Pinnacle metal-on-metal hip replacement is a potential disaster
Johnson & Johnson recently experienced one of the most expensive medical device failures in history with its ASR all metal artificial hip recall. However, the growing Pinnacle failure rate may end up costing J & J more than the estimated $3B ASR recall. There are currently 1,600 law suits pending in US courts.
Doctors who are tracking large groups of patients with both products estimate that more than 10 percent of the Pinnacle all-metal hips will have failed in the next two to three years…
Many patients with the Pinnacle metal-on-metal device are experiencing the same problems as those who got the ASR product, including pain and swelling, limited mobility, and dislocation. Perhaps most concerning, some doctors say, is the high levels of cobalt and chromium in the bloodstream resulting from wear of the all-metal implants. Metallosis, as it is known, can lead to cardiovascular, neurological, renal and thyroid problems, in addition to destroying soft tissue, muscle and bone…
Litigation is what it is, but the ASR is a very different system and has a very different design and has very different clinical performance” than the Pinnacle, said Mindy Tinsley, a spokeswoman for DePuy. “We recalled it because it was not performing as it should.”
Read the full article…“Insight: As lawsuits climb, J&J may have new hip trauma” via Reuters
Here’s a link to an article about the Pinnacle hip replacement from “Drugwatch”
Cigarettes are dangerous to your health, but there are new smokers every day. There is a growing body of evidence that metal-on-metal hip replacements are dangerous to your health. Why choose this option when other less risky options are available?
January 16, 2012 Update:
After an estimated 500,000 patients in the United States have received a type of artificial hip that is failing early in many cases, the Food and Drug Administration is proposing rules that could stop
manufacturers from selling such implants. Under the proposal, which the agency is expected to announce on Thursday, makers of artificial hips with all-metal components would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs. Currently, companies have to show only that their devices resemble ones already on the market, and they are not required to conduct clinical studies before selling them.
The F.D.A. action is intended to close a loophole in the 1976 federal law under which medical devices were first regulated. It is the agency’s first use of powers that Congress granted to it last year to deal with medical devices, like all-metal hips, that have been in regulatory limbo for decades [via NY Times].