Hernia Mesh Complications-Canadian Concern over Insufficient TestingMay 24, 2017
Hernia repair is a common surgical procedure, with approximately 80,000 people having such procedures in Canada every year, and about 20 million worldwide. Dr. John Morrison, the president of the Canadian Hernia Society and one of the country's foremost authorities on surgical abdominal mesh says that almost all hernias are now repaired with mesh. Dr. Morrison feels that some products are brought to market without appropriate research or sufficient clinical trials.
About 15 percent of abdominal hernia patients develop complications and severe pain, often from complications stemming from the mesh itself. Since 2000, Health Canada has recalled or removed 12 brands of hernia mesh from the market, mostly due to reports of infection or perforation.
There have been 185 reports of serious injury and other complications, including three deaths, in Canada. "The mesh can erode into other organs over a period of time," Dr. Morrison told CTV News, adding that studies show 10 to 20 percent of hernia patients are left with chronic pain. A part of Dr. Morrison's practice deals with removing plastic mesh that has migrated and punctured organs. He has seen how mesh has moved into the bladder and stomach, and says that many young people (the average age of developing a hernia is 50) have become incapacitated.
The national law firm Parker Waichman LLP has extensive experience in medical device lawsuits and is closely monitoring potential hernia mesh litigation. Attorneys at the firm are available to answer any questions for those individuals seeking legal information.
Attempts to Alleviate the Mesh Issues
Morrison and other colleagues, say the mesh material is allegedly the major reason for so many complications and subsequent recalls. Some medical device companies market products that have not changed much since kugel mesh was approved in 1996. The hernia patch is made of plastic chemical polymer with a ring around the patch that may break and move into the patient's skin or organs and cause tremendous pain and complications. Some people have died allegedly as a result.
The hernia patch is a welcome improvement, but there is some skepticism as the "new and improved" hernia patch is approved by the U.S. Food and Drug Administration's (FDA) 501(k) process. This allows the new product to forego the typically rigorous clinical trials because the product is "sufficiently similar" to a product that has already been FDA approved, such as the kugel mesh.
Lawsuits Involving Mesh Products
Atrium, the maker of Secure Mesh, is facing a wrongful death lawsuit. This hernia mesh product was coated with Omega 3 acids, or fish oil, that apparently caused severe reactions leading to infection and adhesions, and allegedly to death. Secure mesh did not undergo clinical trials, but with rats, rather than human beings. Two of the 18 rats implanted with Atrium's mesh died.
In addition, Physiomesh, made by Ethicon, a subsidiary of Johnson & Johnson (J&J) is a mesh products that was recalled in 2016 after about 650 adverse event reports filled with the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Considering there were over 330,000 Physiomesh devices sold and implanted worldwide, hundreds of lawsuits are anticipated.
Despite these disturbing numbers of adverse events and recalls, companies such as Ethicon and Atrium continue to release their mesh products to the market through the 501(k) process. There is some speculation that abdominal mesh lawsuits are expected to equal or even outnumber transvaginal mesh lawsuits.
In another case, a $20 million verdict has been awarded against J&J in punitive damages, when a 12-member jury hearing the case in Philadelphia returned the verdict after testimony was given by the plaintiff demonstrating she suffered life-altering injuries when the mesh eroded inside of her. The verdict also includes a $2.5 million award for compensatory damages.
According to court documents, the plaintiff alleged she had undergone surgery to implant Ehicon's TVT-Secur mesh to treat her stress urinary incontinence. However, just two months later, her doctor discovered erosions in the material. The plaintiff complained that the eroding mesh began causing her pain and she was eventually forced to undergo three additional surgeries, to remove the material. However, despite all efforts, portions of the mesh remain in her body and she had developed chronic pain and urinary dysfunction, according to court papers.
The plaintiff alleged that Ethicon's TVT-Secur mesh was "defective in design, warnings and instruction" and that J&J released the product to market in full knowledge of the significant risk associated with the mesh implants, specifically the danger that the mesh would erode inside patients.
Legal Advice and Information Regarding Mesh Implants
If you or someone you know suffered injuries associated with a hernia repair mesh implant, you may be eligible for valuable compensation. 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).