Covidien Parietex Mesh Lawsuits
Covidien’s Parietex hernia mesh has been used regularly in hernia repair procedures since 2011. Unfortunately, the popular device has been associated with many adverse health risks. Patients have reported injuries including organ perforation, infection, and adhesions.
Many patients have had to undergo emergency revision surgery to remove and replace the device. In some cases, the device’s defective design has prevented the mesh from being removed, at all. As a result, patients are forced to deal with chronic pain and worry about their health for the rest of their lives.
Have you developed health issues after receiving a Covidien Parietex implant? If so, you may have the right to obtain compensation. Contact Rosen Injury Lawyers to learn about the benefits of filing a hernia mesh lawsuit. Our experienced attorneys are here to help you fight for the money you deserve. Call to get started with a free consultation today.
Lawsuits Say Parietex Products Are Defective, Dangerous
Covidien is facing a growing number of product liability lawsuits in connection with its Parietex mesh patches. These lawsuits allege:
- Covidien manufactured and marketed defective hernia mesh devices
- Defects cause considerable harm and chronic pain
- Covidien knew about the potential health risks associated with Parietex mesh devices, and
- Covidien failed to warn medical care professionals and patients of these alleged risks.
Patients who have received a Parietex hernia mesh implant are demanding compensation. Defects inherent in Parietex products have caused them harm. Now they want Covidien to take responsibility for their defective medical device. Plaintiffs are seeking compensation for medical bills, lost wages, emotional distress, and pain and suffering.
Covidien Parietex Composite Ventral Patch
Covidien, a subsidiary of Medtronic, is a leading hernia mesh device manufacturer. The company’s Parietex Composite Ventral mesh device is widely used in hernia repair surgeries across the country. Parietex patches are popular because they can be used to patch hernias through minimally-invasive laparoscopic procedures.
Device Design and Fixation
Covidien’s Parietex mesh patches are designed using polyester and a proprietary coating. The coating is applied to reduce the risk of oxidation after surgery, a common cause of device failure.
Parietex patches are positioned into a patient’s abdomen using narrow handles. Handles allow surgeons to position the mesh properly and flatten the device against the abdominal wall. This helps to make sure that the mesh is centered directly over the hernia.
The Parietex device is designed with an “innovative fixation system.” Four “semi-peripheral points,” or hooks, are located at the edges of the mesh patch. The four-point system encourages the mesh patch to attach to healthy tissue, rather than damaged tissue at the center of the wound.
Parietex Patches Failing at Alarming Rates
Despite this supposedly-innovative design, Parietex mesh patches have been associated with an increased risk of device failure. Failure in Parietex devices has been linked to the mesh’s unsealed edges. The open structure accelerates oxidation, causing the devices to fray and degrade.
Patients have been forced to undergo invasive revision surgeries to fix problems caused by the first implant. Some patients have been re-opened only to find that a Covidien mesh had broken apart inside the body. Frayed devices lead to debilitating organ perforations and severe infections. Others were told that the Parietex device had adhered to the body, making safe removal impossible.
Covidien’s Controversial Use of Polyester in Parietex Devices
Many hernia mesh products are manufactured using polypropylene. Polypropylene is a flexible and inexpensive plastic. Parietex is unique because it is made using polyester. Covidien’s decision to create a polyester-based hernia mesh in 2011 is interesting. Why? By 1998, the scientific community had decided that polyester was unsafe. A study published in the Journal of American Medical Association Surgery specifically advised against the use of polyester in hernia mesh devices.
The use of polyester in a hernia repair patch is problematic for several reasons.
- Polyester is less sturdy and more difficult to implant than other alternatives.
- Polyester has been linked to a higher risk for severe infections and device failure.
- Polyester is associated with an inflammatory response in the body after implantation.
- Coatings applied over polyester are associated with an increased risk of inflammation.
Why would Covidien move forward with a polyester mesh device, knowing that it wasn’t the best option? The company knew that it would take advantage of the FDA’s 510(k) pre-approval process.
The 510(k) process allows companies to bypass FDA safety testing requirements that are typically necessary when a new medical device is proposed. Covidien knew that the FDA would extend pre-market approval if it claimed that Parietex patches were substantially similar to an existing medical device. Parietex was able to hit the market without being tested in clinical trials. Any problems with the device would only be discovered after years on the market.
Covidien chose to allow hernia repair patients to be the guinea pigs for its Parietex patches.
Have Covidien Parietex Mesh Patches Been Recalled?
No. Even though the FDA has issued warnings about the potential risks of hernia mesh devices, no Covidien Parietex devices have been recalled.
However, dozens of patients have reported adverse events and side effects to the regulatory agency. Health issues associated with Covidien Parietex devices include:
- Bowel obstruction
- Organ perforation
- Chronic pain
- Adverse tissue reaction
- Hernia recurrence, and
- Mesh revision surgery.
Reporting adverse health issues to the FDA can help to encourage the agency to issue a safety recall.
Covidien Line of Parietex Hernia Mesh Products
Covidien and Medtronic currently manufacture and sell several Parietex mesh products:
- Parietex Composite Ventral Patch
- Parietex Optimized Composite Mesh
- Parietex ProGrip Mesh
- Parietex Folding Mesh
- Parietex Flat Sheet Mesh
- Parietex Plug and Patch System
- Parietex Composite Open Skirt Mesh
- Parietex Optimized Open Skirt Mesh
- Parietex Composite Hiatal Mesh
- Parietex Composite Parastomal Mesh
- Parietex Hydrophilic Anatomical Mesh, and
- Parietex Lightweight Monofilament Mesh.
Have you received a Parietex hernia mesh implant? Do not hesitate to contact Rosen Injury Lawyers to learn about your legal options. Your first consultation is free, so call today.
Get Help With Your Parietex Injury Lawsuit
Are you struggling with painful injuries because of a defective Covidien Parietex patch? Did you have to have a second hernia operation to remove and replace the mesh device? Contact Rosen Injury Lawyers to learn about your legal options. You may have the right to file a hernia mesh injury lawsuit.
Covidien should be held accountable for any injuries caused by its defective Parietex device. Our hernia mesh attorneys are prepared to help you fight for the money you deserve. Call our office today to schedule a free consultation and learn more.