Category Archives: Medtronic Infuse

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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Retailers Accused of Selling Fraudulent Herbal Supplements

Major Retailers Accused of Selling Fraudulent Herbal Supplements

The NYS attorney general’s office has accused four national retailers of selling fraudulent dietary supplements.

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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InFuse® Bone Graft No Better than Traditional Graft, Review Finds

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An independent, dual review, found that Medtronic’s InFuse® product provided limited benefits. The bone graft product was also found to cause potential harm, including a small increased risk of cancer and works no better than traditional bone grafts, according to … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

Yale’s Infuse® Bone Graft Study Expected in June

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A Yale University report concerning the bone graft product Infuse® is expected out next month. Device maker, Medtronic, commissioned Yale University researchers to conduct independent studies of its Infuse® bone graft products, allegedly in response to a June 2011 report … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse, Medtronic Infuse |

Yale’s Medtronic Reporting Expected Next Month

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As the fallout from a conflict-of-interest scandal continues, drug maker Medtronic, announced in its fiscal fourth-quarter earnings report that the results from a long-awaited Yale review are expected to be published next month. Medtronic has been the focus of a … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse, Medtronic Infuse |

Infuse® Maker, Medtronic, Cutting Staff

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Device maker, Medtronic Inc., just announced another scheduled staff cut. We recently wrote that Medtronic was laying off about 4 percent of its spinal business workforce worldwide, which amounted to about 230 of it spinal division’s 5,600 employees, This is … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse, Medtronic Defibrillators, Medtronic Infuse |

Medtronic Cutting Spinal Business Workforce

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Device maker, Medtronic Inc., is laying off about 4 percent of its spinal business workforce worldwide. The layoffs amount to about 230 of it spinal division’s 5,600 employees, said Twin Cities Business, according to Mass Device.com. As layoffs are being … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse, Medtronic Infuse |

Expert: Spinal Fusion Surgery Linked with Increased Risks of Cancer

As spinal fusion surgery continues to be associated with controversy, probes, and patient injuries, a recent North American Spine Society (NASS) annual meeting discussed cancer links to products such as Medtronic’s InFuse®. Synthetic, or genetically engineered, recombinant human Bone Morphogenetic … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

Medtronic INFUSE® Linked to Biased Studies, Emerging Injuries

Synthetic recombinant human Bone Morphogenetic Protein (rhBMP-2), manufactured by Medtronic under the brand INFUSE®, remains at the center of controversy following a government report and reports of new injuries associated with off-label use of the medical device. Late last year, … Continue reading

Posted in Defective Medical Devices, Medtonic Infuse, Medtronic Infuse |

Medtronic’s Infuse® Research Called Into Question

Medtronic has been at the center of a conflict-of-interest scandal following release of a government report that revealed that none of some 13 Medtronic-funded clinical trials reported Infuse® side effects. This, despite that data provided to federal regulators revealed that … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

Medtronic Profits Plummet Amid Infuse® Troubles

The legal costs involved with its Infuse® bone growth product have led to a profit fall for Medtronic. As we’ve explained, Medtronic Infuse®—approved by the U.S. Food & Drug Administration (FDA) in 2002 to stimulate spine growth in patients suffering … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse |

INFUSE controversy causing continual decline in Medtronic’s market share

As more negativity surrounds the Medtronic INFUSE bone growth product, the company’s market share and stock value continue to decline. According to a report from Trefis.com, a stock analysis service, the recent U.S. Senate findings that Medtronic manipulated purportedly scientific … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse | Tagged , |

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