FDA Reclassifies Transvaginal Mesh as a High-Risk Device

Last week, the Food and Drug Administration (FDA) reclassified transvaginal mesh products as class III or “high risk” medical devices. This fact alone doesn’t mean much without some context, but don’t worry, we’ll touch on that soon.

Medical Devices and You: What Do the Classifications Mean?

The FDA categorizes medical devices into one of three groups – Class I, II or III – with the classes being representative of the risks the devices present and the necessary regulatory controls that need to be taken for devices in that category.

Class I

The first class of medical devices is reserved for products that present the least potential for harm. These types of devices are often simpler in design than Class II or Class III devices. Under this classification, we find things like elastic bandages, hand-held surgical instruments and those exam gloves that doctors like to snap on their wrists, you know the ones. Class I products make up 47% of the medical devices regulated by the FDA.

Class II

Medical devices in Class II are held to a higher standard of assurance than those in Class I and are subject to special regulatory controls, including labeling requirements and post-market surveillance. Simply put, a higher potential for harm means stricter rules and regulations. Class II devices make up 43% of FDA-regulated medical devices and include powered wheelchairs, acupuncture needles and infusion pumps. This is the class transvaginal mesh products used to belong to.

Class III

The final class makes up only 10 percent of the medical devices regulated by the FDA. Class III devices are usually those that support or sustain human life, have a vital role in preventing health issues and/or present a potential, unreasonable risk of illness or injury. Included among these devices are implantable pacemakers, automated external defibrillators and, as of last week, transvaginal mesh products.

What Does Reclassification Mean for Mesh Manufacturers?

Along with the news that their mesh products have been reclassified, pelvic mesh manufacturers have been given 30 months, until summer 2018, to prove that their products are both safe and effective. These companies will now be required to submit premarket approval applications (PMA) – and demonstrate that their products meet the safety standards set by the FDA’s most demanding approval process.

Previously, these products were cleared through a different process known as 501(k) clearance. This process allowed mesh manufacturers to bypass clinical trials and have their devices approved after showing that the meshes were “substantially similar” to ones that was already on the market. Mesh manufacturers had a fast track to get their products on the market and avoided any serious pre-approval scrutiny.

What Does Reclassification Mean for the Litigation?

A development like this might seem like a huge advantage for patients involved in the multidistrict litigation, but it isn’t yet clear if that’s going to be the case. The FDA’s decision is significant because it’s what plaintiffs have been arguing all along, that the devices have a notable degree of risk and should have never been fast-tracked to the market. But, it is plausible that manufacturers could argue that the reclassification of the devices is irrelevant to the MDL and may attempt to bar plaintiffs from introducing the news as evidence at trial. Arguably, courts will decide on the admission of this new information on a case-by-case basis. But, if juries don’t hear about the development in the courtroom, the reclassification could have little impact on these cases.

Some attorneys believe that they can use the FDA’s new regulations to add some weight to their arguments, but at this time no one can be sure how influential this reclassification will be in court.