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Feds say risks may not back up spine-fracture treatment.(use of bone cement to treat osteoporosis-caused fractures)(Brief Article)
2003 MAY 1 - (NewsRx.com & NewsRx.net) -- Injecting a special glue into osteoporosis-caused spinal fractures is a pain-easing treatment growing in popularity, but the U.S. government is reminding doctors that it may be linked to serious and occasionally life-threatening side effects.
Bone-thinning osteoporosis can cause people to lose height and suffer serious pain as their vertebrae crack. Using procedures called vertebroplasty or kyphoplasty, doctors can stabilize or even prop back up the crushed bone with injections of bone cement.
The U.S. Food and Drug Administration (FDA) has never approved that specific use of bone cement, although the procedures have been increasingly offered since the late 1990s.
Orthopedic surgeons have long known the cement can sometimes leak, posing a risk.
Since 1998, the FDA has received reports of 45 patients who suffered serious complications associated with the procedures: severe nerve pain, blood clots ...
- FDA issues warning about bone cement.
- News wire article from: United Press International November 6, 2002 700+ words
...reaching. The bone cement, called polymethylmethacrylate...warning from the FDA said two procedures...made available. "FDA is currently working...effectiveness of bone cement in vertebroplasty...symptoms from leakage of bone cement." He added...risk. I think the ...
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...Drug Administration (FDA) clearance of Palacos G antibiotic-loaded bone cement. Utilized in approximately...antibiotic-loaded bone cement. Dane A. Miller...pleased to receive FDA clearance on Palacos G bone cement which should improve...
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...and Drug Administration (FDA) to begin marketing and...TM) P with Tobramycin Bone Cement in the United States...TM) P with Tobramycin Bone Cement represents a combination of the most popular bone cement in the U.S., Simplex...
- Biomet Announces FDA Clearance of Palacos G Antibiotic-Loaded Bone Cement.
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...announced today the FDA clearance of Palacos...antibiotic-loaded bone cement. Utilized in approximately...antibiotic-loaded bone cement. Dane A. Miller...pleased to receive FDA clearance on Palacos(R) G bone cement which should improve...
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...Drug Administration (FDA) has cleared for U...Genta, an antibiotic bone cement. These new products...spacer cleared by the FDA for distribution to the...expand our growing line of bone cement products for two stage...pleased to have received FDA clearance on these new...
- Exactech Gains FDA Clearance for U.S. Distribution of Additional Antibiotic...
- Press release article from: PR Newswire June 9, 2004 700+ words
...Cemex(R) Genta Bone Cement Complement Company's FDA-Cleared Hip...an antibiotic bone cement. These new products...cleared by the FDA for distribution...growing line of bone cement products for two...have received FDA clearance on these...
- Company receives FDA clearance to market KyphX HV-R Bone Cement for kyphoplasty.
- Newspaper article from: Medical Letter on the CDC & FDA May 9, 2004 700+ words
...Administration (FDA) to market KyphX...Viscosity - Radiopaque) Bone Cement for the fixation...polymethylmethacrylate Bone Cement is designed to have...Our KyphX HV-R Bone Cement is the first material...on the CDC & FDA editors from staff...
- Advanced Biomaterial Systems Receives FDA Clearance to Market ABS's...
- Press release article from: PR Newswire January 21, 2005 700+ words
...and Drug Administration (FDA) today to market ABS...Symphony(TM) VR Radiopaque Bone Cement for the fixation of pathological...cancers, myeloma). "This FDA clearance now allows ABS...Symphony(TM) VR radiopaque bone cement as a complete and controlled...
Source: HighBeam Research, Feds say risks may not back up spine-fracture treatment.(use of bone...