- On 30/10/2012
- In News
The Australian market for the DePuy hip devices were subjected of a total pullout in December 2009. In August 2010, DePuy implemented a global recall. Between 2008 and the time the recall was issued, the Food and Drug Administration (FDA) have documented hundreds of complaints from ASR clients, many of whom are required to have a second hip replacement surgery.
The infamous DePuy hip replacement recall was so much striking that on December 14, 2011, the New York Times published an article saying that three U.S. senators made a proposal of a bill on reinforcing medical device regulations. The three senators were Charles E. Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI).
Furthermore, the Times said “these lawmakers have proposed a wave of medical device industry-friendly bills that would further streamline FDA regulations, allowing more product clearances.”
“There is clearly a need for scrutiny once products are implanted or used on patients,” Senator Blumenthal said.
This synchronized effort from a diverse group of senators demonstrates that policymakers are listening to patients, companies, and consumers about their concerns on the potential negative consequences from indulgent rules on medical device. Legal observers also say that it also shows that senators are recognizing the important role industry play in improving health care and outcomes for patients.
With approximately 93,000 recipients worldwide, the ASR XL Acetabular System and the ASR Hip Resurfacing System were recalled after data revealed that the devices fail prematurely in one out of eight people who have them. These two implant designs have been manufactured and marketed since 2003.