In 2012, it was revealed that Ethicon, a subsidiary of Johnson & Johnson sold Gynecare Prolift for three years without receiving approval from the FDA. The FDA only became aware of the product after Ethicon attempted to use the device as a predicate for its 510(k) approval of a different device in 2007. For several years, the Gynecare Prolift product was marketed as an “innovative and effective surgical option” for women with pelvic organ prolapse (“POP”).
Ethicon claimed that Prolift did not require approval given that it was very similar to a previously approved device. However, the FDA indicated that it was improper to market the product without proper clearance and submission of an approval application. It is estimated that 100 complaints regarding the product had been reported once the FDA discovered that Ethicon had marketed the product without approval. Even worse, Ethicon had touted Prolift as having “rare complications” in patient brochures.
This is one of several events that has prompted widespread concern regarding the 510(k) approval process. This approval process permits manufacturers to base their applications for approval on a predicate device or previously approved device. By basing approval on a previous device, the company is not required to perform any clinical testing or supply clinical data on its products. See our previous blog post on the danger of the 510(k) process here.
Manufacturers have argued that the 510(K) process is very important to providing new and innovative medical devices to the public. However, the number of complications and recalls occurring in dozens of these vaginal mesh products has created panic regarding patient safety. In July 2011, the FDA stated that complications associated with the use of vaginal mesh products for treatment of pelvic organ prolapse are not rare. In January 2012, the FDA required mesh manufacturers to supply detailed information regarding the adverse events and complication rates associated with their products. Most recently, on April 29, 2014, the FDA reclassified mesh products used for pelvic organ prolapse as “high risk products.” The FDA found that the products carry significant risks.