![]() ![]() No such protocol was implemented for patients under age 18. For these products, manufacturers are required to submit clinical data to show that they are safe and effective. Medtronic Infuse and other similar products are classified as high-risk (Class III) medical devices. “Any product that affects bone growth could have the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates.” the alert states. According to the safety alert, however, these issues are even more pressing in patients under age 18 because they tend to be smaller and their bones are not done growing. The product is already controversial in adults, with similar adverse events reported. The FDA never approved Medtronic Infuse for patients under the age of 18. This type of bone graft is meant as an alternative to autograph bone, where bone is harvested from another part of the patient’s body, and allograft where bone is transplanted from another individual. The agency said it was aware of reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing and swelling, linked to using the bone graft substitutes in patients under the age of 18.īone graft substitutes containing recombinant proteins or synthetic peptides such as Medtronic Infuse are used to promote bone growth in patients with a bone defect. Food and Drug Administration (FDA) warned that bone graft substitutes containing recombinant proteins or synthetic peptides, such as Medtronic Infuse, should not be used in patients younger than 18. Medtronic Infuse Bone Graft substitutes containing recombinant proteins or synthetic peptides In a safety alert issued Jan. Pennsylvania Sexual Abuse Lawsuit Lawyers.Clergy Sexual Abuse Lawyers | Priest Abuse Attorneys.Hypoxic Ischemic Encephalopathy Lawsuits.Stevens Johnson Syndrome (SJS) Disease Injury Lawyers.Cerebral Palsy Malpractice Injury Lawsuits.Bicycle, Scooter, and Electric Bike Accidents.If you or a loved one has suffered injury because of Medtronic Infuse treatment, contact us online or call 61 to schedule a free initial consultation. We work quickly to help our clients get justice. The sooner you speak to a lawyer who understands defective medical device claims, the better off you will be. You only have a limited time in which to file a lawsuit if you have been harmed by an Infuse bone graft. So far, Medtronic’s Infuse has been the subject of more than 700 lawsuits, with many more expected in the near future. Some question whether Infuse bone treatments offer any benefits over traditional treatments that do not carry the same risk of side effects. ![]() Medtronic has been accused of paying off researchers for favorable results, as well as violating rules about how medical products can be marketed. The concerns over the Infuse product have been compounded by allegations of falsified research and conflicts of interest. If you were treated with Infuse and suffered side effects such as cancer, male sterility, unwanted bone growth or chronic pain, we can help you. We are committed to holding the makers of dangerous products accountable for the harm they do to consumers. Off-label uses, meaning uses not approved by the FDA, make up the vast majority of the market for Infuse.Īt The Gori Law Firm, our dedicated attorneys protect the victims of harmful drugs and defective medical devices. Of the many patients who have received the treatment, only a small percentage actually had that procedure done. Infuse is a genetically engineered protein that has been approved by the FDA for use on patients who are undergoing an anterior lumbar fusion. Infuse is a product made by Medtronic that is intended to encourage bone growth at the site of a spinal surgery. More than 1 million people have had Infuse implanted in their spines, worldwide. Helping The Victims Of Medtronic Infuse Treatment ![]()
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