A Palm Beach County woman is suing Medtronic Inc. for products liability. English says she developed uncontrolled bone growth in her spine after she received an Infuse Bone Graft implant during spine surgery.
The Infuse Bone Graft, which is bioengineered, is not FDA-approved for posterior-approach lumbar spine surgery. In her Florida defective medical device complaint, English claims that Medtronic misrepresented the risks involved with getting an Infuse implant and improperly marketed the device for uses not approved by the FDA.
English says that the extra bone growth she experienced has caused her to experience nerve compression, which has resulted in ongoing, chronic, and serious pain. Her products liability lawyer says that research had shown that use of Infuse in off-label surgeries can lead to this type of bone growth around and into the spine.
Already, English has had to undergo two surgeries to get rid of the additional bone growth. Daily activities (standing or sitting for a length of time) can lead to leg and back pain.
English is not the first person to sue Medtronic over her Infuse implant and more Infuse lawsuits are likely. In June, Spine Journal reported that physicians who had been given millions of dollars by the medical device maker systematically did not reveal the serious complications linked to Infuse. Researchers noted that the rates of complications is 10 to 50 times more than what is actually noted as an estimate in medical literature.
Manufacturers are supposed to make sure patients know of the risks involved in using one of their medical devices. If, in fact, Medtronic took steps to conceal the risks involved and a patient that had Infuse implanted sustained serious complications that he/she was never warned about, that person may have reason for filing a Florida products liability lawsuit. If a doctor purposely neglected to warn the patient of these risks, he/she could be sued for Palm Beach, Florida medical malpractice.
Infuse lawsuits pile up for Medtronic, Mass Device, September 20, 2011
Spine Journal Takes Aim At Infuse Research, MedPageToday, June 28, 2011
Senators Seek Information on Side Effects of Medtronic Bone-Growth Product, NY Times, June 22, 2011
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