Hernia Mesh Injury
The medical community has increasingly discussed safety concerns related to certain hernia mesh products. A recent study even asks whether the benefits of hernia mesh outweigh the long-term risks. Research indicates hernia mesh complications, like mesh erosion, organ perforation and infection may negate the benefits of mesh products over long-term periods of time.What is a Hernia
A hernia occurs when an internal organ, intestine or other fatty tissue protrudes through an opening or weak spot in the surrounding muscle or connective tissue. Hernias frequently occur at the patient’s abdominal wall. The most common types of hernias include:
- Inguinal – In the inner groin
- Incisional – Through an incision or scar in the abdomen
- Femoral – In the upper thigh/outer groin
- Hiatal – Inside the abdomen, along the upper stomach/diaphragm
- Umbilical – At the belly button
- Ventral – In the general abdominal/ventral wall
Because hernias are so common, Alabama’s Workers’ Compensation Act even has a special provision concerning compensation for the condition. That section makes it difficult to obtain workers’ compensation benefits from your employer.Hernia Repair
Hernia repairs are among the most common surgeries. More than a million hernia surgeries are performed each year in the United States.
Hernia surgeries may be laparoscopic repairs or open repairs. Laparoscopic surgeries are minimally invasive procedures where the surgeon inserts tools through small incisions in the abdomen. Laparoscopic and open repair surgeries can both be performed with or without the use of hernia mesh.
Why do surgeons use hernia mesh? Hernias have a significant rate of recurrence. Surgeons frequently use surgical mesh to strengthen the repair and reduce the risk of recurrence. Does this benefit outweigh the long-term risks of injury from the mesh?Hernia Mesh Products
Manufacturers have marketed numerous hernia repair mesh products in recent years. Many of these products have been marketed without adequate research or testing. Regulatory approval of these products is often obtained by manufacturers through the FDA’s 510(k) process. That fast-track process raises tremendous safety concerns for patients and the public. We believe this fast-track process puts potentially defective and dangerous products on the market without adequate clinical testing. Our firm has represented numerous consumers of other products, like transvaginal mesh implants, who also suffered serious injury by defective products approved through the same 510(k) process.
Hernia mesh complications can be serious. Complications can cause severe pain, disability and the need for additional surgery. According to the U.S. Food and Drug Administration (FDA), the most common adverse events reported for hernia repair surgeries, include the following:
- Scar-like tissue that sticks tissues together (adhesion)
- Intestinal blockage
- Hernia recurrence
The Blackwell Law Firm is currently reviewing potential cases for patients who have required a revision surgery due to certain defective and dangerous hernia mesh products. The current surgical mesh products being investigated by our firm include:
Johnson & Johnson’s Ethicon subsidiary introduced Physiomesh to the market in 2010. Like many other products later found to present substantial injury risks, Physiomesh received regulatory approval through the FDA’s 510(k) process. Physiomesh is a polypropylene mesh intended primarily for minimally invasive ventral hernia repair and other fascial deficiencies.
In May 2016, Ethicon announced a global market withdrawal of its Physiomesh product. Ethicon removed Physiomesh from the market after an analysis of unpublished data from two European databases indicated the product was associated with much higher rates of recurrence and revision compared to other mesh products.
Ethicon has indicated it does not intend to sell its Physiomesh product in the future. However, Physiomesh has already been implanted in thousands of patients who may suffer needless pain and other complications from the design of the product.
Atrium C-Qur Hernia Mesh
Atrium first introduced its C-Qur mesh in 2005. Atrium’s C-Qur mesh also received fast-track approval through the FDA’s controversial 510(k) process. The process lacked clinical trials needed to establish patient safety.
Atrium has introduced a number of different C-Qur mesh products. All of these products are polypropylene mesh with an outer coating gel made from omega 3 fatty acids (Fish Oil) called the O3FA layer.
Many patients across the United States have reported severe problems following Atrium C-Qur hernia mesh surgery. Patients, physicians and medical studies have raised issues with serious complications including:
- High rates of infection
- Allergic reactions
- Abdominal pain
- Organ perforation
- Chronic pain
- Revision surgery
- Inflammation and/or Inflammatory reaction
If you or a loved one have suffered personal injury following the use of one of these hernia mesh products, give us a call. Consultations are always free and confidential. We are available to discuss your issues or answer questions.