a hernia is not causing symptoms or complications, doctors generally will monitor it to see if it improves. Surgery is the only option for a permanent fix. If surgery is performed, a hernia mesh device often is utilized as part of the repair process.
There are several types of hernias: ventral (abdominal wall), inguinal (inner groin), femoral (upper thigh or outer groin), hiatal (upper stomach), incisional (from a surgical cut), and umbilical (navel).
The incisional hernia occurs when there is a tear in the muscles of the abdominal wall, such as the site where a cut was made during a previous operation, for example a C-section.
Hernia surgeries can be performed through open repair or laparoscopically. With open repair, the surgeon makes a large incision close to the hernia. With laparoscopic, the incisions are minimal in size.
Hernia mesh products can be made of absorbable or non-absorbable material. If absorbable, the mesh is meant to breakdown over time, after natural tissue has formed to prevent the hernia from recurring. If non-absorbable material is used, the mesh is intended to remain in the body permanently.
A key concern with hernias is strangulation. This is where the blood supply to an organ is being blocked because the organ is pushing through the abdominal wall or tissue.
Manufacturers of hernia mesh products include: (i) Ethicon, Inc., a subsidiary of Johnson & Johnson, which produces the Physiomesh, Proceed, and Prolene; (ii) Atrium Medical Corporation, a division of MAQUET Medical Systems, which produces the C-QUR; (iii) C.R. Bard (Davol), which produces the Composix, Ventralex, Kugel Patch, PerFix, and Sepramesh; and (iv) Covidien (Medtronic), which produces the Parietex.
Hernia Mesh Lawsuit News
A Secret for Patients Undergoing Hernia Repair
Serious complications can occur if the surgical mesh or other devices break or become twisted or dislodged; a commonly used mesh product was recalled in 2006 by its manufacturer because of the potential for breakage inside patients, and a number of class-action suits have been brought by patients who experienced complications like bowel perforation and infection. Reported in Wall Street Journal - Hernia Repair Secrets
J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Johnson & Johnson subsidiary Ethicon recalled one of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh. Reported in MassDevice - Physiomech Recall
FDA and Scientific Studies Regarding Hernia Mesh
Hernia Surgical Mesh ImplantsHernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the risk. Despite this benefit, there are situations where the use of surgical mesh for hernia repair may not be recommended. Reported in FDA - Mesh Implants
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia RepairThis was a randomized controlled trial comparing two systems of mesh and fixation for laparoscopic ventral and incisional hernia repair. The study was terminated early because the researchers were noticing a high recurrence rate. Reported in Clinical Trials - Laparoscopic Repairs
Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphyMesh repair has a small reduction in recurrence rates compared with suture repairs for primary ventral hernias, but an increased risk of seroma and surgical site infections. Reported in Journal of American Medical Association - Synthetic Mesh Versus Sutures
Long-term Recurrence and Complications Associated With Elective Incisional Hernia RepairAmong patients undergoing incisional repair, sutured repair was associated with a higher risk of reoperation for recurrence over 5 years compared with open mesh and laparoscopic mesh repair. With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications. Reported in Journal of American Medical Association - Hernia Mesh Complications
Ventral hernia repair with synthetic, composite, and biologic mesh: characteristics, indications, and infection profile"Three main types of prosthetic mesh are available. Synthetic mesh, such as polypropylene (PP) or polyester, is characterized by high tensile strength and vigorous tissue ingrowth . . . . Composite, or barrier-coated, mesh is a dual-sided prosthetic having a synthetic parietal side to promote a strong repair and a visceral surface that repels tissue ingrowth and decreases adhesion formation. Biologic mesh is a collagen-based human, porcine, or bovine scaffold that may be implanted in the extra- or intra-peritoneal position." Reported in Surgical Infection - Ventral Hernia Repairs
Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral HerniasPrimary ventral hernias, such as umbilical and epigastric hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias. This study was to determine the best size hernia meshes to use in different situations, but the study had to be terminated because the researchers perceived an abnormally high rate of infections. Published in Clinical Trials - Umbilical Hernias
Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution"We have seen several patients with serious late complications of these meshes placed intraperitoneally. Some of these patients needed small bowel resection and mesh removal. Others developed a recurrence because of improper deployment of the mesh in the intraperitoneal position." Published in The World Journal of Hernia and Abdominal Wall Surgery
Last Modified: November 26, 2020 @ 9:32 am