The Food and Drug Administration (FDA) has announced it will not be recalling or banning transvaginal mesh products – or at least not yet. It's important news for the thousands of women currently taking legal action against mesh manufacturers, and could have a big impact on how mesh devices are brought to the U.S. market in the future.
What prompted this announcement? Was the FDA seriously considering banning mesh products?
The agency was responding to a 2011 petition made by advocacy group Public Citizen. The group requested that the agency recall mesh products on the market and ban their future sale. The group also asked that the agency to adopt a stricter approval process for new mesh implants.
Who is Public Citizen?
Public Citizen describes themselves as a “non-profit, consumer rights advocacy group and think tank.” Their petition was filed after thousands of women filed lawsuits claiming that they suffered serious injuries after being implanted with vaginal mesh products.
Why did the FDA decide not to recall or ban vaginal mesh?
There are a few different factors at play here. For instance, vaginal mesh isn’t universally agreed to be defective. The European Union, for example, is just now considering approving its use for more treatments. Additionally, only a handful of mesh products sold in the United States have actually been recalled or taken off the market. To ban a product entirely, the FDA is required by federal law to find the product causes “unreasonable and substantial risk of illness or injury.” Clearly, they’ve not done so – but that doesn’t mean there’s no action being taken.
What is the FDA doing about this problem then?
The FDA, in a letter published this week, pointed out that it is already considering changing the way it allows transvaginal mesh products onto the market. In April, the agency announced that it issued two proposed orders that would reclassify mesh implants as “high risk” and require the products to go through the premarket approval process before being given the OK.
What is pre-market approval?
There are two different ways for products to get approval for use in the United States. Pre-market approval requires manufacturers to submit studies and significant amounts of evidence to support the safety and efficacy of their products. This process is lengthy and expensive, but generally subjects medical devices to strict requirements. The second way to get approval is known as 510(k), which grants approval on the basis that a new product is significantly similar to an already-approved device. This is how most transvaginal mesh products got onto the market in the first place – and the route that may no longer be available to mesh manufacturers if the FDA finalizes its proposals. The FDA expressed concern, however, that the pre-market approval process will make it too difficult for manufacturers to actually get their mesh products on the market, potentially limiting patients’ medical options if manufacturers are unwilling or unable to meet the stricter rules of a pre-market approval process.
So, the FDA is turning down Public Citizen’s petition on the grounds that it’s already doing what they ask for?
In a way. Essentially, Public Citizen wanted three things: 1) to order manufacturers to recall existing mesh products; 2) to ban the products’ future sale; 3) and to require manufacturers to receive premarket approval for the sale of any new mesh products. In responding to the last request, the FDA said it couldn’t make this change because of technical reasons, but said that its own proposals “initiate the process that could ultimately result in the action you seek.” And while the agency did not decide to recall mesh products and ban their future sale, it has left the option open for individual products, should such action become necessary.
When will the FDA make its final decision on premarket approval?
The agency’s proposal on premarket approval is not finalized, and even when it is, new clinical trials will need to be conducted to determine whether approved products should stay on the market. It’s likely that the changes will take many years.
So, what will this change right now?
Unfortunately, not a lot. One of the reasons Public Citizen petitioned the FDA was because the group felt it was taking too long for the agency to take action against the mesh products. Public Citizen seemed happy that the proposed order on premarket approval is still on the table, but their director, Michael Carome, added that the action was long overdue and would take longer still to come into effect. Currently, the FDA is getting feedback on its proposals to require premarket approval for mesh products.
In some ways, the FDA has basically announced that it has decided not to make a decision – or at least not yet. Mesh approved through the 510(k) route will continue to be sold, and while the proposal to bring in premarket approval is open to public comment, no official plans are in place to change the way these products get to market.