Tracking Systems in the U.K Key to Care for Hip Implant Patients, But Non-Existent in the U.S.

Santa Cruz, CAThe study, published in the Bone & Joint Journal, finds that the rate of metal-on-metal (MoM) hip implant patients undergoing revision has increased over time. Researchers at the Universities of Oxford and Bristol have suggested the observed differences are in part due to increased patient surveillance. In the U.S., patient surveillance is pretty much left up to the patient.

National Joint Registry

Using data from the National Joint Registry (NJR), the researchers were able to examine five-year revision rates for MoM hips implanted from 2007 onwards and compared them to MoM hips implanted before 2007. The NJR identifies problems with medical devices and also works closely with other regulatory agencies “to ensure that all patients are monitored and cared for appropriately,” said Professor Ashley Blom, who leads the NJR data analysis team. “This [analysis of data] has resulted in increased awareness of potential problems and increased surgical experience for hip revision surgery performed for abnormal reactions to metal. It is therefore unsurprising that revision rates for all types of metal-on-metal prostheses have been rising over time, reflecting that hospitals and surgeons are intervening in a timely manner.”

The FDA and MAUDE

So, why doesn’t a system like the UK’s National Joint Registry exist in the U.S.? Drugs are labeled, dated and tracked by the FDA. A head of lettuce is tracked from the ground it grew in to Walmart’s shelves. But no one knows how many medical devices are implanted in America because the FDA lacks a tracking system. In another recent study on knee replacements, the authors reviewed the FDA’s MAUDE database (April 2017) for reports of certain knee failure and found it “not consistent and competing companies cannot provide data on the revised components”. The authors believe these incidences “might be underreported, as company representatives from another companies cannot report to MAUDE database”.

Those reports, and reports regarding other medical device failures, may be the tip of the iceberg. Madris Tomes, a former FDA employee who worked on the FDA’s MAUDE database and formed her own company called Device Events, says there are major flaws in the database.

(MAUDE is a database that houses medical device reports submitted by reporters such as manufacturers and hospitals. But the reporting is voluntary. The FDA itself admits that its assessment of medical device safety is inconclusive because manufacturers and hospitals often submit incomplete, inaccurate, untimely, unverified, or biased data.)

No Clinical Testing

Most high-risk devices on the market, including hip implants, have undergone little, if any, clinical testing due to the FDA's fast-track approval process.

Jeanne Lenzer, author of ''The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It(pub. 2017) says that 32 million Americans have at least one medical device implanted in our bodies, from artificial joints to surgical mesh to birth control devices. And most Americans believe that federal regulators demand all this hardware to undergo rigid clinical trials. Lenzer, who writes for BMJ (formerly known as the British Medical Journal) has collected multiple instances in which patients have suffered and died in this “Wild West” unregulated area of medical devices, including “metal-on-metal” hips that injured thousands, including a doctor crippled and with rotted tissue surrounding a flawed implant.”

That crippled doctor is orthopedic surgeon Stephen Tower, who specializes in hip implants. Lenzer wrote in the New York Times (Jan 14, 2018) that, five years after he was implanted with a MoM hip-- Johnson & Johnson’s ASR XL—Tower underwent revision surgery to have it replaced. Tower’s surgeon found that cobalt leaking from the ASR hip had caused metallosis, “destroying not only local muscle, tendons and ligaments, but harming Dr. Tower's heart and brain as well,” wrote Lenzer.

Tower tried to warn his colleagues and J&J that the implants were harming patients, to no avail. His hip implant wasn’t recorded in a registry. Meanwhile, J&J continued to market metal-on-metal hips. In 2010 it quietly withdrew the ASR XL model from the market, citing slow sales, but continued to sell the Pinnacle--a similar model with the same problems—until 2013.

Lenzer credits lawsuits for forcing disclosure of many medical device problems. She calls for government action for our collective health and safety. Up until that time, more hip implant lawsuits will be filed.