Author Archives: Mara Lepmanis

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent

Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer. This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions

Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...

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Aggressive Drivers and Road Rage Pose a Threat to NY Drivers

Many individuals in New York and across the country experience anger and impatience when driving through traffic. People get frustrated when they are late to a meeting or an appointment and traffic has come to a standstill. As many as … Continue reading

Posted in Accident, Motor Vehicles |

Slap Bracelets Recalled due to Laceration Hazard

On September 7, the Consumer Product Safety Commission (CPSC) published a recall regarding bracelets sold with storybooks due to a potential laceration hazard. Studio Fun International recalled approximately 86,000 slap bracelets that were sold in the United States and in … Continue reading

Posted in Children's Toys, Health Concerns, Product Recalls |

Faulty St. Jude Riata Defibrillators may have Fatal Consequences

Patients who still have recalled St. Jude Defibrillators leads in their chests have many reasons to be vigilant. Premature insulation failure in the recalled device has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that leads to … Continue reading

Posted in Defective Medical Devices, Health Concerns, Product Recalls, Recalled Medical Devices, St. Jude Defibrillators |

2018 Chevrolet Equinox, GMC Terrain, GMC Acadia Recalled

Approximately 2,900 vehicles of the model-year 2018 Chevrolet Equinox, 2018 GMC Terrain SUVs, and 2017-1018 GMC Acadia SUVs have been recalled, according to the Daily Hornet. The problem is that the right front intermediate driveshaft may fracture. If the driveshaft … Continue reading

Posted in Defective Products, Health Concerns, Legal News, Product Recalls, Recalled Vehicles |

Samsung Galaxy Note 4 Recall due to Potentially Hazardous Batteries

The most recent unfortunate news for Samsung’s beleaguered line of Galaxy Note smartphones is that over 10,000 refurbished batteries for the Note 4, a three-year-old phone, are being recalled due to a risk of overheating, with the potential of fires … Continue reading

Posted in Cellular Phone, Defective Products, Product Recalls |

Cook Medical Recalls Medical Device due to Blood Clot Risk

The U.S. Food and Drug Administration (FDA) has identified the Cook Medical Zenith Alpha Thoracic Endovascular Graft as a Class I recall, the most serious type of recall where there is a “reasonable probability that the use of or exposure … Continue reading

Posted in Defective Medical Devices, Defective Products, Health Concerns, Legal News, Product Recalls, Recalled Medical Devices |

Papaya Salmonella Victims Increase to 141 with More Possible

As of August 11, 2017, the Centers for Disease Control (CDC) is reporting that 141 people in nineteen states have confirmed cases of strains of salmonella traced back to papayas imported from Mexico. Victims range in age from 1 to … Continue reading

Posted in E. Coli, Food Poisoning, Food Products, Health Concerns, Listeria, Recalled Food Products, Salmonella |

Increased Risk of Bone Fractures with Invokana and Invokamet XR

Despite a multitude of warnings for a drug taken for treatment of type 2 diabetes, the U.S. Food and Drug Administration (FDA) has expanded indications for Invokamet (canagliflozin and metformin). Invokamet along with Invokana (canagliflozin), carry warnings for adverse reactions … Continue reading

Posted in Health Concerns, Pharmaceuticals |

Endo Agrees to Additional $775M Settlement for a Total of $2.6B

As of August 7, 2017, Endo International has agreed to set aside an additional $775 million to resolve the company’s remaining mesh lawsuits’ allegations related to the Transvaginal Mesh (TVM) Multidistrict (MDL) Litigation pending in the U.S. district Court of … Continue reading

Posted in Defective Medical Devices, Defective Products, Health Concerns, Product Recalls, Recalled Vehicles, Transvaginal mesh |

General Motors Recalls 800,000 Trucks due to Power Steering Defects

Nearly 800,000 pickup trucks are being recalled by General Motors because they may suddenly lose power steering while the truck is being driven, and the sudden steering jolt may cause drivers to lose control of the vehicle, reports Fortune. About … Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls, Recalled Vehicles |

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