Report a Defective Medical Device

FDA Approves New Obesity Device

In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It’s the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes.
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New Hope For Hip Implant Patients?

1 in 10 hip replacement surgeries fail, forcing the patient to undergo risky revision surgery. If the hip implant fails, it usually infects the bone. In the subsequent osteotomy, the doctor must remove both the defective implant and the infected bone. That bone loss makes the revision surgery a very low-percentage gamble, because there is not enough remaining healthy bone to anchor a second implant.
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New da Vinci Surgical Robot to Hit Market in 2015

Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan.
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FDA Issues Largest-Ever Medical Product Recall in 2014

The U.S. Food and Drug Administration (FDA) issued its largest recall of medical products ever in 2014, according to the Regulatory Affairs Professional Society (RAPS). The recall, posted to the FDA’s website in August, was of 233 Class I products manufactured by Puerto Rico-based Customed.
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Dangers of FDA 501(k) Classification

When new products or medical devices are considered for approval for the consumer market, manufacturers must first undergo a rigorous system to have the device approved. The U.S. Food and Drug Administration (FDA) divides approved medical devices into three categories: Class I, II, and III. Class I devices are not subject to as much regulatory control as Class III—Class III devices are usually those which carry a greater risk to the patient or consumer.
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Jury Awards $3.27 Million in Transvaginal Mesh Suit

Surgical mesh was developed in the mid-20th century as a way to treat hernias. The implant was originally intended to be placed beneath the skin to patch the hole in the abdomen and block intestines and other tissues from protruding, according to the U.S. Food and Drug Administration. It can be made from either biological or synthetic materials.
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Senators Call for Recall of Power Morcellators

In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).
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FDA Warnings Issued to Autism Therapy Companies

Official warnings have been handed out to several companies advertising autism therapies and cures. Five total treatments were flagged in the statement from the FDA, which was announced during Autism Awareness Month. While some of the therapies are noted as useful medical therapies, there have not been scientific studies that show a connection to autism improvement.
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL
  • Lawyer.com