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 main concern with hernias is strangulation, when the hernia blocks the blood supply to a part of the body. This can cause severe pain and tenderness in the area.
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 mesh.
Hernia mesh is a loosely woven sheet of flexible mesh used to patch the weakness or plug up the hole in lieu of stitching. 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, to fill in a hole in the abdominal muscle or laid over or under it to prevent any further protrusions.
FDA approval of Ethicon Physiomesh Flexible Composite Mesh
In 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 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.
It didn’t take long for Ethicon’s Physiomesh to begin showing signs of problems.
Mounting problems with Physiomesh
Mere months after Physiomesh hit the market, the FDA began receiving reports of device failures and complications, including the recurrence of hernias, reoperations to fix the adhesions, 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 or ventral hernias. The study, which was published in the journal Surgical Endoscopy, 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 events with Physiomesh to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database including complaints of mesh failures, such as mesh migration, shrinkage, bunching or folding. These failures led to hernia recurrence, adhesions, and complications like bowel obstruction, pain, and inflammatory reactions.
Many patients 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, requiring surgery to remove the mesh as well as a portion of the patient’s small intestines.
Ethicon Physiomesh Recall
In 2016, Ethicon announced it was withdrawing 10 models of Physiomesh from the global market after two large, independent hernia registries found an unusually high number of recurrence and reoperation rates with the mesh for laparoscopic ventral hernia repair.
On May 25, 2016, Ethicon 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).”
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.
Physiomesh Lawsuits: Patients may be entitled to compensation
Beasley Allen Law Firm is currently investigating cases of recurring hernias, complication or the need for revision surgery in patients who have received Ethicon’s Physiomesh for hernia repair. 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.