The first Ethicon Physiomesh lawsuit is set for trial January 22, 2018. However, according to a recent study in JAMA (Journal of the American Medical Association), this could be the first of many that may emerge due to a mounting number of reports from patients of hernia surgical mesh complications.
What is Surgical Mesh?
Surgical mesh is a medical device made to provide support for tissue and organs that have been damaged or weakened. Mesh is used to reinforce a hernia repair or strengthen abdominal wall tissue. Unfortunately, there has been an increase in surgical mesh lawsuits due to allegations that the various meshes do not work as they were intended and are associated with serious complications.
The mesh is fabricated from animal tissue or synthetic materials and can be absorbable, non-absorbable, or a combination of both. Absorbable mesh loses its strength over time and is not meant as a long-term reinforcement, according to the U.S. Food and Drug Administration (FDA). The absorbable mesh, made from animal tissues degrades as the patient’s new tissue grows which should then take over and provide strength. Non-absorbable mesh is made from synthetic materials and is meant to be a permanent implant.
Hernia Mesh Lawsuit
In 2013, a man had the Physiomesh implanted to repair an abdominal wall hernia. He had to return to the hospital two years later when he was suffering from abdominal pain, fever, chills, and redness on his abdomen, according to the plaintiff’s claim.
The plaintiff suffered severe damage to his abdomen and intestines due to infection in and around the Physiomesh. He had two abdominal abscesses and intestinal fistulas from the mesh that made another surgery necessary. The plaintiff accuses Ethicon, a subsidiary of Johnson & Johnson (J&J) of negligence, strict liability, and breach of warranty. He also alleges that Ethicon designed an “unreasonably dangerous and defective product,” according to court documents. The lawsuit also maintains that the Physiomesh was not sufficiently tested and did not meet Ethicon’s usual standards and requirements.
Other abdominal mesh brands facing lawsuits due to allegedly causing complications are: Atrium Medical C-Qur Hernia Mesh; C.R. Bard’s Sepramesh; C.R. Bard’s Ventralex ST Hernia Patch; and C.R. Bard’s 3DMAX Mesh.
Product liability attorneys at Parker Waichman are actively reviewing potential lawsuits regarding medical devices including the Ethicon Physiomesh.
Hernia Mesh Study
In February 2017, JAMA published a study titled, “Recurrence and Mesh-Related Complications After Incisional Hernia Repair” that indicated patients with hernia mesh have a lower rate of hernia recurrence. However, complications may occur up to five years after the hernia surgery. In addition, according to the study, patients with mesh suffered more complications that often required major and additional surgeries.
“In this …. study including 3,242 patients, mesh repair was associated with a lower risk of reoperation for recurrence compared with non-mesh repair over a 5-year follow-up period… However, a risk of long-term mesh-related complications for open and laparoscopic mesh partially offset these benefits.”
The rate of mesh complications has greatly increased over five years. Out of those study participants, an amazing 1,050 – almost one-third – required additional abdominal surgery. Major complications were bowel obstruction, perforation, and bleeding. The larger the mesh, the greater the risk of complications.
Abdominal mesh complications may soon equal, or even surpass transvaginal mesh complaints, of which over 100,000 lawsuits have been filed. Despite reports questioning the benefits of abdominal mesh, and studies showing the risks may outweigh the benefits, mesh manufacturers continue to sell possibly defective hernia mesh and doctors continue to perform hernia mesh surgeries.
A study published in JAMA in October 2016 concluded that the “benefits attributable to mesh are offset in part by mesh-related complications.”
About 800,000 hernia repairs are performed in the United States and surgeons typically choose mesh as their best option. However, this study may cause doctors to question the current use of abdominal mesh to repair hernias, especially large pieces of mesh.
Physiomesh Voluntary Withdrawal
In 2016, Ethicon issued a voluntary withdrawal of its flexible composite physiomesh after data from two registries suggested the physiomesh had higher than expected recurrence rates. In announcing the withdrawal, Ethicon remarked that the problem may be linked to product characteristics, operative factors, and/or patient factors.
The FDA reports the common complications linked to hernia surgery that use hernia mesh are pain, infection, bowel obstruction, hernia recurrence, and adhesion (when the mesh adheres to the patient’s tissue).
“In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications,” the FDA reports.
Legal Advice and Information Regarding Mesh Implants
If you or someone you know suffered injuries associated with a hernia repair mesh implant, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).