Under the proposal, which the agency is expected to announce on Thursday, makers of artificial hips with all-metal components would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs.
Currently, companies have to show only that their devices resemble ones already on the market, and they are not required to conduct clinical studies before selling them.
The F.D.A. action is intended to close a loophole in the 1976 federal law under which medical devices were first regulated. It is the agency’s first use of powers that Congress granted to it last year to deal with medical devices, like all-metal hips, that have been in regulatory limbo for decades.
The move comes amid one of the biggest device-related failures in decades. Just a few years ago, all-metal hips — implants in which the ball and cup component is made from a metallic alloy — were used in one of every three joint replacement procedures performed annually in the United States.
Traditional hip replacements, which are made of materials like plastic and metal, typically last 15 years before wearing out. But the all-metal hips, which companies rarely tested in patients before aggressively marketing them, are failing at high rates not long after implantation.
As a result, thousands of patients have been forced to undergo painful and costly operations to replace the devices. In addition, tiny particles of metallic debris released as the artificial joints move have caused severe tissue and bone damage in hundreds of patients, leaving some of them disabled.
Dr. William H. Maisel, deputy director for science at the F.D.A., said the agency’s proposal would require makers of all-metal hips to produce clinical data to justify their use because of the “large number of patients who received these products and the numbers of adverse events associated with them.”
The use of all-metal implants has plummeted, with the devices now accounting for about 5 percent of hip implants. For some of those devices, which are used in a procedure called resurfacing that is an alternative to total hip replacement, the F.D.A. already requires clinical trials before granting approval.
The impact of the proposal on manufacturers of traditional all-metal hips will not be immediate, and industry lobbyists may oppose its adoption or seek to modify it. Agency officials said it would most likely take a year for the rules to be finalized; after that, producers will have 90 days to submit clinical data to support a device’s safety and effectiveness.
In 2011, the F.D.A. ordered manufacturers of all-metal hips to conduct post-marketing studies to determine, among other things, whether the implants were shedding high levels of metallic debris. Dr. Maisel said he expected that device makers might try to use data from those studies to satisfy the proposed requirements.
If a company decided not to submit clinical data or if the information failed to meet agency standards, it would have to stop selling the implant.
The regulatory limbo involving all-metal hips resulted from the Medical Device Amendments of 1976. The law set differing test requirements for various devices, depending on the perceived risk of using them or the role they played in sustaining a patient’s life and health.
Producers of devices considered high risk, like implanted heart defibrillators, had to perform clinical trials to obtain F.D.A. approval for new products. But makers of devices considered less risky, like hospital pumps, had to show only that a new product resembled one already on the market.
However, at the time the legislation was passed, several types of medical devices, including all-metal hips, were already on the market. So lawmakers crafted what was supposed to be a temporary solution: regulators would treat potentially high-risk products like the hips as moderate-risk products until officially determining how to classify them.
But in the case of all-metal hips, the final classification never happened. Over the years, the F.D.A. started procedures to classify the implants but never completed them. Implant companies also lobbied the agency to classify all-metal hips as moderate-risk products rather than high-risk ones.
The result was that device makers like Johnson Johnson and Zimmer Holdings were able to start selling a new generation of all-metal hips a decade ago without running clinical tests.
Under the Food and Drug Administration Safety and Innovation Act of 2012, the agency now has a more streamlined way of classifying older devices. It no longer has to seek an economic review of a decision’s impact, a process that can take years, said Nancy K. Stade, the F.D.A.’s deputy director for policy.
About 20 types of older medical devices still await reclassification.
In recent weeks, the first of thousands of patient lawsuits involving the most troubled all-metal device, an implant once sold by the DePuy division of Johnson Johnson, have started to come to trial. Some plaintiffs’ lawyers say it may cost Johnson Johnson billions of dollars to resolve the litigation, which involves an implant called the Articular Surface Replacement.
On Thursday, the F.D.A. also expects to issue new guidance to doctors monitoring patients who have received all-metal hips.
For the first time, the agency will recommend that patients who are experiencing pain or other symptoms that indicate possible device failure undergo routine testing to detect levels of metallic ions in their blood.
Dr. Maisel said the agency was not recommending a specific ion level at which doctors should consider replacing an implant. Instead, he said physicians should monitor such tests over time and use that data, along with other information, to make such decisions.
Article source: http://www.nytimes.com/2013/01/17/business/fda-to-tighten-regulation-of-all-metal-hip-implants.html?partner=rss&emc=rss
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