Can Your Hip Replacement Kill You?

Can Your Hip Replacement Kill You?
When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial
one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson.
In addition to the 510(k) pathway, medical device companies can avoid clinical testing
for the highest risk devices through the supplement pathway by telling the F. D.A.
Despite Dr. Tower’s repeated efforts to warn his colleagues and the company
that the implants were harming patients, Johnson & Johnson continued to market metal-on-metal hips.
Although the standard for approval of a new drug usually calls for two randomized, controlled
clinical trials, the standard for many medical devices is no standard at all.
Many people assume that the Food and Drug Administration requires rigorous testing of medical devices
before they are approved, the same as the lengthy approval process it requires for new drugs.
About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents,
surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.
The use of these loopholes is widespread: A study published in The Journal of the American Medical Association in 2009 found
that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.