Hernia mesh surgery is one of the most frequently conducted surgical procedures in the world. In the United States alone, approximately 800,000 patients undergo the procedure to treat the discomforts caused by the condition.
Unfortunately, the hernia meshes have been responsible for causing multiple complications among a substantial number of patients. Each year, the FDA receives thousands of complaints regarding these items leading to public safety announcements and hernia mesh recall orders.
Unfortunately, the hernia meshes have been responsible for causing multiple complications among a substantial number of patients. Each year, the FDA receives thousands of complaints regarding these items leading to public safety announcements and hernia mesh recall orders.
What is a device recall?
‘Recalling’ a medical product, according to the FDA, means pulling out a defective item from the market that can cause a potential health risk to an individual. Legally, the FDA can demand the manufacturing companies pull their defective products out of the market.
In recent years, the authority has announced several voluntary as well as involuntary recalls. Some cases, the orders are issued due to poor packing or storage errors. But sometimes, the FDA has issued these orders for serious complications like adhesion and mesh migration.
Some of the common complications associated with recalled meshes include:
- Chronic pain
- Hernia recurrence
- Adhesion
- Mesh migration
- Organ perforation
- Mesh shrinkage
Difference between market withdrawal and recall
According to the FDA rules and regulations, recall and withdrawal are completely different concepts. Withdrawal happens when the said product is not subjected by any lawsuit or legal action. In these circumstances, the companies can take the medical device out of the market to fix its issue. Later on, the company can re-launch the updated product.
Most corporations voluntarily withdraw their products from the market to avoid recall orders.
These brands have gone with hernia mesh recall after receiving repeated complaints regarding the quality of the product:
|
Name of Corporation
|
Name of the Product
|
Reason
|
|
Atrium
Medical
|
C-QUR Edge Mesh
|
Faulty Packaging
|
|
Ethicon
|
1. Proceed Surgical Mesh,
2. Physiomesh Flexible Composite Mesh
|
Poor quality of laminate coating leading to the
development of a fistula.
Also, high failure rates.
|
|
Bard
Davol
|
Bard Composix Kugel Mesh
|
Potential for causing fistula or bowel perforation.
|
Have you endured complications caused by these implants? Then, you should contact Bernstein, DeCailly & Marshall, PLLC. They can help you with getting you due to compensation. For more information, visit http://bdmlawyers.com or call 844-875-4747.
