FDA: Little Use for Metal on Metal Hips

Fda (Photo credit: Wikipedia)Source:  AP


The Food and Drug Administration has asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

The FDA has not said that the devices should be removed from the market,  but most panelists said there were few, if any, cases where they would recommend implanting the devices.  "I do not use metal-on-metal hips, and I can see no reason to do so," said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.  This is consistent with physicians in Great Britain and Australia who stopped installing metal on metal hips several years ago.

For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.

The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.

About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall of 93,000 metal hips in 2010.

FDA's experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. However, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals

For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants. If the FDA ultimately follows the group's advice, U.S. recommendations would be less involved than those already in place overseas. Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.

FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.

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 long-term effects of metal particles.

But public health advocates say it could take a decade before that information is available.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first.

David Langton talks about configuration issues with the Depuy ASR

Training Orthopedic Surgeon David Langton from Newcastle University in the UK has dedicated the last three years of his life studying metal on metal hip replacements, specifically the ASR model, in an effort to attain his PHD. He believes that there is a problem with the configuration of the metal on metal hip replacement, namely the size of the cup. This causes wear to take in the "rim of the cup". "Chromium Cobalt ions concentrate in the hip fluid" and are also released into the blood. This subsequent accumulation of metal ions is "directly related to soft tissue damage and bony damage around the joints". His study has found that hip pain and groin pain are often noted side effects from these metal on metal hip replacements.  

Site: David Langton on Metal on Metal Hips

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FDA to Convene Meetings in June to Review and Discuss Metal on Metal Hips

Logo of the . (Photo credit: Wikipedia)

The AP is reporting that The Food and Drug Administration will hold a meetings  in June to discuss growing safety concerns about metal-on-metal hip replacements.

Metal hip joints have been under scrutiny due to reports of high failure rates. In 2010, Johnson & Johnson recalled roughly 93,000 implants. The FDA already asked device companies to conduct additional follow-up studies to monitor problems with the implants.

The agency says it will hold a two-day meeting beginning June 27 to consider whether more rigorous testing standards are needed.

Earlier this month, British experts said doctors should stop using metal hip joints because data show they have to fixed or replaced more often than older implants.

Orthopedic Surgeon Becomes Victim of Depuy Hip

Logo of CBS News (Photo credit: Wikipedia)
CBS News has been investigating medical products and what they found it something known to may lawyers, but not to consumers and some physicians, that being that many medical products are not as safe or monitored as people may think. According to Consumer Reports, most medical devices are approved only by filing paperwork with the FDA.

Dr. Stephen Tower, an orthopedic surgeon, became a victim of a the Depuy ASR hip which has been recalled and my claim was defectively designed, tested, manufactured, and represented to consumers. The FDA had cleared the device without testing based on "substantial equivalence" to earlier similar devices. Use of metal parts over plastic was supposed to give the patient more mobility so they could participate in all kinds of physical activity.

After a year, he had high levels of chromium and cobalt in his blood and his hip was constantly painful. He started having other problems like disturbed sleep, mood swings, anxiety, hearing loss, and tinnitus, constant ringing in the ears. The symptoms got so bad he couldn't go to work.  Even though he kept calling the DePuy engineers, they claimed they never had any problems with the device. Then a British Medical Journal and BBC Newsnight investigation revealed that millions of people with similar implanted devices also had high levels of toxins seeping into their bloodstream.

 HealthPop reported that the investigation showed that the chromium and cobalt ions leak into surrounding tissue and destroy muscle and bone, eventually spreading to lymph nodes, the spleen, liver and kidneys and potentially causing damage. The ions also had the ability to change a person's chromosomes, meaning genetic changes.

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Biomet Busted for Bribery

Biomet (Photo credit: Wikipedia)

The Wall Street Journal reports Biomet Inc has agreed to pay the government more than $22 million to settle allegations made by the Justice Department and Securities and Exchange Commission that it violated the Foreign Corrupt Practices Act.

        "The Justice Department's Criminal Division announced Monday that the Indiana-based company, which manufactures and sells medical devices worldwide, made various improper payments or paid bribes from 2000 to 2008 to health care providers in Argentina, Brazil and China to secure lucrative business with hospitals," the Washington Times. "During this time, according to information filed in US District Court in Washington, more than $1.5 million in direct and indirect payments were made. Modern Physician reports, "These payments were then falsely recorded as commissions, royalties, consulting fees or scientific incentives, according to the release." 

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Consumer Reports: Americans want more oversight of Implanted Medical Products

U.S. House Committee on Energy and Commerce official Seal. (Photo credit: Wikipedia)Less than 1% of of implanted medical products are subjected to the strenuous PMA (pre-market approval) process of the FDA. And the draft legislation put together by the House Energy and Commerce Health Subcommittee would actually allow the approval process to go even faster. The Senate Health, Education, Labor and Pensions Committee's draft bill does provide some additional protections for patients once devices are on the market, but does nothing new to prevent potentially unsafe medical devices from being sold in the first place.

But according to a new poll by our publishing pals Consumer Reports, 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.

71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

94% indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.

95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress' previous reauthorization of the law.

66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.

Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.

"Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective," said Lisa Swirsky, senior policy analyst for Consumers Union. "Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available."

The Depuy hip problems came to light, in part, due to tracking systems in place in other countries, which indicated higher than normal failure rates.  In this country, the information received by doctors is often limited to data provided by the manufacturer and their sales representatives, which is often times false and misleading.  

As one of my clients told me this morning, "I don't need a doctor to tell me that my hip has failed and needs to be removed, I live it every day."