At least two composite mesh manufacturers, Ethicon Physiomesh and Atrium C-Qur, are being investigated for causing serious surgical complications when used for hernia repair. These types of mesh have been failing at an alarming rate, especially when compared to other manufacturers’ products.
A hernia occurs when an organ bursts through an opening in the tissue or muscle that is meant to secure it in place. They can appear in many areas, such as the belly button, groin area and upper thigh, though they most commonly occur in the abdominal area. Hernias often require surgical repair because if left untreated, they can cause dangerous medical complications.
Many people opt for hernia repair through surgery because without it hernias can cause fever, nausea, vomiting, sudden pain that intensifies, inability to move bowels and the bulge itself can turn dark, red or purple. For these reasons, more than one million hernia repairs are performed annually in the U.S. The most common type of hernia repair surgery is for inguinal hernias. Inguinal hernias are located in the abdominal area.
Surgical mesh can be made from different materials, including biological or inorganic ones. It looks like a woven sheet and acts as a permanent or temporary support for tissue or organs. Temporary ones may dissolve in the body over time, when manufactured effectively.
Defective surgical mesh can cause serious complications, such as infection, hernia recurrence, pain, obstruction, adhesion and perforation. Other adverse events associated are mesh migration and shrinkage, meaning the mesh can decrease in size or move throughout the body, affecting other organs. In certain cases, surgical mesh has even caused perforated bowels, a complication that can lead to sepsis and death.
When it comes to Atrium C-Qurs surgical mesh, many studies have been conducted that have found alarming results. Studies have found that the rates of infection associated with the product are so high that the Food and Drug Administration (FDA) was granted an injunction against the manufacturer. As a consequence of this injunction, the manufacturer has to bring its facilities back into federal compliance so that its products are made in a reasonably safe and effective manner. In the meantime, although many providers have discontinued using the mesh, some continue to use it in surgery.
The issues with Ethicon Physiomesh are slightly different but equally concerning. Studies have found that when providers use the flexible composite mesh in hernia repair that there is a high rate of revision, or the need to go back in surgically and conduct another repair. Revision surgery is painful and carries medical risks. The manufacturers have not been able to answer why this is happening, nor has instructed surgeons on how to use the product in a manner that decreases the chances of revision.
Although Atrium C-Qur and Ethicon Physiomesh are complying with the FDA and have recalled some of their affected products, other models of their mesh remains in use, and patients who have already received their faulty products are at risk for dangerous side effects.
It is the legal responsibility of medical product manufacturers to create products in a reasonably safe and effective manner. When a patient goes in to a provider for surgery, there is always the chance of complications. But, when a defective and dangerous product is being used, or in this case implanted in the body, the risk unnecessarily increases. These products are causing infection, additional surgery, migration and perforation of organs and tissue in patients’ bodies. All of these consequences can cause illness, injury and death.
If you or any of your family members have had a surgical hernia repair surgery and received an Ethicon Physiomesh or Atrium C-Qur mesh implant as part of your operation, be cautious to observe any potential complications. If you are having any health problems, contact a medical professional immediately. Similarly, do not hesitate to contact an attorney at Galfand Berger, LLP with any questions or concerns that you may have, because compensation is available.
The Philadelphia product liability lawyers at Galfand Berger have successfully represented clients who have been injured by faulty or defective medical devices and products. If you have any questions or concerns, an attorney at Galfand Berger, LLP can help. With offices located in Philadelphia, Reading and Bethlehem, we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.