Ethicon’s Physiomesh Breeds Despair After Repair
It happens. After surgery you’re feeling better and the next thing you know, there is a lump in your abdominal area that wasn’t there before. You talk to your doctor and discover you have a ventral hernia, also known as an incisional hernia.
These type of hernias occur when fatty tissue or internal organs migrate through a weak spot at the site of a previous surgical incision. Ventral hernias can develop weeks or even years after surgery. These type of hernias are very common. An estimated 4 million laparotomies are performed in the United States every year. Approximately 2-30% of these surgical procedures produce an incisional hernia.
Incisional hernia repair is one of the most common general surgical operations. Prosthetic mesh is often used to strengthen these repairs. There are many reasons why hernias develop including:
- Congenital defect
- Weakness of the abdominal wall due to surgical incision
- Injuries to bowel area
- Family history
- Frequent heavy lifting
If you had hernia repair surgery between October 2010 and June 2016, your surgeon may have used Physiomesh to repair your hernia.
Ethicon, a division of Johnson & Johnson, introduced Physiomesh as a hernia repair solution in 2010. Physiomesh is made of a sterile and flexible composite mesh. It was designed to repair ventral hernias and other fascial inadequacies.
In May 2016, Ethicon issued a formal withdrawal of its Physiomesh product after an analysis of unpublished information found higher than average recurrence of hernias and an increase in reoperations when Physiomesh was used in the initial surgical procedure.
Complications experienced by hernia repair patients that received Physiomesh include:
- Hernia recurrence
- Severe pain
- Intestinal blockage
- Mesh migration
- Mesh shrinkage
- Surgery to remove the mesh
Ethicon made the decision to introduce Physiomesh without the meticulous pre-market research that may have exposed the potential dangers and risks of using this hernia repair device. The manufacturer decided against obtaining the standard FDA approvals that give health professionals and patients alike the confidence that the device is not dangerous and safe to use. Instead, Ethicon opted to seek FDA approval through the 501(K) exemption process. This process permits products that are considered to be low-risk to forego the pre-market research and trials. This exemption does assert that the manufacturer has the obligation to offer a reasonable assurance of safety and effectiveness.
If you are not sure if you received Physiomesh to repair your hernia, you should contact your doctor or the surgeon who repaired your hernia. Your health professionals will be able to give you the specifics regarding the device that was used during your surgical procedure. Keep in mind, doctors are not obligated to notify their patients of voluntary product withdrawals.
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