It goes without saying that there is little room for error when it comes to medical products that are inserted inside a patient body. It is absolutely imperative that all mistakes be avoided when patients agree to have a device surgically installed in their body to treat a certain ailment. Unfortunately, there are many cases of various objects their either do not work as intended or actually cause more harm. In those cases, lawyers often fight hard to ensure the affected families have their legal rights respected.
Spinal Implants Problems
One of the more recent examples of this scenario involves BMP spinal implants–like one known as Infuse. Some “off label” uses of the device may actually cause injuries and harm to patients.
A recent PR web story discusses the situation.
According to the release, the U.S. Food and Drug Administration (FDA) recently issued a public health notification on certain uses of the BMP spinal implant–that includes Medtronic Infuse bone graft in cervical spinal fusions. The release notes that these uses may cause patients to suffer unacceptable injuries. The potential damage includes swelling of the tongue, mouth, neck, and throat. In addition, certain patients may have difficulty breathing, suffer nerve damage, experience compressions of neurological neck structures, and have difficulty swallowing. In the most extreme case, the problems may be fatal.
The main concern is that the Infuse BMP spinal implant was only approved by the FDA for spinal fusion surgeries using approach at the front of the body in the lumbar region of the spine. Even then, some reports have critiqued even this limited approval, noting that there may be problems with the Medtronic Infuse bone graft product that the FDA approved.
In addition, there are concerns about the marketing of the product for uses not approved by the FDA. This is a serious problem, and our attorneys know that many
legal battles involving medical devices and medications stem from potential marketing concerns–with manufacturers trying to “sell” the product by suggesting its use in ways not approved by the FDA.
In this case it appears that some suits have already been filed alleging off-label promotion of these BMP spinal implants. News reports on that suit suggest that as much as 85% of all sales of the product were for “off label” purposes. The suit suggested that sales representatives for Medtronic may have actually promoted the product for those off-label reasons. All of this eventually resulted in a settlement in the case amounting to $85 million.
However, that settlement does not end the legal matter. Many other individual patients may have been hurt as a result of these practices. Those individuals may be entitled to recovery for the losses they experienced as a result of these medical devices problems.
If you are in Chicago or throughout Illinois and believe that your may have been harmed by one of these spinal implants, be sure to get in touch with a lawyer working on these cases. The attorney can explain the situation and determine the best way to proceed in your individual case.
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