Lawsuits against Hernia Mesh Implant Manufacturers Continue to Mount
It is estimated that roughly 350,000 hernia surgeries are performed in the U.S. each year, and in the majority of those procedures, surgeons use mesh implants to help support weakened or damaged abdominal tissue. While mesh is believed to lower the rate of hernia recurrence, it has also been associated with a whole host of painful and serious complications.
A study published earlier this year confirmed what many people have suspected for many years: the rate of complications is significantly higher in hernia surgery patients with mesh implants than for those without mesh implants.
And yet, surgeons continue to refer to the use of hernia mesh as the “gold standard” in surgical treatment. Not surprisingly, hernia mesh lawsuits continue to mount.
Which Hernia Surgical Mesh Devices Have Caused the Most Problems?
In 2005, the FDA issued the first in a series of recalls involving Kugel Mesh Hernia Repair Patches manufactured by C.R. Bard. A piece of the plastic mesh patch device was prone to breaking, leading to bowel perforations – a painful, life-threatening complication. In the biggest hernia mesh settlement to date, C.R. Bard agreed to pay $184 million to more than 3,000 people who claimed significant injuries as a result of the mesh.
Several other mesh devices are currently the subject of multiple pending lawsuits, including:
- Atrium C-Qur™: Dozens of lawsuits are pending against the makers of this mesh, which is unique in that it has a fish oil coating. Patients implanted with this mesh have reported:
- Severe infections and inflammation
- Wound dehiscence or extrusion (opening of the surgery site) weeks to months after surgery
- Failed incorporation of the mesh
- Severe adhesions or scar tissue
There have also been reports of the mesh adhering to the patient’s bowel, making it difficult to remove if there are complications.
- Johnson & Johnson Ethicon PhysioMesh™: In May 2016, Ethicon withdrew Physiomesh™ from the market after two large hernia registries in Europe indicated an unusual number of problems with the device, but not before thousands had been implanted in hernia patients in the U.S. Ethicon said it was not sure what was causing the problems, but patients have reported:
- Migration of the mesh
- Bowel obstruction
- Severe adhesions or scar tissue
Other hernia mesh products with high complication rates include Bard Ventralex™ ST, Bard Ventralight™ ST, Covidien Parietex™ Composite Mesh, Covidien ProGrip™ Mesh, and Johnson & Johnson Ethicon Proceed™ Mesh.
Despite all these problems, the FDA continues to approve new hernia mesh devices through its 510(k) premarket notification clearance process, which allows companies to skip the rigorous premarket safety testing required for many other types of medical devices. And medical device makers continue to aggressively market hernia mesh, despite the growing number of complaints.
If you have had any problems with a hernia mesh implant, you need a strong advocate on your side. Please contact an experienced medical malpractice attorney at Sommers Schwartz now to review your case and determine the appropriate next steps.
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