On April 26, 2018, the FDA announced that Sofradim Production issued a Class 2 recall for one of their popular hernia mesh products. According to the company, it issued the recall because some patients reported abdominal hernia recurrence following hernia repair.
If you underwent a hernia repair procedure and haven’t experienced a recurrence, speak with your doctor. If you already experienced a hernia recurrence and had to undergo a second surgery, you could be the victim of a defective product.
Versatex Monofilament Mesh is one of several surgical mesh products offered by Medtronic. Using surgical mesh is one of the most popular ways to repair an abdominal hernia.
When they work, mesh products help reduce the chance of hernia recurrence more than other methods of repair. Unfortunately, these medical products don’t always work. When they fail, they can cause a patient’s hernia to come back or cause other problems, such as infection.
Right now, it appears that only one size of the Versatex Mesh (50 x 50cm) is currently under recall, covering 699 devices. Medtronic has not released any information about how common the defect is.
The FDA maintains a database known as the MAUDE Adverse Event Report. MAUDE, or Manufacturer and User Facility Device Experience, allows people to submit any issues they have with a device. This includes mandatory reports from manufacturers themselves to voluntary reports from patients.
To date, there are 23 reports entered for the recalled mesh.
| Event Type | Date Received | Web Address |
| Injury | 2018/01/09 | Link |
| Injury | 2017/12/18 | Link |
| Injury | 2017/12/15 | Link |
| Injury | 2017/12/12 | Link |
| Injury | 2017/12/12 | Link |
| Injury | 2017/12/08 | Link |
| Injury | 2017/11/27 | Link |
| Injury | 2017/11/27 | Link |
| Injury | 2017/11/21 | Link |
| Injury | 2017/11/16 | Link |
| Injury | 2017/11/10 | Link |
| Injury | 2017/10/13 | Link |
| Injury | 2017/09/25 | Link |
| Injury | 2017/09/15 | Link |
| Malfunction | 2017/08/31 | Link |
| Malfunction | 2017/08/31 | Link |
| Malfunction | 2017/08/30 | Link |
| Injury | 2017/08/30 | Link |
| Injury | 2017/08/07 | Link |
| Injury | 2017/07/12 | Link |
| Injury | 2017/07/07 | Link |
| Injury | 2017/06/28 | Link |
| Injury | 2017/06/19 | Link |
The MAUDE database does not track every injury or malfunction. It also does not represent the official opinion of the FDA. However, the database is a tool used by manufacturers and the government to look for trends as well as potentially defective products.
The FDA assign recalls to three different levels, depending on how serious the issue is. A Class II recall falls right in the middle. “Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA explained. If to put it another way, the product might cause harm, but that harm is reversible. In the case of a defective hernia mesh, any harm it causes might be fixable, but only after a painful, expensive surgery.
April 26, 2018
The FDA publishes the official recall notice for the Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M.
February 23, 2018
Sofradim Production informs medical organizations that purchased their mesh product about the recall.
June 19, 2017
The FDA MAUDE database receives the first report of hernia recurrence involving the Versatex Monofilament Mesh. According to the report, the patient fell off an exam table and felt a pop. The sudden movement apparently caused the mesh to dislodge, and the patient underwent revision surgery to repair their hernia.
When your hernia mesh failed, you had to have a second, painful surgery and go through recovery all over again. You missed work and time with your family that you wouldn’t have missed if the mesh used during that first surgery wasn’t defective.
Companies like Medtronic market their products as safe and effective. When they sell something that’s unsafe, such as the Versatex Monofilament Mesh, they are responsible for the damage their products cause. A product liability claim is one way, often, the only way, victims of their defective surgical mesh can hold these manufacturers accountable.
A settlement from your claim will help you cover your medical costs and make up for the time you lost because Medtronic made a defective product. Your claim can also send a message to the company that safety is important. Knowing that there is a consequence for failure will hopefully encourage the manufacturer to make its products safer in the future.
Console and Associates has 25 years of experience handling personal injury claims. Over that time, we’ve worked with law firms across the country, including those that handle defective hernia mesh claims. If we cannot handle a claim, our goal is to connect you with an experienced attorney who can. If you suffered as a result of a defective mesh, call today. We’ll ask you a few questions so that we can put you in touch with the right attorney.
