On December 14, 2011, the New York Times published an article regarding the recent legislation presented to the U.S. Senate that would require manufacturers track the post-approval performance of artificial hips and other medical implants. The bill is in response to recent criticism of the F.D.A.’s 510(k) process, which allows for the approval of a medical implant if it is “substantially similar” to another device already on the market. If approved, the bill would require device manufacturers to track implants even after these have been approved for sale.
The new legislation arises amidst growing problems with medical devices, including all-metal hip implants. The senators who drafted the bill also sent out letters to five device manufacturers asking for documentation on how these companies track recalled devices and product safety measures. Johnson & Johnson, the manufacturer of the recalled all-metal DePuy ASR hip device, was one of the companies that received a letter. Congress wants to know when and to what extent the company was aware of device failure in the all-metal ASR model.
Although Johnson & Johnson voluntarily recalled the ASR device in August 2010, the company is nonetheless facing criticism for not acting fast enough to recall the device. A recent Australian report indicates that the company was likely aware that serious problems existed with the ASR device before issuing a recall. Due to these problems, patients with the recalled DePuy ASR device have filed approximately 3,660 cases as of January 2012 against DePuy, Johnson & Johnson and related entities.
See the full New York Times article at: