Synthes Vertebral Body Replacement FDA Recall – Side Effects
Every year, about 50,000 Americans suffer spinal injuries. While some back injuries are minor pulls and strains that improve with rest and medications, other injuries can lead to extensive, permanent damage. One of the more serious spinal injuries is severe vertebral fracture or collapse. This injury destabilizes the whole spine and often requires immediate surgical intervention. Fortunately, advances in spinal surgery technologies allow surgeons to restore damaged vertebrae through sophisticated surgical procedures, such as vertebral replacement surgery.
Vertebral Body Replacement Surgery
During vertebral body replacement surgery, the damaged natural vertebral is removed and a special surgical device is inserted in the space of the removed vertebral body. This surgical technology, referred to as a vertebral body replacement, assumes the role of the natural vertebral. Fully integrated in the spinal cord, the implant strengthens the spine and improves spinal alignment, which in turn leads to decreased pain and improved range of motion. Within a year of the vertebral replacement surgery, many patients can perform all of their pre-surgery activities and do not experience any back pain.
Synthes FDA Recall
Three leading manufacturers of vertebral body replacements in the United States are Medtronic, Stryker and Synthes. While the initial patient reports showed vertebral replacement devices were largely successful, recent developments have raised alarm. On November 12, 2009, the FDA issued a Class I recall of vertebral replacement devices manufactured by Synthes. The Synex FDA recall includes all lots of a vertebral replacement labeled Ti Synex II Central Body Replacement. The FDA issued the recall after it learned that the device had collapsed inside the spines of six patients only months after being implanted. In several other patients, the Synex vertebral replacement decreased in height, causing loss of spinal integrity and increased back pain. Synthes manufactured and distributed the defective device from July, 2007 to September, 2009. The defective devices have part numbers ranging from 04.808.001 - 0111.
Synthes Lawsuits
Because medical device companies are allowed to distribute only products that are reasonably safe, negligent failure to adhere to this standard can make corporations liable for damages incurred by unsuspecting customers. If it can be demonstrated that Synthes acted negligently in causing serious injuries, the company might be required to provide victims with adequate compensation. However, compensation is not automatic and victims have to take appropriate legal action in order to assert their rights against the medical device manufacturer.
If you continue to experience moderate to severe back pain several months after receiving Synex II vertebral replacement, you might be entitled to rightful compensation for your medical expenses, physical and mental suffering, time off work and reduction in lifestyle. In order to explore your legal options, you should consult several Synex lawyers. By carefully evaluating your claim, the attorneys can help you decide whether bringing a personal injury lawsuit against Synthes might be beneficial. If the facts so indicate, Synex lawyers might file a lawsuit on your behalf. Initiating legal action sometimes compels negligent companies to offer victims sizeable settlements in order to avoid trial by jury.
Contacting a Skilled Synthes Attorney
If you have received a Synex II vertebral body replacement and your symptoms have worsened, you may be able to obtain rightful compensation from the device manufacturer, Synthes. Please contact the offices of Viles & Beckman, LLC at 1-800-64-VILES to schedule a personal consultation. During the meeting, the dedicated Synthes lawyers will thoroughly review your situation, explain your legal rights and help you assess your options. If the facts so indicate, the attorneys might recommend filing a personal injury lawsuit against Synthes.
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