The medical device industry is in a state of transition currently as the FDA has announced plans to overhaul the device approval process. Whether or not this comes to fruition, there is a greater focus on tracking medical devices after they are implanted to gauge whether or not each device has been effective. This scrutiny would be given in order to better make improvements in the medical devices.
In addition, the driving theory behind this movement is that patients should have better information about the device that is implanted in them. Defective medical devices have been a leading cause of death and injury in this country. Many believe that patients deserve to have the most information possible about what they may face in the future. At the same time, better information may lend credence to efforts to continuously ensure that medical devices function properly.
In this area, the United States is behind the progress that has been made in this area in Europe. Across the Atlantic, there has been a concerted effort to track medical implants. All implants in Europe and the United Kingdom and identified and tracked after they are implanted. The tracking continues even after an implant is removed from a patient.
The new FDA procedures would involve plans to significantly change the approval process for new medical devices. The FDA plans to continue tracking devices even after they are approved. This would involve real-world information as to how these devices are functioning after they have been implanted in patients. This effort would rely upon a national system that would be the repository for this information. If this new process is implemented nationwide, it will be slowly rolled out with several demonstration projects being the first use of this system.
One of the most prevalent medical devices that is in existence is the hernia mesh. There are several hundred different types of these meshes and they have been implanted in million of patients as a means of fixing their hernias. However, hernia meshes have failed at increasing rates. In some instances, the failure of the mesh has caused serious complications that has resulted in either the need for an emergency procedure or a follow-up procedure to replace the failed hernia mesh. While there is much information about hernia mesh failures in the public realm, there is little in the way of statistics or further explanations of these device failures.
Currently hernia mesh is categorized as a Class II medical device in the United States. This means that there is a streamlined FDA approval process. The maker of the hernia mesh need only show that the hernia mesh is similar to another product that is currently approved by the FDA in order to gain approval.
However, the tide may be turning for hernia mesh in light of the well-documented instances of its failure after implantation. Now, there are negative connotations associated with hernia mesh regardless of how justified they are. Currently, there is little effort internationally to track hernia mesh after it is implanted. Denmark is the only country to have a national hernia mesh registry. In Denmark, it is compulsory to enter information unto the hernia mesh database. To the extent that there are these types of databases in other countries, any type of participation in the database is optional. This leads to a lack of tracking of hernia mesh devices, which is alarming given the wide variety of hernia meshes that are available in the marketplace and the growing number of device failures.
The lack of overall participation in a hernia device registry is something that can be easily change. However, in order for the change to be made, it must be demanded someplace. In the U.S., that process could be engineered by the FDA if it chose to do so. Alternatively, a professional society that oversees hernia operations could also demand that this change be made.
Given that there are over 300 different types of hernia meshes in the marketplace, there is no one uniform approach that would determine which mesh is suitable for each patient. If this were tracked in a database, it would be easier to match the patient with the right type of mesh. While it is not a guessing game at present, more precise information would make this process more scientific and perhaps reduce the rate of hernia mesh failures. Then, doctors would have an idea which meshes are more suitable for certain body types. In other words, more data will lead to a more individualized solution to the question of which is the best mesh to use in each patient.
In general, there needs to be more research conducted into how the body responds to hernia mesh over time. This could perhaps avoid instances of large-scale recalls of hernia meshes in the market. Hernia meshes may not be per se defective, but a lack of research and tracking leads to meshes that are mismatched to the patients in which they are implanted.
While biometric mesh may be safer than the synthetic meshes that have drawn the attention for their failures, there has been little research into these meshes as well. There is not much that is known about the effectiveness of these meshes after implantation because the studies have not been extensive enough. It is thought that biometric meshes have a higher recurrence rate than synthetic meshes but have a lower rate of severe complications that result from their usage.
There are some types of hernia meshes that have had a better track record than others. The meshes that have been recalled are well-known to the public. However, it is difficult to know the full effectiveness of a mesh without the real-time tracking. This would involve tabulating every single hernia mesh that has been implanted into a patient. Of course, this work would have to start from scratch with future mesh implants because it would simply not be possible to catch up on nearly 60 years of hernia mesh implants.
Nevertheless, there is no reason why the growing movement towards tracking medical devices should not encompass hernia meshes. This is even more true given that hernia mesh is one of the most widespread medical devices that are in use today. This initiative has already started in some fashion. The American Hernia Society has begun providing surgeons with more information about the meshes that they are using in surgery. Eventually, this may expand to include a unique identifier for each mesh that is used so that it can be tracked.
Hernia meshes have been used for six decades without much of an understanding of some of the statistical patterns associated with their usage. The hope is that by introducing tracking and statistics, these devices can be used in a smarter manner that can both reduce the rate of complications as well as the chance that a follow-up surgery will be needed for a recurrence.