Developing a hernia is a common injury for which more than three million people are diagnosed each year in the U.S. Hernia can happen to babies and young children as well as adults and more than one million will undergo a hernia repair procedure this year alone. Unfortunately, some of the products used to repair a hernia can cause patients to suffer serious side effects and adverse events. We help victims of hernia mesh complications get the compensation they need and the justice they deserve.
Ethicon Physiomesh Hernia Repair Mesh
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If you develop a hernia, it means that an organ or tissue is pushing through the cavity wall which usually helps hold it in place. To repair a hernia, doctors typically use a mesh product to secure and strengthen the bulge or gap. Unfortunately, commonly used hernia mesh repair devices are at the center of numerous lawsuits and multidistrict litigation, including mesh made by Ethicon, Bard, and Atrium Medical.
Johnson & Johnson subsidiary Ethicon is at the center of thousands of lawsuits alleging injury, adverse events, and serious complications. The Physiomesh hernia repair mesh was approved through a questionable FDA process that allows devices to enter the market quickly if the product is substantially similar to a device that has already been approved for the market. The 510(k) process allows a device to enter the market faster because it does not require the products to undergo at least two large clinical trials, which are required for traditional pre-market approvals.
In 2010, the FDA approved the mesh for use and four years later, a second version of the mesh was approved. But in 2016, after receiving reports of increased rates of infection and patients having to undergo additional surgeries to have the device removed, the device was recalled from the market. Other adverse event reports said patients suffered complications and adverse events including:
- Mesh failure and erosion
- Abdominal pain
- Serious infections
- Organ perforation
- Revision surgery
Currently, more than 1,200 lawsuits have been centralized to U.S. District Court for the Northern District of Georgia to be heard by the Honorable Judge Richard W. Story [MDL-2782 IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation]. In May 2018, Judge Story issued an order to allow patients to preserve their mesh implants for trial.
Atrium Medical C-QUR Hernia Mesh
In 2006, the FDA approved C-QUR hernia mesh by Atrium Medical Corp via the 510(k) process. This abbreviated post-market approval process is a controversial process in which devices are approved based on their similarity to other devices. Unfortunately, the FDA does not look at whether the approved devices are safe and effective, or if they have been recalled from the market or connected to serious adverse events. To approve a product through the 510(k) process, the FDA only ensures the new device is much like other devices that have been approved. While the C-QUR mesh was approved because of its similarity to other devices, it is marketed and advertised as being different from any other device on the market. The mesh has an Omega-3 coating that is supposed to act as a barrier that prevents scarring and adhesions. However, the hernia mesh product is associated with an inflammatory response that could cause you to develop the very thing the mesh was marketed as preventing: adhesions.
But that’s not all. In 2012, the FDA issued a warning about foreign material contamination, patient infections, and questionable sterilization processes. In 2013, the government agency issued a Class 2 recall for the C-QUR Edge because the Omega-3 coating was adhering to its packaging. Now, victims of these and other meshes are seeking justice. Hundreds of lawsuits have been filed on behalf of patients who suffered significant injuries from the devices. At least 400 of these cases have been centralized to U.S. District Court for the District of New Hampshire under District Judge Landya McCafferty, with the first bellwether trial slated for early 2020.
Bard & Davol Hernia Mesh
Lawsuits have been filed on behalf of patients who suffered complications and adverse events from hernia mesh made by C.R. Bard and subsidiary Davol including the Kugel Patch. This mesh and others made by Bard have repeatedly been recalled over the past two decades, including Bard’s 3DMax, Composix E/X, PerFix Plug, Sepramesh, Ventralex ST.
Currently, the manufacturer and subsidiary Davol are facing allegations that their products have caused patients to suffer serious injury, including:
- Chronic and debilitating pain
- Inflammatory responses
- Unwinding mesh that causes severe pain
- Spermatic cord mesh adhesions
Because of the number of lawsuits currently pending and the number that is expected to be filed in the future, the Judicial Panel on Multidistrict Litigation is hearing arguments concerning the centralization of all hernia mesh lawsuits filed against Bard.
Brief Overview of Hernia
Hernias are generally named after the body area in which they occur, and the most common types of hernia are:
- Femoral hernia in the upper thigh or outer groin
- Hiatal hernia in the upper stomach/diaphragm
- Incisional hernia from an abdominal scar or incision
- Inguinal hernia in the inner groin
- Umbilical hernia in the belly button
- Ventral hernia in the abdominal/ventral wall
If you develop a hernia, you should see your physician as soon as possible. Some hernias will only require watchful waiting, while a more serious hernia may require surgical repair. If you do not seek treatment, your hernia could continue to grow and lead to further injury and complications.
To repair a hernia, doctors typically implant a thin, flexible mesh over the bulge or tear to close it and strengthen it. Unfortunately, some of these hernia mesh products are made by companies that failed to ensure the devices were safe for use before they put them on the market. If you or a member of your family received a Bard, Atrium Medical, or Ethicon mesh and then developed serious adverse events or complications, you may be entitled to significant compensation.
Patients who have received these devices for hernia repair have reported severe complications and side effects including:
- Intestinal blockages
- Chronic pain
- Foreign body reactions
- Mesh contractions and shrinkage
- Mesh erosion and migration
- Organ perforation
- Rejection of the implant
- Reoccurrence of a hernia
- Serious allergic reactions
- Serious Infection
- Wound abscess
If your hernia is treated through surgical repair involving certain mesh products, you may have to have additional unplanned surgical procedures to try to remove the mesh and repair any damage it may have caused. These additional surgeries may be far more complex than the surgery to repair a hernia.
We Help Hernia Mesh Victims
Lawsuits have been filed across the country in both state and federal courts on behalf of patients who have suffered injuries after receiving hernia mesh implants. These lawsuits have been filed against mesh makers like Bard, Atrium Medical, and J&J’s Ethicon unit alleging the products can cause severe infections, adhesions, and perforate organs and tissue. Some of the patients who have been implanted with hernia mesh have had to undergo unplanned surgeries to have the mesh and mesh fragments removed and to have internal injuries repaired.
Patients and their families are accusing these mesh manufacturers of:
- failing to adequately test the mesh devices before selling them
- making and distributing defective products
- intentionally hiding the risks of mesh products
- misrepresenting the safety and efficacy of the hernia mesh devices
Patients who suffered injury after receiving hernia mesh want to know when Bard and the other manufacturers knew or should have known that the mesh could cause serious adverse events and why they and their doctors were not warned of the dangers of these mesh products before the mesh was implanted.
If you or a member of your family were implanted with a hernia mesh after 2006 and were forced to have at least one additional surgery because of mesh complications, you may be eligible to seek justice and compensation for your injuries and losses including for:
- Intestinal obstruction
- Mesh shrinkage
- Migration of mesh
- Non-healing wound
- Recurrence of the hernia
At the Pulaski Law Firm, our attorneys are aggressive defenders of the rights of those harmed by the medical devices they depend on, and we fight to ensure our clients receive the justice they deserve and the financial compensation they need, and we stand ready to fight for you.
Hernia mesh manufacturers have the same high duty to make sure their products are safe before they sell them on the market. If the device maker fails that duty and patients suffer harm, the device maker may be held liable by law. Patients who suffered injury have more than the right to compensation, they have the power to force mesh makers to stand in front of a judge and jury and explain why they failed to warn the medical community and their patients about the risks of adverse events and serious complications and why they put their bottom line before the health of patients.
If you suffered a severe injury after receiving a hernia mesh in 2006 or later, contact us now to learn if you qualify to seek justice and to hold mesh manufacturers accountable for the injuries their products cause.