On August 24, 2007, the U.S. Food and Drug Administration (“FDA”) directed Johnson & Johnson (“J&J”) to cease the sale of Gynecare Prolift vaginal mesh implants until the agency could determine whether the device was in fact “substantially equivalent” to other products on the market—an integral issue weighing on the product’s ultimate approval by the FDA. Now, it appears that, despite the FDA’s directive, J&J continued selling the implant for another nine months.
In its August, 2007 letter to J&J, the FDA expressly stated that J&J “may not market this [implant] device until you have provided adequate information . . . . If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.” The FDA also noted that there is potentially a high risk of organ perforation when the mesh is used vaginally. Ultimately, the FDA cleared the implant for sales in May, 2008 without sanctioning J&J or otherwise imposing punishment.
The primary issue centers around whether, under FDA guidelines, the Gynecare Prolift vaginal mesh implant was “substantially similar” to a device already approved by the FDA. If so, J&J would not have to apply for separate approval of the Prolift device. The FDA’s decision in May, 2008 to not sanction J&J for its mischaracterization of the Prolift device has been criticized by many and is thought to be a perfect example of the FDA’s limited resources and enforcement clout. Of no surprise, J&J stands by its “good faith” approach to the marketing and sale of Prolift, and disputes overwhelming reports of the device’s potential threat to patients’ safety.
Source: Bloomberg News