Abdominal wall hernias often require surgical correction. A surgeon can typically repair a hernia without the use of a mesh product and/or the surgeon can use a material, such as a biologic mesh, that poses less risks than many synthetic products that are currently on the market.
Many of the synthetic hernia mesh products marketed since the year 2005 to the present were rushed to the market using the FDA’s 510k clearance process and were manufactured and marketed with little to no studies as to the safety of the device. Many of these devices have been silently withdrawn from the market or otherwise have been recalled.
These problematic hernia mesh devices contain design defects and undisclosed or under-disclosed risks such as: (1) use of “coatings” on the mesh product that cause adverse reactions and infections; (2) excessive mesh and tissue contraction; (3) tendency of the mesh to migrate, shrink, or turn into a hardened ball or mass; and (4) excess foreign body reaction and rejection of the mesh in the body. These mesh products can cause nerve damage, bowel damage, and cause the need for further surgery.
The hernia mesh lawsuits claim the medical devices are defectively designed and the manufacturers have failed to properly warn medical providers of the serious adverse complications and device failures.
The Poole Law Group works with Levin, Papantonio and we are accepting clients who received a hernia mesh and have experienced one or more of the following side effects.
Hernia Mesh Complications
- Additional Surgeries
- Bowel Obstruction/Perforation
- Chronic Pain
- Mesh Migration
- Organ Damage
- Hernia Recurrence
Hernia Mesh Recalls
From 2005-2007, C.R. Bard issued several recalls involving its Kugel Mesh product as a result of a problem associated with potential bowel tears.
In 2012, the FDA sent Atrium a warning over its failure to respond and address numerous complaints of infections due to the C-QUR. In 2015, a federal judge issued an injunction, prohibiting Atrium from manufacturing and distributing the product.
In May 2016, Ethicon voluntarily withdrew the Physiomesh Flexible Composite Mesh after studies determined the medical device was more likely to result in a failed hernia repair when compared to other similar products.
Ethicon mailed an urgent field safety notice to hospitals and doctors telling them to immediately return any unused products, and to stop using the product. Ethicon admitted that the design of its hernia mesh was one of the causes of the failures. At the time Ethicon issued the warning, the FDA had received approximately ten reports of fatalities associated with the Ethicon Physiomesh.
There are multiple brands and types (e.g., synthetic, geometric) of mesh that are involved in lawsuits. For a full list of the mesh products under FDA recall in 2019, please visit this FDA webpage and run a search using the term, mesh.
If you or someone you know has had a hernia mesh surgery and experienced one or more of the side effects described above, you may have a claim for compensation. For a free evaluation, please take the brief survey provided here and one of our team will get back to you quickly.
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