FDA Reclassifies Vaginal Mesh as a High-Risk Device

7468288776_36c800e74e_bMedical devices are among the most commonly litigated items in product liability lawsuits. To recover damages in a defective medical device lawsuit, the plaintiff must show that the device in question is unreasonably dangerous or that the device the plaintiff received suffers from a manufacturing defect that renders it unreasonably dangerous.

In one of its first actions for the new year, the U.S. Food and Drug Administration (FDA) has issued two orders increasing the regulation of transvaginal surgical mesh products used to treat pelvic organ prolapse (POP). The first order reclassifies transvaginal mesh used in POP procedures as a Class III device. Class II devices are those that generally involve moderate risks, while Class III devices are high-risk devices.

The second order requires transvaginal mesh makers to prepare premarket approval applications that provide support for the devices’ efficacy and safety in POP repair procedures. Under the premarket notification system, a manufacturer must show the FDA that its device is at least as safe and effective as a comparable device that is already on the market that was not also approved through the premarket notification process. In other words, the manufacturer must show that the device is substantially equivalent to an existing device.

In a statement announcing the finalization of the orders, the FDA indicated that women who received transvaginal mesh devices experienced severe pelvic pain, bleeding, organ perforation, infection, painful intercourse, and urinary incontinence issues. POP occurs when the muscles and tissues in the pelvic floor are weakened, stretched, or torn, rendering them incapable of providing support for internal organs like the uterus, bowel, or bladder. The mesh is designed to hold these organs in place and to prevent them from prolapsing into the vagina. Despite this, the FDA has received countless notices from doctors and patients describing severe and painful adverse events.

In 2008 and 2011, the FDA issued warnings regarding transvaginal mesh products used in POP procedures. Shortly thereafter, many product liability lawsuits were filed against transvaginal mesh manufacturers, seeking damages for these conditions. As a result of this litigation, Johnson & Johnson ceased manufacturing its transvaginal mesh product. The two orders that the FDA finalized this month were originally proposed in April 2014, and they were designed to build on the warnings the agency provided in 2008 and 2011.

Five other manufacturers continue to market transvaginal mesh products for use in POP applications, subjecting them to the FDA’s new Class III designation. According to the FDA, the new classification is intended to strengthen the clinical requirements for transvaginal mesh products used in POP procedures.

If you or someone you love have suffered injuries as the result of a transvaginal mesh device, you may be entitled to compensation. At Moll Law Group, our dedicated team of defective medical device lawyers has helped many women receive the compensation they deserve after suffering devastating injuries. We represent plaintiffs across the United States, including in California, New York, and Florida. Call us now at 312-462-1700 or contact us online to set up your free confidential consultation.

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