Hernia Mesh Recall
Hernia Mesh Recall Information: Ethicon Physiomesh and Atrium C-QUR
North Carolina Product Liability Lawyers Explain Risks of Defective Mesh Implants
Medical devices such as surgical implants should improve your health or relieve a medical condition. A hernia mesh, for example, should help the muscles of the body heal after a tear. However, when these devices contain product defects, the resulting injures and complications are often serious or even deadly. This is especially true for a device like a hernia mesh that is placed inside the body, usually permanently. Still, in recent years several companies have issued product recalls of hernia meshes that are prone to failure. Victims of these defective medical devices may face months or years of recovery, additional surgeries and life-threatening infections.
If you or a loved one sustained injuries from a device that is now subject to a hernia mesh recall, then you may be entitled to compensation from the manufacturer. At Riddle & Brantley, our product liability lawyers have experience representing victims of defective medical devices. We can investigate your injury and medical history to determine which parties are liable for your damages. The companies that manufacture these devices are often large, and have teams of legal experts protecting them. However, your own lawyer can represent your best interests and help you stand up for your rights after a medical injury caused by product defects.
What is a Hernia?
A hernia is a medical condition that occurs when an organ, intestine or fatty tissue squeezes through a hole or weak spot in the surrounding area of the body or connective tissue. Hernias result from a combination of pressure and a tear or weakness of the muscle or tissue around the pressure point. The pressure causes the organ or tissue to push through the opening or weak spot.
The muscle weakness that causes a hernia can exist from birth or can occur later. Often, a hernia results from a combination of the two, where loss of muscle later in life aggravates natural muscle weakness. For example, after an injury, a patient may remain off his feet for some time. This may cause atrophy to the core muscles around the abdomen, leading a preexisting weakness in the abdomen to worsen. When the patient returns to work and begins lifting objects again, putting pressure on the abdomen, a hernia may result.
What are the Different Types of Hernias?
The most common type of hernia occurs in the abdomen, although they are also possible in the muscle of the upper thigh and groin. Hernias can be external, with a bulge becoming visible outside the body all or part of the time—in many cases, tissue only protrudes through a hernia when the patient bears weight or exerts effort with the torn muscle. However, hernias can also be completely internal and still cause pain and more serious conditions.
Hernias are typically classified into one of several types:
- Inguinal (occurring at the inner groin)
- Femoral (occurring at the upper thigh or inner groin)
- Incisional (occurring at the site of a scar or the site of a prior surgery)
- Ventral (occurring in the ventral abdominal wall)
- Umbilical (occurring at the belly button)
- Hiatal (occurring inside the abdomen, along the stomach
Inguinal hernias are the most common type of hernias in the United States. They comprise an estimated 75 percent of all cases. The vast majority of people suffering from hernias elect to undergo surgical repair due to discomfort and the risk for serious complications, like organ strangulation. Surgeons perform most of these procedures laparoscopically, using scope equipment. This kind of surgery requires a smaller incision site, thereby reducing recovery time. In over 90% percent of these surgical repairs, doctors implant surgical mesh at the site of the hernia to strengthen the abdominal wall and prevent recurrence.
What is Hernia Mesh?
Hernia mesh, similar to transvaginal mesh, is a medical device that a surgeon places either across or inside a muscle tear to close the opening and facilitate healing. Ideally, the mesh allows the body’s own tissue to grow around it, effectively repairing the hernia. However, many different companies manufacture many different types of hernia mesh.
Generally, mesh products are either “absorbable” (intended to dissolve in to the body after some time) or “non-absorbable” (intended to remain in place permanently). Most absorbable meshes are organic, derived from human or animal tissue. The most common types of absorbable mesh are derived from pig organs, and are processed and disinfected to reduce the threat of infection or rejection by the human body. Non-absorbable meshes are almost exclusively non-organic synthetic.
Like many medical devices, numerous different manufacturers make hernia meshes under various brand names. Then, “distributors” sell the meshes to surgeons and hospitals. The label on a mesh product might prominently display the name of the distributor, but not the name of the manufacturer. As a result, it is not always clear who exactly is liable when product defects cause mesh failure or injury.
It is also important to note that a hernia mesh recall depends on the manufacturer and brand of the mesh, not the distributor. In some instances, recalls do not even extend to all meshes of a particular brand, but only to certain lot numbers on the products. Typically, a recall will include products issued over a certain range of time in order to ensure inclusion of all devices potentially affected by the product defects.
Recently, both Ethicon and Atrium have issued a hernia mesh recall for non-absorbable, synthetic devices made of polypropylene.
What are the Most Common Product Defects in Hernia Meshes?
A defective hernia mesh may result in any number of complications, including severe injuries and wrongful death. If a sufficient number of devices exhibit the same manufacturing or design defects, then the manufacturing company may issue a hernia mesh recall. Over the last several years, many companies have issued such recalls for both hernia and transvaginal mesh. Common reasons for these recalls include:
- Products that are not sterile, creating an increased risk of infection. In these instances, the Food and Drug Administration (FDA) recommends destroying these products. However, it recommends that meshes that had already been implanted in a patient be monitored for signs of infection, but not necessarily removed.
- Design defects. These often cause an increased risk of failure of the mesh but not necessarily harmful side effects. For example, some recalled mesh lots showed a weave pattern and structure that allowed for an increase of tearing of the mesh, which can lead to recurrence of a hernia, particularly in patients who are overweight or perform heavy duty jobs, thus putting high amounts of pressure on the mesh. However, some design defects can be potentially lethal or cause serious side effects, like mesh migration.
- Manufacturing defects. These may cause the mesh to fail or fray, often creating sharp or jagged edges. In these instances, the mesh can damage surrounding tissue or even perforate organs.
What Are the Dangers of Defective Hernia Mesh?
Product defects in a hernia mesh implant can cause serious complications. Some of the most common symptoms and side effects of mesh defects include:
- Mesh adhesion. Adhesion occurs when scar tissue develops around the mesh that creates various problems throughout the body.
- Obstruction. This occurs when the mesh or scar tissue around it causes blockage of the large or small intestines.
- Heavy bleeding, in excess of what is normal after a hernia repair.
- Fistula, which is an abnormal connection between organs, vessels or intestines.
- Seroma or fluid build-up at the surgical site.
- Perforation, which is a hole in the neighboring tissues or organs.
- Contraction or mesh shrinkage.
- Mesh migration. This occurs when the mesh shifts or moves in the body, often leading to bowel obstruction.
- Wound reopening
- Revision or repair surgery
Any of these occurrences can result in the hernia reopening and lead to serious infection as well. If left untreated, wrongful death may result. However, even if doctors diagnose the complications quickly, additional surgeries are usually necessary in order to remove the defective medical device and treat any resulting conditions.
Can I File a Hernia Mesh Lawsuit?
Many patients who have sustained injuries from defective mesh have mounted hernia mesh lawsuits against the manufacturers of the products. Several of these have become class action lawsuits. A class action allows a group of people to consolidate their similar claims into one lawsuit, instead of maintaining hundreds or even thousands of cases. Many of these actions have reached successful settlements, while some remain open to individuals who wish to mount claims and share in the recovery. Settlements can include recovery for medical expenses, other costs for medical care, wage loss and payment for pain and suffering. As of September 2017, the current status of litigation involving these defective medical devices is as follows:
Ethicon – Physiomesh: In May of 2016, Ethicon withdrew its Physiomesh flexible composite hernia mesh from the United States market. The company issued this hernia mesh recall after studies revealed complications associated with the product, causing it to fail in many cases. Physiomesh was also commonly used in transvaginal mesh implant procedures to repair POP (pelvic organ prolapse) and SUI (stress urinary incontinence). Recently, a multi-district litigation (MDL) was established in the Northern District of Georgia. These cases are beginning to take shape as Case Management Orders are starting to be issued.
Atrium – C-Qur: The C-QUR hernia mesh includes a coating made from fish oil to prevent the synthetic material from causing allergic reactions. However, this coating can peel off both in the packaging and in the body after surgery. The company issued a recall for the packaging material only in 2012, after discovering these product defects. However, Atrium continued to market the mesh itself for several years.Lawsuits against Atrium Medical Corp., manufacturer of the C-QUR mesh, were consolidated into a MDL established in New Hampshire in December of 2016.
Bard – multiple products: Litigation into these defects is just beginning. A few cases have been filed in the state courts of Rhode Island but there is no federal MDL established yet.
Covidien – multiple products: These cases are also very new. There is no formal state court or MDL actions at the present time but several firms are in the early stages of beginning this process.
Affected by a Hernia Mesh Recall? Contact Our Product Liability Lawyers Today
If you have undergone a hernia repair or other procedure and believe Physiomesh or C-QUR may have been used in the procedure, then you may be entitled to compensation. Contact our North Carolina product liability lawyers right away to learn about your legal rights.
We are happy to assist victims of defective medical devices throughout the country. We have offices throughout North Carolina, including locations in Goldsboro, Raleigh, Jacksonville and Kinston. Call (800) 525-7111 or contact us online to schedule your free initial consultation.