Ann Morrison experienced pain, rashes and inflammation soon after receiving all-metal replacements for each of her hips.
By BARRY MEIER and JANET ROBERTS
Published: August 22, 2011
The federal government has received a surge in complaints in recent months about failed hip replacements, suggesting that serious problems persist with some types of artificial hips even as researchers scramble to evaluate the health dangers.
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.
Last year, the devices were replaced, but by then, she said, debris-caused tissue damage was so extensive that she now needs a brace to walk and still cannot work. She called the F.D.A.’s order for medical studies a “joke.”
“We will be the little crash test dummies here until they figure out the health ramifications for us down the road,” said Ms. Morrison, who has sued the DePuy division of Johnson & Johnson, which made her implants.
To conduct its analysis, The Times reviewed complaints filed with the F.D.A. from 2007 through this June for several implants, including the A.S.R. and the Durom cup, a component sold by Zimmer Holdings.
Typically, the number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to. The filing volume for the A.S.R. and the Durom cup probably reflects a surge of lawsuits filed against their makers.
The Times review found some 7,500 complaints about the A.S.R., nearly 5,000 of them coming since January. In the case of the Durom cup, about 1,600 complaints were filed with the regulator from 2007 to this June.
Because complaints to the F.D.A. are not uniform, it is impossible to say how many adverse reports about all-metal hips have been submitted. For example, the Times analysis found some 200 complaints about an all-metal version of another DePuy device called the Pinnacle as well as 400 additional complaints that noted metal-related problems in Pinnacle patients. But the Pinnacle is sold in several versions, so it was not clear how many of the metal-related complaints were linked to the all-metal device.
A spokesman for Zimmer Holdings said the Times review was “in the ballpark” of the company’s assessment of the drug administration’s filings. A DePuy spokeswoman declined to disclose the number of A.S.R. complaints that the company forwarded to the F.D.A. She maintained that the Pinnacle was performing well.
DePuy, Zimmer and another producer of metal hips, Wright Medical, declined to discuss the study proposals they had submitted to the F.D.A. to comply with its May order. A fourth company, Biomet, said it had proposed mounting a study of 400 patients who received its devices that would draw in part on studies already under way. The F.D.A. declined to release producers’ proposals, saying that they contained “confidential commercial information.” The agency has until November to decide on the plans’ adequacy.
In an effort to recruit patients, companies have recently contacted, researchers said, health systems like Kaiser Permanente and hospitals that operate their own implant registries.
Meanwhile, researchers say it may be a year before standard protocols are formulated that may be central to the future studies, like a uniform procedure to measure metallic ions in a patient’s blood or how to calibrate diagnostic equipment to best detect tissue damage.
U.S. advisers call for new medical device regimeTuesday, August 2nd, 2011
Please read this latest article published on Reuters regarding new medical device regime:
(Reuters) – An advisory group said the U.S. fast-track approval process for medical devices is fatally flawed and should be replaced, but the Food and Drug Administration said the recommendation was a non-starter.
The FDA had asked for the Institute of Medicine report as part of a broad agency review of its device unit, an area dogged by high staff turnover, funding woes and major recalls in recent year of devices ranging from artificial hips to heart defibrillators.
The IOM found the fast-track approval process, called 510(k), does not adequately protect patients and recommended a more thorough approval process likely to raise the costs for device makers with pre-market and post-market device reviews.
“What we are recommending is that the 510(k) is fatally flawed in terms of it not evaluating safety and effectiveness of a device,” said Dr. David Challoner, chairman of the IOM’s committee.
But the finding was swiftly rejected by the FDA’s top device official.
“FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The 510(k) program allows medical devices to get to market faster if they are “substantially equivalent” to an existing product.
Critics say the accelerated 510(k) process is too widely used and leads to inadequate testing for some risky devices, but it is defended by the industry as necessary to speed technologies to patients.
The medical device industry has argued for either leaving the 510(k) process as it is or further streamlining the approval process. Most new medical devices — about 4,000 in 2009 — are cleared through the accelerated program.
The industry group Advanced Medical Technology Association, or AdvaMed, said Congress and the FDA should not seriously consider the report’s conclusions.
“(The report) proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure,” AdvaMed’s CEO and president Stephen Ubl said. “This would be a disservice to patients and the public health.”
The FDA has proposed changes, including the possibility of creating a new category of more risky devices that would require more data to win approval.
But the IOM committee said the FDA should not waste its limited resources on changing the current program. Instead, the committee said the FDA should focus on developing a new framework.
High-profile incidents include a massive recall last year of artificial hips by Johnson & Johnson’s DePuy unit. Some 93,000 patients worldwide had that line of hip implant.
Automated external defibrillators, used in public places such as airports to revive cardiac arrest victims, have also made up a significant portion of 510(k) recalls in recent years. Health officials are looking at thousands of reports of malfunctions which may have led to patient harm or death.
Medical devices range from simple bandages to complex implants such as pacemakers, stents and artificial knees. Other than Johnson & Johnson, the largest medical-device makers include Medtronic Inc, Boston Scientific Corp and Abbott Laboratories Inc.
The IOM suggested the FDA start collecting information to build the new process, including post-market data for devices. Congress should then enact legislation to design the regulatory framework, according to the report.
“A new system needs to be put in place that will be more effective especially in post-market surveillance,” said Challoner.
Wright Profemur Z Stem shows 11.2% Failure Rate – Where is the FDA???Thursday, June 24th, 2010
Data on the success or failures of hip implants is difficult to come by in this country, as there is no national joint registry that tracks these devices. Australia, however, does maintain such a registry, which collects data from every knee and hip implanted on that continent. This data is invaluable to patients and healthcare providers, as well as medical device manufacturers. Quite simply, this information reveals what implants are working and which are problematic.
The annual report of the Australian Joint Registry shows that the Profemur Z hip implant, manufactured by Wright Medical Technologies (Arlington, TN), amazingly shows an 11.2% failure rate at the three year interval (see page 104). This implant has a modular stem, meaning it is not one piece, but two (see photo). Theoretically, this allows the surgeon more options for modifying the implant geometry and should yield better results, however, the fact of the matter is that these Profemur Z implants are fracturing and failing at an alarming rate.
All this begs the question: where is the FDA? A review of the FDA’s adverse event reporting database shows 10 failures of these hips in the past 5 months, and it should be noted that it is generally understood that this database reflects a gross under-reporting of adverse events, meaning the actual number of failures is likely higher. Clearly the Profemur Z Hip stem is problematic and the issue needs to be addressed by Wright Medical Technologies.
If you or a loved one has suffered from a fractured Profemur Z Hip Implant, please contact us immediately to speak to an attorney.
Recent Hip, Knee, and Replacement Joint NewsMonday, May 3rd, 2010
Defective joint and product liability lawyers, Keefe Bartels & Clark have begun investigation of Wright Medical Technology Total Hip Implants
The defective joint implant attorneys at Keefe Bartels & Clark have begun investigating reports regarding total hip implants manufactured by Wright Medical Technology, Inc., a Tennessee Corporation. Wright manufactures and distributes orthopaedic implants including implants for the hips and knees. The FDA’s Manufacturer and User Facility Device Experience Database (MAUDE) indicates several reports regarding the failure of Wright Total Hip Systems that use the Conserve product line as well as the Profemur Product lines.
The defective product attorneys at Keefe Bartels & Clark are currently screening patients who had the Conserve Plus Cup and the Profemur Stem and/or Neck implants utilized in their total hip replacement and are experiencing problems or have experienced a device failure. In some cases, these components fracture, resulting in a “catastrophic” failure of the hip implant device. Other components may not promote, and may in fact, retard, bony ingrowth, resulting in the devices loosening and requiring additional surgery to repair or replace the failed component. These implants may have been designed or manufactured in a defective manner. If you believe you may have one of these hip implant components, and are suffering from pain, swelling, or limitation on your range of motion, or if you have had to have the hip implant revised, please contact the defective hip implant lawyers at Keefe Bartels & Clark immediately.
New Jersey Court Announces Application for Mass Tort Designation of Litigation involving Stryker Trident Hip Implants and assignment for centralized management in Atlantic County, New Jersey.
Motion made for Mass Tort designation for Stryker Trident Hip System
Pursuant to New Jersey Court Rule 4:38A and the Revised Mass Tort Guidelines, application has been made to the New Jersey Supreme Court requesting that the claims made against Stryker Corp., and its subsidiary Howmedica Osteonics Corp., regarding the Stryker Trident Hip Implant System be designated a Mass Tort and sent to Judge Higbee in Atlantic County New Jersey for centralized management.
The Stryker Trident Hip Implant is a ceramic implant that has been the subject of numerous claims involving the hip implant making squeaking noises. This sound is caused by the high levels of friction at the acetabular interface of the implant. This condition can be an indicator of more serious problems with the implant in the future, and the hip implant attorneys at Keefe Bartels & Clark allege that these devices suffer from either a manufacturing or design defect which is resulting in the squeaking hip noise reported by some patients. If you or a loved one has a hip implant that is squeaking, please contact our office immediately.