Though there are several types of hernias, most occur when an organ or tissue protrudes through a weak spot in abdominal muscles. This can cause a bulge in the stomach or groin region that aches or burns, and it can also cause heartburn, vomiting and occasionally swelling of the testicles. The condition often requires surgery where mesh, like Physiomesh, which is intended for laparoscopic use, is used to fill in a hole in the abdominal muscle or laid over or under it to prevent any further protrusions.
On May 25, 2016, Ethicon, a subsidiary of Johnson & Johnson and manufacturer of Physiomesh, issued a voluntary recall of the product due to high rates of reoccurrence. In a safety notice, the company said unpublished data using two large independent hernia registries found the need for additional operations increased when Physiomesh was used in comparison to when other similar meshes were used in abdominal, or ventral, hernias.
The company said it has not been able to pinpoint a cause for the product’s failure, but in the health interest of patients, which are at a higher risk of needing additional surgery or experiencing another hernia, Ethicon removed the product from the global market and advised medical professionals who previously treated patients with the product to “follow patients in the usual manner.”
A number of other studies have found Physiomesh to lead to additional hernias or to be the cause of additional surgeries, organ perforation, mesh migration, sepsis and even death. A study published in the journal Surgical Endoscopy concluded patients treated with Physiomesh suffered “significantly greater hernia recurrences and postoperative pain compared with (Ventralight patients).”
The U.S. Food and Drug Administration (FDA) cleared Physiomesh through a 510k submission, known as a Traditional or Abbreviated Premarket Notification Submission in April 2010. The submission classifies a product as “substantially equivalent” to other products on the market and allows it to forgo providing the extensive safety and efficacy testing required of new products or products determined to have undergone significant changes. Ethicon maintained the mesh was substantially similar to Proceed mesh it already had on the market at the time, though Proceed mesh was recalled in October 2010 due to layers of the mesh separating once implanted.
Many reported complications in hernia surgeries, according to the FDA, are associated with now-recalled surgical mesh, which it credits as the main cause of bowel perforation and obstruction complications. Defects in Physiomesh were found only after it was put on the market.
We are currently investigating cases involving serious injury or death as a result of Ethicon’s Physiomesh.
If you or a loved one has received hernia treatment that included Physiomesh and have experienced complications, reoccurring hernias or the need for additional surgeries, you may have a claim. Please contact us today by filling out the brief questionnaire or by calling toll free at 1-800-898-2034 for a free, no-cost, no-obligation evaluation of your case.