FDA probes safety issues with metal hip implants
By Matthew Perrone Boston Globe
AP Health Writer / June 25, 2012 (FiDA blog bold)
WASHINGTON—Metal hip replacements implanted in a half-million Americans may be failing earlier than expected, but it could be years before U.S. health regulators have a clear picture of the problem.
The Food and Drug Administration holds a two-day meeting starting Wednesday to scrutinize the safety of metal-on-metal hip implants, following years of patient reports of pain and swelling that sometimes requires removal of the devices. It is a challenging, but familiar, predicament for the FDA: reviewing the safety of a device that was expected to be superior, but which may actually be more dangerous than what came before.
For decades nearly all orthopedic implants were made from plastic or ceramic. But in the last 10 years some surgeons began to favor implants made with metal stems and sockets. Laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.
But recent data gathered by surgeons in the U.K. appears to show just the opposite.
In March, British experts at the world's largest artificial joint registry told doctors to stop using metal-on-metal hip replacements, citing an analysis showing they have to be replaced more often than other implants. Hip replacements are supposed to last between 10 to 15 years, but more than 6 percent of patients with metal hips needed them replaced after less than five years. That compared with just 2 percent of people who had ceramic or plastic joints. Both types of devices are prescribed for people suffering hip pain and limited movement due to arthritis or injury.
British regulators now recommend that people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies as the components rub against each other.
The FDA has not made any recommendations of its own for the estimated 500,000 American patients with the devices.
FDA scientists say they want to consider all available information before making their recommendations -- not just the data from the U.K.
"Why look at a single registry when there's data from around the world?" said Dr. William Maisel, FDA's chief scientist for medical devices, in an interview with the Associated Press. "This is an opportunity for us to look at all the available information so that we can have a thoughtful conversation about what clinical recommendations can be made."
Maisel said the FDA is working to combine data from foreign countries and the U.S. to determine which groups of patients and implants are most problematic. On Wednesday and Thursday the FDA will ask a panel of experts to recommend the best practices for monitoring patients with the devices. Panelists will consider blood tests, medical imaging and laboratory tests.
But some U.S. orthopedic specialists say they have already reached their own conclusions about metal hips.
"In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective," said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.
The FDA's deliberative approach to tackling the hip implant issue is in some ways a necessity. Unlike other countries, the U.S. has no national registry to track the performance of implants over time.
The FDA received 16,800 negative event reports involving metal hips between 2000 and 2011, but regulators stress that number is not very useful. Many doctors do not report problems to the FDA, and the volume of reports is influenced by news reports on safety issues.
A registry set up by Minnesota's HealthEast Care System recorded four times as many replacement surgeries for patients with metal-on-metal hips as those with other implant types. However, a similar registry set up by health care provider Kaiser Permanente found no difference between the two groups.
With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.
FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the effects of metal particles that often seep into the bloodstream as the implants wear down.
But Sedrakyan and others say it could be a decade or more before that information is available. In a commentary published last week in the New England Journal of Medicine, Sedrakyan and two co-authors pointed out those studies must run at least eight years to return the information FDA is seeking. Based on the authors' analysis of FDA records, the FDA has reached agreements on the design of less than 25 percent of the studies, and it's unclear whether any of the studies have actually begun. The FDA notified the companies last May.
The prospect of safety findings arriving in eight or 10 years is little comfort to patients like Mary Weaver, 48, who had both hips replaced with a metal implant from Johnson & Johnson in 2007 and 2008. J&J recalled the ASR hip replacement in 2010, after reports that it was failing in some patients after only a few years of implantation.
Due to increasing pain and elevated metal levels in her blood, Weaver had both implants removed in 2011. She was let go from her job due to the time needed to undergo both surgeries, and is currently unemployed.
"I hope that no one has to go through this -- it's frustrating, it's emotionally draining," said Weaver, who lives in Mount Jackson, Va. "It's not just hard on you, it's hard on your whole family because your quality of life is not what it used to be."
Like 90 percent of medical devices sold in the U.S., most metal-on-metal hips were approved via the FDA's fast track program for medical devices. Under the so-called 510k system, the agency waives clinical testing requirements for devices which appear similar to others already in use. Since plastic and ceramic hip replacements had been on the market since the 1950s, most metal hip replacements were approved without new clinical testing.
"I am so furious they would use my wife as a lab rat, along with the other 500,000 people who don't have a clue what is happening," said Dwight Schrag, 69, of Bellevue, Wash. Schrag's wife Mary received J&J's ASR hip in 2006 and had it removed due to pain and other side effects in 2010. Schrag is one of a number of speakers who have signed up to speak during a public comment session at the FDA meeting.
It's not the first time the FDA's fast-track program for clearing devices has come under fire.
Last summer the Institute of Medicine said in a report that the FDA should abandon the 35-year-old system because it provides little assurance that the implants are actually safe. The Institute is composed of medical experts who advise the federal government.
Although the FDA itself requested the report from the Institute, agency officials rejected the group's conclusions, saying the 510k system works well for the vast majority of devices.
explanthis comment: FiDA blog/Joleen Chambers
The profitable medical device industry has conflated justice so completely that the American citizenry blindly pays for the #1 expenditure of Medicare: joint replacements. The industry has so many entitlements: no warranty on product, no clinical testing, no national registry, no need to report adverse events, pre-emption in state court because of FDA, no compensation to victims of failed products without a David/Goliath courtroom battle and unrestricted direct-to-consumer marketing. Even with all these advantages, the industry fights a tax that would help fund the FDA/CDRH. Do they not have faith that they can make $$ and produce a safe and effective product? Consumer beware!