Clear and informative labeling is standard in many areas of public life, yet medical devices, such as hernia mesh, lag far behind. A recent study indicates real and dangerous consequences from inferior labeling practices for patients.
Hernia Mesh products are the subject of increased controversy and scrutiny as they have been found to be responsible for a wide range of injuries to patients who suffered from complications associated with them. For many, the warnings they received from their physicians provided them with limited understanding of the potential harm associated with the product being surgically implanted to repair their hernia. These complications have resulted in many people facing mounting medical costs, lost wages and other damages as a result of the injuries from hernia mesh, leaving many with little recourse but to pursue a hernia mesh lawsuit.
Insufficient information and warnings from product manufacturer have resulted in physicians and patients being unable to determine the true risk of injury associated with hernia mesh products. According to a study published by the Journal of the American College of Surgeons, hernia mesh labels need to follow uniform guidelines.
Research performed by Washington University at the St. Louis School of medicine examined products approved through the Food and Drug Administration’s (FDA) 510(k) fast-track approval process along with packaging for mesh products and the Instructions For Use (IFU) that is provided to physicians. A large number of hernia mesh products are approved through the 510(k) program.
The researchers found that hernia mesh devices in particular and, more generally, all medical devices, are deficient in critical scrutiny and specifications when compared to the labeling present on food labels.
They concluded that “While standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines.” This results in a situation of “extreme underreporting and lack of consistency of clinically important mesh properties.”
Hernia Mesh Lawsuits
Hernia Mesh Lawsuits continue to pursue justice for those injured by the damaging behavior of the product manufacturers. These products include Ethicon Physiomesh and other Hernia Mesh products.
After its release in March of 2010, Ethicon Physiomesh was used in hernia repair surgeries until its recall in May 2016 over concerns raised about high failure rates.
If you or a loved on has suffered as a result of a hernia mesh implant or hernia repair surgery, please contact our law firm to discuss protecting your rights. Consultations are always free and we look forward to the opportunity to speak with you.