Issues on Metal-on-Metal Hip Implant Tackled by US Senate

Health issues involving the defective hip implants don’t seem to come to an end. The United States Senate has studied this issue, report says. Recently, investigation on metal-on-metal hip replacements is being requested by the Senate’s special committee.   This is an adjunct to former hearings.

The US Senate Special Committee on Aging held a hearing on the approval process of the Food and Drug Administration and the recall of DePuy’s hip replacement on April 13, 2011.

Diana Zuckerman, president of the National Research Center for Women and Families, took the stand and stated that the products that gained approval through the 510 (k) process have greater chances to getting recalled than the ones that were subjected to clinical trials.

Katherine Korgaokar, who was affected by the DePuy hip replacement, has also taken the witness stand. She had hip replacement in 2006 and was happy with the outcome of the surgery. After learning of DePuy’s recall, she underwent blood test and found that her metal ions were 1000% higher than expected.

Marcia Crosse, health director of the Government Accountability Office, told US lawmakers about the inability of the FDA to sufficiently safeguard the public from harmful medical devices.

Almost half a year after the hearing, a letter requesting for added investigation on the all-metal hip replacements was sent to the chairmen of the Committee on Energy and Commerce by the Democratic Party Leaders.The letter, dated October 12, 2011, emphasized the importance of reducing inefficiencies at the FDA. It also underscored the need for ensuring patient safety. Lawmakers further stated in the letter that a hearing on the recent Institute of Medicine report be conducted.  The current review system has to strengthen to make sure that medical devices are safe and effective, as concluded in the IOM report.

The proponents of the letter were quoted as saying, “This is a critical opportunity to improve the efficiency of the process while at the same time strengthening assurances of safety and efficacy.”  “Hearings to ensure that all relevant sides of the issue can be fully examined by the Committee, including the importance of safety, are critical to ensure a balanced perspective for members,” they added.

The DePuy Orthopedics is one of the manufacturers involved in the all-metal hip implant crisis.  An estimate of 93,000 defective devices was given to patients worldwide.  The company voluntarily issued an ASR hip replacement recall  in August 2010 to address the questions thrown at their device.  Furthermore, it is strongly advised that patients and surgeons promptly report manifestations of failing implant.

Reference:

democrats.energycommerce.house.gov/index.php?q=news/energy-and-commerce-democratic-leadership-calls-for-further-examination-of-fda-medical-device-r

kdlaw-blog.net/2011/04/20/u-s-senate-examines-depuy-asr-hip-implant-complications/

center4research.org/2011/04/testimony-of-diana-zuckerman-phd/

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