Covidien’s Hernia Mesh Devices Linked to Life-Threatening Injuries
What should I watch out for?
An abdominal hernia occurs when part of an organ is displaced and bulges through a weakening in one of the muscle walls that surround the abdominal cavity. If the hernia occurs in the abdominal wall, the sac that protrudes through the weakened area may consist of a piece of intestine or lining of the colon.
Hernia repair is a common surgical procedure in the United States. Hernia mesh is a medical device used by surgeons to strengthen the hernia repair and supposedly to reduce the rate of hernia recurrence. However, many patients requiring hernia mesh repair have had to endure a second, or revision surgery, because the hernia mesh device inside them is defectively designed and causes serious injuries.
Problems exist on many models of hernia mesh, including those hernia mesh medical devices manufactured by Covidien. Covidien Parietene mesh, Pariextex Ventral Patch, SurgiPro and Symbotex mesh products are some of the hernia mesh medical devices made by Covidien. For years, patients and medical professionals have alerted the U.S. Food and Drug Administration (“FDA”) about the dangers of certain hernia mesh products.
What side effects do defective Hernia Mesh devices cause?
Complications from Covidien hernia mesh devices are similar to complications from other FDA-approved hernia mesh devices manufactured by Atrium, Bard, Ethicon and Gore-Tex Medical.
Some common adverse events that can occur with the use of hernia mesh are:
- Pain
- Infection
- Bleeding
- Hernia recurrence
- Adhesion, or scar-like tissue that adheres to other tissues
- Obstruction, or blockage of the large or small intestines
- Seroma, or fluid build-up at the surgical site
- Organ perforation
- Fistula
Other complications that can arise with the use of hernia mesh are:
- Additional surgery
- Mesh migration or movement
- Mesh shrinkage or contraction
- Mesh failure
All of these complications can be life-threatening if not properly treated.
If you receive a hernia mesh repair and have experienced any of the above-mentioned symptoms, contact your physician immediately.
Who makes these Hernia Mesh devices?
Covidien is an Irish-headquartered global surgical products and medical device manufacturer. Covidien merged with Tyco International in 2007 and kept the Covidien name. In 2015, Covidien was purchased by Medtronics for $42.9 billion. The company now manufactures surgical products, medical devices and medical supplies with companies in 150 countries and almost 40,000 employees.
Some of the hernia mesh devices manufactured by Covidien linked to pain and severe side effects requiring revision surgery or removal are:
- Parietene mesh
- Pariextex mesh
- SurgiPro mesh
- Symbotex mesh products
Covidien’s Parietex mesh product encompasses a large portion of its business. These hernia mesh products include:
- Parietex Surgical Mesh
- Parietex Composite Ventral Patch
- Parietex ProGrip Self-Fixating Mesh
Many of the Parietex mesh devices are made of polyester compared to polypropylene. The polyester is soft and delicate compared to hernia mesh devices comprised of polypropylene. Many patients report severe inflammation and complications from the polyester hernia mesh devices.
What are the other Hernia Mesh products?
There are several hernia mesh devices and manufacturers. Besides Covidien, some of the most common mesh devices and manufacturers are:
- Atrium: C-Qur, C-Qur Edge, C-Qur Mosaic, C-Qur Tacshield, C-Qur VPatch, Proloop, VitaMesh Blue
- Bard: 3D Max, Max Light, Composix, Composix E/X, Composix Kugel, Composix L/P, Kugel, Marlex, Perfix, Spermatex, ST Mesh, Ventralex ST, Ventralight ST, Ventrio, Ventrio ST, Visilex
- Covidien/Medtronic: Parietene, Parietex, SurgiPro, Symbotex
- Ethicon: Physiomesh, Prolene Hernia System, Proceed
- Gore-Tex: Dual Mesh
These devices were approved by the FDA through the 510(k) clearance process. This allows the FDA to place a medical device on the market if it is substantially equivalent to a previously marketed device.
What is a Hernia and a Hernia Mesh device?
A hernia is when part of an organ protrudes through a weakening in one of the muscle walls. Hernias are generally found in the groin, upper part of the stomach, belly button or through a previous abdominal surgical scar.
Many times, there are no clear reasons for hernias to occur. Certain activities and medical problems can lead to hernias, including cystic fibrosis, enlarged prostrate, lifting heavy objects, physical exertion and poor nutrition.
Hernias may be treated with surgical repair to alleviate pain and discomfort, which may require the use of hernia mesh. Hernia mesh is a medical device, which looks like a loosely woven sheet, used by surgeons and marketed as popular solutions for patients facing a hernia.
Hernia mesh devices are made out of different types of materials that can help support the body’s weakened muscle tissue. Some hernia mesh devices are made from inorganic materials which permanently stay in the body, while others are made from biological materials that purportedly dissolve over time in the body.
The FDA estimates that there are over one million hernia repairs every year. While hernia mesh is used by surgeons to reduce the recurrence rate of hernias, hernia mesh injuries are on the rise since their introduction in the early 2000s.
Are there ongoing concerns with Hernia Mesh repair?
In April 2017, the FDA published an article that called into question the long term safety of hernia mesh devices. The article noted that: “…Pain, infection, recurrence, adhesion, obstruction and perforation are the most common complications associated with recalled mesh.”
Numerous types of hernia mesh devices have been recalled by their manufacturers after many reports of injuries and complications. Covidien’s hernia mesh devices cause complications including organ perforation, adhesion, obstruction, revision surgery, infection and other dangerous side effects. However, these hernia mesh devices are still on the market and continue to cause major problems in patients.
Be on Watch
Hernia repair surgery is a very common surgery in the United States. Hernia mesh devices are frequently used by surgeons to reinforce the hernia repair and are supposed to reduce the number of complications in patients. Unfortunately, hernia mesh devices are causing serious damages to patients, including the hernia mesh devices manufactured by Covidien. Covidien makes many mesh devices, including Covidien Parietene mesh, Pariextex Ventral Patch, SurgiPro and Symbotex
If you or a loved one had a hernia mesh repair and experienced complications, you may qualify for financial compensation for medical expenses, medical treatment, loss of income, and injuries suffered.
Call us at (888) 458-6825 or send us an email inquiry to discuss your legal options.
The consultation is free and confidential.
Resources:
- FDA Hernia Surgical Mesh Implants https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/herniasurgicalmesh/default.htm
- Medtronics http://www.medtronic.com/covidien/en-us/products.html
- Covidien Wikipedia https://en.wikipedia.org/wiki/Covidien