Proceed Mesh Recall
The medical company Ethicon, a subsidiary of Johnson & Johnson, manufactures the Proceed Ventral patch. This patch is very commonly used in hernia repair providing structural support to the abdominal wall in hopes of preventing reoccurrence. Shortly after being introduced to the market, reports began flooding in from patients noting serious injuries as a result of having prolonged exposure to the mesh. A Proceed mesh recall was issued by the company on January 4, 2006. Notices were sent to hospitals instructing them to immediately stop using the product and, to return all remaining products to Ethicon.
Recalls were issued because the structural integrity of the product was being compromised once implanted in patients. The Proceed Ventral patch features a multi-layer construction. The base or structural layer is made of a light polypropylene material. Throughout this site you will notice polypropylene is mentioned multiple times. Most if not all hernia patches feature this material which is notorious for causing problems. The second layer of the patch is constructed from Oxidized Regenerated Cellulose (ORC).
What is ORC?
Great question. Let's start with cellulose. Cellulose is an organic carbohydrate and, the main component in a plant's cellular wall.
Tree trunks gain their strength and stability from the million of cells that are composed of this material. As such, it make sense to use this material as a means of providing support to openings in the abdominal wall. The problem is the material must be synthetically manufactured so it can be absorbed by the human body. Ethicon uses a process that applies radiation to the patch, thus oxidizing the cellulose.
Oxidation of the patch allows the cellulose to become absorbable in the human body but weakens the polypropylene. Exposure to radiation causes the polypropylene fibers to break down over time. Eventually the patch either tears, breaks off or migrates inside the body causing a number of serious conditions. The most common issue, however, is the separation or delamination of the two layers.
Proceed Mesh Recall
A Proceed mesh recall was issued for the delamination issue in 2006 , 2010 and 2014. Although Ethicon issued these recalls, surgeons continue to find faulty degraded patches in patients years after these notices.
The FDA continues to receive submissions through it MedWatch program. MedWatch is designed for consumers to report dangerous drugs and products. Below is just small sample of the many submission related to the Proceed patch:
- Adverse Event - Material Separation
- Adverse Event - Material Separation (2)
- Adverse Event - Device Migration
These cases occurred within the past few months and we expect to see more and more. Return to this page periodically for updated Proceed mesh recall information.
Besides delamination, the Proceed patch also has other notable flaws. The oxidation manufacturing process mentioned above breaks down the polypropylene material over time. Patches will shrink and become brittle inside the patient's body. Before long, they tear or break off and migrate inside the body. Some patients have undergone repeat operations to remove fragments of the patch. Even worse, sometimes the broken pieces are never found!
Blowouts are the other issue. As we know, the proceed patch is comprised of a super-light polypropylene designed to provide strength and flexibility. Once the patch begins degrading (sometime in as little has 6 months) it becomes increasingly weak in the center. This eventually leads to "blowouts". A blowout is when the bowel punctures through the mesh and re-herniation occurs. This leads to intense pain and bowel strangulation.[Read more about other common issues]
Proceed Mesh Injuries
Injuries are widespread and range from minor pain to severe life-threatening complications. (Check out our news blog for the latest Proceed mesh cases and settlement amounts).
Patients have reported cases of re-herniation as result of punctured or torn mesh patches. When the mesh is punctured, strangulation of the bowel occurs and additional surgery is required.
Other injuries include adhesion to internal organs which occurs when contact is made with polypropylene. Once the ORC layer erodes, the polypropylene can bind directly to organs and tissue becoming very difficult to remove. Bowel obstruction, infection and many of the other common hernia mesh complications have also been reported with the proceed patch. Again, this is due to the underlying issue of using polypropylene material.
Proceed Mesh Settlements
Patients implanted with the Proceed patch should contact us today to determine eligibility. It's possible that you may have been implanted with a recalled device. If you're experiencing pain, or have undergone multiple operations to remove or repair the device, you may be eligible. Settlement amounts depend on the nature and details of your case.[Additional Ethicon mesh settlements]
Updated Proceed mesh recall information can be found on this page and, in our news blog.
Published By: The Mesh Attorney
Author, creator and expert on hernia mesh related injuries, case and settlements.
Contact us now if you're suffering. You may be entitled to substantial compensation and the consultation is always FREE.
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