Bard PowerPort devices have been linked to serious injuries and deaths. As of May 2024, the Bard PowerPort Multidistrict Litigation (MDL) has increased by 189 cases. These lawsuits are consolidated in MDL 3081, or In re: Bard Implanted Port Catheter Products Liability Litigation before Judge G. Campbell. These lawsuits request…
Articles Posted in Medical Devices
ResMed Notified Consumers About Potential Danger of Masks With Magnets
Manufacturer ResMed makes CPAP masks that contain magnets. These masks have varying coverage of a patient’s face. Recently, the company gave consumers updated instructions for using the masks and held a voluntary global field action to update its guide for these masks. The notification warned consumers of a potential magnetic…
The FDA Informs Providers About Labeling Updates
Surgical mesh products are used to repair and reinforce soft tissue in patients where the tissue has some weakness. In particular, mesh is used to help reinforce the hernia. However, doctors have increasingly been using surgical mesh products, even though the safety and effectiveness in breast surgery hasn’t yet been…
FDA Warns of Serious If Rare Drug Reactions to Certain Antiseizure Medicines
Certain antiseizure medications involve serious risk of drug reactions. One of these is levetiracetam, which has been FDA approved for 24 years, and is used both by itself and with other medications to control seizures. It’s sold under the brand names Keppra, KeppraXR, Spritam, and Elepsia XR. It is also…
The FDA Issued a Safety Communication About the Synovo Total Hip Resurfacing System
Doctors sometimes perform total hip arthroplasty or total hip replacement using the Synovo Total Hip System, which features resurfacing implants. The United States Food and Drug Administration (FDA) has recommended that health care providers not use Synovo Total Hip Resurfacing System. While it’s also advised that the hip systems be…
Baxter Issues Urgent Medical Device Correction for Novum IQ Syringe Infusion Pump
Recently, Baxter International, Inc. announced that its Novum IQ syringe infusion has the potential to provide an incomplete infusion. It issued an Urgent Medical Device Correction for the product. The company is developing a software upgrade to fix the problem. There have been no serious injuries reported so far. However,…
FDA Issues Warning of Rare but Serious Drug Reaction to the Antiseizure Medicines
The United States Food and Drug Administration (FDA) recently warned consumers that certain antiseizure medications can cause a rare but serious response called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). When not diagnosed and treated rapidly, these can prove fatal. The affected seizure medications are levetiracetam (Keppra, Keppra XR,…
Lawsuits Filed in Connection with CoolSculpting Procedure
CoolSculpting is a brand name for an FDA-approved fat reduction procedure, cryolipolysis, in which the more stubborn fat deposits on a patient’s body—love handles—are frozen, for purposes of getting rid of them. Skin freezes at a lower temperature than fat, and the CoolSculpting device works by taking advantage of that.…
Volara System Recalled
A broad range of chronic conditions are treated with the Volara System, which provides continuous positive expiratory pressure (CPEP) to expand your lungs and airways, along with continuous high-frequency oscillation pulses to free mucus plugs and make it easier to cough and breathe less effortfully. However, if you use the…
Protecting Against the Risks Associated with Breast Implant Surgery
Photo Credit: nimon / Shutterstock.com Breast augmentation, or augmentation mammoplasty, has been the most common elective cosmetic surgery in the United States for over a decade. Last year alone, there were over 300,000 breast augmentation surgeries performed across the United States. This figure represents a 3% increase from the year…