MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA

Cheryl Clark, for HealthLeaders Media , July 5, 2012

As health providers focused on the Supreme Court's ruling last week, a quieter but much more human drama about medical harm and suffering—and what federal policymakers should do about it—was unfolding inside a hotel just beyond the Maryland beltway.

For two days, a parade of orthopedic surgeons, biomedical device reps, safety experts, poison specialists, risk managers, lawyers, and patients appeared before a U.S. Food and Drug Administration panel to talk about the disastrous problems, questions, and fear surrounding MoMs.

MoMs, or metal-on-metal hip replacement or hip resurfacing systems, represent between 27% and 40% of the estimated 500,000 hip surgeries performed a year in the U.S., an industry valued at about $12 billion a year in 2009, although new procedures are apparently in decline.

Presumably, after this meeting, the FDA's 18-member Orthopaedic and Rehabilitation Devices Panel is thinking about what to do to clarify the safety of these devices. Should they recommend suspension of all further MoM implants as many patients and physicians recommend? And how should they further inform fearful patients who as yet have no symptoms what they should do in the meantime?

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1 comments on "MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA"

carol (7/6/2012 at 3:36 PM)
The panel has said that they won't ban the devices, but they did have recommendations for more limited use. They said that people who show signs of failure (swelling, pain, etc.) should have X-rays and blood testing for metal ions, a guideline that UK regulators already issued awhile back. They also said that the FDA should provide some kind of reference range for the metal ion tests, since there is currently no standard




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