Imagine having a surgery that’s gone terribly wrong, only to discover – too late – that the doctors used a medical device its manufacturer knew could be dangerous, and worse, one that snuck right past the Food and Drug Administration (FDA).
Couldn’t happen in this country? Wrong. More than 1,000 patients with incontinence and pelvic problems in New Jersey have lived this real life nightmare – and they are fighting back. They’re suing the transvaginal mesh (TVM) manufacturer, Ethicon, a subsidiary of healthcare giant, Johnson & Johnson. And they are keeping close eye on the supposed regulator in this tale, the FDA.
In fairness, the FDA has issued safety alerts about mesh products since 2008, and in January 2012, the agency issued Ethicon what’s known as “522” orders, mandating the medical device manufacturer conduct studies of devices that may injure patients. On June 4, 2012, Ethicon ceased selling four of its transvaginal mesh products. Ethicon then asked the FDA to halt the existing “522” orders.
But New Jersey Judge Carol E. Higbee, who is overseeing the TVM cases, seems a bit suspicious; she’s ordered Ethicon to produce all relevant communications between it and the FDA.
Perhaps Judge Higbee knows that in 2007 the FDA said Ethicon’s “Gynecare Prolift” TVM product had a “potential high risk for organ perforation” just some of the “adverse events” as the FDA like to call complications. Others include mesh erosion, the formation of scar tissue, nerve entrapment and damage, the return of incontinence and prolapsed, painful intercourse, eroded lives and marriages, among other serious problems.
The agency ordered Ethicon to stop selling the product until the manufacturer could show the agency whether the device was substantially equivalent to other similar medical devices. The company defied the FDA order and sold the device anyway for nine additional months – while it negotiated with the FDA, which eventually cleared the product.
It’s that “substantial equivalency” rule that allowed the polypropylene medical mesh to be cleared for sale under the agency’s 510(k) notification rule. If a new device is the “substantial equivalent” of a device already on the market, it does not need to be tested and the manufacturer notifies the agency that it plans to sell the medical device.
Who determines whether it is equivalent? The manufacturer has total say.
And as if that were not enough – the FDA will clear a device that is substantially equivalent to one that was recalled for major safety problems!
Mesh devices, metal hip replacements, and the list of potentially dangerous medical devices that, because of this loophole have never actually been tested in clinical trials, goes on and on.
Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced the SOUND Devices Act in February 2012 to close that loophole, but could not get enough support. They promise to try again.