The Ethicon Prolene Hernia System and the Ethicon Prolene 3D Patch are implantable hernia mesh devices that are frequently used for inguinal hernias. They are designed and sold by Ethicon, a subsidiary of Johnson & Johnson, and have been connected to serious defects that cause chronic pain and other injuries. These products are currently the subject of numerous hernia mesh lawsuits.
- 1. What are Ethicon’s Prolene Hernia System and 3D Patch?
- 2. How to tell if a device is an Ethicon Prolene Hernia System or 3D Patch
- 3. Defects in the Ethicon Prolene devices
- 4. No recall for the Ethicon Prolene implants
1. What are Ethicon’s Prolene Hernia System and 3D Patch?
The Ethicon Prolene Hernia System and the Ethicon Prolene 3D Patch are implants that are used to treat inguinal hernias and prevent them from recurring.
Each device consists of a plastic mesh made of polypropylene. In the Prolene Hernia System, the mesh stacked into two flat layers and kept apart by a short segment of more polypropylene mesh. The Prolene 3D Patch is made of the larger layer from the Prolene Hernia System, but the other layer is compressed into an oval-shaped plug that is attached to the flat layer of mesh.
The devices are used to treat inguinal hernias. These hernias involve intestinal tissues that push through weakened muscles in the abdominal wall and into the inguinal canal. Inguinal hernias are especially common, and especially dangerous, for men because the inguinal canal is where their spermatic cord is located. If the hernia is large enough or in the wrong place, the intestinal tissue can cause infertility.
Surgeons treat inguinal hernias by making an incision near the patient’s kidney and either pushing the hernia back through the abdominal wall or cutting it out. The surgeon can then use a hernia mesh implant like the Ethicon Prolene Hernia System or the Ethicon Prolene 3D Patch, to seal the hole and strengthen the weak muscles in the abdominal wall that allowed the hernia to happen.
Once the implant is inside, the polypropylene mesh in both the Hernia System and the 3D Patch create scar tissue on the abdominal muscles that grows into the pores of the mesh. Together with the mesh, this extra tissue provides enough support for the weakened muscle to keep a hernia from recurring.
2. How to tell if a device is an Ethicon Prolene Hernia System or 3D Patch
You can identify an Ethicon Prolene Hernia System or an Ethicon Prolene 3D Patch by matching their unique characteristics or by finding a product number.
The Ethicon Prolene Hernia System has the following characteristics that, when taken together, make it unique:
- There are two flat layers of polypropylene mesh, connected by a hollow cylinder of mesh,
- The connecting mesh cylinder is around 1.5 centimeters tall, and
- One of the flat layers of mesh is circular, while the other flat layer of mesh is shaped like a rectangle with rounded corners.
The Ethicon Prolene Hernia System also uses the following product numbers, based on the size and dimensions of the mesh patches1:
|4.5 x 10 centimeters||Medium||PHSM|
|4.5 x 10 centimeters||Large||PSHL|
|5.5 x. 12.8 centimeters||Extended||PSHE|
The Ethicon Prolene 3D Patch has the following traits:
- It has a flat layer of polypropylene mesh shaped like a rectangle with rounded corners, called the “overlay,”
- The overlay can either be uncut (the Extended model) or have a keyhole shaped tear from the edge of the implant to a hole near the middle (the Pre-shaped model), and
- A three-dimensional oval or diamond shaped ball of polypropylene mesh connected to the overlay with a suture.
Product numbers for the 3D Patch depend on the size of the implant and whether it was the Extended or Pre-shaped model2:
Product numbers that end with numbers often indicate how many devices came in the box.
3. Defects in the Ethicon Prolene devices
The Ethicon Prolene 3D Patch and Hernia System are defective because of their reliance on polypropylene. Polypropylene is a cheap plastic substance that oxidizes, or erodes in oxygen. The tissues and the blood that surround a hernia mesh implant are rich in oxygen, making it completely foreseeable for the mesh implant to deteriorate over time.
When polypropylene deteriorates, it shrinks. The mesh’s shrinkage is a problem because the mesh is designed to create scar tissue that joins the mesh to the abdominal wall and muscles. When the mesh shrinks, it pulls on these muscles. The pain and discomfort this can create can be chronic and intense if nerves have formed in the scar tissue that has developed.
4. No recall for the Ethicon Prolene implants
Neither the Ethicon Prolene Hernia System nor the Ethicon Prolene 3D Patch has been recalled. Victims who have suffered from the defects in the devices have been forced to file hernia mesh lawsuits to recover compensation for their losses.