Public Health Watchdog Alerts the Public about the Dangers of Metal-on-Metal Hip Implants

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After research findings reveal links to cancer, the British Hip Society (BHS) advises against use of large diameter (>36 mm) metal-on-metal total hip replacements.

Public Health Watchdog, a media outlet created to inform and protect the public from defective drugs and medical devices, is warning against the use of metal-on-metal hip implants. After analyzing data from the National Joint Registry and other clinical studies, the British Hip Society (BHS) has officially advised against further use of large diameter metal-on-metal primary total hip replacements. The BHS has not, however, extended this advice to hip resurfacing.[britishhipsociety.com/MoM%20Update.htm]

Large diameter heads include femoral components that are 36 millimeters or greater in diameter. According to the New York Times, studies have shown that large heads are particularly harmful because the induced interaction between the big head and the cup or stem results in increased metallic debris, which can cause significant damage to nearby tissue. The BHS advises the healthcare community to follow the updated guidelines issues by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). [nytimes.com/2012/02/29/health/metal-hips-in-britain-require-longer-monitoring-regulators-say.html]

The safety of all types of metal-on-metal hip implants has become an important, highly publicized question in the public health community, particularly after the DePuy recall in 2010 when the ASR Resurfacing System and ASR Acetabular Hip Replacement System were pulled from the market. According to the New York Times, DePuy admitted to a failure rate as high 13 percent within five years of implantation. [nytimes.com/2010/08/27/business/27hip.html?_r=2] [nytimes.com/2012/02/22/business/flawed-depuy-hip-implant-had-early-fda-notice.html?scp=1&sq=flawed%20depuy&st=cse]

For patients with large diameter heads, the new MHRA guidelines recommend annual patient follow-up for the life of the implant, regardless of whether or not the patient is showing symptoms of distress, according to Public Health Watchdog. They have also applied this protocol to all types of DePuy hip replacements. Those with small diameter heads (less than 36 millimeters) who exhibit symptoms require a yearly follow-up for at least five years. [mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con143787.pdf]

Previously, The BHS raised concerns over large diameter metal-on-metal hips last year at the British Hip Society Annual Conference. The conference cited problems such as elevated chromium and cobalt levels in the blood, metal reactions, loosening of the implant and tissue necrosis. [britishhipsociety.com/pdfs/BHS_MOM_THR.pdf]

According to Public Health Watchdog, a recent study published in the British Journal of Medicine (BMJ) discusses the serious, long-term health problems metal hip users face, and also reveals how manufacturers and regulators negatively contributed to the situation. According to the study, manufacturers such as DePuy were aware of the possibility of cancer and other serious side effects, but chose to omit the information, instead marketing the product for further use. In fact, studies have documented these risks since 1975. Furthermore, the article states, regulators put inadequate effort into the issue, readily approving design modifications for patient use without any clinical studies due to a regulatory loophole. [bmj.com/content/344/bmj.e1410]

As a result of increasing amounts of negative reports, last May the U.S. Food and Drug Administration (FDA) ordered all metal-on-metal hip manufacturers to conduct studies of the implants in attempt to assess their safety. [nytimes.com/2011/05/11/business/11hip.html]

Contact:    Parker Waichman LLP
            Herbert Waichman, Partner
            (800) LAW-INFO
                (800) 529-4636
                 http://www.yourlawyer.com

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