Food and Drug Administration (FDA): Legal Definition

The Food and Drug Administration, known as the FDA, is a government agency in the United States. This agency is in charge of the approval and oversight of medications, medical devices, and other medical products. They collect complaints about products, track reports of complications, and can recall defective products when necessary.

The U.S. Food and Drug Administration and Hernia Mesh Approval

Many of the hernia mesh products currently on the market in the United States received FDA approval through a program known as 510(k) Premarket Clearance. This program allows manufacturers to submit new products and get approved for use by the FDA, without conducting clinical trials.

To obtain this type of FDA marketing clearance, the product must be “substantially equivalent” to products already approved and on the market. This takes into account the safety and effectiveness of the already-approved device, as well as its use. It does not, however, need to be of the same materials.

Known Issues with Hernia Mesh Products

The FDA collects and tracks adverse event reports related to all products they approve, including surgical mesh products. They also keep an eye on peer-reviewed, scientific literature. According to the FDA, the most common complications of hernia repair using surgical mesh products include:

  • Pain near the surgical site
  • Increased risk of infection
  • Hernia recurrence
  • Adhesion
  • Bowel obstruction
  • Bowel perforation

There is also the risk of complications that occur because of mesh migration and mesh shrinkage. Many of these adverse events can require additional surgery to remove, repair, or replace the mesh patch. Removal, especially, can be difficult. These revision surgeries are often more invasive than the initial hernia repair.

Hernia Mesh FDA Action

According to the FDA, the primary cause of the most serious adverse events—bowel perforation and bowel obstruction—are mesh products the manufacturers later recalled. It’s true many manufacturers have either recalled surgical mesh products or voluntarily withdrew patches from the marketplace over the last few years. This includes products from leading manufacturers:

  • Atrium
  • R. Bard, Inc.
  • Ethicon

Still, hundreds of these mesh implant products remain on the market, and countless people receive the implants every year. When they look at the number of products on the market and the frequency of reported complications, some question why the FDA has not recalled many more of these hernia mesh products. If you know the type of surgical mesh your surgeon used, you can search for a recall on the FDA database.

If you underwent hernia repair surgery, received a surgical mesh implant, and you later suffered complications, you may be able to take legal action against the manufacturer. At the Law Offices of Ogle, Elrod & Baril, PLLC, our team can help you request your medical records and identify the mesh manufacturer and brand utilized in your hernia repair.

Call us today at 865-546-1111 to get started.