Many complications related to hernia repair and use of surgical mesh have been reported to the FDA. Hernia mesh frequently causes life-threatening complications as it can erode into the bowel, affect the small and large intestines, require multiple additional surgeries for extraction and partial bowel removal, weeks of hospitalization, colostomies, systemic infections, and more. Various complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh, also known as a “composite mesh,” is also more likely to cause injuries than a non-coated hernia mesh.
The most common complications associated with recalled or defective hernia mesh are:
Adhesions (scar-like tissue that sticks tissues together)
Obstruction of the large or small intestines
Abnormal Connection between Organs, Vessels, or Intestines (fistula)
Fluid Build Up at the Surgical Site (Seroma)
Holes in the neighboring tissues or organs (Perforation)
Mesh Migration or movement
Mesh Shrinkage (contraction)
Severe Abdominal Pain
Organ Perforation, Adhesions or Erosion
Surgical Removal of Hernia Mesh
Victims from around the country are reporting severe complications from hernia mesh products that are currently on the market. Some (not all) of the Defective Hernia Mesh Products are as follows:
ETHICON PROCEED MESH
Proceed is a composite hernia mesh with a partially absorbable layer made of a polypropylene base that entered the market in 2003. Because the coating is designed to absorb over a period, the polypropylene becomes directly exposed to patients organs causing severe, life-threatening complications. Over 18,000 Proceed hernia meshes have been recalled. In 2005, the FDA issued a recall of this device due to reported complications that the device disintegrated inside patients’ bodies, resulting in severe infections, and causing serious adhesions and fissures. Ethicon itself has issued several recalls for the Proceed in 2011 and 2014. The Proceed hernia mesh is still on the market and continues to be implanted in patients nationwide.
ATRIUM C-QUR MESH
C-QUR entered the market in 2006 and is made of polyethylene plastic and coated with Omega-3 fatty acid fish oil. C-QUR is intended to be a permanent implant. The fish oil is supposed to prevent inflammation and scarring from tissues adhering to the mesh. However, studies show the device has higher adhesion and infection rates that many other hernia mesh brands.
The earliest independent studies found that there was a significant increase in adhesions and immune response around these mesh implants. The most recent case study in 2016 further supported these findings. In 2013, the FDA issued a recall of over a thousand C-QUR’s. Additionally, the FDA issued a warning letter to Atrium regarding the company’s failure to adequately address multiple complaints related to the infections from C-QUR hernia mesh. In 2015, the District Court of New Hampshire entered a permanent injunction against Atrium preventing it from manufacturing and distributing C-QUR. From 2008 to 2015, Atrium produced a number of other product variations of the C-QUR, all which are still available on the market. Lawsuits from around the country are being consolidated into a Multi-District Litigation in New Hampshire.
C.R. BARD KUGEL MESH
The Kugel mesh patches are comprised of a double layer of monofilament polypropylene, to be used in minimally invasive laparoscopic procedures. When implanted it is folded for insertion into the body but opens up to its full shape and size with the help of a memory recoil ring. The Kugel was one of the first and most well-known hernia meshes to be recalled. Several recalls of the Kugel occurred between 2005-2007 because of a high number of devices breaking and causing bowel perforations. However, the main problem with the Kugel is that it is made of polypropylene, which shrinks over time, and as it shrinks, the device breaks. The Kugel is still on the market.
C.R. BARD VENTRALEX ST HERNIA MESH
Ventralex ST came to the market in 2002 and is a polypropylene hernia mesh patch with a similar coating to that used on the C-QUR. The Ventralex ST was designed based on the Kugel, another C.R. Bard mesh product which had several recalls. Reported complications of severe infections and allergic reactions have been reported. The Ventralex ST is still in the market.
C.R. BARD SEPRAMESH HERNIA MESH
SepraMesh entered the market in 2005 and is a composite polypropylene mesh with an absorbable coating. The lipid coating in the SepraMesh triggers high levels of chronic inflammation once implanted leading to slow wound healing and chronic infections. SepraMesh is still on the market.
C.R. BARD 3DMAX HERNIA MESH
The 3DMax mesh has been on the market since 2009 and is a bare polypropylene mesh that has a curved and cupped designed to fit the inguinal canal to treat groin hernias. It can also be attached to the spermatic cord in men. Because of its unique design and low-quality plastic which is known for premature failures, when the polypropylene begins to degrade and shrink, the 3DMax cracks, pieces break off, and it commonly folds on top of itself. Complications with the 3D Max have included severe debilitating pain after implantation, and in most extreme cases, when it is removed there is a heightened risk of losing a testicle. The 3DMax is still in the market.
The PerFix Plug is a woven polypropylene hernia mesh plug used to repair groin hernias. The PerFix Plug’s design has small pores (holes) throughout its mesh, and soon after implementation, the nerves grow into these pores and attach to the mesh. When the polypropylene degrades and erodes, the nerves become stretched causing debilitating pain. The PerFix Plug also runs the heightened risk of losing a testicle when removed if it has eroded into the spermatic cord. The FDA issued a recall in 2014 for labeling errors. The PerFix Plug mesh is currently on the market. At Ollennu & Associates, we have a comprehensive approach to handling Defective Hernia Mesh Cases and Hernia Recalls. Our approach has proven successful time and time again for our clients. We possess the knowledge, innovation, and resources required to effectively handle all defective medical products and defective medications claims or lawsuits all the way through trial if necessary. We have a strong support team of professionals that include personal injury attorneys with knowledge and practical and professional experience in pharmaceutical and device clinical research, nurse investigators, litigation paralegals and legal assistants. We work hard to pursue our clients’ interests aggressively, fairly and responsibly.
FREQUENTLY ASKED QUESTIONS ABOUT HERNIA MESH CLAIMS AND DEFECTIVE HERNIA RECALLS
What is a Hernia Mesh? Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials. The animal-derived mesh is made of animal tissue, such as intestine or skin, that has been processed and disinfected to be suitable for use as an implanted device. These animal-derived meshes are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine) source. The non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement to the repaired hernia. The absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.
What Should I Do If I have an issue with the Hernia Mesh Surgery?
Call and firm or attorney that handles defective medical device claims and hire an attorney immediately. You need an experienced medical product liability attorney to represent you. Right now anyone not eligible and willing to participate in a settlement must still litigate their case in court.
Should I wait to file my Hernia claim?
Don’t wait. By law, you only have a limited period of time to file your hernia claim or recall. Even if you haven’t had a revision surgery to replace the recalled defective implant, you may still be able to file a case in court to protect your rights.
Should I sign the offer made to me by the Device Company?
Don’t sign anything at all. First, consult with an attorney who handles defective hernia mesh cases or recalls. Otherwise, you could sign away important rights.
Why should I file a Hernia Mesh Lawsuit?
Help yourself and help others! Filing a defective hernia mesh lawsuit or pursuing a recall can help offset costs caused by the implant failure, including:
Hospital & medical bills
Long-term medical care
Pain & suffering
Loss of future earnings
Some hernia mesh products were rushed to market without adequate testing. Thousands of people were treated like human guinea pigs and suffered unnecessary complications. If you have undergone a hernia repair and a certain type of mesh used and your hernia mesh failed and required (or will require) surgical repair, you may qualify for significant financial compensation from the manufacturer. Please allow us to provide you with a free evaluation of the situation and help you determine if the hernia mesh used in your surgery is faulty or defective.
WHY SHOULD I JOIN AN EXISTING DEFECTIVE HERNIA LAWSUIT?
Help Yourself, Help Others. You may be legally entitled to significant compensation without having to ever appear in court. Your mesh may have been manufactured by a corporation that aggressively sold mesh that was not adequately tested and that they knew were likely to fail or cause serious injury. If you suffered complications from your mesh, you should contact us for a free case evaluation.
WHAT IF I CAN'T AFFORD ATTORNEY'S FEES? IS THERE ANY COST TO ME?
There is no cost to you unless we win. We believe everyone should have access to justice, so we do not charge any up-front fees. We only get paid if you get paid. If we don't get you a settlement, we don't get paid.
WHAT IS A HERNIA?
A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur in the abdominal wall. Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.
WHAT ARE SOME TYPES OF HERNIAS?
The most common types of hernias are:
Inguinal: occurs in the inner groin
Femoral: occurs in the upper thigh/outer groin
Incisional: occurs through an incision or scar in the abdomen
Ventral: occurs in the general abdominal/ventral wall
Umbilical: occurs at the belly button
Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
WHAT CAUSES THE NEED FOR HERNIA REPAIR SURGERY?
Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is present at birth, but more often it occurs later in life. Anything that causes an increase in abdominal pressure can cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing. Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.
TREATMENT OPTIONS FOR HERNIAS
Hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias, and the rest are for other types of hernias.
Watchful Waiting – Your surgeon will watch the hernia and make sure that it is not getting larger or causing problems. Although surgery is the only treatment that can repair hernias, many surgical procedures are elective for adult inguinal hernias. Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if recommended by their surgeon.
Laparoscopic - The surgeon makes several small incisions in the abdomen that allow surgical tools into the openings to repair the hernia. Laparoscopic surgery can be performed with or without surgical mesh.
Open Repair - The surgeon makes an incision near the hernia and the weak muscle area is repaired. Open repair can be done with or without surgical mesh. Open repair that uses sutures without mesh is referred to as primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.
Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Since the 1980s, there has been an increase in mesh-based hernia repairs—by 2000, non-mesh repairs represented less than 10% of groin hernia repair techniques.
WHAT ARE SOME OF HERNIA REPAIR SURGERY COMPLICATIONS?
Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation). The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction). Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with the recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.
Call us for a free case evaluation: 860-218-2122. We are a phone call away Hemorrhage. For all Defective Hernia Mesh matters our firm does not get paid by the client unless we are successful.