PHYSIOMESH LAWSUIT AND RECALL
Different types of hernia mesh devices made by various manufacturers have been associated with design defects that could cause severe and even life-threatening complications after hernia surgery
Physiomesh Lawsuit and Recall
Different types of hernia mesh devices made by various manufacturers have been associated with design defects that could cause severe and even life-threatening complications after hernia surgery.
Surgical mesh lawsuits have been filed alleging the various meshes that do not work as they were intended and that are linked to serious complications.
Multiple hernia mesh lawsuits have been filed recently as a result of problems with the Ethicon Physiomesh, Atrium C-Qur, and Kugel Patch brands.
Ethicon, a Johnson & Johnson subsidiary company, announced a recall for Ethicon Physiomesh Flexible Composite Mesh on May 25, 2016, after data from European hernia registries disclosed higher rates of hernia recurrence and reoperation in patients who received Ethicon Physiomesh Composite Mesh when compared to patients who received a similar mesh product for hernia repair.
Manufacturers of hernia repair mesh FAILED to adequately research their products post-surgical effects and properly warn patients and doctors about risks associated with these devices.
In many cases, it appears the manufacturers knew or were warned about these problems before the hernia mesh device was released to the market.
Hernia Mesh Problems
According to a study published in Research Gate journal, 10% of people implanted with hernia mesh experienced infections after surgery.
“Common adverse events: Patient reported recurrence (4.8%), investigator confirmed recurrence (1.55%), seroma (4.5%) and hematoma (1.6%).”
An independent review, “Mesh Infection and Hernia Repair” published in March 2016, stated that “The use of a prosthetic mesh to repair a tissue defect may produce a series of post-operative complications, among which infection is the most feared and one of the most devastating”
FDA Hernia Mesh Recall
In October 2014, the FDA issued an official warning about problems related to use of hernia mesh devices:
"FDA wants to inform you about complications that may occur with the surgical mesh that is sometimes used to repair hernias"
In 2010, the FDA issued a Class I Recall and Safety Investigation of Counterfeit Polypropylene Surgical Mesh.
“On June 2, 2010, FDA classified the distributor's voluntary recall as a Class I recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death”
The American College of Surgeons stated in its internal session “Infected Mesh: Prevention Strategies and Management” that “The problem of mesh infection has grown as the accepted practices of incisional and ventral hernia repair include the use of mesh in almost all circumstances”
The Huffington Post ran an article in 2001 with the alarming title “FDA Says ‘No More Mesh’ for Hernia Repairs — What Are the Consequences?"
The FDA announced that mesh, used during surgery to treat pelvic organ prolapse, has an extremely high rate of erosion (up to 10%) and probably shouldn’t be used.
Hernia Mesh Complications
Multiple studies and research results have shown the following possible complications from hernia mesh devices like Physiomesh, Atrium C-Qur, Kugel Patch and others:
- Severe groin pain
- Need for surgical revision
- Hernia recurrence
- Mesh folding
- Mesh migration or movement
- Tissue adhesion
- Seroma or fistula
What is Surgical Mesh?
Surgical mesh is a loosely woven sheet used as a permanent or temporary support for organs and other tissues during surgery.
Surgical mesh is created from synthetic and/or biological materials.
Surgical mesh is designed to provide support for tissue and organs that have been weakened or damaged.
Abdominal surgical mesh (a.k.a. hernia mesh) is used to help repair hernias in the patient's abdomen.
Surgical mesh has been used in hernia repair surgeries since the 1950s.
In the United States, hernia repair is one of the most commonly performed surgeries, with more than one million people having this surgical procedure every year.
ETHICON PHYSIOMESH® Flexible Composite Mesh is a registered trademark of JOHNSON & JOHNSON
C-QurTM is a registered trademark of Atrium Medical Corporation
Bard®, PerFix®, 3DMax®, Composix®, Dulex® and Kuge®l are registered trademarks of C.R. Bard Inc. or an affiliate
Ventralex® and CruraSoft® are trademarks of C.R. Bard, Inc. or an affiliate Davol Inc.
What is hernia?
Hernia is a bulging of an organ or tissue through an abnormal opening.
What is hernia mesh?
Mesh, also referred to as a "patch" or a "screen," is a product that many surgeons use to repair hernias. surgeons typically use a sterile, woven material made from a synthetic plastic-like substance, such as polypropylene. The mesh can be in the form of a patch that goes under or over the weakness, or it can be in the form of a plug that goes inside the hole. Mesh is very sturdy and strong, yet extremely thin
What is revision surgery?
It is any surgery performed to fix or lessen injuries caused by the implant. These surgeries may allow the original implant to remain or for the implant to be replaced.
What is extrusion of the mesh device?
Extrusion of the mesh device is when the mesh erodes through the skin and tissues and becomes exposed through the skin.
What is hardening of the mesh device?
The plastic materials these devices are made of can often become hard and brittle after surgery. As a result, the hardened mesh can break apart into sharp mesh fragments that cut surrounding tissue and perforate nearby organs. When mesh abnormally hardens, especially in the walls where muscles constantly expand and contract, pain, infection, tissue destruction, and nerve damage may occur as a result.
What is mesh failure to incorporate?
Polymer materials often used in surgical mesh might not incorporate into human tissue properly. Poor tissue incorporation increases hernia recurrence and an infection risk. As a result, many patients have experienced the surgical mesh tear apart inside of them. Inability of mesh material to properly incorporate results in the mesh floating and moving around in the patients.
What is bowel obstruction?
A gastrointestinal condition in which digested material is prevented from passing normally through the bowel.
What is bowel perforation?
Gastrointestinal perforation (GP) occurs when a hole forms all the way through the stomach, large bowel, or small intestine. A bowel perforation is a surgical emergency, and needs immediate treatment to prevent further complications such as infection or even death.
What is fistula?
An abnormal connection between organs.
What is seroma?
A seroma is a collection of fluid that builds up under the surface of your skin. Seromas may develop after a surgical procedure, most often at the site of the surgical incision or where tissue was removed. The fluid, called serum, doesn’t always build up right away. The swelling and fluid may start collecting several weeks after surgery.
What are mesh adhesions?
Adhesions are fibrous bands that form between tissues and organs, often as a result of injury during surgery. They may be thought of as internal scar tissue that connects tissues not normally connected.