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Report Slams Regulators’ Response To Metal-On-Metal Hip Implant Debacle

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An emerging report slams regulators’ response to the ongoing metal-on-metal hip implant debacle. The just-published report appears in the British Medical Journal (BMJ) and accuses regulators of allowing hundreds of thousands of patients who underwent surgery for implantation with metal-on-metal hip implants, of being unknowingly exposed to dangerous, toxic substances.

A joint effort of the BMJ and BBC Newsnight, the report accuses United Kingdom and Untied States health regulators of permitting patients to remain unaware of the danger and alleges that hip replacement manufacturer DePuy Orthopaedics was aware and worried about the possible patient harm linked to devices, even as it touted these products, noted Medscape. DePuy is a unit of Johnson & Johnson.

According to report author and BMJ investigations editor Deborah Cohen, MD, the implants’ health risks concern the devices’ pelvic cup and femoral head, which are constructed of a cobalt-chrome alloy, wrote Medscape. NewsInferno has previously explained that earlier hip devices are constructed with nonmetal components such as ceramic or polyethylene. The metal-on-metal design, explained Medscape, concerns a total hip replacement system that replaces the femoral head with a metal ball and involves hip resurfacing, which involves a metal cap attached to the femoral head.

Ongoing use of these devices breaks down the metal, allowing metal ions to be released deep into area tissue, destroying muscle and bone and leading to a number of adverse health effects, some long-term and some disabling, said Dr. Cohen. Some metal ions are carcinogenic; can become blood-borne; and can lodge in the lymph nodes, spleen, liver, and kidneys, added Dr. Cohen, said Medscape. According to Dr. Cohen, the scientific community has long been aware—for decades—of the genotoxic risks associated with cobalt and chromium ions.

Dr. Cohen’s article specifically looked at DePuy’s ASR, a metal-on-metal hip replacement technology introduced in Europe in 2003 and comprised of two different systems: the ASR XL Acetabular System for total hip replacement and the ASR Hip Resurfacing System, noted Medscape. As NewsInferno has written, the U.S. Food and Drug Administration (FDA) allowed the ASR Acetabular Hip Implant System to be cleared through its 510(k) protocols, a fast-tracking process that does not require human testing, because the device was allegedly similar in design to a previously approved device. BMJ pointed out that a number of other devices were cleared this way. By 2010, the FDA had approved 175 implants in the same way.

The ASR Hip Resurfacing System was never cleared by the FDA and was ineligible for 510(k) process because it was deemed a new procedure and had to go through clinical trials. In 2009, the agency rejected the device after DePuy’s studies revealed a problem with early failure. By August 2010, DePuy recalled its ASR implants worldwide after it learned that the devices were experiencing very early failure rates.

Dr. Cohen writes that DePuy was aware of the potential problem with genotoxicity well before 2010 and quoted a 2005 internal DePuy memo:

“In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic. The mechanism is not known and only 24 local malignancies have been reported in patients with joint replacements. Also worrying is the possibility of distant effects. One study suggested a threefold risk of lymphoma and leukemia 10 years after joint replacement. ”

The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) investigated genotoxicity and metal-on-metal hip implants and ruled, in 2007, that patients should sign a consent form before surgery that details the risks with metal debris and genotoxicity, said Mindscape. “But this requirement was not communicated widely—no alert was put out to surgeons or patients,” Dr. Cohen wrote.

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