Surgical Mesh Complications: Should You File a Lawsuit?

Currently, there are thousands of lawsuits against hernia mesh manufacturer Covidien LP, a major business unit of Medtronic, combined into federal multi-district litigation MDL 3029. Patients claim that several Covidien hernia mesh products are defectively designed and that the manufacturer failed to adequately warn doctors about the risks associated with them.

If you have experienced pain or other complications after having revision surgery as a result of Covidien surgical hernia mesh, contact us today or call 1-866-900-7078. You may be eligible for compensation.

What Is Surgical Mesh?

Years ago, before the advent of surgical mesh, doctors hand sutured weakened or damaged tissue such as hernias, surgical wounds, and vaginal wall and pelvic prolapses. Yet what they found, particularly with hernia repair, was that between 24% to 54% of patients needed an additional repair operation, reports the New England Journal of Medicine (NEJM) in 2000.

The answer to this problem was thought to be surgical mesh, and during the 1970s, the product gained popularity. Surgical mesh can be made from organic material (pig or cow organs) or synthetics, such as polypropylene plastic. It is used to shore up damaged tissue like a hernia, pelvic prolapse, or other weakened tissue from surgical repair. Surgeons began using synthetic mesh because it is easier to work with. It seemed like a win-win for everyone. Surgeons. Patients. And the mesh manufacturers.

However, the NEJM reported in that same study that surgical recurrence rate for mesh patients was still as high as 34%. Many mesh patients have had to live with recurring surgeries, physical and emotional pain, misery, and life-altering complications from surgical mesh repair.

Complications From Surgical Mesh Repair

When a surgical mesh repair fails, severe complications can occur.

The Journal of the American Medical Association (JAMA) reports that mesh-related complications requiring surgery continued to occur throughout a five-year follow-up period after incisional hernia repair. The article concludes, “With long-term follow-up, the benefits attributable to mesh are offset in part by mesh-related complications.”

These complications can include:

• Pain and swelling
• Adhesions (when tissue adheres to the mesh), which some describe as burning, itching, poking, or stabbing)
• Bowel obstruction, which can be life threatening, with early symptoms of fever, abdominal pain, nausea and vomiting
• Infections, such as fever, tenderness, and discharge around the surgical site
• Mesh migration when the mesh moves from its original position
• Mesh shrinkage when the mesh contracts after implantation
• Repair, which can be riskier and more complicated after mesh failure because tissue and muscle typically adhere to the mesh and must be removed with the problematic mesh
• Hernia recurrence

Problems With Surgical Mesh

While there are thousands of lawsuits over various types of surgical mesh, the Covidien hernia mesh lawsuits associated with MDL 3029 make the following types of allegations:

1. Several of Covidien’s surgical mesh products are synthetic, made of polypropylene plastic, and have reportedly caused severe adverse reactions.
2. Covidien mesh product lines, such as Parietex, ProGrip, and Symbotex, were cleared through the FDA’s 510(k) approval process, a regulatory loophole that does not require safety testing.
3. There was inadequate material testing of Covidien’s non-inert polyester design, and porcine collagen barriers would degrade over time after implantation.
4. Covidien knew or should have known about the degradation risks of its surgical mesh products, but failed to adequately warn physicians.

Synthetic Polypropylene (Plastic) Surgical Mesh

Surgical mesh can be made from animal tissue or synthetics like plastic. Those found to be particularly problematic are made from polypropylene (plastic) because they tend to have limited flexibility and a high risk of adhesion. Covidien’s hernia mesh products are made of polypropylene, monofilaments polyester, or a combination of materials.

The body naturally fights off anything it sees as a foreign object, similar to when you get a splinter in your finger. Polypropylene mesh is a foreign object the body will try to break down. When additional coatings are added to the mesh, the body has more foreign substances to attack. As the body attacks these invaders, the mesh composition changes and can often become rock hard. Once hardened, it will never soften again and can lead to life-long pain in and around the mesh area.

Mesh Approved Without Safety Studies

When a drug or medical device manufacturer wants to save time and money and rush a product to market, there’s a loophole in the FDA clearance process in certain instances. The FDA 501(k) clearance process allows a manufacturer to skip the testing and approval process if they can show their product is “similar to those already cleared” for patient use.

All the manufacturer needs to do is show the FDA evidence substantiating that their device is similar to those already approved on the market and that it appears to be safe. Current lawsuits allege that Covidien bypassed clinical trial of polyester mesh products by claiming that they were “substantially equivalent” to  previously cleared products.

Possible Types of Compensation Sought in Covidien Hernia Mesh Cases

If you, or a loved one, have experienced pain or other complications or have had revision surgery as a result of mesh used in hernia surgery, you may be eligible for the following types of compensation:

• Medical expenses
• Lost wages
• Emotional and physical pain and suffering
• Other damages

In the first bellwether trial of MDL 3029, a federal jury returned an $88 million verdict against Covidien, finding that the company concealed the truth about the dangers of Symbotex hernia mesh. This is not a final settlement, and the manufacturer is likely to pursue post-trial motions.

Who Can File a Covidien Hernia Mesh Lawsuit?

The Law Offices of James Scott Farrin is investigating claims involving patients who need surgical removal of Covidien hernia mesh because of:

• Pain
• Infection
• Hernia recurrence
• Adhesions
• Bowel obstruction
• Mesh migration
• Mesh shrinkage

Contact us today and we can listen to your story, answer your questions, and recommend next steps.

Personal Injury Lawyers Offer FREE Case Evaluation

Other mesh manufacturers have settled thousands of lawsuits with victims who have accused them of making defective products, fraudulently promoting their safety, and not making the doctors or the public aware of potential problems, including the potential for additional surgeries to replace faulty mesh.

If you, or a loved one, have had serious health complications involving surgical hernia mesh removal, contact us or call 1-866-900-7078 today. You do not have to face this alone. We are here to help.

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The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.