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malfunctions 9 articles

Public access defibrillator recalled due to power/battery defect

Another public access cardiac defibrillator model is being recalled by the manufacturer due to a defect that could delay or prevent treatment to a patient during a cardiac event. The recall comes six months after the Food and Drug Administration (FDA) proposed more oversight for makers of emergency external defibrillators due to dozens of recalls of the devices and about 45,000 reports of device failures in the past seven years. Automated external defibrillators (AEDs) are life-saving devices that send a jolt of electric current to the heart of individuals who are unconscious and suffering from cardiac arrest. The jolt is ... Read More

Transvaginal mesh may cause or worsen autoimmune diseases

Transvaginal mesh (TVT) used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence has been associated with serious risks including mesh erosion, infections, and chronic pain. But the device may also leech dangerous toxins into the body causing or exacerbating autoimmune diseases, according to research compiled by TVT-NO!, a foundation for survivors of transvaginal mesh. “It has been noted (that) many women have been diagnosed with autoimmune diseases such as Lupus and Fibromyalgia after the insertion of TVT mesh,” the foundation warns on its website. Transvaginal mesh is a type of surgical mesh that ... Read More

New iPhone, iPad app helps people manage their urinary incontinence

Urinary incontinence is a medical disorder that many women keep to themselves until symptoms become so bothersome they eventually talk to their doctors. Now, a newly released iPhone and iPad app can help millions of people discretely manage their urinary incontinence. The free iDry app provides users with tools to help urinary incontinence sufferers manage their condition. It also provides valuable information to physicians to enhance treatment, and gives urology researchers a comprehensive database of urinary incontinence activity, interventions and results. Developed by Jeff Pepper, founder of Three Ten LLC, iDry helps people overcome urinary incontinence by easily logging events, ... Read More

Man sues maker of surgical mesh

A Texas man is suing the manufacturer of the surgical mesh used to repair his hernia, alleging the device was defective and caused infections. The lawsuit was filed against C.R. Bard, maker of surgical mesh and other medical devices. The man claims that shortly after surgery his pain became worse and his surgical site became infected. He underwent a second surgery, where surgeons found that the problem stemmed from the mesh dislodging and eroding. Surgical mesh is a woven fabric used for chest wall reconstruction, strengthening tissues, providing for support for internal organs, and treating surgical or traumatic wounds. The fabric ... Read More

Transvaginal mesh prevents urinary incontinence, but may lead to serious side effects

Surgical mesh devices implanted during surgery for pelvic organ prolapse repair reduce the risk of patients suffering urinary incontinence after surgery, according to a new study. But researchers urge women to use caution as the likelihood for serious adverse events is higher in women receiving the sling than in women who were treated with superficial incisions. “We should avoid using them with all patients undergoing a procedure for pelvic organ prolapse,” said study co-author Kimberly Kenton, Loyola University Health System. The study showed that while the mesh helped prevent urine leakage, women who received the mesh were significantly more likely ... Read More

Feds approve new tracking process for medical devices

Medical devices will now be manufactured with a code that will help them be tracked in order to gauge safety issues and notify recipients in the event of a recall as part of a new rule passed this week by federal regulators. The new process assigns a unique device identifier, or UDI, to each device, which provides basic information such as manufacturer name, type of device, model, and expiration date. Some devices may include batch lot numbers to help identify devices in the event of a recall. UDI information will be stored in a database that is accessible to the public; ... Read More

J&J sold transvaginal mesh product against FDA’s orders

Johnson & Johnson continued to sell its transvaginal mesh product for nine months after the Food and Drug Administration (FDA) told the company to stop marketing the controversial device, court records show. This discovery could lead to higher awards in the more than 1,400 lawsuits filed against Johnson & Johnson’s Ethicon unit by women who say the mesh caused organ perforation, pain, scarring and nerve damage. In a letter dated August 24, 2007, the FDA told Johnson & Johnson to stop sales of Gynecare Prolift until the agency could determine whether the device was “substantially equivalent” to other transvaginal mesh ... Read More

Defibrillator recall reinforces need for tougher quality standards

A nationwide recall is underway for a type of automated external defibrillator (AED) manufactured by Cardiac Science. The device, designed to resuscitate patients who are in cardiac arrest, has a defect that may cause it not to deliver adequate defibrillator therapy, which could lead to serious injury or death. This recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products may cause serious adverse health consequences or death. AEDs by various manufacturers have been plagued by defects over the years, ... Read More

Transvaginal mesh makers ordered to conduct safety studies

The Food and Drug Administration (FDA) has ordered manufacturers of surgical mesh used to treat pelvic floor disorders to conduct three years of trials to determine just how dangerous their devices are and whether they provide any benefit over older methods of treatment. The order comes just months after the FDA began a safety review on the mesh after discovering a five-fold jump in deaths, injuries and malfunctions associated with the devices. Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used ... Read More