Was Your Hernia Repair Affected by the Urgent Field Notice?
Hernia Mesh manufacturer Ethicon issued an Urgent Field Notice May 25, 2016. The notice was issued to medical staff in the field calling for them to discontinue use of the popular Physiomesh product after two unpublished studies showed patients implanted with Physiomesh products had a higher recurrence of surgery and re-operation than those implanted with others. The studies were compiled based on data subsets stemming from recent hernia registries in Germany and Denmark. The fact that an urgent field notice was issued afterward is concerning. Lets unpack this further to see the possible implications for you and your potential claim.
Physiomesh Products Affected by the Recall
To begin with, the recall notice applies to the ten different types of Physiomesh listed below. Note that while the product name is the same, the main determinant of difference is size and shape.
- PHY0715R Rectangle 7.5cm x 15cm
- PHY1015V Oval 10cm x 15cm
- PHY1515Q Square 15cm x 15cm
- PHY1520R Rectangle 15cm x 20cm
- PHY1520V Oval 15cm x 20cm
- PHY2025V Oval20cm x 25cm
- PHY2030R Rectangle 20cm x 30cm
- PHY2535V Oval 25cm x 35cm
- PHY3035R Rectangle 30cm x 35cm
- PHY3050R Rectangle 30cm x 50cm
Notice how the product code correlates to the size and shape of the mesh. This information can be used by hospital staff to verify whether or not your hernia surgery utilized one of the products above should you begin to experience problems post surgery. Common side effects/problems after hernia surgery include pain, swelling and redness at the suture site. Other issues include include fever, chills and nausea. And while it is true that these experiences are somewhat universal in nature to hernia surgery patients, it is important for you to get evaluated by your doctor should you experience any of the issues previously mentioned to make sure they were not caused by your Physiomesh product. Here’s Why.
When a company issues a voluntary recall, such as the one involving Ethicon Physiomesh by Johnson & Johnson, it is for reasons of concern. Product recalls are typically issued if the company feels a product is unsafe due to something like a manufacturer defect, or if they feel it could be used in an inappropriate manner because it looks and functions similar to another consumer product. The Ethicon Physiomesh recall is particularly concerning.
An urgent field notice issued to all medical staff recalling unexpired product means there was enough data available in the unpublished studies for Johnson & Johnson to deem the product unsafe. And while the recall is voluntary on the part of Johnson & Johnson, return of the Physiomesh product is required by the purchaser.
Furthermore, the product warranted such concern to the point that additional instructions were issued by the company involving those patients already implanted with the product, but who as of yet, had experienced no issues. The implication is the likelihood of issues developing in patients with Ethicon Physiomesh products is higher than those implanted with other devices.
Therefore, it is imperative for you to see your doctor if you experience any of the post surgery complications mentioned previously. You might want to schedule an evaluation appointment even if you are not experiencing problems or have not had a hernia surgery for an other reason. Court records show that Physiomesh was used in other fascial tissue repairs that could have been repaired by other means, most notably laparascopic surgery.
Hernia Mesh Recall: What You Can Do Right Now
Your health and safety are not something to play around with. If you suspect your hernia mesh repair is causing problems for you, call us. We have an experienced team of lawyers ready to help you navigate the claim process, should you have a claim. There are also several things you can do beforehand.
First, use the hernia mesh product information at the beginning of this article as a reference point. Call the hospital where your surgery was performed and ask for the records department. They should be able to pull the product number of the particular type of Ethicon Physiomesh used for your surgery and cross reference it with the ten numbers you have listed above.
Next, schedule an appointment with your physician for evaluation. He or she will be able to determine whether or not your hernia mesh product is a contributor to any post hernia surgery problems you may be experiencing. In order for a claim to be filed on your behalf, it must be proven that the product caused any issue you may be experiencing post surgery.
Finally, contact us with the information you have and we will assist you the rest of the way. Even if you do not have all of the information you think you need, or if you have questions about the types of information required to file a claim, give us a call. We can help.
The consultation is free and costs nothing but your time. Your health is important after all. If you are suffering from a hernia mesh repair, please reach out. We can help.