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FDA Cautions Against Unapproved Tools for Diagnosing Head Injuries


Earlier this month, the U.S. Food and Drug Administration (FDA) warned against using unapproved devices to diagnose concussions and other types of head injuries. In a press release issued on April 10, the FDA cautioned against smartphone and tablet-based applications marketed to coaches, parents, and trainers used to assess changes in brain function. They claim » Read More

2018 Medical Device Recalls


The U.S. Food and Drug Administration (FDA) recently released its list of recalled medical products for 2018. When malfunctioning and dangerous medical products are used by consumers, permanent disabilities can occur. The complete list of recalled medical devices is posted online in the FDA’s Medical Device Recall Database. Some commonly used medical devices that were » Read More

Illnesses Due to Breast Implants


Millions of women worldwide have breast implants for cosmetic reasons and undergo this procedure for surgical reconstruction following mastectomies. Yet, the Food and Drug Administration (FDA) issued a stark new warning to two implant manufacturers as part of a larger federal review of the safety and long-term effects of medical devices. Women have alleged for » Read More

FDA Regulatory Requirement Changes


Implanted medical devices can save lives or restore mobility, but many of them have proven to have unforeseen consequences long after implantation. While medications must go through a human testing process prior to approval by the U.S. Food and Drug Administration (FDA), that is not the case with many medical devices. Currently, manufacturers going through » Read More

FDA Medical Device Approval Change Coming


Over the past decade, approximately 83,000 Americans have died due to defective medical devices. That shocking number is a major reason behind the Food and Drug Administration’s (FDA) decision to change its medical device approval process. The overhaul is necessary, as the current approval process dates back more than 40 years – eons ago, in » Read More

Cordis IVC Filter Lawsuit


In early December of 2018, twenty-seven people filed a lawsuit against the Cordis Corporation, the manufacturers of the OptEase® Vena Cava Filter, also known as an IVC filter. The plaintiffs allege that these defective IVC filters have resulted in life-threatening blood clots and other serious injuries. Because of the nature of the filter, some of » Read More

Robotic Surgeons


There is room for human error in everything that we do. Despite the years of training that doctors endure, they, too, experience the reality of what it means to be human. And though they work long hours, they cannot be everywhere. For patients far away, and to help minimize the risk of human error, physicians » Read More

Essure Birth Control Sales End


The controversial Essure birth control device will no longer be marketed in the United States. Pharmaceutical giant Bayer recently announced it will no longer sell the device, as of December 31, 2018. This effectively ends all sales, since Essure is no longer available in other countries. The device, made from flexible coils, is designed to » Read More

Essure Complications and Medical Device Lawsuits


In 2002, the Federal Food and Drug Administration (FDA) approved Essure. Essure was designed as a medical device to prevent pregnancies in women. Women are inserted with two of the devices, which resemble a coil, one in each fallopian tube, to assist the body in creating a natural blockage in the tubes in order to » Read More

Attune Knee Replacement Failures


Individuals suffering from chronic knee pain and immobility have turned to artificial knee replacements to regain an active lifestyle. Artificial knee replacement surgery can help a patient increase the range of motion in their knees and regain the use of their muscles and ligaments. DePuy Synthes’s Attune Knee Replacement System, a Johnson & Johnson product » Read More

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