On August 22, 2011 the NY times published the results of its own study of Adverse Event Reports to the Food and Drug Administration (FDA) by patients with metal on metal artificial hip systems. The results confirm widespread failures with the DePuy ASR hip system.
Read the full NY Times Hip Implant Complaints Surge, Even as the Dangers Are Studied article.
The Adverse Event Reporting System (AERS) is a database the FDA uses to monitor problems with products it has approved. The reporting system compiles information submitted by doctors, pharmacists, and nurses, as well as patients and their family members. The database also includes reports from manufacturers. This type of reporting is entirely voluntary for healthcare professionals and the public, but is supposed to be mandatory for manufacturers. An Adverse Event Report will include device information, the reaction or problem, and the ultimate outcome for the patient. The database is an important tool for the FDA because it helps keep track of products after their initial approval. The FDA uses research teams to continuously evaluate this system for safety concerns. Depending on the scope and severity of reports it receives, the FDA may issue warnings, change required labeling, restrict uses, or–in rare cases–take a product out of use entirely.
After reviewing the available Adverse Event Reports for metal on metal artificial hip systems, the New York Times reported that the FDA has received more than 5,000 complaints about theses implants between January and August, 2011. This is more complaints than they received the previous 4 years combined. The vast majority of complaints to the FDA report a device failure after only a few years, and over 75% of the complaints were for the DePuy ASR hip systems.
The New York Times analysis of the AERS for metal on metal artificial hips is the latest information on top of an ever-mounting pile of evidence regarding the dangerousness of the DePuy ARS hip system. These reports clearly demonstrate that the DePuy ASR system is markedly different and substantially more dangerous to patients then other artificial hip systems. The pertinent question that needs to be answered is: For how long a period of time BEFORE the ASR recall did DePuy know of the product’s dangers? SUGARMAN is committed to revealing the answer to this question and will continue to represent patients who have been harmed by a DePuy ASR artificial hip.