Transvaginal Mesh Products Marketed Without FDA Approval

In the midst of festering concerns, vaginal mesh products and their corresponding developers have received an immense amount of criticism. The most recent of which has taken aim at world renown Johnson & Johnson (J&J). In the latest development over vaginal mesh scandals, J&J has been accused of selling a particular vaginal mesh implant for three years before U.S. regulators approved it. Subsequently, this device is now the subject of approximately 550 current lawsuits by women who claim it injured them.

For decades, surgical mesh products have assisted in the treatment of abdominal hernia repairs. However, surgical mesh has recently transitioned into what the healthcare community is calling transvaginal mesh. These products are intended to assist in the treatment of compromised vaginal tissue that has sustained a traumatic injury from a number of complications such as stress urinary incontinence (SUI), pelvic organ prolapse (POP) and childbirth. Accordingly, J&J introduced their version of transvaginal mesh in March of 2005, the Gynecare Prolift.

However, regulators at the U.S. Food and Drug Administration (FDA) acknowledged that they were not made aware of the Gynecare Prolift until 2007, when J&J sought approval for a similar device. Despite not having known about the Gynecare Prolift, the FDA approved both devices the following year.

In defending their choice of marketing the Gynecare Prolift without FDA consent, J&J acknowledged that they were within the parameters set forth by the FDA’s 510K plan. “510K” refers to the Medical Device Amendment (MDA) statutory provision from which FDA granted itself the authority to make exceptions for post-1976 medical devices that the Agency deemed “substantially equivalent” to older products. Essentially, the process works like this: if a manufacturer wants to market a new medical device that falls into a category FDA deems is of “low risk” (e.g., surgical mesh), that product can be marketed without the usual pre-market testing and without formal FDA approval so long as the manufacturer can show that the device is relatively close in design and intended use to a product that is already being marketed. That is so even if the “old” product was itself never tested or approved by FDA.

What’s worse is that, as it happened, the vast majority of products introduced to the market since 1976 have fallen into this 510K “loophole,” so that most medical devices sold today have never been tested in compliance with the pre-market testing requirements of the MDA, nor have they been formally “approved” by FDA. As a result, there have been countless high-profile recalls, including J&J’s decision in 2010 to withdraw 93,000 hip prosthetics with higher-than-expected failure rates. Congress has been pushing for an overhaul of the system.

According to J&J representatives, their actions “were responsible, appropriate and consistent with FDA regulations. Numerous clinical studies suggest that when combined with proper surgical technique, surgical mesh can improve patient outcomes, and Ethicon’s devices are among the most studied devices on the market for this condition.”

While J&J assumed the 510K provision allowed them to place the Gynecare Prolift on the market without approval, an FDA representative acknowledged that the “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance. As a result, J&J’s unauthorized Gynecare Prolift sales may cost them more to resolve lawsuits that are currently pending against the product. “They were initially able to put the Prolift on the market without even telling the FDA,” said a plaintiff representative, who is suing J&J on behalf of more than 100 women.

The current transvaginal mesh lawsuits may be directly correlated to the influx of deaths, injuries and malfunctions associated with the surgical implantation of these devices. An FDA report acknowledged a fivefold increase in the occurrence of these complications over the years.