The U.S. Food and Drug Administration recently released a warning about a specific brand of surgical mesh that has been counterfeited and distributed to hospitals and medical care providers. The C.R. Bard/Davol surgical mesh has been tampered with and illegally duplicated in four known product sizes.
The sizes involved include Bard Flat Mesh 2"x 4" Lots 48HVS036 and 43APD007; Bard Flat Mesh 10"x 14" Lots HUSD0629 and HURL0336; Bard Flat Mesh 3"x 6" Lots 43HPD027, 43HPD032; HUSG0540, Lot 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011 and 43IPD038; and Bard Flat Mesh 6" x 6" Lot 43FQD327.
Surgical mesh is used in soft tissue surgery to help repair and reinforce soft and weak areas. The FDA strongly urges hospitals, medical centers, and any other surgical facility that utilizes surgical mesh to monitor the brands in use during all procedures in order to avoid the possible use of the counterfeit material. At this time, the FDA is still investigating the possible consequences of using the counterfeit mesh, as well as who is responsible for its production and distribution.
Patients having recently received surgical treatment involving the mesh should contact their physicians or medical professionals should they experience any health complications that could be related to the mesh. Consumers can also contact representatives of C.R. Bard/Davol at (800) 556-6275 for additional information regarding potential symptoms and side effects of the counterfeit mesh, as well as product updates.
This latest issue is the second warning that the FDA has issued in the past year, as the administration warned earlier in 2009 that certain types of surgical mesh had garnered reports of complication in hernia surgeries, including injury to other organs from dangerous accidental adhesion, interference and abrasion, and infection.
If you or a loved one has experienced an injury or serious side effect related to surgical mesh or similar products, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with injuries associated with medical devices. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.