Transvaginal & Pelvic Mesh

    Transvaginal Mesh: The FDA’s 510(k) Approval Process

    FDA 510(k)

    The transvaginal mesh approval process has come under intense scrutiny as thousands of women file suit for the injuries the device has caused. The Food and Drug Administration employs a variety of approval guidelines to clear drugs, devices, and other products made by pharmaceutical companies and manufacturers. One such process is the FDA 510(k) process, also known as premarket approval. While created to ensure patients receive the most cutting-edge medical care possible, it’s created a host of issues for both doctors and patients.

    FDA 510(k) Program: A Device Clearance Loophole

    Many devices, however, are able to bypass these rigorous requirements through the 510(k) approval process. These measures are applied to devices and drugs that are “substantially equivalent” to products that have already been approved. In short, this means that if a device is  similar to something that has already been cleared, it doesn’t need to go through the rigorous scrutiny and testing that other devices do.

    Doctors say this allows for unsafe devices to be cleared because they slightly resemble other existing products, undermining patient safety and allowing drug makers to expedite the push-through of a new product. They system is more than 35 years old, and countless products have been cleared using it.

    FDA 510(k) and Transvaginal Mesh

    One such device cleared through the 510(k) process is transvaginal mesh. TVM had a substantial equivalence to a product that was recalled more than 15 years ago. Called ProteGen Sling (and made by Boston Scientific), it had never been used vaginally before it was cleared. It cited similarity to slings used to treat hernias as one of its predicates, therefore making its way to the market with no technical testing. This highlights an important flaw in the 510(k) approval system: Some of the original products did not go through nearly as rigorous testing as consumers think, and many times, a new device is cleared in the same fashion.

    According to Boston WBUR’s CommonHealth, implanting transvaginal mesh through the vagina completely defies the rules of surgery, as the vagina is “contaminated” with an entire flora of bacteria. When a device is implanted inside the vagina, the surgery is therefore not performed in a sterile manner. Mesh erosion is not necessarily the movement of a foreign object through tissue so much as an infection with associated wound breakdown.

    After injuries and complaints continued to mount against TVM device makers, the FDA issued a warning suggesting that injuries associated with the implantation of this device were common and that TVM may not be superior to traditional surgical solutions.

    As a result, the FDA’s approval process is under scrutiny, and Congress continues to push for a complete revamp of the 510(k) process. Other defective products cleared through this process include Johnson & Johnson hip pulls, external heart defibrillators. An article by Bloomberg Business indicates that more than 29 percent of devices cleared by the FDA through the 510(k) process are no longer on the market.

    History of the FDA 510(k) Approval Process

    So why was this method of approval created? The FDA hoped that it would allow for high-tech medical care to reach hospitals and practices faster, resulting in better medical care for everyone. Applications are submitted to the FDA by drug makers and reviewed within 90 days. Unfortunately, any kind of drug or device that doesn’t undergo rigorous testing is risky. A book called Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years was written by the Institute of Medicine of the National Academics and answered two important questions regarding this practice:

    • Does the current FDA 510(k) Approval Process protect patients in an optimal manner and promote innovation to support public health?
    • If not, what are the recommended administrative, legislative or regulatory changes to provide optimal patient protection and support public health through the FDA 510(k) Approval Process?

    These questions, asked by the FDA itself, concluded that the process is flawed and that no revisions should be made to the 510(k) process. They recommended that the FDA should instead design specific regulations for pre- and post-market regulations and approval.

    Speak with an Attorney

    If you or someone you know has been affected by one of these drugs and devices, you may be eligible to file a lawsuit. To get started, it’s a good idea to have your case reviewed by an attorney who is familiar with the many mass torts currently consolidating cases like these. He or she can help you understand how to best make your claim, how much you can ask for in damages and how you should approach being compensated for your injury.

    Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as, Yahoo!, MSN, AOL, Xfinity,, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.

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