Bill Would Require More Monitoring of Implants (NY Times)
Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that would force manufacturers to track the performance of such products after they were approved for sale.
The bill would allow the Food and Drug Administration to compel companies to track implants, such as replacement hips, that belong to a category of products that do not require human testing for approval.
The proposal is an effort to address longstanding complaints by patient advocates and others like the Institute of Medicine about a system known as the 510(k) process that the F.D.A. uses to clear the sale of certain implants like artificial joints. To sell a new product under that system, a producer need only show that it is “substantially similar” to a product already on the market.
Thousands of the all-metal hips that are now failing prematurely in patients were approved through the 510(k) system. The new proposal would not require added premarket testing of such implants but would broaden the F.D.A’s postapproval oversight by giving it the authority to mandate that companies collect data on device performance. The bill, if adopted, would also tighten federal scrutiny of product recalls.
The bill was sponsored by two Democrats, Herb Kohl of Wisconsin and Richard Blumenthal of Connecticut, and a Republican, Charles E. Grassley of Iowa. In a telephone interview, Mr. Blumenthal said that the legislation would enhance patient safety without slowing device approval. He called the all-metal hips a “classic example” of why such monitoring was needed.
“There is clearly a need for scrutiny once products are implanted or used on patients,” he said.
A wave of recently introduced bills backed by the medical device industry would “streamline” F.D.A. rules to allow new products to reach market more quickly. And while the bill introduced Wednesday most likely faces an uphill fight, it may serve as a negotiating chip in a Congressional debate next year over F.D.A. device regulation.
A spokeswoman for the F.D.A., Karen Riley, said that the Obama administration had not taken a position on the bill. Wanda Moebius, a spokeswoman for a device industry trade group, the Advanced Medical Technology Association, said the group had not seen the bill but added that studies had shown that the current 510(k) approval process was “remarkably safe.”
Along with introducing the bill, the three senators sent letters Wednesday to five major producers of medical devices seeking documents about how they track product safety and recall devices.
The companies were Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker.
Specifically, in the case of Johnson & Johnson, Congressional investigators want to know when the company was warned that one of its all-metal hips — the A.S.R., or Articular Surface Replacement — was failing and how it tracked those problems. Last year the DePuy division of Johnson & Johnson recalled the device after it had been implanted in some 93,000 patients worldwide, including 40,000 in this country.
As of early October, about 3,500 lawsuits have been filed against Johnson & Johnson in connection with the A.S.R., and studies here and abroad suggest that the A.S.R. may have already failed a few years after implant in more than twice that number of patients here. Artificial hips are supposed to last 15 years or more before requiring replacement.
Last month, a legislative panel in Australia issued a report that concluded that Johnson & Johnson was probably aware of serious problems with the A.S.R well before recalling it. The panel also characterized the company’s responses to its questions as “decidedly opaque.”
“Many people could have avoided considerable pain, suffering and diminished quality of life if the company had acted in a responsible manner to known problems with these devices,” the Australian report stated.
In a statement, a spokeswoman for DePuy, Mindy Tinsley, said, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”