Ethicon, a Johnson & Johnson subsidiary, manufactured a number of hernia mesh products which have caused serious complications for many patients. As a result, many of these patients have begun filing claims in the Ethicon Physiomesh® hernia mesh lawsuit. While one of the primary concerns with this line of products is the high rate of hernia recurrence and the need for revision surgeries, other serious complications have also been reported. These products' defective design prevents the adherence of the mesh to the abdominal wall, resulting in a failure to adequately repair the hernia. Patients have been forced to undergo multiple procedures and severe pain as a result of the implantation of these defective devices.
If you or a loved one had a hernia repaired with an Ethicon Physiomesh® product and have experienced complications, you may qualify for substantial compensation. An experienced attorney can thoroughly evaluate your claim and guide you through the legal process. Contact our legal team today to get started.
Ethicon Physiomesh® Hernia Mesh Products
In 2010, the U.S. Food and Drug Administration (FDA) approved Ethicon’s Physiomesh® hernia mesh products. Since these products were similar to other mesh products already on the market, they did not undergo the extensive testing typically required. Instead, they were approved through the FDA’s 510(k) program. The Ethicon Physiomesh® Flexible Composite Mesh was available in a wide range of shapes and sizes to fit a variety of needs:
- Ethicon Physiomesh® Flexible Composite Mesh PHY0715R – Rectangle, 7.5cm x 15cm
- Ethicon Physiomesh® Flexible Composite Mesh PHY1015V – Oval 10cm x 15cm
- Ethicon Physiomesh® Flexible Composite Mesh PHY1515Q – Square 15cm x
- Ethicon Physiomesh® Flexible Composite Mesh PHY1520R – Rectangle 15cm x
- Ethicon Physiomesh® Flexible Composite Mesh PHY1520V – Oval 15cm x 20cm
- Ethicon Physiomesh® Flexible Composite Mesh PHY2025V – Oval 20cm x 25cm
- Ethicon Physiomesh® Flexible Composite Mesh PHY2030R – Rectangle 20cm x
- Ethicon Physiomesh® Flexible Composite Mesh PHY2535V – Oval 25cm x 35cm
- Ethicon Physiomesh® Flexible Composite Mesh PHY3035R – Rectangle 30cm x
- Ethicon Physiomesh® Flexible Composite Mesh PHY3050R – Rectangle 30cm x
Like other hernia mesh products, Ethicon Physiomesh® utilizes polypropylene. Because the polypropylene has presented significant problems when it comes into contact with certain tissues, such as the intestines, the manufacturers of these hernia mesh products have begun coating one side of the mesh, which acts as a protective barrier.
What sets the Ethicon Physiomesh® apart, and also makes the product defective, is that both sides of the mesh are coated. This prevents the polypropylene from adhering to the appropriate tissues to repair the hernia. As a result, patients have suffered numerous complications.
Complications Associated with Ethicon Physiomesh® Products
Although hernia recurrence is a risk with any repair surgery - even those that do not utilize a mesh product - studies have shown that the recurrence rate with Ethicon Physiomesh® products is significantly higher. Patients have been subjected to the painful symptoms again and another operation in an attempt to repair the hernia once more. Recurring hernias are often larger and more difficult to treat.
In addition to the high hernia recurrence rate, Ethicon Physiomesh® also poses other problems for patients. The product design uses less polypropylene, presumably in an attempt to reduce complications related to the material. Unfortunately, this is more likely to lead to degradation of the product, which can cause the mesh to break apart and even migrate within the patient’s body.
As a result, Ethicon Physiomesh® has seen higher rates of other complications, including:
- Bowel obstructions
- Seroma, or fluid buildup
- Total mesh failure
Ethicon Physiomesh® Product Recalls
Ethicon Physiomesh® hernia mesh products have not been recalled. Johnson & Johnson and Ethicon have declined to initiate a voluntary recall, and the FDA has not forced one.
However, in May of 2016, Ethicon issued an urgent field safety notice instructing surgeons across the globe to discontinue the use of Physiomesh®. This resulted in a complete U.S. market withdrawal for all of Ethicon’s Physiomesh® Flexible Composite Mesh products.
Although Ethicon indicated in the notice that complications may have been related to certain characteristics of the hernia mesh product, they claim that they were unable to identify any specific design flaws.
Contact Our Legal Team for a Complimentary Case Evaluation
The first lawsuits against Ethicon are currently scheduled to take begin in 2018. Several patients have already filed claims, and as awareness spreads about the dangers of the Ethicon Physiomesh® products, we expect thousands more to file claims. Current claims focus on the product’s defective design and the high rates of hernia recurrence associated with the product. Ethicon is also facing numerous lawsuits for their defective transvaginal mesh and bladder sling products.
If you or someone you love has had a hernia repaired with an Ethicon Physiomesh® product and suffered serious complications, you may be entitled to substantial compensation for your losses. Contact our legal team today to schedule your complimentary case evaluation with one of our experienced attorneys.