Physiomesh Flexible Composite hernia mesh has been associated with an increasing amount of injuries such as bowel obstruction, fistulas, seromas, infection and mesh migration. Physiomesh is also the target of multiple lawsuits across the nation.
Note: Physiomesh is not the only hernia mesh product that our lawyers are filing lawsuits on. Please visit the following link to read more about the controversy surrounding a number of defective hernia mesh products: Hernia Mesh Lawsuit
Physiomesh hernia mesh has gained attention in courthouses across the country due to the increased occurrence and reporting of adverse effects prompted by the implant. Thousands of Physiomesh lawsuits have been filed across the country to hold hernia mesh manufacturers accountable for the damaging results of defective hernia mesh devices.
Physiomesh mesh implants (devices or patches) are manufactured by Ethicon, a subsidiary of pharmaceutical giant Johnson & Johnson. In May 2016, Ethicon issued a voluntary Class II recall of Physiomesh from the U.S. markets due to complications in patients with the mesh implant. Independent studies showed Physiomesh caused a higher rate of revision surgeries than other mesh products on the market due to poor construction. A Food and Drug Administration Class II recall indicates a product poses “temporary” or “medically reversible” complications.
Physiomesh was approved in April 2010 through an FDA 510(k) clearance that allows “substantially equivalent” medical devices to bypass clinical trials. This controversial practice has allowed manufacturers to put patients at risk of experiencing severe complications from failed mesh such as bowel perforation, infection, device migration and more.
An estimated one million people undergo hernia repair surgery each year in the United States. They typically develop in the inner groin (inguinal), outer groin (femoral), belly button (umbilical), upper stomach (hiatal), or due to an incision (incisional), and Physiomesh is one of the more popular products.
Hernias occur when an organ or fatty tissue squeezes through a weakened spot in a muscle or connective tissue, causing a painful bulge. They occur for a variety of reasons such as poor diet and nutrition, incorrectly lifting heavy objects, persistent coughing, diarrhea or constipation, and more. Smoking contributes to weakening muscles throughout the body which are therefore more likely to develop a hernia.
Mesh became a popular treatment for hernia repair surgery in the 1980s. The net-like quality of mesh is intended to stimulate healthy tissue growth by keeping the bulging hernia in place. It is placed over the site of a hernia and held in place with either surgical tacks, stitches, glue or staples, at the surgeon’s discretion.
Like many hernia mesh implants, Physiomesh is constructed of polypropylene, which is a form of plastic. Polypropylene is the same material used in Ethicon’s highly controversial transvaginal mesh implants and bladder slings. Ethicon has faced thousands of lawsuits for defective transvaginal device implants.
Ethicon has continued to develop mesh products, despite reported complications. Physiomesh was developed with the intention that a lighter quantity of polypropylene would combat previous versions of Ethicon’s hernia mesh implants. However, the lighter weight of the mesh has contributed to disintegration, migration, tearing and more.
Types of Physiomesh Injuries Reported in Hernia Mesh Lawsuits
Serious accounts of defective Physiomesh hernia mesh products have been reported through the Food and Drug Administration Adverse Event Report System (FAERS).
Common complications from Physiomesh include:
- Nausea and vomiting
- Device migration
- Bowel obstruction
- Revision surgery
- Nerve damage
- Mesh shrinkage
- Adhesion (a “melting” of the mesh into surrounding organs and tissues)
- Pain (from a shrunken or deformed patch)
Packaging Issues Reported With Physiomesh
In addition to defects in the makeup of the mesh implant, the foil packaging of Physiomesh has been under scrutiny for subjecting the implant to unsterile conditions. The packaging has a tendency to wrinkle and create small holes, subjecting the patch to contamination which is then implanted in a patient, unbeknownst to the surgeon. Though surgeons are required to examine medical devices prior to surgery, the clandestine holes are very hard to detect.
FDA Physiomesh Warning
In April 2017, the FDA made an announcement that, “…Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with the recalled mesh. In the FDA’s analysis of medical adverse event reports, recalled mesh products were the main cause of bowel perforation and obstruction complications.”