The Medtronic INFUSE Bone Graft uses a genetically engineered protein to help fuse damaged vertebrae and was deemed “revolutionary” when launched in 2002. The bone graft offered doctors an alternative to more traditional forms of treatment for patients suffering from degenerative disc disease, but the medical device was (and is) only approved for use in the lower back region. Allegedly, this did not stop Medtronic from marketing the INFUSE Bone Graft as a form of treatment for injuries of the cervical spine (neck region). It is important to note that it is illegal for a medical device manufacturer to market a product for purposes other than approved by the U.S. Food and Drug Administration (FDA). Complications Associated with Off-label Use of the Medtronic INFUSE Bone Graft In 2008, the FDA warned physicians of the dangers associated with the “off-label” use of the INFUSE Bone Graft. (The term “off-label” is commonly used to describe the use of a drug or medical device for purposes other than approved by the FDA.) The FDA warned physicians that use of the bone graft in the cervical spine could cause life threatening complications, including compression of the airway and neurological structures of the neck, severe dysphagia (difficult swallowing), and swelling of the neck, throat, mouth, and shoulders. If not treated promptly, these complications could result in the death of [...] Read more »
The Wall Street Journal reported today that problems with the recalled heart defibrillator leads were known about for as much as five years before they were recalled. The recall of faulty St. Jude cardiac defibrillator leads was sparked by a warning letter issued to doctors in December 2010. Reportedly many physicians reported problems with the device years earlier, including the director of Johns Hopkins Medicine’s arrhythmia service, and the chief of electrophysiology at the University of Pittsburgh Medical Center. These doctors said they had encountered the so-called “inside-out” abrasion with their own patients between 2006 and 2009. These malfunctions were reported to St. Jude and company officials told them the incidents were isolated. St. Jude spokeswoman Amy Jo Meyer says the company as communicated “proactively” with doctors and the FDA. Following the 2010 warning, the FDA issued a second, November 2011 recall, citing insulation problems, including inside-out abrasion and externalized conductors. Individuals who have experienced electrical malfunction with a St. Jude heart device may be entitled to compensation for their medical care expenses, lost earnings, pain and suffering, and other damages. For more information, visit: http://www.dangerousproductslawyer.com/defective-st-jude-defibrillator-leads.
On September 19, 2012, Zimmer Holdings Inc. received a warning letter from the U.S. Food and Drug Administration (FDA) after inspection of its Puerto Rico plant raised concerns over the manufacturing of certain hip implants. In the letter sent to Zimmer, the FDA noted testing and manufacturing issues specifically related to the company’s manufacturing of Trilogy Acetabular Hip System, which has been sold in the United States since 2003. The FDA’s letter states that Zimmer has not implemented a testing mechanism to show that its products have met design specifications. The letter also states that the company has not validated the effect of manufacturing operations on Trilogy Acetabular Hip System products that utilize metallic spikes. Metallic spikes are used to connect the hip replacement device to the patient’s bone when cement and screws cannot be used. The medical device maker said it is notifying consumers of the manufacturing issue and has suspended release of the spiked hip device products until the effect of manufacturing operations can be validated. The FDA requires all drug and medical device manufacturers to take certain steps to ensure a product’s design and manufacturing quality. Estey Bomberger – More than 70 Years Experience Helping the Injured If you or someone you know has experienced complications as a result of receiving a Trilogy Acetabular Hip System, you would be well advised [...] Read more »
Individuals who have experienced a serious complication after receiving a Medtronic INFUSE Bone Graft must not wait to seek the legal counsel of a dangerous product attorney at the law firm of Estey Bomberger. We have more than 70 years collective experience representing individuals harmed by a defective or dangerous product and can help victims injured by the INFUSE Bone Graft. Waiting to contact one of our trusted attorneys could result in the denial of a claim and therefore, result in the victim being denied the chance to obtain compensation for injury-related damages. We are currently reviewing claims involving Medtronic Bone Graft injuries, so please call our firm as soon as possible. We will quickly review your case to determine your eligibility to file a personal injury claim. INFUSE Bone Graft Overview In 2002, the U.S. Food and Drug Administration (FDA) approved the INFUSE Bone Graft for the treatment of degenerative disc disease in the lumbar (lower back) spine. However, the INFUSE Bone Graft has not solely been used in the lumbar spine. The bone graft has also been used to treat injuries and diseases of the cervical spine (the FDA has not approved the medical device for use in the cervical spine). The use of the INFUSE Bone Graft in cervical spine procedures is commonly referred to as “off-label” use. Off-label use is the [...] Read more »
According to the news release posted on Thursday, the FDA has recommended all patients with a St. Jude Medical heart defibrillator to undergo X-ray or other imaging tests to check the defibrillator leads for any abnormalities in the insulation. Due to the high number of lead failure, St. Jude Medical had stopped the selling of Riata devices in 2010 and recalled the products in November of last year. However, at the time of the recall, St. Jude estimated that about 79,000 units of potentially defective devices remained implanted in patients whose lives depend on their heart defibrillators. If you or a loved one has suffered heart complications due to a defective St. Jude Riata or Riata ST defibrillator, it is strongly recommended to seek legal advice from an experienced defective medical device injury lawyer. Defective Defibrillator Leads Riata and Riata ST are implantable heart defibrillators that monitor the patient’s heart rhythm and delivers electrical shocks to correct any abnormalities that could lead to a potentially life-threatening condition. The electrical shocks are administered through the defibrillator leads, which are insulated metal wiring that projects from the defibrillator and connects to the heart. Patients rely on these devices to ensure their hearts are beating normally. But when the lead wiring breaks through the insulation, electrical problems that affect the performance of the device can develop. Studies found [...] Read more »
Over 10 million Americans have osteoporosis, a condition characterized by the loss of bone mass, resulting in spongy or porous bones. Synthes, a medical device manufacturer developed a bone cement called Norian, used to fill the cavities formed in serious osteoporosis patients. Although the product Norian XR was FDA approved in December 19, 2002 for use in the arms, legs, skull, and pelvis, the approval came with the following warning: “not intended for treatment of vertebral compression fractures.” Serious Health Risk One of the primary concerns about using Norian XR bone cement in the vertebrae was because calcium phosphate, a component in the device, had a tendency to form blood clots. Because a major vein runs through the spine, carrying blood from the lower body, back to the heart, the potential for the blood clot to reach the heart and lungs posed as a serious health risk. However, the Norian XR was the only device to receive an FDA warning against spinal use, which caused the company to aggressively urge the federal agency to remove the warning label. Meanwhile, Synthes executives carried out illegal testing in spinal fusion patients. Persuading Surgeons A clinical trial would have cost the company approximately $1 million. Instead of following protocol, the company began to market the Norian bone cement for use in spinal procedures not approved by the FDA. [...] Read more »
According to the recall issued on July 6th, the Rejuvenate modular neck and ABG II implants can potentially cause premature implant failure, metallosis, and other complications related to fretting and corrosion at the modular neck junction. The metal neck stems used in Stryker total hip replacements have been found to release metallic debris and ions which can cause: Premature implant failure Metallosis Development of pseudotumors Tissue necrosis Osteolysis Stryker has pulled the devices from the global market after post-market surveillance indicated that the Rejuvenate and ABG II modular necks were prone to fretting and corrosion, a defect that can cause serious harm to patients. Identifying Metal Related Complications Any persistent problems related to a hip replacement should be reported to your orthopedic surgeon as soon as possible. Because metallic debris can cause severe tissue and bone damage in the area near the implant, it is important to identify any problems early on; otherwise, extensive amounts of bone excision may become necessary in the future. Patients who experience the following symptoms are advised to seek medical attention immediately: Hip pain Swelling at the joint site Clicking or popping noises from the hip implant Joint dislocation Metal Hip Devices The Stryker Rejuvenate and ABG II devices are not metal-on-metal hip implants. However, the Stryker systems feature a metal-on-metal component that is the primary [...] Read more »
On Monday morning, a couple from Bakersfield won the first transvaginal mesh injury lawsuit against medical device manufacturer, C.R. Bard. The plaintiff Christine Scott was awarded a $5.5 million verdict in a lawsuit alleging Bard Medical had marketed and sold a device they had known to be unsafe. The Avaulta mesh Christine had received to treat her urinary incontinence caused her serious pain as her colon tissue continued to grow through the tiny holes of the device. By the time Christine considered a lawsuit, she had already undergone eight revision surgeries, but continues to suffer from complications and may still require additional surgeries in the future. Recalling Transvaginal Mesh Devices Although C.R. Bard had discontinued its sale of the Avaulta mesh earlier this month on July 1, 2012, the company continues to sell its dangerous device in other countries. In addition, there is several other transvaginal mesh devices remain on the market. Manufactured by other medical device companies that pose the same risks as the Avaulta mesh implant, such as: Mesh erosion Mesh contraction Neuro-muscular problems Vaginal scarring Vaginal wall shrinkage Pain during sex FDA Review of Transvaginal Mesh Devices Last year, the FDA issued a notice, informing patients and healthcare providers of the potential risk for serious complication related to transvaginal mesh devices. In its review, the FDA concluded that surgeries performed [...] Read more »
The EnVe Ventilators by CareFusion has been recalled due to a problem that can cause intermittent or continuous change in the Positive End Expiratory Pressure (PEEP) setting of the machine. It is important for the patient using mechanical ventilation to maintain a certain level of PEEP to prevent risks associated with end-expiratory alveolar collapse. In some cases, a leak can occur in the patient breathing circuit during the use of the EnVe Ventilator, causing there to be a decreased PEEP. However, such leaks will trigger visual and audible alarms to alert the healthcare professional of the changes in ventilation. Preventing Respiratory Failure When a medical condition or injury causes inadequate spontaneous ventilation, a mechanical ventilation such as the EnVe Ventilator is used to help support the patient’s respiratory system. Such devices provide assistance for breathing until the patient’s underlying condition is corrected or resolved over time. CareFusion advises healthcare professionals to constantly monitor patients dependent on mechanical ventilation, so that in the event of a malfunction, patients can continue to receive ventilation support through alternative means. According to the FDA notice, the firm has not received any reports in association with the devices. More information regarding the Enve Ventilatory recall can be found on the CareFusion website.
The Aestiva/5 7900 is a ventilator manufactured by GE Healthcare, and has been on the market since July 2, 2010. The company recently became of the dangerous potential for the two vaporizers in the device to operate simultaneously. In cases where both the vaporizers are administering the same agent, patients can be at risk of an overdose. The simultaneous function of the vaporizers can also be dangerous by delivering an unsafe combination of drugs. Because of the serious risks posed by the device, the FDA labeled the GE ventilator recall has been marked with a class I status, meaning there is reasonable chance for patients to suffer serious or fatal complications related to the use of the recalled device. The serial numbers of the devices affected by the recall include: AMRP01031, AMRP00966, AMRP01030, AMRP00968, AMRP00967, AMRP01033, AMRP00970, AMRP00969. Overdose of Anesthesia Ventilators are used to mechanically deliver air into patients who is physically unable to breathe. The Aestiva/5 7900 was a ventilation device used in surgery to deliver anesthesia to the patient as well as monitoring the patient’s respiratory system. And while the patient’s vitals are monitored during a surgery, it is possible for serious levels of overdose to occur and for patients to suffer serious side effects as a result. According to the recall notice, the defects related to the Aestiva/5 7900 ventilators can [...] Read more »