While injuries and deaths due to the use of hernia meshes continue to rise and lawsuits against manufacturers pile up, the U.S. Food and Drug Administration is either demonstrating total incompetence – or it is turning a blind eye to what is happening. It raises the question of just who the FDA is protecting.

Today, despite increasing knowledge of the dangers of hernia mesh products, the market continues to expand; more than 100,000 of these devices are implanted in U.S. patients annually. Despite the documented dangers of these products, many of them remain on the market – and so far, the FDA is doing little, if anything, to remove them.

In an article published on its website last year, the FDA stated that “Many complications related to hernia repair with surgical mesh that have been reported…[they] have been associated with recalled mesh products that are no longer on the market.” That was in April 2016; only a month later, Johnson & Johnson subsidiary Ethicon withdrew its Physiomesh product from the market.

The company denies that the Physiomesh was subject to a recall, however, and to date, there is no information at the FDA website about the device. In actuality, very few hernia mesh products have been recalled by the manufacturers, and none by the FDA. Most of the lawsuits being filed against Ethicon, C.R. Bard and other mesh manufacturers involve products that have never been subject to recall, or that the companies simply discontinue.

It is not for want of information. For years, doctors and sales representatives have filed adverse event reports with the FDA, alerting the agency to product defects that result in debilitating pain, infection and organ perforation among other problems. Despite this clear information, the FDA has yet to take any sort of meaningful action to get these products off the market. Today, one would be hard-pressed to locate any adverse event reports on hernia mesh products at the FDA website.

Arguably, one of the problems is that many patients experiencing complications due to a hernia mesh implantation may not show those symptoms for a decade or more. This is a major reason why many of these problems were not noted in early studies, which in themselves were questionable. Most of those studies were funded by the manufacturers themselves and involved relatively few subjects who were not monitored for a sufficient length of time.

Today, there are over 50 different hernia meshes still being sold and utilized by surgeons for hernia repair. At least ten of them, manufactured by Ethicon, Medtronic, C.R. Bard and Atrium, have been associated with serious patient injuries. There are cases in which a mesh is necessary in order to repair a hernia, but these cases certainly do not make up even close to the majority. Despite this, meshes are still commonly used for cases in which such a procedure is unnecessary.

Meanwhile, the FDA continues to sit on its hands, while allowing medical device manufacturers to have a “free pass” through its 510(k) Pre-market Clearance process. Considering that the current commissioner of the FDA has close ties to the industry and apparently has no intention of improving the agency, it appears that patients’ only hope lies in educating themselves, questioning their doctors when a hernia mesh is recommended – and turn to the courts when they are injured.

SHARE

K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante’s Inferno, and The Missionary’s Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.