For some patients, surgical mesh is an effective treatment for hernias. Nevertheless, the U.S. Food and Drug Administration (FDA) sees an average of over 500 adverse event reports per month for this treatment option. Most of these reports did originate from hernia mesh products that have since been recalled, but surgical mesh continues to pose risks.
How Hernia Mesh Works
Hernias occur when abdominal pressure from heavy lifting, obesity, and/or other ailments causes your organ or tissue to penetrate your muscle or connective tissue. If you have a hernia, you will have to wait for your affected muscle to heal or have the problem surgically repaired. In some cases, the muscle is so weak that it needs reinforcements, and hernia mesh offers a solution. Surgical mesh can also reduce the likelihood of your hernia coming back (recurring).
When you receive a hernia mesh implant, a false muscle made of synthetic material or animal tissue meshes with your weakened tissue or muscle. Over time, the implant wears down and your tissue regains its former strength. Afterward, the implant remains in your body indefinitely.
What Goes Wrong
Your body has the potential to reject any foreign substance, and hernia mesh is no exception. If your body reacts negatively to the mesh, you could experience complications.
Complications include but are not limited to:
- Hernia recurrence
- Adhesion (when your tissues scar and stick together)
- Obstruction (when the mesh blocks your intestine)
- Fistula (abnormal organ, blood vessel, or intestinal connections)
- Seroma (fluid buildup at the surgical site)
- Perforation (a hold in tissues or organs near the mesh)
- Migration (the mesh moves within your body)
- Contraction (the mesh shrinks)
If you experience any of the above, your surgery may have failed, and you are undergoing what the FDA calls an “adverse event.”
You can report your adverse event to the FDA here or by telephone (1-800-FDA-1088).
Is an Adverse Event Normal?
Every surgical procedure comes with some risks, but surgical mesh procedures are a bit different. This is because the products are manufactured by a third party (not you, not your surgeon). Many of the adverse event reports recorded by the FDA originated from defective hernia mesh products. While these products have been recalled, counterfeit medical devices and products with high failure rates were surgically implanted into patients for years.
Some of the most infamous brands of surgical mesh are:
- C-QUR hernia mesh products from Atrium Medical
- Physiomesh Flexible Composite Mesh from Ethicon (Johnson & Johnson)
- Bard Flat Mesh (Marlex Mesh) from Bard/Devol
Atrium Medical mesh devices had a unique fish-oil-derived coating that increased the risk for adhesion and infection. They recalled their product in 2013 for “packaging problems” after a federal injunction from the FDA and the U.S. Department of Justice. In November 2019, the company faced a total of 1,679 pending lawsuits over their defective hernia mesh implants.
Similarly, Ethicon meshes allowed hernias to recur and sometimes adhered to organs in the body. In May 2016, Ethicon, a subsidiary of Johnson & Johnson, pulled their defective product from the global market. As of November 2019, Ethicon faced 2,482 pending lawsuits.
Bard/Davol had a batch of counterfeit polypropylene surgical mesh distributed under its brand name by RAM Medical, Inc. in 2010. The samples were not sterile and inauthentic, thus increasing the risk of infection and other complications. In response, the FDA issued a safety communication and investigation. Drugwatch® figures from November 2019 revealed 3,550 lawsuits pending over Bard/Davol products.
If You’ve Had a Hernia Mesh Adverse Event, Hire a Lawyer
Because so many hernia mesh products have been recalled, you should talk to an attorney if you experience any complications after your hernia mesh surgery. Even if you do not know the brand-name of your implant, our attorneys can investigate your injuries and hold the responsible parties liable, if appropriate.
Call us at (214) 307-8387 for a free consultation, and discuss your case with our lawyers directly 24/7.