Friedman Law Offices, P.C., L.L.O.
Phone: 866-458-5468
Toll Free: 888-419-6876

Hernia Mesh - Complications Leading to Recalls (Part 1)

Friedman hernia Mesh.jpg

 

Hernias are a common health problem, with more than one million hernia repairs performed each year in the United States. For most hernia repairs, a mesh is used. The hernia mesh market has been getting some attention lately as a result of the FDA disallowing use of some meshes. While the FDA has recalled a few products based on the complications resulting from the mesh, some manufacturers have voluntarily removed their products from the market. In this two part series we'll touch on four of the meshes that have been removed from the market for various reasons.

Ethicon Physiomesh

The Ethicon Physiomesh Flexible Composite Mesh was created by Johnson & Johnson's Ethicon Division to repair hernias. Physiomesh is primarily made from the light-weight plastic, polypropylene, which is the same material Ethicon uses to make their trans-vaginal mesh and bladder slings. Both of which have been the cause for thousands of lawsuits. 

Though denying the alleged life-threatening complications of polypropylene, Johnson & Johnson voluntarily withdrew the Physiomesh from the market on May 25, 2016. This was after two registries found that patients who received the hernia mesh reported a number of severe complications such as infections, bowel injuries, adhesions, and severe abdominal pain.

The FDA originally cleared Ethicon's Physiomesh in April of 2010 with the 510k clearance, which allowed Ethicon to skip rigorous testing before going to market. Ethicon claimed that the Physiomesh was substantially similar to the Proceed hernia patch, which they also manufacture.

Compared to its predecessors, Physiomesh uses a lighter-weight polypropylene. The light-weight design means there is less polypropylene in the mesh, making it much weaker than its heavier-wight predecessors. Ethicon hoped the smaller amount of polypropylene would mean less complications, however, the smaller amount of material has only led to the mesh tearing. Some patients have reportedly had their bowels blow through the Physiomesh.

Atrium's CQur VPatch Mesh

The FDA recalled the CQur hernia mesh in 2013 after patients reported chronic pain, infection, device rejection, hernia recurrence, and even allergic reactions caused by the device. The recall stated that "If the product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve." https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119925 

The culprit to the unwanted adhesion was an Omega 3 oil, which coated the mesh, originally designed to assist the patient in the healing process and reduce the chance of the mesh attaching to internal tissue. Other issues reported to the FDA including the C-Qur mesh shrinking and causing foreign body reactions.

If you live in Nebraska and have had a medical device implanted that made you ill, our attorneys can work to recover money to pay your medical bills, lost wages, permanent or temporary disability, rehabilitation or other costs related to your condition. Please don't hesitate to contact us for more information.

No Comments

Leave a comment
Comment Information

Office Location:

3800 Normal Boulevard
Suite 200
Lincoln, NE 68506

Toll Free: 866-458-5468
Toll Free: 888-419-6876
Phone: 866-458-5468
Fax: 402-476-8364
Map & Directions

Phone Numbers:

Contact Us