Concerns about the defective hip implants are continuously growing. As reported in media, the United States Senate is engaged in finding the answers. Recently, investigation on metal-on-metal hip replacements
is being requested by the Senate’s special committee. 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.
The president of the National Research Center for Women and Families, Diana Zuckerman, told US lawmakers that products approved through the 510(k) process are more likely to undergo a recall than those who went through premarket trials.
Another witness presented in the hearing was Katherine Korgaokar, who was affected by the DePuy hip replacement recall. She was pleased with how her hip replacement in 2006 has changed her way of living. When she found out the DePuy hip recall, she submitted herself for a blood test and discovered that the metal ions detected in her body were 1000% higher than normal.
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. Also emphasized in the letter is the need for guaranteed patient safety. Also part of the letter is the call for a hearing on the recent report of the Institute of Medicine. 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.” 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.”
One of the manufacturers facing the crisis on metal-on-metal hip implants is the DePuy Orthopedics. Approximately 93,000 defective devices were implanted 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.