What is a hernia?
There are several types of hernias, but most occur when an organ or tissue protrudes through a weak spot in the abdominal muscles. This can cause a bulge in the stomach or groin region that aches or burns. Depending on where the hernia is, it can also cause heartburn, vomiting and, occasionally, swelling of the testicles.
The main concern with hernias is “strangulation” of the small intestines. This occurs when the hernia blocks the blood supply to a part of the body. Strangulation can cause severe pain and tenderness in the area, and cut off blood supply, which is a medical emergency.
Some hernias, especially those that do not cause symptoms, do not require repair. But many do. In cases of strangulation, immediate surgery is required. Repair in either case may be done by open surgery or laparoscopic surgery, which can be performed with or without hernia mesh.
What is hernia mesh?
Hernia mesh is a loosely woven sheet of flexible mesh used to support weakened or damaged tissue. The majority of hernia mesh products currently on the market are constructed from synthetic materials or animal tissue.
One type of hernia mesh, made by Johnson & Johnson subsidiary Ethicon, is Physiomesh Flexible Composite Mesh, a flexible polypropylene mesh designed to reinforce the abdominal wall, preventing future hernias from occurring. Physiomesh is intended for laparoscopic use.
A study published in the journal Surgical Endoscopy involving two large, independent hernia registries found an unusually high number of recurrence and reoperation rates with Physiomesh compared to similar meshes for laparoscopic ventral hernia repair. As a result, on May 25 2016, Ethicon issued a voluntary recall of 10 models of Physiomesh.
Ethicon said it has not been able to pinpoint a cause for the product’s failure, but in the health interest of patients, the company 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.”
According to the FDA, many of the reported bowel perforation and obstruction complications in hernia surgeries are associated with Ethicon’s now-recalled surgical mesh.
Hernia Mesh Complications
Many hernia mesh complications that have been reported to the FDA have been associated with recalled mesh products no longer on the market. The most common complications associated with recalled hernia mesh include:
- Hernia recurrence
- Adhesion (scar-like tissue that sticks tissues or organs together)
- Obstruction (blockage of the large or small intestine)
- Perforation (hole in neighboring tissues or organs)
Other potential adverse events include:
- Mesh migration
- Mesh shrinkage (contraction)
According to the FDA, recalled hernia mesh were the main cause of bowel perforation and obstruction complications.
What is Physiomesh Flexible Composite Mesh?
In April 2010, the Food and Drug Administration (FDA) cleared Ethicon’s Physiomesh Flexible Composite Mesh for marketing under the agency’s 510(k) submission, known as a Traditional or Abbreviated Premarket Notification Submission. 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 that its mesh was substantially similar to Proceed mesh it already had on the market at the time. However, Proceed mesh was recalled in October 2010 due to layers of the mesh separating once implanted.
It didn’t take long for Ethicon’s Physiomesh to begin showing signs of problems, too.
Mere months after Physiomesh was put on the market, defects were discovered. The FDA began receiving reports of device failures and complications, including the recurrence of hernias, reoperations to fix the adhesions, bowel obstruction, and infections. Some patients required reoperations to remove and replace the mesh.
In 2014, an interdisciplinary forum called the Polish Studies Group conducted a randomized interventional clinical study comparing Physiomesh with another mesh for the repair of abdominal hernias, also called ventral hernias. The study was terminated due to the “high recurrence rate and findings during the reoperations.”
Toward the end of 2016, the FDA had received hundreds of adverse event reports associated with Physiomesh submitted to its Manufacturer and User Facility Device Experience (MAUDE) database. Complaints included the mesh migrating, shrinking, bunching or folding. These failures led to complications such as hernia recurrence, adhesions, bowel obstruction, pain and inflammatory reactions.
Many patients who experienced mesh failure had to undergo revision surgery to remove and replace the mesh. In one case, the mesh had migrated to a patient’s small intestines, causing an enterocutaneous fistula, and requiring surgery to remove the mesh as well as a portion of the patient’s small intestines.
There are more than, 2,000 lawsuits filed in Federal court nationwide against Johnson & Johnson’s Ethicon over its allegedly defective hernia mesh, Physiomesh. On June 2, 2017, the Judicial Panel on Multidistrict Litigation consolidated those cases under Judge Richard W. Story in the Northern District of Georgia.
On July 17, 2018, more than 20 cases filed in New Jersey state court were consolidated into a multicounty litigation under Judge John C. Porto in the Superior Court in New Jersey.
Beasley Allen Law Firm is currently investigating cases of recurring hernias, complications, the need for revision surgery, or death in patients who have received Ethicon’s Physiomesh hernia mesh.
If you or a loved one has received hernia treatment that included Physiomesh and have experienced complications, 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.