Ethicon Physiomesh patches are used to help repair abdominal hernias. However, this product has been linked to many serious injuries and side effects, including abdominal pain, damage to internal organs and hernia recurrence. It was recalled by the manufacturer in June 2016.
If doctors used an Ethicon Physiomesh patch to repair your hernia, and you have suffered side effects or had to undergo additional surgery, you should speak with our Cincinnati Ethicon Physiomesh lawyers. Our skilled defective medical device attorneys can inform you of your legal options in a free, no obligation legal consultation. You will not be charged for our services unless we secure a favorable settlement or jury verdict.
FDA APPROVAL
Ethicon Physiomesh hernia patches hit the market in March 2010, after receiving approval from the U.S. Food and Drug Administration (FDA) through its 510(k) approval program.
The 510(k) program allows the FDA to approve a medical product as long the manufacturer shows it is substantially similar to another product that has already received FDA approval. In this case, Ethicon demonstrated that Physiomesh patches are similar to Proceed hernia patches, also manufactured by Ethicon.
The 510(k) program also allows products to bypass the rigorous research and testing that other products are subject to under the FDA's normal approval process.
PHYSIOMESH SIDE EFFECTS
Hernia patches like Ethicon Physiomesh are designed to provide permanent support to damaged or weakened tissue.
Physiomesh is a synthetic patch constructed with flexible plastic filaments that are woven into a fabric between two layers of Monocryl, which prevents the fabric from adhering to tissues or internal organs. This is critical because the fabric contains polypropylene, which can cause severe injuries to patients if it adheres to any body parts.
Physiomesh is made with less polypropylene than other hernia patches, which makes the patch weaker and increases the risk that it will rip apart and expose patients to polypropylene.
When these patches fail, they can cause many severe, potentially life-threatening injuries, such as:
- Abdominal pain
- Urinary problems
- Bleeding
- Disfigurement
- Granulomas
- Damage to internal organs
- Obstructions in the bowels
- Seromas
- Severe infections
- Protrusion of the mesh
- Hernia recurrence
Many patients who experienced these side effects had to undergo corrective surgery to remove the patch and avoid further injury. However, surgery increases the risk of infection, excessive bleeding and injury to nearby organs and tissues.
Have you suffered side effects after being implanted with Ethicon Physiomesh? The experienced Cincinnati lawyers at O'Connor, Acciani & Levy may be able to file an Ethicon Physiomesh lawsuit.
STUDIES ON ETHICON PHYSIOMESH PATCHES
Since this product was approved in 2010, the FDA has received more than 600 reports of adverse events related to these patches.
Multiple studies have bolstered the connection between Ethicon Physiomesh and dangerous side effects and complications.
In a randomized study published in the spring of 2016, researchers studied 50 patients implanted with Physiomesh and 50 patients implanted with Ventralight patches. They discovered that 20 percent of Physiomesh patients developed hernias while none of the Ventralight patients did. Researchers concluded that elastic mesh may be a safer alternative for laparoscopic hernia repair.
A June 2016 study revealed that Physiomesh patients suffered more hernias regardless of the technique used to implant the device.
In August 2016, researchers published a study comparing Physiomesh to two other hernia patches. They found that the other two patches were more effective in supporting damaged tissue to help the hernia heal. The study also revealed that Physiomesh caused more patients to suffer seromas than the other two patches.
ETHICON PHYSIOMESH LAWSUITS
In April of 2016, the first Ethicon Physiomesh lawsuit was filed by a man who alleged he developed an intestinal fistula and multiple abscesses after being implanted with a patch to repair a hernia.
Another lawsuit was filed in September 2016 by a woman from Florida who claims the patch grew into her intestines. She needed surgery to have the mesh removed. The lawsuit alleges that the product has a defective design and is unreasonably dangerous.
A Georgia woman also filed a lawsuit against Ethicon after she experienced pain and nausea after being implanted with the patch. She had to have corrective surgery to fix the damage done by the patch.
These could be the first of many Ethicon Physiomesh lawsuits to be filed. About 300,000 people have been implanted with these patches since they were approved in 2010, according to a November 2016 estimate.
Our Cincinnati Ethicon Physiomesh lawyers are ready to pursue compensation through a class action lawsuit. We are committed to holding manufacturers liable for producing and distributing dangerous medical devices that cause severe injuries to patients.
Your initial consultation with our attorneys is completely free and comes with no obligation to pursue a claim. The attorneys at O'Connor, Acciani & Levy have a long track record of obtaining fair compensation for victims of negligence.
