Covidien

Introduction

Though there have been no trials or settlements to date, patients are starting to file their lawsuits against Covidien. There are four main implants subject to potential litigation:

1. Parietex
2. Parietex Composite
3. Parietex ProGrip
4. Parietex Plug & Patch System.

History of the Case

Covidien Parietex Surgical Mesh

According to one patient’s adverse event report, their Covidien Parietex surgical mesh failed altogether. That patient reported needing additional surgeries to locate the mesh, which had migrated. A CT scan finally found it at the bottom of the patient’s stomach.⁽⁷⁾

Covidien Parietex Composite Mesh

In another report made in May 2017, a patient needed to have a “panniculectomy because fat necrosis had grown onto the mesh and was hurting.” Not only was the patient hospitalized, it was reported this patient so far had undergone two hernia repair procedures. The adverse event type was “serious injury and the event outcome [was] hospitalization.”⁽⁸⁾

In a separate case, a patient reported they “had hernia repair surgery and [were] implanted with [Parietex] composite mesh.” After the mesh was implanted the patient reported they were “[h]ospitalized once for infection and then had to have the mesh surgically removed after another infection.” ⁽⁹⁾

Covidien Parietex ProGrip Mesh

In one instance, an adverse event report discussed a patient who underwent a left inguinal hernia surgical procedure and received a Covidien Parietex ProGrip mesh. Afterward, “the patient experienced increased pain…” In an attempt to alleviate the pain, “the patient had cryo-ablation to [deaden] the nerves…The patient needed to continue to have injections…to help with the pain.”⁽¹⁰⁾

In another adverse event report, a patient stated they underwent surgery to repair an inguinal hernia. The surgeon used a Covidien Parietex ProGrip mesh. Just weeks after having the surgery, the patient reported they “developed extreme debilitating pain at the surgery site and into the groin area. After many attempts to relieve the pain through pain management, with little to no relief,” the patient “had a second surgery to remove the mesh.” ⁽¹¹⁾

In addition, in another report a patient underwent a bilateral laparoscopic inguinal hernia repair. According to the patient, “the mesh gave away causing swelling in [the] left groin, passing urine and other medical complications.” The patient underwent a revision surgery, and suffered complications.⁽¹²⁾

Both the Covidien ProGrip and Symbotex hernia meshes are monofilament polyester designs that remain on the market despite ongoing litigation. The Symbotex features a resorbable adhesion barrier intended to protect organs from the underlying polyester mesh and is typically used for ventral/abdominal wall hernias. The ProGrip utilizes thousands of microgrips that act like Velcro to attach the mesh to tissues, eliminating the need for traditional tack fixation. Unlike many competing products made from polypropylene plastic, these polyester meshes can create more inflammation, slow healing, and increase infection risk. Lawsuits claim the polyester material is more brittle and susceptible to “fatigue fracture, breakage, fragmentation and other mechanical failures” than alternative hernia mesh products.

Injuries Related to Product

If you’ve experienced one of the following injuries, you may have a claim in the Covidien hernia mesh lawsuit.

Consumers are filing their lawsuits for adverse reactions and injuries emanating from the use of these products. Some of the most common complications reported to the FDA include:

• Mesh failure
• Chronic pain
• Infection
• Hernia recurrence
• Mesh migration
• Bowel obstruction
• Organ Perforation

Other complications and injuries may result as well — the same type of injuries that can result from any defective hernia mesh product.

Additional Literature

Interested in learning more about the hernia mesh lawsuit? Read the following additional case literature.

7. U.S. Food & Drug Administration. (2017, May 9). MAUDE Adverse Event Report: Covidien/Sofradim Parietex Hernia Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6559912&pc=FTL

8. U.S. Food & Drug Administration. (2017, May 15). MAUDE Adverse Event Report: Sofradim Production SAS Parietex Composite Mesh Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6637296&pc=FTL

9. U.S. Food & Drug Administration. (2015, March 10). MAUDE Adverse Event Report: Sofradim Production Parietex Composite Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4609208&pc=FTL

10. U.S. Food & Drug Administration. (2017, February 22). MAUDE Adverse Event Report: Sofradim Production SAS Unknown Parietex ProGrip Mesh, Surgical, Polymeric. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6432373&pc=FTL

11. U.S. Food & Drug Administration. (2014, December 30). MAUDE Adverse Event Report: Sofradim Parietex ProGrip Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4386930&pc=FTL

12. U.S. Food & Drug Administration. (2012, July 23). MAUDE Adverse Event Report: Sofradim Production Parietex ProGrip Mesh. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2715719&pc=FTL

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