Hernia Mesh: A Marketing Ploy Enabled by the FDA

In a recent interview on America’s Lawyer regarding hernia mesh injuries, Florida litigation attorney Mike Papantonio noted that many “medical innovations” are nothing more than the result of slick marketing campaigns that have little or nothing to do with advances in treatment and healing – and everything to do with profits.

If patients are injured or killed as a result, that’s just part of the cost of doing business. Papantonio points out, “The company looks at the numbers, they say we can harm this many people, we’re making this many billions of dollars. At the end of the game, we may have to pay out one billion, but we’ve made 10 billion, so it is a good profit margin.”

It’s a “game” that Corporate America in general has been playing for decades – but in recent years, the medical device industry has been upping the ante. Furthermore, they are being enabled by a corrupt and dysfunctional FDA. This time around, a new, growing group of victims are paying the price.

The product is known as the “hernia mesh.” In terms of materials and construction, it is virtually identical to the pelvic mesh that continues to be a cause of action for thousands of plaintiffs. Last year, Johnson & Johnson paid out $120 million to settle approximately 2500 lawsuits over a pelvic mesh manufactured by its Ethicon division. Even with the settlement, however, Johnson & Johnson still faces more than 42,000 additional lawsuits.

Johnson & Johnson is not the only one. Bard Medical, which is currently targeted by a growing number of plaintiffs who have suffered injuries due to the KugelTM Hernia Patch, is another example of a corporate “repeat offender.” In 2015, Bard wound up paying $200 million to settle 3,000 lawsuits over the Avaulta Pelvic Mesh. This device was prone to erosion into the patient’s tissues, causing infections, chronic pain and other complications, including organ perforation and possible allergic reactions to the polypropylene material.

The KugelTM Hernia Patch is made from the same material, and causes similar injuries. One would think that Bard Medical and other corporate offenders would have learned their lesson. And perhaps they have. It’s just been the wrong lesson, thanks to the dysfunction of a federal regulatory agency that was charged with protecting natural humans as well as liability laws and penalties that have little in the way of teeth. All of this has wound up enabling Corporate America to continue inflicting injury and death while continuing to make huge profits.

At the heart of this dysfunction is the increasingly infamous 510(k) Pre-market Clearance Process. This FDA loophole

…requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance…this allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.”

If the device is determined to be “substantially equivalent,” it is given the green light – with no need for testing or clinical trials. Bard Medical, Johnson & Johnson, Atrium (which dominate the hernia mesh market) and other medical device manufacturers have been quick to take advantage of this loophole of biblical proportions.

Given the experiences these companies have had with their pelvic meshes, this sort of recidivism on their part is inexcusable – but there are reasons why they chose to go ahead with the manufacture and marketing of a device they must have known would cause injuries and result in liability. To be exact, there are 3.8 billion reasons, for that is the dollar value of the global hernia mesh market as of last year. That market is expected to increase to $4.5 billion over the next seven years.

In light of that kind of revenue, even settlements of $200 million are pocket change. Furthermore, such settlements are indeed part of their “cost of doing business.” Money that is paid out by a corporation as part of an out-of-court settlement is generally deductible as a business expense under the Internal Revenue Code. This not only explains why few of these cases go to trial, it also explains corporate criminal recidivism. There is no real penalty for these criminals (and ultimately, the taxpayer picks up the tab).

Human offenders are locked up, and when murder with malice aforethought is involved, are still executed in a number of states. However, corporate “people” are not subject to such punishments. By rights, a corporation that knowingly markets a device or a product they know will result in serious injury and death is guilty of a capital crime and should be deprived of liberty (the right to do business for a time) or even life (by revoking its charter). At the very least, corporate tax deductions for settlement payouts should be eliminated.

At the same time, the FDA needs to be held accountable. In 2011, a joint study published in the Archives of Internal Medicine showed that the majority of medical devices recalled over the previous five-year period for causing “serious health problems and death” were those that had been cleared through the 510(k) process. In some cases, the FDA determined that the devices didn’t pose enough of a risk to even require regulation. At the same time, there are at least two companies in the business of consulting with medical device manufacturers on how to get their products through the process easily. Some companies manage to get this approval without even revealing the actual purpose of the product – strongly indicating that the FDA is not doing its job.

Corporate greed is definitely part of the problem, but unfortunately, it runs deeper than that, involving corruption and carelessness not only in the boardroom, but in the legislature and regulatory agencies as well. Until these factors change, we will continue to see more injuries and deaths caused by devices such as the KugelTM Hernia Patch.


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