Ethicon recalled 10 models of its Physiomesh hernia mesh in May 2016 due to hernia mesh complications.
Hernia mesh has been linked to hernia mesh complications including recurrence of hernias, infections, reoperations to fix the adhesions, bowel obstruction, and organ or tissue perforation. If you or a loved one has been injured by Ethicon’s Physiomesh hernia mesh, you may have a case against the manufacturer.
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. It is intended for laparoscopic use. Physiomesh was recalled in 2016 after it was linked to numerous hernia mesh complications.
Hernia mesh lawsuit
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. Hernia mesh complications include recurrence of hernias, infections, reoperations to fix the adhesions, bowel obstruction, and organ or tissue perforation.
Beasley Allen is handling lawsuits for people who have undergone hernia repair surgery using Physiomesh and suffered hernia mesh complications.
Hernia mesh complications
Many hernia mesh complications that have been reported to the FDA are associated with Physiomesh’s recalled hernia mesh no longer on the market due to hernia mesh failure.
Symptoms of hernia mesh failure include:
- Pain, either shooting, radiating or chronic at or near the surgery site, including in a testicle
- Burning sensation at the surgery site
- Inflammation or swelling
- Feeling the mesh inside you
- Painful ejaculation or intercourse
- Tugging feeling inside abdomen
- Tingling or pins-and-needles sensation
The most common complications associated with recalled hernia mesh failure:
- Mesh migration: When the hernia mesh loosens, breaks or tears from the site where it was originally implanted and moves inside the body.
- Mesh shrinkage or contraction: When mesh shrinks or contracts from its original size.
- Erosion: When mesh migrates within the body, the integrity of the mesh can break down and begin to erode into tissue.
Hernia mesh failure can cause problems such as:
- Adhesion: This occurs when hernia mesh sticks to internal tissues or organs.
- Obstruction: Obstruction can occur if the mesh migrates or adheres to the tissue and causes a blockage of the large or small intestine, leading to symptoms such as constipation or diarrhea.
- Perforation: This occurs when the mesh erodes or shrinks and bores a hole in neighboring tissues or organs.
- Hernia recurrence: This may require an additional surgery.
- Infection: Signs of infection include severe headaches, fever, and sweating. Infections may also lead to sepsis.
According to the FDA, recalled hernia mesh was the main cause of bowel perforation and obstruction complications.
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.
Hernia mesh recall
On May 25, 2016, Ethicon issued a voluntary recall of 10 models of Physiomesh after 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.
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 hernia mesh from the global market and advised medical professionals who previously treated patients with Physiomesh 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.
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 hernia mesh was substantially similar to its Proceed mesh it 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.
What is Physiomesh Flexible Composite Mesh?
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.
Hernia mesh lawsuits
Currently, there are more than 3,000 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. Four hernia mesh cases were selected to serve as bellwethers, the first of which is scheduled to begin Jan. 25, 2021. The second is planned for March 29, 2021, and the third on June 7, 2021. No date has yet been set for the fourth bellwether hernia mesh case.
On July 17, 2018, an additional 20-plus 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.
Other hernia mesh lawsuits
Hernia mesh manufacturers C.R. Bard and Atrium also face lawsuits over hernia mesh complications.
- Bard faces more than 9,000 lawsuits consolidated in the Southern District of Ohio. The first bellwether was scheduled for May 2020, but was postponed to September 2020 and finally to Jan. 11, 2021, due to the coronavirus pandemic. In 2011, C.R. Bard paid $189 million to settle about 3,000 lawsuits involving its Davol’s Kugel hernia patch, which had been recalled due to hernia mesh complications in 2005.
- Atrium faces more than 2,300 lawsuits over its C-QUR hernia mesh in New Hampshire federal court. The first bellwether trial in that multidistrict litigation was scheduled for May 2020 but was moved to 2021, at Atrium’s request, due to COVID-19. The trial is now set for Jan. 20, 2021.
Hernia mesh lawyers
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.