Following its first big mesh product settlement in 2016 – $120 Million to resolve up to 3,000 vaginal mesh cases – Johnson & Johnson is once again under fire. This time, it’s the multinational medical device company’s hernia mesh that’s causing complications.
Last week, Ethicon Inc., a subsidiary of Johnson & Johnson, was hit with another lawsuit over complications surrounding its Physiomesh™ Flexible Composite Mesh hernia patch. The product is intended to repair a ventral hernia: a bulge or hole in the abdominal wall, often caused by scar tissue from unhealed surgical incisions.
According to this lawsuit, the Illinois plaintiff suffered adverse reactions shortly after being implanted with a Physiomesh device. When the device failed, she underwent revision surgery to remove the device, debrided abdominal wall tissue, and a hernia sac. But she then had to endure additional surgery for further problems. These included abdominal wall reconstruction, repair of a recurrent hernia, and extensive adhesiolysis to remove thick adhesions of the Physiomesh from her small intestine.
So you get the picture: Apparent repair of the original ventral hernia evolved into a string of terrifying issues. All, unexpectedly, because of 1 defective product.
Ethicon Physiomesh lawsuits are just the latest among several other product-liability cases brought against Johnson & Johnson in the past year. For example, victims of ovarian cancer inflicted by its talc-based baby powder reached a $70 Million settlement. Other defendants were awarded $1 Billion for faulty hip implants: the third largest settlement of 2016.
Evidently, the company hasn’t yet learned its lesson with regards to product safety.
How Does Hernia Mesh Work, and What Went Wrong?
When hernias develop, they can sometimes simply be stitched back together. But larger hernias will require more than a few stitches – and that’s where surgical mesh comes in.
Hernia mesh, made with polypropylene, works by patching the area of weak tissue. Unlike stitches, it provides added strength to ensure the opening cannot pull apart in the future. Unfortunately, the goal of avoiding future hernias is exactly what Ethicon failed to achieve.
In Ethicon’s Physiomesh lawsuit, the victim’s complaint pointed specifically to the unique design of the device. This design incorporates a distinct multi-layer coating: 2 layers of poliglecaprone-25 film over 2 layers of polydioxanone film. The complaint alleged that this particular coating – exclusively used by Ethicon and no other company in the U.S. – prevented adequate incorporation of the mesh into the body.
When hernia mesh products are inserted incorrectly, complications are not limited to hernia recurrence. They also include:
- Bowel obstruction
- Chronic pain
- Mesh migration
- Foreign body response
In the Illinois Physiomesh lawsuit, the victim experienced extreme inflammatory and chronic foreign body responses, resulting in an adverse tissue reaction. This, in turn, migrated to and damaged the surrounding tissue.
Lawsuits Filed by Patients Harmed by Ethicon’s Dishonesty
What’s clear from Physiomesh cases is that the supposedly innovative design of the mesh simply isn’t worth the risk of severe adverse reactions. But why is it only now clear, after the product was introduced almost 7 years ago?
The problem is that many patients and doctors were not warned or adequately informed about the device’s risks when it was posed as a treatment option. And this failure, of course, lies with Ethicon. Of course, the risks outlined above far outweigh the benefits that patients should experience; had victims been aware of such risks, it’s likely they would’ve opted for something else.
Ethicon recalled its defective Physiomesh Flexible Composite Mesh in May last year when studies found a link between Physiomesh use and further hernias or potential revision surgery. But the damage already seems to be extensive, and the Illinois victim isn’t the only 1 to have filed a lawsuit. The first will go to trial in 2018.
In designing products that are unfit for use in hernia repair, Ethicon chose business over patient safety, plain and simple. But business is sure to take yet another significant knock when these settlements are reached.