New York, New York (PRWEB) May 01, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, is today commending ProPublica for its recent investigation which revealed that several problematic medical devices, including DePuy Orthopaedic Inc.'s recalled ASR metal-on-metal hip implants, were approved by the U.S. Food & Drug Administration (FDA) without the benefit of clinical trials. In addition to DePuy ASR hip implants, other devices cited by the ProPublica report include surgical mesh products used in the treatment of stress urinary incontinence and pelvic organ prolapse (also known as transvaginal mesh devices). [propublica.org/special/four-medical-implants-that-escaped-fda-scrutiny]
According to ProPublica, the DePuy ASR hip implants were recalled in August 2010, after they had been implanted in almost 100,000 people. The metal-on-metal hip replacement devices were recalled worldwide after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had the devices implanted had to undergo revision surgery within five years of the implant. [depuy.com/asr-hip-replacement-recall]
The FDA approved the DePuy ASR hip implant via its 510(k) approval protocols, which allow devices to come to market without clinical trials if a manufacturer can show it is "substantially equivalent" to a device already on the market. According to ProPublica, such approvals have been the subject of controversy. Among other things, ProPublica cited a review conducted last year by the Institute of Medicine which revealed that from 2005 to 2009, three out of four recalled high-risk devices had been cleared through the 510(k) clearance process or had been exempt from FDA review altogether. In issuing that report, the Institute called on the FDA to discontinue the 510(k) approval process entirely. [iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/Report-Brief.aspx]
Numerous transvaginal mesh devices have also come to market under the 510(k) protocols since the late 1990s, according to ProPublica. The FDA has been conducting a safety review of these devices since 2008, and revealed in a July 2011 Safety Communication that, from January 2008 through December 2010, it had received 2,874 new reports of complications associated with transvaginal surgical mesh products. The FDA is now considering rescinding 510(k) approvals for transvaginal mesh devices used in pelvic organ prolapse repair, and has asked the makers of such devices to conduct safety studies of the products. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm]
According to Parker Waichman LLP, far too many patients are already living with serious health consequences because the FDA has allowed so many medical devices, including DePuy ASR hip implants and transvaginal mesh products, to come to market without any prior clinical testing. For that reason, the firm once again calls on the FDA to reform the way it approves medical devices for market.
For more information regarding FDA medical device approvals, please view this video blog produced by Parker Waichman LLP.
Parker Waichman LLP offers free legal consultations to victims of defective metal-on-metal hip replacement implants, transvaginal mesh products, and other faulty medical devices. If you or a loved one were injured by a medical device, please visit their medical device injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective medical device lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney