Patients with hernias often require surgery to place stitches and make repairs where the hernia is located. In the case of patients with a ventral hernia which is found in the abdominal wall, surgical repairs can be time intensive and painful to recover from. Ventral hernias can also commonly occur after surgery which make repair efforts even more difficult.
To offer ventral hernia patients a faster and less intrusive surgical procedure, surgeons have started using hernia patches which are made of porous prolene polypropylene mesh. These flexible mesh patches are designed to keep the internal organs and tissues in place and permanently stop hernias from occurring.
In May 2010, Ethicon placed their own version of surgical mesh on the market called Physiomesh. The manufacturer wasn’t required to test the hernia mesh on humans since they claimed it was “similar” to other types of mesh. Unfortunately, this particular mesh has distinct design differences that have dire consequences. As a result, patients around the United States are now experiencing major pain, hernia recurrence, adhesions, and debilitating consequences after having the mesh inserted.
In May 2016, Johnson & Johnson issued a voluntary global market withdrawal for Ethicon Physiomesh hernia mesh. Multiple lawsuits are now targeting the manufacturer claiming that the product should have been tested and features a defective design. If you’ve had the mesh surgically inserted and are experiencing complications, you may be eligible to file a Physiomesh hernia mesh lawsuit as well. First, let’s go over the facts.
How Does Ethicon Physiomesh Flexible Composite Mesh Work?
A ventral hernia is a bulge of tissues, organs, or intestines that works its way through an opening, defect, or surgical incision in a patient’s abdominal wall. Hernias that happen at surgical locations are called incisional hernias. These tend to occur at a body’s weak point or where the skin or tissues are abnormally thin.
Most types of hernia mesh are created with bioabsorbable components which the body will partially absorb. This helps the body create a naturally-enforced barrier that separates the tissues securely and strongly. Most types of mesh are also made with porous materials which additionally promote natural ingrowth. This allows the body to accept the mesh and prevent adhesions.
With Ethicon’s Physiomesh intraperitoneal onlay mesh (IPOM), the porous mesh material is surrounded by thick polymer films that are supposed to provide additional support, but end up causing a chronic foreign body reaction. The abdominal tissues view the Physiomesh patch as a foreign object and are forced to grow “on” it rather than absorb it. This causes painful, severe adhesions as well as inflammation and infection.
As mentioned above, this type of hernia mesh was not tested on humans. The preclinical simulated test results weren’t promising, however. They resulted in adhesions, migration of the patch, and mesh shrinkage. Ethicon, the manufacturer of the Physiomesh hernia mesh, blamed the results of the study on the study’s design and hid the results. The company was granted access to the FDA’s 510(k) approval program which allowed them to skip additional testing and quickly make the product available for sale.
Physiomesh Hernia Mesh Complications
Patients who have had the Physiomesh hernia mesh inserted have come forward reporting several severe, painful reactions and symptoms. The most common—which are reported by at least 50% of those who have had the mesh inserted—include the following:
- Severe pain
- Bowel obstruction
- Mesh shrinkage, tearing, or migration
- Hernia recurrence (often caused by mesh shrinkage, migration, or tearing)
- Painful, dense adhesions (scar-like tissue that abnormally grows inside the body)
- Seroma (fluid buildup under the skin)
- A lack of natural ingrowth between the mesh and the abdominal tissues (which goes against the product’s original advertising campaign)
For victims of the above complications and symptoms, a second surgery is required to remove the mesh hernia patch and repair the damaged tissue.
When Johnson & Johnson issued a recall for the Ethicon Physiomesh Flexible Composite Mesh, the company said that the recall was due to risk factors related to hernia recurrence. Ethicon stated that they believed the higher recurrence/revision rates were due to a “multifactorial issue” that included product characteristics as well as operative and patient factors. The defects are currently under investigation and there are no plans to place it back on the market again.
Don’t Wait to File a Physiomesh Hernia Mesh Lawsuit
If you or a loved one has had abdominal hernia repair surgery between the years 2010 and 2016 and feel you may have had the Ethicon Physiomesh patch inserted, you should follow up with your doctor—even if you are not experiencing any of the symptoms listed above. You should have the mesh device removed and replaced with a safer type of mesh or repair procedure.
If, unfortunately, you’ve already begun to experience negative symptoms such as those listed above, you should act as quickly as possible and get the medical help you need. Afterwards, you are encouraged to contact Thomas Law Offices and find out if filing an Ethicon Physiomesh lawsuit is in your best interest. Ethicon had no right to hide the mesh’s preclinical test results. Their actions directly resulted in the pain and suffering of innocent victims.
There are currently three lawsuits due to go to court at the beginning of 2018. Many more lawsuits are expected to follow. Thomas Law Offices has years of experience taking on and succeeding with other product liability and defective medical device lawsuits. We won’t hesitate to take your case to court and fight vigilantly on your behalf.
For more information, contact our Kentucky office today. Tad Thomas, Physiomesh hernia mesh lawyer, and his expert team of product liability attorneys will be happy to assist you right away. Don’t let corporations control the health and safety of our nation. With the help of our law firm, you can fight back.