Proceed Mesh & Ventral Patch by Ethicon – Complications and Legal Claims

The Ethicon Proceed Mesh and the Ethicon Proceed Ventral Patch are hernia mesh products that are implanted during hernia surgeries. They are made by Ethicon, a subsidiary of the pharmaceutical giant Johnson & Johnson. Both devices, however, have several defects that can seriously injure patients who have them implanted and can cause chronic pain. Numerous hernia mesh lawsuits are currently pending against the manufacturer.

1. Ethicon’s Proceed Mesh and Proceed Ventral Patch

The Ethicon Proceed Mesh and the Ethicon Proceed Ventral Patch are implantable medical devices used to treat hernias. Both devices have two faces: The inward-facing side is made of polypropylene plastic mesh, while the outward-facing side is made of oxidized regenerated cellulose.

Both are used during hernia surgeries. After making an incision and correcting the hernia, a surgeon can implant an Ethicon Proceed Mesh or Ventral Patch on the weakened muscle at the location of the hernia. The mesh on each device is designed to create scar tissue that grows from the weakened muscle into the mesh’s pores, combining the strength of the mesh to the muscle. This additional support is supposed to prevent future hernias at the location.

Meanwhile, the coating of oxidized regenerated cellulose is meant to keep the polypropylene mesh from creating scar tissue and adhering to tissue on the back side of the implant.

2. Identifying the Ethicon Proceed Mesh and Ventral Patch

The Ethicon Proceed Mesh and the Ethicon Proceed Ventral Patch can be identified by product number, or by using a combination of the devices’ unique traits.

Product numbers of the Ethicon Proceed Mesh depend on the size and shape of the implant¹:

Shape	Size	Product Number
Square	15 x 15 centimeters	PCDM1
Square	30.5 x 30.5 centimeters	PCDL1
Rectangle	5 x 10 centimeters	PCDB1
Rectangle	7.5 x 15 centimeters	PCDR1
Rectangle	10 x 20 centimeters	PCDD1
Rectangle	20 x 30 centimeters	PCDJ1
Rectangle	25 x 35 centimeters	PCDW1
Oval	10 x 15 centimeters	PCDN1
Oval	15 x 20 centimeters	PCDG1
Oval	20 x 25 centimeters	PCDH1
Oval	26 x 34 centimeters	PCDT1

The product numbers for the Ethicon Proceed Ventral Patch only depend on the device’s size²:

Size	Product Number
4.3 x 4.3 centimeters	PVPM
6.4 x 6.4 centimeters	PVPS

The Proceed Mesh can also be identified using the following characteristics:

One side is made of a porous plastic mesh, while the other is made of cellulose, which feels like a smooth, silky, thin fabric, and
The side made of cellulose is cream or tan colored, while the side made of plastic mesh has blue stripes on it.

The Proceed Ventral Patch looks like a button, and has the following traits that can distinguish it from other hernia implants:

It has the same two sides as the Proceed Mesh: One made of a porous plastic mesh, and the other made of a smooth, silky, thin, fabric-like cellulose material,
The plastic mesh side has blue stripes on it, while the cellulose side is tan or cream colored,
The device is round, not oval or rectangular, and
There are two straps, protruding over an inch each, coming off the side of the device that is made of cellulose.

3. Why the Ethicon Proceed implants are defective

Ethicon’s Proceed devices suffer from several debilitating defects: The mesh can erode or rupture, and the cellulose can fail to prevent the device from adhering to unwanted tissues.

3.1 Erosion of the Ethicon Proceed’s mesh

A primary defect in the Ethicon Proceed Mesh and the Ethicon Proceed Ventral Patch is the polypropylene mesh, which erodes and deteriorates when it comes in contact with oxygen. Because this mesh is made to combine with tissues in the body after implantation, when it shrinks it can pull on those internal muscles and cause discomfort and pain. When nerves have grown into the mesh, that tugging action can cause chronic pain.

Most hernia mesh devices have this deterioration problem because most rely heavily on polypropylene mesh. However, the implants in Ethicon’s Proceed line are especially prone to erosion because of how Ethicon sterilizes the cellulose layer.

All hernia mesh devices are sterilized before being packaged and shipped. Most hernia mesh implants are sterilized with ethylene oxide. However, the Ethicon Proceed implants are sterilized with radiation, possibly because this radiation oxidizes the cellulose layer used on the Proceed implants to make the cellulose absorbable in the body.

By adding oxygen to the cellulose side of the Proceed implant, this radiation sterilization process triggers the deterioration process in the polypropylene even before it is shipped to hospitals. By the time a device is implanted, it could have been eroding for months or even years.

3.2 Light mesh can rupture or tear

Ethicon touted its Proceed implants as having far less polypropylene mesh than other hernia mesh devices. While the claims insinuated that having less mesh was a good thing and that it minimized the chances of a complication, it overlooked the fact that less mesh made the device weaker.

There are numerous reported cases of patients suffering recurring hernias that broke right through the Ethicon Proceed Mesh or Ventral Patch.³ In some other cases, the mesh was so weak that it tore during the implantation, significantly complicating the procedure.⁴

3.3 Cellulose coating can fail to contain mesh

Because the polypropylene mesh can create serious problems if it sticks to the wrong tissues, muscles, or organs, Ethicon’s Proceed implants coat the backside of the product with cellulose. This cellulose, however, does not always succeed.

The cellulose layer is porous enough that the polypropylene mesh can reach right through it and cause enough scar tissue that it joins to the muscles and tissue on the far side. Additionally, the cellulose layer is poorly fixed to the layer of polypropylene mesh, and can peel right off the mesh to leave it exposed. Finally, the cellulose layer is designed to be absorbed in the body over time. If the cellulose is absorbed before the polypropylene mesh has created enough ingrowth in the tissues it was supposed to join, it can begin to combine with other tissues, as well.

4. No recall for the Ethicon Proceed Mesh or Ethicon Proceed Ventral Patch

In spite of the numerous problems with the Ethicon Proceed Mesh and the Ethicon Proceed Ventral Patch, there has been no recall to pull them from the market and they continue to be used during hernia surgeries. Victims who have been hurt by the implants have filed thousands of hernia mesh lawsuits against Ethicon and Johnson & Johnson.

Legal References:

Ethicon Proceed Product Description.
See note 1.
See MAUDE Report 2210968-2013-00947 and MAUDE Report 2210968-2011-00694.
See MAUDE Report 2210968-2017-31446 and MAUDE Report 3124889.

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