Despite the number of horror stories of hernia patients who have suffered debilitating pain and even died as a result of hernia mesh repairs, the market for this questionable medical device continues to grow – and mesh procedures still have defenders and apologists in the medical profession. Those who defend the use of hernia mesh say that the benefits outweigh the risks, and that complications are relatively rare. But are they?
According to an investigation published last year in the British Medical Journal, as many 30% of patients who underwent hernia mesh operations over the previous six years may have experienced complications. Other prominent U.K. surgeons put the figure closer to 12 percent. Unfortunately, various National Health Service trusts across Britain lack consistent policies for patient treatment or follow-up.
An earlier study, published in the Journal of the American Medical Association in October of 2016, found that the complication rate for patients who had open hernia mesh surgery was 5.6 percent within 5 years. Those whose surgeries were laparoscopic fared slightly better, with a complication rate of 3.7 percent. Although supporters of hernia mesh have claimed that mesh repairs lower the rate of hernia recurrence, the authors of the U.S. study found this was not necessarily the case. They write, “Mesh implantation prevented the need for subsequent reoperation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.”
The JAMA report also notes that while proof of long-term safety is required before pharmaceutical medications are given FDA approval, this is not always the case for devices such as the hernia mesh. This, they point out, is due to 501(k) Premarket Notification, which allows medical device manufacturers to bypass safety testing requirements by claiming the new device is “substantially similar” to an older one already approved for the market. The authors say their study “highlights the need to assess the long-term safety of interventions before making definitive conclusions about their benefits.”
While there are indications that the FDA might be reconsidering the 501(k) process, it is doubtful that any meaningful change will come under the current blatantly corporatist Administration. Meanwhile, industry analysts are touting “extensive growth opportunities” in the hernia mesh market that are anticipated over the next decade. Among mesh manufacturers that stand to gain from this trend are Johnson & Johnson’s Ethicon unit, Medtronic, C.R. Bard and Cook Medical – all of which have been sued over mesh injuries in the past and have had to pay out some hefty judgments.
Unfortunately, punitive damages in these cases have been limited by the U.S. Supreme Court as well as several states in the name of “tort reform” – making it difficult to truly punish these corporate miscreants in any meaningful way. To these multi-billion dollar corporations, paying out a few hundred million is just part of the cost of doing business.
Until such time as things change and medical device manufacturers that create dangerous products can truly be held accountable, the only remedies are to bring civil suits so that victims are at least compensated for their pain and suffering and loss of income and consortium – and to educate the public on the risks of hernia mesh surgery.