Staff at the Food and Drug Administration are recommending that the agency take another look at the standards regarding testing for an adverse reaction to metal-on-metal hip implants, according to a report by Bloomberg News on Monday. The recommendation comes ahead of a two-day meeting of an FDA advisory panel later in the week which is due to address the subject more formally.
The FDA issued a press release back in March of this year asking for "expert scientific and clinical advice on the risks and benefits" of the implants. The request was prompted by reports that as many as 16,800 patients who had received a metal-on-metal hip implant during replacement surgery had suffered ill effects from the device.
Here are some of the key details surrounding the FDA's renewed scrutiny of the devices.
* The advisory panel, which is due to convene on Wednesday and Thursday of this week, will be looking at several different aspects of the devices. Monday's staff recommendations had to do with the protocols surrounding just how and when testing is done to determine whether or not a patient is tolerating the implants.
* Staff members are recommending that the advisory panel specifically address how and when ion testing and imaging is used to discover whether or not the metal-on-metal hip implant is damaging surrounding tissue, according to Bloomberg.
* The FDA's posted agenda for the advisory panel notes that the agency will be taking a closer look at the data surrounding risk factors for the devices, as well as testing, complications, failure rates, and clinical follow-up procedures.
* Last Thursday, medical professionals expressed skepticism that FDA-requested studies into the implants' effectiveness would prove useful to the agency's decision-making process regarding the devices. A report by Medpage Today charged that the FDA's decision to allow manufacturers to study their own products and submit reports to the agency would severely limit the usefulness of any of the findings, thus making it difficult for the agency to establish a clear idea of the risk factors involved with the devices in order to establish protocols regarding their use.
* A report by the Associated Press on Monday indicated that as many as half a million Americans who have had either one of the two different types of metal-on-metal hip implants may be experiencing problems with the devices much sooner than expected.
* The AP report also noted that researchers in the U.K. found after conducting studies earlier this year that the devices appear to have a five-year failure rate that is much higher than the ceramic or plastic versions that were previously favored, of 6 percent versus 2 percent.
Vanessa Evans is a musician and freelance writer based in Michigan with a lifelong interest in health and nutrition issues.
- Food and Drug Administration