FDA Straddles the Fence Over Transvaginal Mesh

Washington, DCIn spite of so many women dealing with a problematic TVT sling that causes them pain and suffering, the US Food and Drug Administration (FDA) has formally given a thumbs-down to consumer advocacy group Public Citizen after the latter petitioned the drug regulator to recall existing mesh products and ban their future sale.

Dr. Michael Carome, the director of the Health Research Group for Public Citizen and the author of the petition, called the FDA’s position ill-advised and timid.



The step the FDA is taking is to order existing manufacturers of TVT mesh products to conduct stringent tests akin to the kind of pre-market testing normally seen in clinical trials, and usually required before a product is brought to market.

The idea of a pre-market clinical trial is to test out the product on a small group of participants over an extended period of time, in order to gauge the effectiveness, risks and outcomes on a smaller, representative sample. If there are problems, the larger population at large is spared potential transvaginal mesh complication.

But that didn’t happen with TVT mesh. It hasn’t happened with a lot of products currently on the market. That’s due to the FDA’s 510(k) clearance process that spares a manufacturer the expense and the usual years-long wait to bring a product to market. The 510(k) clearance holds that a forthcoming product substantially similar to a product already on the market and being used successfully, need not go through the rigorous clinical trial process, and thus can reach the market sooner, benefitting the intended constituency of patients.

In the case of the transvaginal sling, which is used to shore up and rein in sagging internal organs and tissue associated with Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), two conditions that most commonly affect child-bearing women at middle age, the 510(k) clearance made sense on paper, given that mesh had been used successfully for hernia repair.

However, in reality, the TVT sling - which used to be fashioned from a woman’s own tissue in a more invasive surgical procedure - has proven to behave differently in the POP or SUI sling indication, and there have been thousands of cases of transvaginal mesh complications.

And about just as many mesh victims have filed a transvaginal mesh lawsuit.

What will it take to prompt the FDA to act?

Public Citizen, for its part, has been lobbying the FDA to ban the product outright for some years now. The FDA, in fact, first put transvaginal mesh and the TVT sling procedure under the microscope as early as 2008. Only recently did the FDA decide to order existing manufacturers of transvaginal mesh to support their products with stringent pre-market testing - something critics have been suggesting the FDA should have done from the very beginning.

That’s all well and good, says Public Citizen, but it could take years before the benefits of the FDA’s lukewarm position on the problem will filter down to patients. In the meantime, thousands more women could be put in harm’s way.

In refusing Public Citizen’s request to undertake a total ban, the FDA says that the advocacy group’s wish may partially be granted in a “roundabout way,” given that some manufacturers of the transvaginal tape sling will decide not to carry through with the time and the expense of pre-market testing with the existing products, and abandon their lines of vaginal sling altogether.

That has, indeed, happened with a few manufacturers.

But not all. And the FDA refused to revoke the 510(k) clearance option for new manufacturers, bringing new products to market.

Will the FDA fall on its double-edge sword?

Critics - Public Citizen among them - say the response is totally backwards. Instead of requiring intensive pre-market clinical trials to prove a product worthy of entering the market, the FDA is continuing to allow manufacturers of new mesh products to bring those products to market quickly via the 510(k) clearance. If there’s a problem after the fact, then the FDA might order pre-market testing while the product continues to remain on the market if the manufacturer so chooses.

The FDA, previously, has said that in its opinion TVT sling surgery using mesh may no longer be the safest treatment option for POP and SUI. But it stops short of suggesting that, in its opinion, it isn’t the safest option. Just that it “may not be” the safest option. At the same time, the FDA maintains that sufficient benefit exists for POP and SUI patients compared with non-surgical repairs.

In this way, the FDA straddles the fence.

Carome put it this way: “I think, as they do all too often, they’re bowing to the interests of [corporations] and not acting in the interests of patients and public health,” Carome said. That statement appears to ring true, given the FDA’s own guidelines with regard to banning a medical device under existing federal laws. A ban, according to the FDA, is only appropriate if the product or device in question “presents substantial deception or an unreasonable and substantial risk of illness or injury.”

It appears as if the thousands of reports of adverse reactions with a mesh-based vaginal sling - and ensuing lawsuits - are not enough for the FDA to invoke a ban.