Personal Injury
Injuries Health Alerts Medical Devices 2009 Medical Device Advisories Synthes Bone Cement
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Personal Injury
Injuries Health Alerts Medical Devices 2009 Medical Device Advisories Synthes Bone Cement
Possible lawsuit: Certain Bone cements and fillers are not approved for use in spinal fracture procedures
Norian clinical trial patients may get a free lawsuit review if Synthes bone filler/cement was used in their treatment.
According to the Food and Drug Administration, use of bone cements and fillers that are not approved for spinal fracture treatment can lead to potentially deadly medical events.
Read the 2002 FDA Notification
Complications with bone cements and bone void fillers
The FDA says
leakage of bone cements can result in soft tissue damage as well as nerve root
pain and compression.
Other reported complications generally associated with the use of bone cements in the spine include pulmonary embolism, respiratory and cardiac failure, abdominal intrusions/ileus, and death.
Each of these types of complications has been reported in conjunction with use of these products in both vertebroplasty and kyphoplasty procedures.
Reported complications associated with the use of bone void fillers in the spine include pulmonary embolism, respiratory and cardiac failure, and death.
Bone void fillers are cleared for use only in non load bearing applications.
On Tuesday, June 16, 2009, Norian Corporation, Synthes, Inc., and four top Synthes executives, were charged by a federal grand jury for allegedly scheming to conduct clinical trials using a bone cement on spinal fractures without the approval of the Food & Drug Administration.
Read the Department of Justice press release, June 16, 2009.
The filler was approved in 2002 by the F.D.A. for use in general bone repair, but regulators insisted that Synthes not promote its use for spinal procedures.
Bone cement lawsuit resources
If you or a loved one suffered an injury or death as a result of a suspected use of Norian bone cement in spinal surgery, please complete the form below to get a free review of your possible lawsuit.
A representative of our firm will be in touch shortly.
see also:
Spine surgery
Was bone filler by Synthes Inc. used during your spine surgery? LawyerContact us if Synthes bone filler was inserted during spine surgery
Medical Devices
Medical device maker Synthes faces federal criminal charges: LawyersWas Synthes medical device (bone filler) used in your spine surgery?
Background
Preeminent NYC law firm accepting cases involving Norian bone cementWin compensation for misuse of Norian bone cement on spine, law firm
