The Squeak and the FuryThe Squeak and the Fury
July 1, 2008
Over the past several years, ceramic-based hip replacements have become all the rage. Now, they're incurring it.
Ceramic-on-ceramic hip implants, as well as related ceramic implant components, have grown in popularity in recent years. Their rising adoption stems from studies citing better durability and less debris generated than their metal- and plastic-based counterparts. But reports have been trickling in from some patients with ceramic implants of a symphony of distracting sounds produced by the implants.
And the issue has reached a fever pitch. The recent ruckus revolves around a front-page article published in the May 11 issue of The New York Times (NYT). The article centers on a "medical mystery" consisting of the emission of squeaking, grinding, and popping sounds from ceramic-based hip replacements. In the story, patients afflicted with the unfortunate quality-of-life-altering sound effect relay the embarrassment and annoyance that accompany it. Furthermore, the patients and some healthcare professionals express their fears that the noises could be indicative of a more-serious problem with the implant.
Rumblings of this noisy and disruptive phenomenon have cropped up on the Internet and in articles in the past on a smaller scale. But since the NYT--often viewed as the most-respected news outlet in the country--addressed the issue and brought it to the public's attention, articles, criticisms, and rampant blog entries have ensued, proliferating the Internet and making its way to TV news. Since being mentioned in the NYT article, a YouTube posting by a patient demonstrating his squeaky implant has racked up more than 30,000 views at the time this issue of MPMN went to print.
The Trident ceramic implant manufactured by Stryker Corp. is receiving the brunt of the backlash, as it has been fingered as the main culprit. In January, Stryker had even issued a voluntary recall of some components in the Trident line that were manufactured in its Ireland plant; however, the OEM claims that it was unrelated to noises, according to the NYT.
Stryker responded to the negative attention with a letter to the editor of the NYT stating, "There is no clinical evidence to suggest that squeaking is a precursor to 'malfunction'...Stryker's 12-year-and-running multicenter clinical trial of its ceramic hip implant system shows a survivorship of greater than 95%, high patient satisfaction, a reduced rate of osteolysis, low rates of dislocation, and one of the lowest revision rates ever reported for a prospective study."
Despite the damage control attempted by the orthopedics OEM, ceramic hip replacements are facing some tough times in the public court of opinion. General outrage and concern, wariness of the material, and an increase in lawsuits are likely to follow. The priority, of course, is identifying what exactly is causing the squeak and immediately addressing the problem to prevent it from happening in future models. Next, OEMs need to restore patients' trust in ceramic implants. After all, aside from the assortment of squeaks they produce, ceramic implants have demonstrated good performance and wear resistance. OEMs need to first quiet the implants and then the critics so that all that's left is the sweet sound of silence.
Shana Leonard, Editor
Copyright ©2008 Medical Product Manufacturing News
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