Abdominal Mesh Recall
Abdominal Mesh Recall
After two separate studies have found the product ineffective, Ethicon has withdrawn the Physiomesh Composite Mesh hernia patch. The studies found a better chance of recurrence (a hernia reopening) which leads to additional surgery, compared to similar products.
Nolan Caddell Reynolds is accepting Physiomesh induced injury cases. If you or somebody you know had hernia recurrence or surgery, use the form below to contact our Drug Recall Litigation Team for a free consultation.
What is a Ventral Hernia?
Ventral hernias occur when internal organs squeeze through a hole or weak spot at the site of a previous surgical incision. Ventral hernias can occur weeks, months, or even years after a surgery. Small hernias can be repaired with a few stitches. Large and complex hernias often require major reconstructive surgery on the abdominal wall.
Each year,100,000 to 150,000 ventral hernia are repaired in the U.S. Commonly, surgeons stitch a mesh patch over the hernia to strengthen the abdominal wall. However, some meshes are better at preventing recurrence than others. Another problem is that mesh increases the risk of rare but serious long-term side effects.
What is Physiomesh?
Physiomesh is a hernia patch made of flexible, non-absorbable, plastic filaments woven into a fabric. The patch is laminated between two layers of Monocryl (poliglecaprone), which is intended to have anti-inflammatory or anti-adhesion benefits.
FDA Approved Without Clinical Trials
Physiomesh was FDA approved with a 510(k) application, allowing it on the market (in March of 2010) without new safety studies because it was “similar” to other types of hernia mesh on the market.
Pulled Off Market Due to Revision Surgery Risk
In 2016, Johnson & Johnson voluntarily withdrew the Ethicon Physiomesh® Flexible Composite Mesh from the global market due to an increased risk of side effects. Studies from Germany and Denmark found higher rates of hernia recurrence and reoperation compared to similar products, according to the FDA.
Complications of Hernia Mesh
- Chronic pain
- Hernia recurrence
- Adhesion (scar-like tissue that sticks tissue together)
- Intestinal blockage
- Mesh migration
- Mesh shrinkage (contraction)
Do I Have a Physiomesh Lawsuit?
Nolan Caddell Reynolds is currently accepting Physiomesh induced injury cases. If you or somebody you know had hernia recurrence or surgery, use the form below for a free consultation!