Hernia surgeries are commonplace and constitute an important revenue stream for U.S. hospitals. They generate almost $50 billion in hospital revenues per year, on more than one-million surgeries. Hospitals and surgeons who repair hernias have widely adopted the use of hernia mesh to repair hernias, with more than 80 percent of hernia surgeries involving the use of hernia mesh. If you have undergone surgery to repair a hernia, it’s likely your doctor used mesh. Even with the wide adoption of hernia mesh, patients continue to experience complications with its use.
If you suffered complications after hernia surgery, you are not alone. Medical device companies responsible for manufacturing and selling hernia mesh to doctors and hospitals have sold defective mesh, causing patients to experience severe side effects and require additional surgery. Contact the experienced Hernia Mesh attorneys today at Florida Law Group at (813) 463-8880 for a free consultation to discuss the details of your post-surgical struggles and determine your eligibility to recover damages.
What Is Hernia Mesh?
Hernia mesh is a kind of surgical mesh used to repair hernias by providing structure and support to weak and damaged tissue. Those who have a hernia are prone to have more, and mesh provides support which prevents recurrences. Today, the majority of hernia mesh is made of absorbable and/or non-absorbable synthetic materials or absorbable animal tissue from cows and pigs. Non-absorbable mesh is a permanent implant, while absorbable mesh breaks down over time as new tissue growth occurs.
What Complications Might Result From the Use of Hernia Mesh?
According to the U.S. Food and Drug Administration’s (FDA)study of adverse events related to hernia surgeries, the most common adverse events after hernia repair with mesh are:
- Hernia recurrence
- Bowel obstruction
- Bowel perforation
- Mesh migration
- Mesh shrinkage
The FDA states many of these complications have been associated with recalled mesh products that have been pulled from the market; and, recalled hernia mesh products are the primary cause of bowel obstruction and perforation complications.
Common Hernia Mesh Defects and Product Liability
Hernia mesh implants are complex, fragile devices that can be defective in a number of different ways:
- The hernia mesh can cause the patient’s body to respond negatively due to the use of materials that incite an allergic reaction
- The hernia mesh may deteriorate over time, leading to breakage
- Pieces of the hernia mesh may cut into surrounding tissue, causing significant damage to one’s organs
- The hernia mesh may be poorly designed or manufactured such that it does not perform its function correctly, thus allowing for hernia recurrence
If the hernia mesh is defective (in design or manufacture, or if the medical device manufacturer fails to warn about an inherent risk or fails to properly instruct end-users), then you may have an actionable product liability claim under Florida law to secure compensation for related injuries.
Potential Medical Malpractice Claims
Hernia mesh implants may give rise to medical malpractice liability in scenarios where there is no actual defect, but where the negligence of a treating healthcare professional caused the hernia mesh to be harmful. For example, if your surgeon failed to exercise proper care when implanting the mesh, which leads to mesh breakage (and a severe infection), you would likely have an actionable medical malpractice claim.
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.
Contact a Tampa Bay Hernia Mesh Attorney Today
If you have experienced complications following a hernia repair surgery, or are scheduled for a revision surgery because of hernia mesh-related complications, you don’t deserve to go through this pain and discomfort because of a negligent medical device manufacturer. Contact The Florida Law Group online or call us at (813) 463-8880 for a free consultation to determine if you are eligible to seek compensation.