December 4, 2022

F.D.A. to Tighten Regulation of All-Metal Hip Implants

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.

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Study Calls Approval Process for Medical Devices Flawed

The government’s system for regulating many medical devices should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to one of the nation’s top scientific groups.

In a report, released Friday, a panel of the Institute of Medicine found that the existing rules were never intended to provide safeguards for screening out dangerous or ineffective products. The panel urged the Food and Drug Administration to devise a new regulatory system for the so-called moderate risk devices — a category that now includes artificial hips, external heart defibrillators and hospital pumps — because the current system was not fixable.

“If you want to make sure that a product is safe and effective, you have to start by asking the question whether it is safe and effective,” said William Vodra, a member of the 12-person panel assembled by Institute of Medicine and a lawyer who has worked closely with device producers.

The report, which was commissioned by the F.D.A., follows a number of recalls of medical devices, like one involving so-called metal-on-metal artificial hips that have failed in thousands of patients, crippling some of them. Those implants received little, if any, testing in patients prior to being implanted in tens of thousands of people.

The report’s findings are certain to touch off an intense lobbying battle over the shape of any future regulations, as device companies moved quickly to attack the study’s findings. Even before the report’s release, allies of the industry had waged an aggressive campaign to discredit it, and had taken legal steps intended to bar the F.D.A. from adopting its recommendations.

Soon after the study’s release, the country’s biggest trade group, the Advanced Medical Technology Association, which represents such industry giants as Medtronic, Boston Scientific and Johnson Johnson, unequivocally rejected the report, saying it did not deserve “serious consideration” from Congress or the Obama administration.

Abandoning the current approval system “would be a disservice to patients and the public health,” the group’s chief executive, Stephen J. Ubl, said in a prepared statement.

Dr. David Challoner, who served as the panel’s chairman, said that members of the group were stunned when they realized that the current system could not be salvaged. The F.D.A. had asked to panel to examine what modifications to current regulations might be useful.

“We surprised ourselves,” Dr. Challoner said.

Dr. Jeffrey E. Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement that many of the report’s findings “parallel changes already under way at the F.D.A. to improve how we regulate devices.” He said he did not believe the existing regulatory system should be scrapped, adding that any significant changes would have to be approved by Congress. The Institute of Medicine review covered the approval system for a wide range of moderate-risk products, known as the 510(k) clearance process. It did not examine devices that carry the highest risk to patients if they fail, like implanted heart defibrillators. Those products go through a separate regulatory pathway that requires extensive testing before sale.

The big problem, the study found, is that the Congressional law that created the 510(k) pathway, the Medical Device Amendments of 1976, required producers of such products only to show that they were “substantially equivalent,” or similar, to one already on the market.

The standard does not require a producer to show that a new device is safe or effective, or even to provide evidence that an earlier device on which a new application is based works well.

The committee’s report emphasized that its members believed most medical devices in use were safe and beneficial. But it added that the existing regulatory system made it impossible to identify problematic or useless ones.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness” of moderate-risk devices, the report concluded, adding, “Furthermore, that it cannot be transformed into one.” The panel concluded that the F.D.A. should act quickly to determine whether artificial joints, such as hips, which are currently approved through the 510(k) process, should have to undergo the type of rigorous scrutiny that high-risk devices now go through prior to sale.

A small industry trade group, the Medical Device Manufacturers Association, also issued a release saying it was “concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies.”

Among other recommendations, the report also urged the F.D.A. to quickly tighten the way it tracked the performance of implanted devices and other products once on the market, and said the agency needed to move more quickly to stop the sales of harmful ones.

In many ways, the report is a rebuke to the medical device industry and its allies, who have been waging a campaign over the last year to dispute the need for any new regulations. More recently, they have criticized the Institute of Medicine’s review as biased.

Last month, the Washington Legal Foundation, a pro-business group, filed a petition with the F.D.A. arguing that the agency was statutorily barred from adopting any of the report’s recommendations because of what it claimed was the panel’s bias.

The legal foundation argued that the Institute of Medicine, which is part of the National Academy of Sciences, had failed to balance the panel by including officials from the device industry, the investment community or patients who had benefited from devices. An F.D.A. official said the agency was happy with the panel’s composition, which included doctors, academics and three lawyers, included two who worked closely with the industry.

The report on Friday addressed several complaints by the industry on possible new regulation, including the claim that toughened rules would slow the introduction of innovative products that could benefit patients.

The panel said there was no way of assessing, based on a review of available evidence, whether current regulations were having either a positive or a negative effect on innovation. The group, however, recommended that the F.D.A. assemble a group to review the issue.

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In Medicine, New Isn’t Always Improved

But the promise of innovation can also prove a trap, a situation now playing out with dire consequences for possibly tens of thousands of people who received artificial hips intended to let them remain active.

The implants, known as metal-on-metal hips, were regarded by device makers and surgeons as a major advance over previous designs that used both metal and plastic. Now federal regulators and medical researchers are scrambling to determine how many implant recipients have been injured by the devices, which can shed dangerous metallic debris through wear.

In a highly unusual move, the Food and Drug Administration last month ordered manufacturers of all metal hips to undertake emergency studies of patients. And lawmakers and others are now calling for a tightening of how the F.D.A. scrutinizes new implants — both before and after they are sold.

A review of the medical world’s embrace of the metal-on-metal hips over the past decade — including interviews with doctors, industry consultants, regulators, medical experts and patients — shows how innovation’s lure led almost everyone to seize on a product promoted as a breakthrough without convincing evidence that it was better or even as good as existing options.

“As a non-American, I don’t completely understand it, but there is a phenomenon in the U.S., the latest and the greatest,” said Dr. Henrik Malchau, who practiced as an orthopedic surgeon in Sweden before going to Massachusetts General Hospital in Boston. “There was a patient demand to get these implants on the misconception that the latest was the best.”

For many manufacturers, the constant churning of new products can be a business necessity, a way to gain an edge on competitors while maintaining or even raising prices. But in recent years, a host of supposed innovations have imploded not long after introduction.

Several heavily promoted artificial spinal disks, claimed by their makers to be major innovations, proved no better than previous ones. After the blockbuster diabetes drug Avandia was linked to heart attacks, a federal study concluded that older drugs were safer and worked better for most patients. And a new heart device component from Medtronic started fracturing after it was implanted in more than 200,000 patients; at least 12 people died in connection with that product.

Some experts, like Dr. Malchau, said they used a special type of metal-on-metal implant known as a resurfacing device in specific patients — mainly taller, middle-age men — because data showed that they worked in that small group. But as with many innovations, metal hips were marketed to all comers. For example, about 65 percent of the implants went to women and older patients, according to an estimate by a consulting firm, Exponent Inc. As it turned out, those two groups appear most prone to failures involving the devices.

“The vast majority of the ‘innovations’ on which we have spent money with respect to orthopedics over the past two decades have not resulted in improved patient outcomes,” said Dr. Kevin J. Bozic, an orthopedic surgeon and professor at the University of California, San Francisco, who has written about artificial joints’ impact on health care costs.

Last year, DePuy, the orthopedics division of Johnson Johnson, recalled one of its all-metal hips, the ASR, which was failing at a high rate. Another manufacturer, Zimmer Holdings, also briefly halted sales of one of its metal models, the Durom.  DePuy, Zimmer and other companies and doctors have said that most patients who received metal hips have done well.

Experts like Dr. Bozic suggest that big gambles on innovation are justified in dealing with diseases, like some cancers, where current treatments are ineffective. But they say that calculus should shift sharply when existing treatments are highly effective, and that doctors need to use better yardsticks before embracing new technologies in those cases or adopt changes slowly.

THE modern artificial hip, which was developed by a British surgeon, Dr. John Charnley, in the 1960s, uses a relatively simple design. A metal “ball” made of cobalt and chromium replaces the top of the thigh bone, while a “cup,” typically made of plastic, serves as an artificial hip socket. By the 1990s, the devices were considered highly effective, with studies then finding that implants still worked a decade after surgery in 95 percent of patients.

Metal-on-metal implants, in which the cup is also made of a metal alloy, had been tried during those early decades, but were largely abandoned after tests found that patients had metal particles in their blood or organs, raising concerns about long-term health risks like cancer.

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Group Faults the F.D.A. on Oversight of Devices

The Food and Drug Administration is allowing some high-risk devices like artificial hips to be sold without strenuous testing, despite promises that it would address regulatory issues affecting them, a federal watchdog group plans to testify on Wednesday.

The group, the Government Accountability Office, found that the F.D.A. has taken some recent steps to determine if certain high-risk medical devices should undergo more testing before being sold. But in the meantime, it is continuing to approve dozens of such devices annually with scant review, exposing patients to risks.

An official with the office is expected to give the testimony on Wednesday at a hearing before the Senate Special Committee on Aging. The office will also present its preliminary findings of what it concluded were shortcomings in how the F.D.A. oversees recalls of troubled devices.

A spokeswoman for the F.D.A., Karen Riley, said that officials there had not seen the G.A.O. testimony and so could not respond directly to it. She added that F.D.A officials planned to testify at the hearing. The panel is also expected to hear from patient advocates and industry representatives.

Among other issues, the Senate hearing is expected to examine the approval and marketing of a now-recalled artificial hip sold by Johnson Johnson known as the A.S.R., or Articular Surface Replacement. An article last December in The New York Times detailed how the medical products giant continued to sell the hip despite repeated reports by physicians abroad that it was faulty.

The F.D.A. permitted Johnson Johnson to sell the artificial hip without conducting clinical trials. A few years after implant, it began disintegrating in patients, shedding metallic debris that has left some patients crippled.

According to reports by doctors in England, the device may fail prematurely in about 50 percent of the patients receiving it.

The F.D.A. has two separate procedures for approving medical devices.

For devices that pose a lower level of risk to patients, a manufacturer need only show that a new product is substantially equivalent to one already on the market. For devices that are more critical, like implanted heart defibrillators, producers have to run clinical trials to win approval.

But some categories of high-risk products like artificial hips and external defibrillators that were already on the market when the F.D.A. began to regulate devices can still enter the market through the less-rigorous pathway. Safety advocates have long urged the F.D.A. to close that loophole.

In 2009, the G.A.O. issued a report recommending that the F.D.A. reclassify such devices either into the high-risk category, the one requiring more testing, or in lower-risk categories that do not require testing. The agency has started to do so, but to date it has not made final decisions for nearly all those products.

At the start of the Obama administration, F.D.A. officials indicated that they would take an aggressive approach to the regulation of medical devices. But in more recent months, they appear to have backed away from that stance.

The F.D.A. has asked the Institute of Medicine to review its device approval process. That group is expected to issue its report later this year.

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