The problems with hernia mesh have long been known. There have been tens of thousands of reports of patients who have experienced complications after their surgery that has used hernia mesh. Further, certain brands of hernia mesh have been recalled due to the risk of recurrence of surgery and other side effects. Nonetheless, the FDA has not issued any type of safety warning for hernia mesh. Given the extensive problems that patients have encountered, the agency’s silence to date regarding hernia mesh warnings is confusing.
FDA confusing silence
The FDA is certainly aware of the issues surrounding the use of hernia mesh. In December 2016, the agency published information regarding hernia surgeries. This information laid out various options that patients have when deciding how to have their hernia repaired. The information discussed hernia meshes to an extent. The information set forth various considerations that patients need to consider when deciding on a surgical options. It did lay out the different types of hernia meshes that are available. It also did describe some of the complications that patients have experienced based on reports from the FDA’s Adverse Events Reporting System. Finally, the agency also referenced recall notices issued for certain types of hernia meshes. However, this information just listed possible complications and did not rise to the level of an FDA warning. At this point, all the FDA has done is communicated about side effects that have been reported as opposed to giving its own opinion about the possible safety problems. This is notwithstanding the fact that the agency receives hundreds of reports each month about negative side effects.
FDA firm action on Pelvic Mesh
The FDA’s silence is even harder to understand given the firm action that it has taken with regard to pelvic mesh. This product experienced some similar types of complications to hernia mesh. Pelvic mesh is designed to treat pelvic organ prolapse in the same manner that mesh is supposed to treat hernia. However, the mesh in many cases shifted or migrated to other parts of the body, causing damage to nearby organs. In other instances, the mesh shrank or disintegrated. After tens of thousands of lawsuits were filed, most of the product manufacturers eventually exited the market. Earlier in 2019, the FDA ordered the remaining two manufacturers to pull their products from the market, ending the sales of this particular mesh.
Nonetheless, the FDA has had little to nothing to say about sales of hernia mesh. Granted, there are many different types of hernia meshes that are available in the marketplace, but meshes that are made of polypropylene have experienced failures at a higher rate which may be a valid reason for some sort of FDA warning. This is the same exact material that pelvic organ prolapse was made out of, and there have been similar complications. Polypropylene is a form of plastic that is also found in product packaging and plastic furniture. Although the hernia mesh manufacturers have represented that polypropylene is inert, there have been many different instances in which bacteria has been able to grow on these meshes or there has been a reaction that has occurred on the mesh. Nonetheless, the FDA information page continues to tout the possible benefits of using hernia mesh.
Even without an FDA warning, there have been numerous recalls of various brands of hernia mesh. Four different brands have been recalled. One of the most publicized recalls was that of Ethicon’s physiomesh product in 2016, which was completely pulled from the market after widespread reports of hernia recurrence after the mesh had failed. This recall occurred months after the FDA issued its information sheet about hernia mesh that details some of the complications. Nonetheless, it did not change the FDA’s position that hernia meshes do not merit an overall safety warning. Over 200,000 lots of the product have been recalled over the years. While there are roughly a million hernia performed in the United States each year, this is still an unacceptably high rate of recalls.
high rate of complications
Not only have there been a large number of recalls, but there is also a high rate of complications worldwide associated with hernia meshes. One British journal estimated that the rate could be as high as between 12-30%. While the FDA has gotten involved when there have been specific issues with individual products, it has largely been silent on the overall problems facing hernia meshes notwithstanding the fact that nearly all of the major brands have had relatively high rates of failure.
Administration has shown a hesitation to challenge large manufacturers
While statistics would generally necessitate that the FDA do something in response to the high complication rate, it is not likely that the agency will do so in the near future. The current Administration has shown a hesitation to challenge large manufacturers of any products when it comes to either defective devices or products. While the FDA did order the pelvic organ prolapse off of the market, there were only two manufacturers of the product left, and it did not have the same implications as a safety warning for hernia meshes.
FDA’s reluctance to lead
Since the FDA has refused to act, much of the initiative to move away from the dangerous types of hernia meshes may have to come from surgeons. Already, there have been reports of surgeons switching to the use of natural hernia meshes made from animal parts as opposed to relying on the plastic meshes. However, these products are still expensive and need to come down in price to become more appealing to the mass market and to convince insurers to fully cover the cost. Internationally, there has been more of a trend that has seen surgeons abandon traditional hernia mesh. In the United States, given the FDA’s reluctance to lead, doctors themselves may have to take the initiative to reduce their usage of synthetic meshes. The negative publicity associated with the pelvic organ prolapse mesh has carried over to hernia mesh. Combined with endless commercials run on television by plaintiffs’ attorneys, the public is now becoming aware of the problems associated with hernia mesh. In addition, numerous patients are coming forward with horror stories about their own hernia mesh surgeries that have been getting widespread media attention.
Safety is not first
While it would be helpful for safety reasons if the FDA would speak out about the issue, it is not a necessity given the fact that a market correction is underway. Nevertheless, the trend would be accelerated if the FDA acknowledged the obvious and classified the numerous reports of complications that it has been receiving as a safety issue. However, that will likely have to wait until the political winds shift.
A hernia mesh attorney can speak with you about a possible claim against the manufacturer of your hernia mesh if you have experienced any complications after your surgery. If you have had side effects, get in touch with an attorney immediately.