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Articles Posted in Medical Devices

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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…

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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…

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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,…

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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,…

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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.…

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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…

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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…

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Federal Appellate Court Upholds Judgment in Favor of Boston Scientific in Pelvic Mesh Lawsuit

Photo Credit: vchal / Shutterstock.com Earlier this week, a federal appellate court upheld a jury verdict in favor of Boston Scientific in a lawsuit regarding its Uphold brand pelvic mesh product. In the lawsuit, the plaintiff alleged that she suffered injuries after a surgical procedure involving Uphold mesh that took…

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JPML to Hear Argument on Forming MDL for J&J Physiomesh Product

Photo Credit: aerogondo2 / Shutterstock.com This month, the Judicial Panel on Multidistrict Litigation (JPML) will hear arguments regarding whether to consolidate the numerous pending cases against Ethicon, a subsidiary of Johnson & Johnson, regarding its physiomesh products. The JPML is the body responsible for overseeing multi-district litigation (MDL), which is…

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Jury Returns $20 Million Verdict Against Johnson & Johnson in Ethicon Pelvic Mesh Bellwether Case

A Pennsylvania jury recently returned a $20 million verdict against major household product and medical device maker Johnson & Johnson in a lawsuit regarding its pelvic mesh products. The lawsuit is part of the ongoing pelvic mesh multi-district litigation (MDL), and it constituted the third bellwether trial to proceed. According…