Hernia Repair Surgeries Are Common
Hernia repair surgeries are among the most common surgeries in the United States. More than a million of these surgeries are performed each year in this country. Hernia repair surgeries can be performed with or without the implantation of mesh. As with mesh used in some other repair surgeries, the question becomes – do the benefits of using hernia mesh for the patient outweigh the risks?
For the last several years, our firm has represented numerous Alabama women injured by transvaginal mesh implants. While that use of implanted mesh involves different issues, the same question arises – is the potential benefit really worth the risks? After years of representing numerous women hurt by implanted transvaginal mesh as well as studying those products and their history, I believe the risks of injury are far too great. Yet, these transvaginal mesh products were approved through the faulty FDA 510(k) process which puts dangerous products on the market without adequate clinical testing. This faulty process has allowed many dangerous and defective medical devices to harm patients across the United States. I could speak at length about our prior work with transvaginal mesh but let me return to the separate topic of hernia mesh.
Why do surgeons use hernia mesh? Surgeons use hernia mesh because hernias have a significant rate of recurrence. Implanted mesh reduces the rate of recurrence and the need for further hernia repairs. So, that’s the potential benefit. Does it outweigh the risks? Mesh complications can be very serious for the patient. Complications from hernia mesh can cause tremendous pain and even disability. According to the U.S. Food and Drug Administration (FDA), the most commonly reported complications for hernia repair surgeries, include:
- Scar-like tissue that adheres
- Intestinal blockages
Those are pretty bad complications. They can cause chronic problems in the patient.
Hernia Repair Mesh Products Are Now Being Investigated
Through the years, several hernia mesh products have been used surgically in patients. Now, questions are being raised about two of these products and the potential personal injury they may cause. Both of these mesh products (like so many other dangerous products) received market approval through the faulty FDA 510(k) process.
Atrium C-Qur Hernia Mesh
Atrium first introduced its C-Qur mesh in 2005. Since then, Atrium has introduced several different C-Qur mesh products. All of the C-Qur products are a polypropylene mesh. They contain an outer coating of gel made from Omega 3 fatty acids (otherwise known as Fish Oil).
Patients across the United States have reported problems after hernia repair surgeries using C-Qur mesh implants. Patients and their physicians have raised issues and complaints including:
- Significant rates of infection
- Chronic pain, including abdominal pain
- Perforation of organs
- Inflammatory and allergic reactions
With the increase in adverse reaction reports, some legal commenters are closely watching developments. From experience with separate products marketed through the FDA’s 510(k) process without adequate pre-market clinical testing, I believe it sometimes takes years for problems to come to light. This faulty process allows medical device makers to test their products on innocent and unsusptecting people. That’s terrible. Patients deserve better.
Ethicon is a subsidiary of Johnson & Johnson. The company introduced Physiomesh in 2010. Physiomesh is also a polypropylene mesh product.
In May of 2016, Ethicon announced a global withdrawal of Physiomesh. That is, Ethicon decided to remove the product from markets across the world. Ethicon refuses to use the term “recall” for its action. Regardless, the question becomes – Why did Ethicon suddenly pull its product from markets across the globe? Ethicon pulled its Physiomesh product after an analysis of data from two large European databases indicated an association with much higher rates of recurrence from Physiomesh than other mesh products.
Ethicon has announced it will not sell Physiomesh in the future. With data potentially surfacing about significant problems, that’s probably a wise decision. Yet, that decision does not help the large number of patients already implanted with the product. How does Ethicon intend to help these patients if they are suffering problems or complications?
Investigating Potential Defects and Patient Injuries
Blackwell Law Firm is investigating both of these hernia mesh products. We believe problems with these products are just beginning to surface. We will continue to research both products, including the materials and design of them. You can read more about the products we are investigating on the Hot Topics section of our firm website. We are also available to answer any questions.