The Ethicon Physiomesh is an implantable hernia mesh made by Ethicon, a subsidiary of Johnson & Johnson. The Physiomesh has proven to be an especially problematic model of hernia mesh, with several defects that can cause serious medical complications and chronic pain. As a result, thousands of hernia mesh lawsuits have been filed over injuries suffered by people who have had the Physiomesh implanted.
- 1. The Ethicon Physiomesh
- 2. Identifying an Ethicon Physiomesh
- 3. Why the Ethicon Physiomesh is defective
- 4. Ethicon’s Market Withdrawal of the Physiomesh
1. The Ethicon Physiomesh
The Ethicon Physiomesh is a medical implant that is used to treat hernias. It is composed of five different layers. The middle layer is a thin mesh made of polypropylene plastic. On both sides of this plastic mesh layer is a thin film of polydioxanone that sticks the polypropylene center to the outermost layers that are made of polyglecaprone-25. Both the outer layer of polyglecaprone-25 and the polydioxanone that sticks everything together are designed to be absorbed in the body after implantation.
Hernias are inner tissues that have pushed through weakened muscles and into places they are not supposed to be. Surgeons performing a hernia repair push the hernia back through the weakened muscle. They can then implant an Ethicon Physiomesh on the location of the hernia. The plastic mesh in the Physiomesh is designed to adhere to the weakened muscle by creating scar tissue that becomes entangled in the mesh’s threads. Both the mesh and this new scar tissue strengthens the muscle and prevents another hernia.
2. Identifying an Ethicon Physiomesh
The Ethicon Physiomesh has several unique traits that can help people identify it from other hernia mesh implants:
- The threads of the plastic mesh have a honeycomb shape and are much further apart than most other hernia mesh products,
- There is a thick coating on both sides of the plastic mesh, and
- There is a blue line drawn across the diameter of the Physiomesh, with a short line intersecting it at its midpoint.
Additionally, the different models of Ethicon’s Physiomesh can be identified using their product numbers, which begin with the Physiomesh model (PHY), describe the device’s dimensions in centimeters, and end with a letter denoting the shape of the implant:
|Rectangle||7.5 x 15 centimeters||PHY0715R|
|Rectangle||15 x 20 centimeters||PHY1520R|
|Rectangle||20 x 30 centimeters||PHY2030R|
|Rectangle||30 x 35 centimeters||PHY3035R|
|Rectangle||30 x 50 centimeters||PHY3050R|
|Square||15 x 15 centimeters||PHY1515Q|
|Oval||10 x 15 centimeters||PHY1015V|
|Oval||15 x 20 centimeters||PHY1520V|
|Oval||20 x 25 centimeters||PHY2025V|
|Oval||25 x 35 centimeters||PHY2535V|
3. Why the Ethicon Physiomesh is defective
The Ethicon Physiomesh proved to be defective in several ways. Not only did the plastic mesh erode over time, it also was so thinly made that it was prone to breaking or rupturing, even in the packaging. Additionally, the absorbable layers used in the Physiomesh can also cause serious problems like migration or adhesion to other tissues, including a patient’s bowels.
3.1 Erosion of the Physiomesh’s polypropylene mesh
Like other hernia mesh devices, the Ethicon Physiomesh uses a cheap plastic called polypropylene, which erodes in oxygen. When polypropylene erodes, it deteriorates and shrinks.
Shrinking polypropylene is a serious problem in hernia mesh products because the mesh is designed to adhere to abdominal tissues and muscles. When the mesh shrinks, it tugs on the tissues that it has stuck to, causing discomfort or chronic pain. This gets much worse if nerves have formed in the tissue that has combined the mesh to the muscle.
3.2 The Ethicon Physiomesh is prone to rupturing
Ethicon Physiomesh was touted as an “ultra-light” hernia mesh that used far less plastic than other products. This was supposed to mean that there would be fewer complications from the plastic in the device. However, it also meant that the Physiomesh was much weaker than other hernia mesh implants. In some cases, the Physiomesh was so weak that a subsequent hernia burst a hole right through the mesh, requiring another hernia surgery.1
3.3 Physiomesh’s coating can lead to migration
The slick coating on either side of the polypropylene mesh was supposed to prevent the Physiomesh from adhering to other tissues in the body. However, it often keeps the mesh from sticking to the muscles and tissues that it was implanted to support before the coatings get absorbed. Numerous instances have occurred where an Ethicon Physiomesh device was implanted in a patient, only to fail to combine with the abdominal wall and migrate somewhere else.2
4. Ethicon’s Market Withdrawal of the Physiomesh
Faced with terrible results like high hernia recurrence and complication rates, Ethicon voluntarily withdrew its Physiomesh device from the market in May, 2016.3 Ethicon replaced the Physiomesh with the Physiomesh Open device. The U.S. Food and Drug Administration (FDA) saw the removal of the Physiomesh as a business decision to replace the Physiomesh device, not a safety-based recall.
So, while the Ethicon Physiomesh stopped being used as a hernia mesh implant in May, 2016, it was never officially considered a recall.