October 25, 2021

Hip Implant Complaints Surge, Even as the Dangers Are Studied

An analysis of federal data by The New York Times indicates that the Food and Drug Administration has received more than 5,000 reports since January about several widely used devices known as metal-on-metal hips, more than the agency had received about those devices in the previous four years combined.

The vast majority of filings appear to reflect patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more.

The mounting complaints confirm what many experts have feared — that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007. About 7,700 complaints have been filed in connection with that recall.

Though immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear.

Hip replacement is one of the most common procedures in the United States and, until a recent sharp decline, all-metal implants — one in which both the artificial ball and cup are made of metal — accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the most problematic devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson Johnson and accounted for 75 percent of the complaints reviewed by The Times. A precise count of failed implants reported to the F.D.A. is hard to come by because of the agency’s overlapping reporting system, though The Times sought to eliminate duplicate reports about the same incident. Some complaints came from outside the United States.

Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries.

“They are grasping at how they are going to get this information,” said Dr. Robert S. Namba, an orthopedic surgeon with Kaiser Permanente.

In addition, researchers are struggling to understand the tissue damage caused by the metallic debris. While some patients experience pain, other patients with the same damage have no pain, complicating decisions about whether to remove devices.

As problems and questions grow, most surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available. Some researchers also fear that many all-metal hips suffer from a generic flaw. Current use of all metal devices has plummeted to about 5 percent of the market, though a few of the models are performing relatively well in select patients.

“It is like playing Russian roulette,” said Dr. Geoffrey H. Westrich, an orthopedic surgeon at the Hospital for Special Surgery in New York, who has stopped using all-metal implants.

Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, said he believed that producers would mount rigorous studies and find answers. But he acknowledged that it could take several years.

“There is not an existing infrastructure for studying this kind of information,” Dr. Maisel said.

For many patients, it is too late. In 2008, Ann Morrison, a physical therapist from Newark, Del., received all-metal replacements for both of her hips. But Ms. Morrison, 50, soon experienced pain, rashes and inflammation.

Article source: http://feeds.nytimes.com/click.phdo?i=1ea800d47e37f478c586d6662145f3e8

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.

Article source: http://feeds.nytimes.com/click.phdo?i=b7e79beb9b47487fa80a756cdacacc51