The recent FDA recall of the Obsidio Conformable Embolic device has sent shockwaves through the medical community, as it has been linked to a heightened risk of bowel ischemia during lower gastrointestinal (GI) bleeds. This Class I recall, the most severe classification, comes in response to two tragic deaths associated with the use of the device.
Manufactured by Boston Scientific, the Obsidio Conformable Embolic device has been under scrutiny after investigations revealed a significant risk of bowel ischemia when the premixed embolic agent is delivered via the aliquot technique, a commonly employed method for embolization procedures aimed at controlling bleeding in the lower GI tract.
The recall affects a total of 1,594 devices in the United States, marking it as a corrective action rather than a complete product removal. The FDA emphasized the severity of the issue, stating that the most serious consequence of using this product with the aliquot technique is the need for major surgery, such as bowel resection or diverting colostomy, to address complications like ischemia or non-target embolization.
Boston Scientific swiftly responded to the recall by issuing an urgent advisory to its customers, advising against the use of the aliquot technique with the Obsidio Embolic device for lower GI bleed embolization procedures. The company urged healthcare providers to prominently display this warning near the product to ensure patient safety.
Reports of adverse events linked to the bowel ischemia issue have surfaced, with 11 incidents documented so far, including seven injuries and two fatalities. The seriousness of these incidents underscores the urgent need for action to prevent further harm to patients undergoing embolization procedures.
Victims of injuries caused by the Obsidio Embolic device face severe health consequences, including bowel ischemia, prolonged hospitalization, and the need for major surgeries such as bowel resection or diverting colostomy. These injuries can have devastating effects on patients’ lives, leading to physical pain, emotional distress, and financial strain. In some cases, the injuries may result in permanent disability or even death.
If you or your family have been affected by the recalled Obsidio Embolic device, whether through harm to individuals or the loss of loved ones, you may consider pursuing financial compensation for your damages through a product liability lawsuit. Product liability laws hold manufacturers accountable for injuries caused by defective or dangerous products, such as medical devices. Victims may allege negligence on the part of the manufacturer, Boston Scientific, for failing to adequately warn about the risks associated with the device or for designing a product with known defects.
The lawsuit process typically begins with gathering evidence to support the victim’s claims, including medical records, expert testimony, and documentation of the device’s defects. Victims must file a complaint against the manufacturer, initiating the legal proceedings. Throughout the litigation process, victims may engage in negotiations with the manufacturer’s legal team to reach a settlement agreement. If a settlement cannot be reached, the case may proceed to trial, where a jury will determine the outcome.
Navigating the complexities of a product liability lawsuit requires legal expertise and experience. Our attorneys have tremendous experience in product liability cases can provide invaluable guidance and advocacy for victims at each stage of the process. Our legal professionals have the knowledge and resources to investigate the case, assess the damages suffered by the victim, and build a strong legal strategy to pursue maximum compensation.
In a successful product liability lawsuit concerning the Obsidio Embolic device, victims may be entitled to various types of damages, including compensation for medical expenses, lost wages, pain and suffering, and diminished quality of life. Additionally, in cases involving severe injuries or wrongful death, punitive damages may be awarded to punish the manufacturer for its negligent actions and deter similar conduct in the future.
Victims of injuries caused by the Obsidio Embolic device should seek legal representation to protect their rights and pursue justice and compensation for their damages. By partnering with Parker Waichman LLP, victims can navigate the legal process with confidence and increase their chances of securing a favorable outcome in their injury or wrongful death case.
If you or a loved one has been harmed by the Obsidio Embolic device, don’t hesitate to contact Parker Waichman LLP for legal advice. Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you. Parker Waichman LLP, a national product injury law firm, is ready to discuss your case. For your free consultation, simply call 1-800-YOUR-LAWYER (1-800-968-7529). Our dedicated team of product liability attorneys is ready to advocate for your rights and help you pursue justice and compensation for your injuries.
