DePuy Hip Recall

Concerns about the defective hip implants are continuously growing. According to press reports, the United States Senate has joined the quest for a solution.  The Senate’s special committee has recently requested for an investigation on metal-on-metal hip replacements.  This is in addition to previous 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.

A patient affected by the DePuy hip replacement recall, Katherine Korgaokar, was also presented in the hearing. She was pleased with how her hip replacement in 2006 has changed her way of living. She had blood exams taken after hearing about the DePuy recall and found results showing a 1000% higher than expected metal ions on her body.

The Government Accountability Office, through health care director Marcia Crosse, also testified about its findings in a recent report showing that the FDA lacked the ability to adequately protect the public from dangerous medical devices.

A letter made by the Democratic Party Leaders in the Committee on Energy and Commerce was sent to their chairmen requesting for further investigation on the metal-on-metal hip replacements roughly six months after the previous hearing.  The letter, dated October 12, 2011, stressed the importance of cutting down FDA’s inefficiencies.It also underscored the need for ensuring patient safety.'

Conducting a hearing on a recent report of the Institute of Medicine was also included in the letter. The IOM report concluded that the current review system needs to be strengthened toward ensuring that medical devices are safe and effective.

The lawmakers stated in their letter, that, “This is a critical opportunity to improve the efficiency of the process while at the same time strengthening assurances of safety and efficacy.”They added that “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.”

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 responded through their voluntary ASR hip replacement recall  in August 2010. Patients and surgeons are also urged to report straight away signs 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

orthopediclaw.com/hip-replacement-recall-senate/

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

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