All medical devices entering the U.S. market, like hernia mesh implants, must be approved by the U.S. Food and Drug Administration. But there are different review processes, and some are not as stringent as others. In recent years, due to the increased rate of recalls for devices like hernia mesh, some of these approval processes have been called into question.

Typically, your hernia mesh implant will have a Class II medical device designation, which means it has a medium to high potential to cause harm. As a Class II medical device, patients assume and expect that their hernia mesh products are approved through the FDA’s more stringent Premarket Approval process rather than the less stringent 510(k) Clearance process. This, however, is not the case. Due to certain qualifiers, many hernia mesh products are approved quickly through the 510(k) process. Here, we answer your questions about these two processes and provide some insight along the way.

• 1. What are the FDA approval processes that hernia mesh medical devices go through?
  • 1.1 Premarket Approval
  • 1.2 510(k) Clearance
• 2. Why does it matter which approval process is used?
• 3. Are there hernia mesh medical devices that have been approved via the 510(k) clearance process?

1. What are the FDA approval processes that hernia mesh medical devices go through?

Like all medical devices, hernia mesh implants are subjected to the FDA approval process before they can be placed in the U.S. market. When a manufacturer wants to market a hernia mesh product, it must notify the FDA 90 days in advance. This allows the FDA time to understand which approval process may be used.

There are two primary approval processes that a hernia mesh product may undergo: either the premarket approval process or the 510(k) clearance process. Which process is required is dependent on:

• The classification of the medical device, and/or
• The presence of a similar or same device already on the market.

If the medical device is a Class II or Class III device, then it must usually go through the Premarket Approval process unless there is already a substantially similar or equivalent Class I or Class II device on the market. What difference does either of these processes make? The difference is in time, money, and actual safety and quality data on the specific device.

1.1 Premarket Approval

The Premarket Approval (PMA) is — as already mentioned — the more stringent process. It is also a longer and more expensive process. Most Class III and some Class II devices must go through this process unless there is an equivalent device already on the market. Success via this process involves proving the device is safe and effective. Proof of the latter is found in clinical and laboratory studies with outcomes that support the claims made of the device.

This process is detailed and lengthy, but it is in place to ensure the product works as described and is safe when it is used. ¹

1.2 510(k) Clearance

The 510(k) clearance, also known as premarket notification, does not require clinical and/or laboratory studies and data proving the product is safe and effective. This process helps companies forego rigorous pre-market and research studies. The process aims to confirm that the medical device going through the process already has an equivalent on the market.

In other words, this path to FDA approval considers if there is a same or similar product on the market rather than test the product for its safety and effectiveness.

A medical device is substantially equivalent to an existing marketed medical device (predicate device) if:

• It has the same intended use as the predicate device, and
• It has the same technological characteristics; or
• It has the same intended use as the predicate device, but
• It has different technological characteristics yet does not raise new questions pertinent to safety and effectiveness.

The law allows the FDA to require a study to produce data on the medical device, but in 510(k) processes, it rarely requests the same. ²

2. Why does it matter which approval process is used?

As implied above, the approval process matters because it determines if data is required to support the claims and safety of the product. Studies show that two-thirds of all medical devices that have been recalled were initially approved through the 510(k) process and not the PMA process. ³ In this study, the researchers reviewed 113 recalls that occurred between 2005 and 2009 –these recalls were determined by the FDA to cause serious health problems or death. ⁴ This study found of those 113 recalls, only 21 had gone through the more stringent PMA process — that’s not even 20 percent of the 113 medical device recalls. ⁵ Eighty of the 113 recalls were approved via the 510(k) path while most of the remaining were exempt from any FDA regulation. ⁶

How medical devices — e.g., hernia mesh products — are approved matters because it is your health and your life at stake. Hernia mesh products specifically have been proven to cause serious risk of injury, including death. At the same time, the number of recalls for hernia mesh products has increased. If you have been injured by a hernia mesh implant, your attorney will analyze the FDA recalls and the research provided on the same as part of the evidence to be used to support your case.

3. Are there hernia mesh medical devices that have been approved via the 510(k) clearance process?

Yes. Most hernia mesh products have been approved via the 510(k) process. This has been made possible because of the “substantially equivalent” exception.

For instance, Ethicon has a history of using the FDA’s 510(k) program to secure fast approval for its medical devices, and one of these devices was the Physiomesh hernia repair implant that has since been permanently taken off the market due to serious injuries caused by the product. The product was available for years — even after numerous adverse reports were filed with the FDA — until a 2016 study demonstrated the Physiomesh implant had a much higher failure rate than most other hernia mesh products. But this product was allowed to go through the quick 510(k) approval process because it was deemed “substantially equivalent” to other hernia mesh products. ⁷

The same applies to many other hernia mesh implants manufactured by Atrium, Bard, Covidien, Gore, and Genzyme. In fact, because of the injuries and complications of these hernia mesh products, most of these same manufacturers have either been sued, have hernia mesh lawsuits pending, or are likely to be sued by injured patients.

If you or a loved one has been affected or injured by a medical device used in your hernia repair surgery, you may qualify for compensation. Our personal injury attorneys are taking lawsuits throughout the United States to defend clients who have suffered and who continue to suffer. We are a team of skilled, experienced, and smart attorneys. Contact our office today to get started fighting for the compensation you deserve.

References

1. Food and Drug Administration. Premarket Approval Process.
2. Food and Drug Administration. 510(k) Clearance Process.
3. Zuckerman DM, Brown P, Nissen SE. Medical Device Recalls and the FDA Approval Process. Arch Intern Med.2011;171(11):1006–1011. doi:10.1001/archinternmed.2011.30
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7. Pawlak M, Hilgers RD, Bury K4, Lehmann A, Owczuk R, Śmietański M. Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. Surg Endosc. 2016 Mar;30(3):1188-97. Doi: 10.1007/s00464-015-4329-0. Epub 2015 Jul 3.