Florida Hernia Mesh Attorneys

Hernia Mesh Recalls in the United States

Currently, more than 70 different mesh products are on the market; yet medical professionals rely on many of the same brands. When patients report complications with surgery, and patterns emerge, medical device companies initiate a recall of their products, sometimes on their own and other times when forced to do so by the FDA. Some of the largest recalls of commonly used hernia mesh include:

C-Qur Mesh by Atrium

Atrium’s C-Qur polypropylene mesh is coated in fish oil to prevent mesh from attaching to the tissue, but this hasn’t always worked as intended. The FDA approved this product in 2006 through the FDA’s 510(k) program, which means Atrium did not have to meet the standards for premarket approval. In July 2013, Atrium recalled C-Qur mesh after evidence emerged that the coating sticks to the lining of the package when exposed to high humidity. The removal of the coating during separation increases the risk of infection in surgical patients.

3DMax by C.R. Bard

C.R. Bard’s polypropylene 3D Max mesh was also approved through the FDA’s 510(k) program. After it came on the market in October 2008, C.R. Bard recalled the mesh because of mislabeling. Patients who have undergone hernia repair with this product complain of pain, typically as a result of the mesh moving, and need to undergo a second surgery to correct issues.

Ventralex ST by C.R. Bard

Also a product of the 510(k) program, Ventralex is a mesh patch composed of self-expanding polypropylene, often used to repair umbilical hernias or hernias occurring at the incision site after a laparoscopic procedure. Bard issued an urgent recall of the Ventralex ST in October 2011 due to package mislabeling.

Composix Kugel Mesh by C.R. Bard

Composix has been at the center of multiple recalls in 2006, as well as thousands of lawsuits resulting in millions of dollars in settlements and court-awarded damages. The recalls stated that the memory coil rings in the mesh could break and cause bowel perforation or chronic fistulas. In the second of four bellwether trials, small trials to test future cases, the jury awarded $1.3 million to a plaintiff who suffered complications from Composix. Over the last decade, Bard has settled more than $200 million in lawsuits as a result of this defective hernia mesh.

Physiomesh by Ethicon, a subsidiary of Johnson & Johnson

In July 2016, Ethicon removed Physiomesh from the market before a forced recall. Patients who underwent hernia repair surgery with Physiomesh had higher recurrences and more revision surgeries compared to other brands of hernia mesh. Ultimately, the FDA issued a recall citing the company did not register as a medical device manufacturer, list recalled devices, or establish internal quality control.

If you underwent hernia repair surgery and suffered complications, your pain and discomfort might result from defective hernia mesh. If you know the type of mesh your surgeon used, you can look up FDA issued recalls here. If you aren’t sure, your attorney can help you obtain the necessary information.

Individual Lawsuits versus Class Action Lawsuits

The lack of accountability in the FDA’s 510(k) program has spawned the recall of millions of medical devices, including hernia mesh products. In some instances, so many patients have been impacted, law firms have initiated class action lawsuits on behalf of whole groups of “similarly situated” clients against manufacturers. In other situations, patients who have suffered injury have filed individual lawsuits against a mesh manufacturer.

If a court rules in your favor in a hernia mesh lawsuit, you may recover losses that include medical expenses, past and future lost wages, and pain and suffering caused by defective mesh. Deciding whether to join in a class action suit or to pursue a suit on your own is a decision you must make with the guidance of a qualified attorney. Each legal pathway to recover damages for your injury has advantages and disadvantages, and both pathways might not be available or prudent in all situations.

The Florida Law Group: Fully Committed to Pursuing Justice

You may be entitled to financial compensation for injuries sustained from a defective hernia mesh, as well as any wages you lost due to having to take a leave of absence from work because of the injuries. Our Florida personal injury attorneys are fully committed to providing you with the best legal support possible and will work relentlessly to assist you in your efforts to obtain financial compensation. We will review the situation with you and explain your legal rights, as well as work with you throughout the process to provide you with ongoing counsel.

Contact us to obtain legal assistance after experiencing complications related to a hernia mesh.