A Johnson & Johnson company, DePuy, recently recalled its Synthes Craniomaxillofacial (CMF) Distraction System because of risks most severely affected children and infants. These devices are used during operations to the trachea and other respiratory organs, so infants are most at risk for injury and death if the device fails. Medical device lawyers at Pintas & Mullins Law Firm highlight this and several other important recalls patients must be aware of.
The DePuy CMF system is an implant used in the lower jawbone, to either stabilize or lengthen the bone. It is most often used to correct birth defects in infants or traumatic jawbone events in adults, by gradually lengthening the bone. This device is being recalled because it can reverse direction, causing the lengthening process to cease.
The lengthening process occurs after surgery, and if it stops suddenly it can cause obstruction of the trachea, or windpipe. The trachea is critically important to allowing air to pass through the throat and into the lungs, so any obstruction is a medical emergency. As mentioned, infants utilizing DePuy’s CMF device are most at risk of death, as sudden obstruction of the trachea could go unnoticed and lead to respiratory arrest and death.
Children and adults with the CMF device who have the ability to maintain an open airway are considerably less likely to suffer a serious injury if the device fails because the trachea would not be obstructed. In all patients, however, any device failure would require immediate medical intervention.
So far there have been 15 reports of injury associated with this specific device, and DePuy has sent an urgent notice to hospitals and consumers. This recall was initiated on April 16, 2014. Any patient who received this implant and suffered serious complications should contact our firm immediately for a free case review. We are currently investigating cases related to many medical devices, particularly those manufactured by DePuy.
If the name DePuy sounds familiar, it is likely because of the massive litigation against it for its defective all-metal hip implants. These metal-on-metal devices were once touted as ‘revolutionary’ new implants that will last for decades and allow better mobility for patients. In reality, the devices were approved without any long-term or adequate testing, and the all-metal components can damage surrounding bone and tissue immensely.
In addition to the bone, muscle and tissue damage, the metal parts grind together through continuous use, release metal ions into the bloodstream. Of course, having high levels of metal debris release into the body is far from healthy, and can lead to metallosis, or metal toxicity. Symptoms of metal toxicity include effects on the kidneys, blood, or nervous, cardiovascular, and gastrointestinal systems.
These metal-on-metal hip and knee devices were implanted in hundreds of thousands of vulnerable patients, despite manufacturer’s knowledge that they would likely fail prematurely. In response to this dire need, two hospitals in New York City are offering free hip and knee replacements for eligible patients.
The hospitals, Lenox Hill in Manhattan and Franklin Hospital in Valley Stream are offering operations for patients in need who are either uninsured or underinsured. We recently reported on the recent adoption of offering to help pay medical premiums for needy patients, and this seems to be in the same vein of assistance. Franklin Hospital has been offering this type of free service since 2011, as an opportunity to give back to the community and help patients who are so often ignored.
To qualify for such a procedure patients must undergo a physical evaluation, live within an hour’s drive of either hospital, and have an income within the federal poverty line (ranging around $11,600 – $23,300 for an individual). These operations are offered through the Operation Walk USA organization, which provides hundreds of free hip and knee replacements per year for patients across the country. More information on this organization can be found here.
This is welcome news after recent reports that more than 115,000 people
could lose their health insurance due to unresolved data issues relating
to immigration and citizenship. Making matters worse, another 363,000
people may see their coverage costs change because of, again, data problems
with income and federal subsidies. This affects people who applied for
medical coverage after immigrating to the U.S., and those who have an
income that makes them eligible to receive federal subsidies.
Although these discrepancies are still being resolved, federal officials cannot guarantee that Americans will not experience complications with their medical coverage in the near future. They urged those with unresolved issues to address them before September 30, and that those with immigration or citizenship issues could qualify for a special enrollment period.
Our medical device recall lawyers are here to help anyone suffering serious complications from defective or recalled medical equipment. If you have any questions about the issues raised in this article or about the DePuy devices being recalled, contact our firm immediately. We provide free legal consultations to concerned patients and their families nationwide.