Hernia Mesh Lawsuit
Hernia mesh surgery is one of the most commonly performed procedures in the U.S., with an estimated 700,000 abdominal hernia surgeries alone performed each year. However, many patients have reported severe surgical mesh complications, including nerve damage, infections, bowel obstruction, hernia recurrence and many others. You may be eligible to file a hernia mesh lawsuit if you have been harmed by this type of medical device. Please contact Baron & Budd by completing our online form or calling 866-829-0176 to learn more about your potential legal options.
Types of Hernias
A hernia is a condition that occurs whenever a portion of the intestine or an organ protrudes through surrounding muscle or connective tissue. Hernias are often visible, especially when someone strains or bears down on the affected area. In order to prevent a hernia from recurring, doctors will typically use a hernia repair mesh plug or patch to reinforce the muscles that surround the problem area.
While there are many kinds of hernias, the most common ones affect the abdomen. In fact, abdominal hernias comprise approximately 60 percent of all hernias. They often occur in the inguinal canal, a portion of the abdominal wall. While inguinal hernias occur in both women and men, in men this occurs in the area from which the testicles descend. This leads to a natural defect known as an internal inguinal ring. If this area does not seal properly, a portion of the intestine or another part of the abdomen can protrude through, leading to bulging as well as severe pain.
Risk factors for inguinal hernias include heredity, obesity, pregnancy, cystic fibrosis and standing for long periods of time on a regular basis.
Inguinal hernias are known as direct or indirect. An indirect inguinal hernia is caused by inguinal ring weakness, while a direct inguinal hernia occurs when the floor of the inguinal canal (located slightly below the ring) is weakened. Direct inguinal hernias are usually found in men 40 years and older, but can affect both men and women.
Some of the other types of hernias include:
- Supravescial hernias – These typically involve obstructions of the gastrointestinal tract and show symptoms similar to that of a urinary tract infection.
- Lumbar hernias – Lumbar hernias cause discomfort in the flanks and result in protrusion of the lumbar triangles, which are located in the lower portion of the back.
- Sciatic hernias – Symptoms of a sciatic hernia include increasing tenderness in the glutes as well as obstructions of the uterus or intestines.
- Obturator hernias – These cause severe pain in the thigh that becomes worse when rotating the area.
Options for Hernia Repair Surgery
There are two main options for hernia repair, laparoscopic and open repair surgery. In a laparoscopic procedure, the surgeon cuts several small incisions into the abdominal area. These incisions create openings for different surgical devices to repair the problem. In an open repair, the surgeon makes a cut near the location of the hernia in order to repair it as well as the weakened muscles that surround it.
Hernia Mesh Recall Timeline
There have been several hernia mesh recalls in the last few years. C.R. Bard, the maker of the Kugel mesh patch, issued three recalls alone from 2005-2007 due to a defect that could result in bowel perforations. The U.S. Food and Drug Administration (FDA) recalled eight different Kugel models from 2006-2007. Since then, more than 3,000 hernia mesh recall lawsuits were filed across the country.
Although Ethicon didn’t issue a recall of its Physiomesh device in the U.S., it pulled the mesh off the market in May 2016.
Surgical Hernia Mesh Devices and the FDA
In October 2014, the FDA issued a Safety Communication announcing patient reports of surgical mesh complications. These included instances of the mesh adhering to intestines, injuries to blood vessels, organs and nerves, infections and others. If you have been injured due to a hernia repair mesh, you can report your problem to the FDA by filing a MedWatch Report. Another way you can let the FDA know is by filing a hernia repair lawsuit. Whenever the manufacturer of a medical device is sued, it is required to report that lawsuit to the FDA.
Recent Surgical Mesh Litigation
Thousands of people across the country have filed lawsuits over surgical hernia mesh complications. For example, a woman in Florida sued Ethicon in September 2016, claiming that the company’s Physiomesh device not only caused her chronic pain but also blocked her intestines. She alleged that the mesh could not be surgically removed because it had become embedded in the wall of her abdomen.
Separately, C.R. Bard agreed to a $184 million settlement in 2011 in a case involving complications associated with its Kugel patch, while a plaintiff in an individual case was awarded $1.3 million in damages in 2010. Many Kugel patch lawsuits are still in progress, including a lawsuit filed by the children of a woman whom they allege died of sepsis due to a defective hernia mesh.
Surgical Hernia Mesh Questions and Answers
There are several kinds of hernia repair mesh devices available, including patches, mesh sheets, woven mesh and permanent mesh.
Synthetic mesh sheets are made of a variety of different materials that are absorbable or non-absorbable depending on the patient’s needs. Other types of hernia mesh devices consist of animal (pig or cow) skin or intestines. Absorbable mesh is meant to degrade over time, allowing new tissue to provide support to the area that suffered the hernia. Non-absorbable mesh, on the other hand, is designed to provide permanent support to the hernia repair.
Many different brands of surgical hernia mesh are on the market, manufactured by a wide variety of companies. Here are some of the most common.
- C-Qur — Manufactured by Maquet (a division of the Getinge Group), the C-Qur first entered the market in 2006. Atrium Medical Corp. originally manufactured the C-Qur, but one of its facilities used to make the device was shut down by the FDA.
- Physiomesh – The Physiomesh, manufactured by Johnson & Johnson subsidiary Ethicon, was pulled from the market in 2016. Several studies showed that the device was associated with a range of complications, including further hernias that required more surgery to repair.
- Proceed – Patients using the Proceed, which is also manufactured by Ethicon, have reported that the device has disintegrated inside the body, resulting in severe infections. In 2005, the FDA issued a recall of the device.
- Kugel, Sepramesh, 3DMax, PerFix – C.R. Bard manufactures all of these brands of surgical hernia mesh, and all of them have been linked to several different complications. For example, many male patients implanted with the 3D Max reported severe pain in their testicles. This device, in some cases, has reportedly attached to the spermatic cord, leading to a risk of testicular loss if hernia mesh removal is needed.
Thousands of patients have reported severe hernia mesh complication symptoms, including erosion of mesh into the bowels that results in the need for several more surgeries and extended hospital stays. In some instances, complications have led to colostomies and removal of a portion of the affected bowel.
Severe infections have occurred as well, with some being so extensive that hernia mesh removal procedures were necessary. Hernia recurrence has also been linked to migration or movement of the mesh.
The Kugel hernia patch has been the focus of thousands of lawsuits from patients alleging that the device broke and led to severe perforations of the bowels. Patients implanted with Ethicon’s Proceed surgical mesh have reported serious adhesions and fissures due to device malfunctions.
Physiomesh models used in hernia repair surgery and recurrent hernia repairs are also problematic, with serious complications like death, bowel perforation, sepsis, evisceration (removal of organs), adhesion, rejection, and bowel obstruction reported.
If you have any of the following hernia mesh complication symptoms, speak with your doctor immediately. These are some of the more common ones.
- Irritable bowel
- Severe pain
- Tender scar
- Trouble urinating
Who is eligible to file a hernia mesh lawsuit?
Anyone who has undergone surgery for a hernia and later experienced surgical mesh complications may be able to take legal action against the manufacturer of the defective device.
At Baron & Budd, we’ve helped many women who have suffered complications from transvaginal mesh devices, and we are now ready to work on behalf of those experiencing surgical hernia mesh complications. Please complete our contact form or call 866-829-0176 for a confidential consultation. We are currently taking cases for hernia mesh complications across the country, and have attorneys for hernia mesh lawsuits in Los Angeles, California; Dallas, Texas; Austin, Texas; Baton Rouge, Louisiana; New Orleans, Louisiana; and San Diego, California to better serve you.