Since 2006, there have been over 100,000 pelvic mesh lawsuits filed against manufacturers for supplying defective and dangerous products. For many of these big-brand manufactures, this is simply deemed the cost of doing business.
While pelvic mesh litigation began attracting more and more attention, many manufacturers shifted their focus to using the same dangerous materials to design new hernia mesh implants.
Hernia Mesh Lawsuits
The punitive damages awarded in the pelvic mesh lawsuits may not be enough to alter the business practices of manufacturers like Boston Scientific and Johnson & Johnson who net several billion in income each year. In addition, many of these manufacturers have been successful in limiting the number of lawsuits that actually make it trial each year.
In some cases, judges may opt to reduce the amount of restitution by up to 90 percent, based on the precedent set by previous cases. Paying at damages of less than $10 million to plaintiffs is unlikely to deter some of the larger manufacturers who are still turning a profit from their potentially dangerous business practices. Without any substantial ramifications for defective pelvic implants, many of these manufacturers have been eager to expand into hernia mesh.
The Hernia Mesh Market
On average, more than a million hernia repairs take place in the United States each year. Skilled repair specialists can fix hernias without the mesh, but it’s not nearly as profitable as for manufacturers. That’s why manufacturers came up with a new way for general surgeons to conduct the repair operations using mesh. Laparoscopic procedures made these operations easier for surgeons, but the mesh needs to be placed closer to the internal organs.
Once the mesh contacts the internal organs, it can stick to the cell tissue and cause serious damage or injuries. Many manufacturers apply absorbable coatings in an attempt to prevent complications. Doing so allows them to raise the price for the mesh exponentially as well. Compounded with aggressive expansion, the projected worth of the hernia mesh market is projected to reach $3.7 billion by 2020. Even the general surgeons can profit from opting for the hernia mesh operations.
The Risks Associated with Hernia Mesh
Most forms of sterilization make the coatings on hernia mesh implants prone to degradation. Several manufacturers have altered their sterilization in an attempt to prevent their hernia meshes from degrading.
The changes in sterilization have caused many of the implanted hernia mesh devices to become contaminated. When the hernia mesh is sterilized improperly, it can contain dormant bacteria known as endospores. After the implant, this bacteria can lay dormant in the body for months or years.
The hernia mesh infection can occur at any time when the bacteria reactivates. Once the implant becomes infected, it will remain infected until it’s removed from the body. The infection eventually turns into biofilm, serving as an ecosystem for bacteria that can cover the whole mesh implant. The only other type of biofilm that exists inside the human body is a dental plaque. Recent research has attributed the sharp increase of antibiotic-resistant bacteria to biofilms.
In order for bacteria to be antibiotic resistant, mutations would’ve had to occur. Once biofilm forms, bacteria begins to mutate up to 60 times faster and survives levels of antibiotics between 100 to 1000 times higher.
Horizontal transfer enables the antibiotic resistance to be shared between different types of bacteria. When explanted, biofilms can contain a number of different kinds of bacteria that are highly antibiotic resistant.
The antibiotic resistance caused by biofilm on hernia mesh implants can leave patients susceptible to develop pneumonia other serious infections. Infected hernia mesh implants actually make patients vulnerable to some of the most antibiotic resistance forms of bacteria. Removing a hernia implant that’s attached to underlying organs could result in a variety of serious consequences, including death.
Aside from the coating, the polypropylene used to construct the mesh poses a number of potential health risks as well. Eroding uncoated mesh devices used for inguinal hernias can cause patients severe and potentially permanent pain as they begin eroding in the body. Some of these patients eventually sustain permanent disabilities because of the polymer used.
Patients all over the world have begun filing lawsuits against device manufactures for the inherent risks and subsequent damages associated with hernia mesh implants.