Product Recall: Please Return Your Hip
WebMD News Archive
A major issue, according to the NIH report, is that the FDA doesn't generally require makers to report problems in retrieved devices as a condition for approval. "If reported to the FDA, manufacturers may fear that proprietary retrieval information may be disclosed," the report states.
However, Jim Benson, who heads the industry lobby group AdvaMed, says both new and existing devices are scrutinized without bias in a rigorous approval process. Furthermore, it's not possible to study as many patients using a device as taking a drug, he tells WebMD.
Doctors need to do a better job of passing on the pluses and minuses of devices to their patients, Benson says, and patients themselves can check out information on the Internet. "It might take a change in law to require manufacturers to directly inform patients ... and that would probably do more damage than good, because it would diminish the physician's role," Benson says.
Another possibility, Brandt says, is that the NIH and the FDA could work more closely together to develop safer and better devices.